bupropion 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anorexics 435 34911-55-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • bupropion
  • (+/-)-Bupropion
  • amfebutamon
  • amfebutamone
  • aplenzin
  • elontril
  • bupropion hydrochloride
  • bupropion hydrobromide
  • bupropion HCl
  • wellbutrin
A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.
  • Molecular weight: 239.74
  • Formula: C13H18ClNO
  • CLOGP: 3.21
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 29.10
  • ALOGS: -3.54
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 312 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 31.28 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma) 0.14 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1985 FDA GLAXOSMITHKLINE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 3631.72 9.93 2909 149109 142764 63194240
Toxicity to various agents 849.43 9.93 1845 150173 245405 63091599
Overdose 478.25 9.93 930 151088 114148 63222856
Intentional overdose 444.24 9.93 704 151314 73448 63263556
Seizure 417.57 9.93 957 151061 131677 63205327
Generalised tonic-clonic seizure 410.99 9.93 423 151595 28593 63308411
Depression 410.04 9.93 1215 150803 195277 63141727
Suicidal ideation 402.32 9.93 613 151405 61808 63275196
Suspected suicide 386.88 9.93 224 151794 6344 63330660
Anxiety 386.42 9.93 1272 150746 216269 63120735
Cardio-respiratory arrest 360.11 9.93 570 151448 59389 63277615
Product substitution issue 299.69 9.93 272 151746 15724 63321280
Serotonin syndrome 287.29 9.93 349 151669 28333 63308671
Temperature regulation disorder 268.49 9.93 173 151845 5959 63331045
Cardiac arrest 254.63 9.93 634 151384 91911 63245093
Electrocardiogram QRS complex prolonged 241.60 9.93 160 151858 5778 63331226
Sleep apnoea syndrome 234.38 9.93 318 151700 28815 63308189
Suicide attempt 233.21 9.93 476 151542 60442 63276562
Sensitisation 227.83 9.93 126 151892 3260 63333744
Agitation 224.12 9.93 463 151555 59294 63277710
Status epilepticus 217.35 9.93 223 151795 15010 63321994
Polycystic ovaries 215.39 9.93 134 151884 4337 63332667
Respiratory arrest 199.60 9.93 313 151705 32332 63304672
Asthma 195.73 9.93 711 151307 126850 63210154
Swelling 184.59 9.93 233 151785 275145 63061859
Food allergy 181.24 9.93 177 151841 11224 63325780
Irritability 180.22 9.93 294 151724 31400 63305604
Ejection fraction 179.86 9.93 96 151922 2310 63334694
Coeliac disease 178.35 9.93 185 151833 12612 63324392
Neutropenia 174.66 9.93 101 151917 174904 63162100
Drug withdrawal syndrome 173.61 9.93 266 151752 26928 63310076
Product odour abnormal 170.19 9.93 76 151942 1220 63335784
Mydriasis 168.71 9.93 174 151844 11782 63325222
Anaemia 160.11 9.93 286 151732 293144 63043860
Pemphigus 157.96 9.93 125 151893 183601 63153403
Arthropathy 154.88 9.93 201 151817 234591 63102413
Immunodeficiency 153.76 9.93 215 151803 20039 63316965
Systemic lupus erythematosus 153.71 9.93 164 151854 208754 63128250
Hyperhidrosis 152.83 9.93 586 151432 107250 63229754
Tremor 147.73 9.93 668 151350 131571 63205433
Febrile neutropenia 141.89 9.93 53 151965 118396 63218608
Acute kidney injury 139.88 9.93 261 151757 263154 63073850
Electrocardiogram QT prolonged 133.38 9.93 378 151640 59152 63277852
Pyrexia 132.37 9.93 628 151390 469850 62867154
Poisoning 131.18 9.93 163 151855 13537 63323467
White blood cell count abnormal 128.55 9.93 112 151906 6130 63330874
Peripheral swelling 127.14 9.93 280 151738 265662 63071342
Psoriasis 125.21 9.93 475 151543 86482 63250522
Glossodynia 124.36 9.93 147 151871 178729 63158275
Sinus tachycardia 120.58 9.93 212 151806 24056 63312948
Thrombocytopenia 117.60 9.93 113 151905 151044 63185960
Helicobacter infection 117.17 9.93 38 151980 92747 63244257
Pancytopenia 116.72 9.93 43 151975 96890 63240114
Headache 116.32 9.93 2144 149874 631097 62705907
Foot deformity 110.55 9.93 221 151797 27632 63309372
Lower respiratory tract infection 109.97 9.93 93 151925 132214 63204790
Folliculitis 107.99 9.93 19 151999 70298 63266706
Duodenal ulcer perforation 107.88 9.93 37 151981 87172 63249832
Drug hypersensitivity 106.62 9.93 1175 150843 309512 63027492
Muscle injury 104.04 9.93 16 152002 65329 63271675
Rhinitis allergic 103.53 9.93 134 151884 11593 63325411
Cardiac failure 103.26 9.93 42 151976 89100 63247904
Joint swelling 103.18 9.93 419 151599 327247 63009757
Infarction 102.23 9.93 69 151949 2572 63334432
Hand deformity 101.54 9.93 140 151878 159317 63177687
Joint dislocation 98.32 9.93 168 151850 18632 63318372
Withdrawal syndrome 97.16 9.93 173 151845 19824 63317180
General physical health deterioration 97.07 9.93 211 151807 201191 63135813
Insomnia 96.62 9.93 861 151157 214391 63122613
Exostosis 96.57 9.93 162 151856 17700 63319304
Therapeutic response unexpected 93.35 9.93 164 151854 18595 63318409
Blister 93.10 9.93 104 151914 129710 63207294
Anger 92.72 9.93 131 151887 12325 63324679
Tardive dyskinesia 92.60 9.93 108 151910 8394 63328610
Retinitis 92.56 9.93 93 151925 6103 63330901
Sympathomimetic effect 92.46 9.93 25 151993 71 63336933
Feeling abnormal 91.03 9.93 638 151380 147754 63189250
Malignant neoplasm progression 89.88 9.93 42 151976 82079 63254925
Carpal tunnel syndrome 89.70 9.93 171 151847 20646 63316358
Alopecia 87.10 9.93 464 151554 337072 62999932
Crying 84.13 9.93 178 151840 23165 63313839
Infusion related reaction 83.00 9.93 305 151713 245216 63091788
Exposure via ingestion 82.71 9.93 63 151955 2846 63334158
Pericarditis 82.29 9.93 117 151901 131462 63205542
Disease progression 82.00 9.93 104 151914 122654 63214350
Abdominal discomfort 79.55 9.93 447 151571 320438 63016566
Blood test abnormal 79.54 9.93 138 151880 15491 63321513
Lupus-like syndrome 79.09 9.93 136 151882 15159 63321845
Hallucinations, mixed 76.81 9.93 75 151943 4754 63332250
Myoclonus 76.74 9.93 137 151881 15731 63321273
Atrial fibrillation 76.68 9.93 100 151918 116536 63220468
Drug abuse 76.24 9.93 360 151658 72158 63264846
Maternal exposure during pregnancy 75.94 9.93 271 151747 219791 63117213
Hypothyroidism 75.19 9.93 249 151769 42383 63294621
Bone erosion 74.45 9.93 144 151874 17573 63319431
Diarrhoea 73.35 9.93 1239 150779 714127 62622877
Dyspnoea 73.22 9.93 1129 150889 660184 62676820
Ejection fraction abnormal 72.38 9.93 48 151970 1737 63335267
Sleep disorder due to a general medical condition 71.91 9.93 115 151903 12073 63324931
Platelet count decreased 71.87 9.93 104 151914 116018 63220986
Memory impairment 71.56 9.93 461 151557 103797 63233207
Rash 70.69 9.93 933 151085 559938 62777066
Pulseless electrical activity 69.64 9.93 88 151930 7433 63329571
Impaired healing 69.39 9.93 86 151932 102456 63234548
Disturbance in attention 69.09 9.93 225 151793 37964 63299040
Stomatitis 68.76 9.93 143 151875 138582 63198422
Hepatic cirrhosis 68.53 9.93 170 151848 24564 63312440
Mental status changes 67.80 9.93 229 151789 39370 63297634
Nephrectomy 67.14 9.93 43 151975 1465 63335539
Gastrointestinal disorder 66.14 9.93 134 151884 131105 63205899
Product residue present 65.54 9.93 63 151955 3916 63333088
Postmortem blood drug level increased 65.47 9.93 31 151987 573 63336431
Postictal state 65.24 9.93 37 151981 1006 63335998
Bursitis 65.01 9.93 216 151802 36825 63300179
Bronchial neoplasm 64.63 9.93 29 151989 471 63336533
Therapeutic product effect incomplete 63.86 9.93 515 151503 124541 63212463
Panic attack 63.47 9.93 155 151863 22176 63314828
Rash erythematous 62.64 9.93 234 151784 42276 63294728
C-reactive protein abnormal 61.60 9.93 17 152001 46079 63290925
Thermal burn 61.22 9.93 74 151944 5972 63331032
Bronchial haemorrhage 59.95 9.93 29 151989 563 63336441
Migraine 59.67 9.93 438 151580 102908 63234096
Asthma exercise induced 59.58 9.93 24 151994 294 63336710
Treatment failure 58.59 9.93 261 151757 198782 63138222
Hallucination, auditory 58.56 9.93 108 151910 12716 63324288
Renal disorder 58.51 9.93 193 151825 32781 63304223
Neutrophil count decreased 58.47 9.93 31 151987 56375 63280629
Liver disorder 57.91 9.93 28 151990 53659 63283345
Bone marrow failure 57.69 9.93 3 152015 29287 63307717
Fluid retention 57.50 9.93 289 151729 59397 63277607
Cholecystitis chronic 57.38 9.93 95 151923 10266 63326738
Sepsis 57.28 9.93 182 151836 152941 63184063
Burning sensation 57.11 9.93 270 151748 54137 63282867
Cerebral venous thrombosis 56.96 9.93 44 151974 2030 63334974
Mucosal inflammation 56.17 9.93 21 151997 46907 63290097
Factor V Leiden mutation 55.93 9.93 21 151997 210 63336794
Hyponatraemia 54.90 9.93 116 151902 111784 63225220
Multiple organ dysfunction syndrome 54.82 9.93 34 151984 56718 63280286
Impulse-control disorder 54.81 9.93 30 151988 760 63336244
Nicotine dependence 54.70 9.93 29 151989 688 63336316
Bipolar disorder 53.83 9.93 80 151938 7880 63329124
Brain injury 53.80 9.93 75 151943 6968 63330036
Hyperkalaemia 53.01 9.93 32 151986 54171 63282833
Nasal turbinate hypertrophy 53.01 9.93 29 151989 734 63336270
Irritable bowel syndrome 52.79 9.93 72 151946 82340 63254664
Sleep-related eating disorder 52.72 9.93 30 151988 821 63336183
Mental disorder 52.68 9.93 159 151859 25760 63311244
Anti-cyclic citrullinated peptide antibody positive 51.72 9.93 127 151891 116085 63220919
Haemoglobin decreased 51.61 9.93 177 151841 145308 63191696
Persistent genital arousal disorder 51.57 9.93 21 151997 265 63336739
Synovitis 51.52 9.93 251 151767 186667 63150337
Fibromyalgia 51.18 9.93 349 151669 80071 63256933
Intentional product misuse 51.16 9.93 284 151734 60633 63276371
Hallucination 51.10 9.93 263 151755 54554 63282450
Weight increased 50.42 9.93 891 151127 259901 63077103
Hepatocellular injury 50.39 9.93 4 152014 27377 63309627
Rubber sensitivity 50.38 9.93 43 151975 2288 63334716
Leukopenia 50.04 9.93 67 151951 77223 63259781
Renal impairment 50.02 9.93 84 151934 88271 63248733
Upper respiratory tract infection 49.82 9.93 352 151666 81695 63255309
Endometrial ablation 49.25 9.93 30 151988 934 63336070
Areflexia 48.79 9.93 48 151970 3070 63333934
Oesophageal spasm 48.73 9.93 48 151970 3075 63333929
Emotional distress 47.81 9.93 179 151839 32370 63304634
Thinking abnormal 47.80 9.93 89 151929 10554 63326450
Affective disorder 47.77 9.93 66 151952 6080 63330924
White blood cell count decreased 47.49 9.93 172 151846 138932 63198072
Hepatic function abnormal 47.25 9.93 15 152003 37127 63299877
Arthralgia 47.12 9.93 1023 150995 568687 62768317
Tachycardia 47.11 9.93 461 151557 117695 63219309
Vertigo 46.88 9.93 274 151744 59613 63277391
Sleep disorder due to general medical condition, insomnia type 46.78 9.93 34 151984 52183 63284821
Discomfort 46.56 9.93 224 151794 167150 63169854
Mood altered 45.87 9.93 106 151912 14637 63322367
Pruritus 45.16 9.93 602 151416 360851 62976153
Wound 45.12 9.93 219 151799 163044 63173960
Cholestasis 45.08 9.93 8 152010 29426 63307578
Nasopharyngitis 44.83 9.93 391 151627 253866 63083138
Depressed mood 44.80 9.93 203 151815 39988 63297016
Laryngitis 44.27 9.93 114 151904 16853 63320151
Cardiogenic shock 44.25 9.93 118 151900 17814 63319190
Gastrooesophageal reflux disease 44.10 9.93 385 151633 95254 63241750
Bronchial disorder 43.58 9.93 31 151987 1259 63335745
Hostility 43.49 9.93 36 151982 1836 63335168
Akathisia 42.99 9.93 78 151940 9068 63327936
Libido increased 42.42 9.93 31 151987 1314 63335690
Brugada syndrome 42.32 9.93 20 151998 368 63336636
Cardiac disorder 42.06 9.93 236 151782 50580 63286424
Reversible cerebral vasoconstriction syndrome 41.75 9.93 41 151977 2617 63334387
Pre-existing condition improved 40.92 9.93 72 151946 8172 63328832
Multiple sclerosis 40.89 9.93 140 151878 24232 63312772
Gastrointestinal haemorrhage 40.78 9.93 83 151935 81093 63255911
Multiple sclerosis relapse 40.03 9.93 225 151793 48253 63288751
Endometriosis 39.67 9.93 56 151962 5264 63331740
Product complaint 38.65 9.93 91 151927 12718 63324286
Liver injury 38.63 9.93 53 151965 60467 63276537
Oesophageal pain 38.62 9.93 46 151972 3655 63333349
Lung disorder 38.28 9.93 56 151962 62205 63274799
Hyperreflexia 37.80 9.93 58 151960 5876 63331128
Pleural effusion 37.56 9.93 107 151911 93103 63243901
Sleep paralysis 37.52 9.93 22 151996 638 63336366
Death 36.72 9.93 653 151365 373728 62963276
Nightmare 36.45 9.93 115 151903 19079 63317925
Asthenia 36.40 9.93 673 151345 382931 62954073
Hypoglycaemia 35.98 9.93 55 151963 60010 63276994
Bruxism 35.46 9.93 43 151975 3482 63333522
Abnormal dreams 35.38 9.93 78 151940 10438 63326566
Foetal death 35.33 9.93 80 151938 10900 63326104
Rheumatic fever 34.95 9.93 31 151987 43080 63293924
Major depression 34.71 9.93 66 151952 7952 63329052
Pneumonia 34.66 9.93 831 151187 455936 62881068
Toxic epidermal necrolysis 34.50 9.93 9 152009 25325 63311679
Mania 34.25 9.93 85 151933 12282 63324722
Drug eruption 34.07 9.93 13 152005 28681 63308323
Complication of device insertion 33.65 9.93 63 151955 7501 63329503
Hepatic failure 33.56 9.93 22 151996 35634 63301370
Epistaxis 33.52 9.93 78 151940 72647 63264357
International normalised ratio increased 33.48 9.93 37 151981 46388 63290616
Gamma-glutamyltransferase increased 33.40 9.93 20 151998 34011 63302993
Product dose omission issue 33.39 9.93 765 151253 233548 63103456
Restless legs syndrome 33.35 9.93 109 151909 18422 63318582
Brain death 33.33 9.93 41 151977 3369 63333635
Job dissatisfaction 33.25 9.93 10 152008 46 63336958
Hypokalaemia 33.06 9.93 132 151886 103672 63233332
Stress 32.86 9.93 274 151744 66893 63270111
Dizziness 32.81 9.93 1299 150719 428626 62908378
Macular degeneration 32.55 9.93 9 152009 24367 63312637
Pupil fixed 32.39 9.93 30 151988 1779 63335225
Alcoholism 32.27 9.93 30 151988 1788 63335216
Adrenergic syndrome 32.21 9.93 9 152009 30 63336974
Economic problem 31.87 9.93 31 151987 1955 63335049
Anti-neutrophil cytoplasmic antibody positive vasculitis 31.86 9.93 37 151981 2862 63334142
Hypercalcaemia 31.74 9.93 14 152004 28308 63308696
Attention deficit hyperactivity disorder 31.72 9.93 38 151980 3038 63333966
Dyskinesia 31.55 9.93 156 151862 31846 63305158
Dermatitis atopic 31.45 9.93 71 151947 9653 63327351
Treatment noncompliance 31.32 9.93 174 151844 37151 63299853
Joint stiffness 31.12 9.93 189 151829 41680 63295324
Choreoathetosis 31.04 9.93 18 152000 511 63336493
Gambling disorder 31.02 9.93 25 151993 1227 63335777
Rash maculo-papular 30.95 9.93 19 151999 31877 63305127
Obsessive-compulsive disorder 30.66 9.93 43 151975 4017 63332987
Product administration interrupted 30.43 9.93 47 151971 4789 63332215
Feeling jittery 29.90 9.93 85 151933 13318 63323686
Ascites 29.88 9.93 32 151986 40696 63296308
Drug screen positive 29.76 9.93 40 151978 3589 63333415
Sputum purulent 29.72 9.93 23 151995 1064 63335940
Renal failure 29.57 9.93 163 151855 117489 63219515
Myelodysplastic syndrome 29.34 9.93 3 152015 16751 63320253
Libido decreased 29.19 9.93 34 151984 2638 63334366
Tachyphrenia 28.99 9.93 25 151993 1349 63335655
Jaundice 28.98 9.93 17 152001 29234 63307770
Anhedonia 28.90 9.93 74 151944 10900 63326104
Vision blurred 28.88 9.93 342 151676 91582 63245422
Cerebral haemorrhage 28.86 9.93 19 151999 30710 63306294
Anorgasmia 28.86 9.93 18 152000 585 63336419
Agranulocytosis 28.84 9.93 12 152006 25122 63311882
Off label use 28.83 9.93 1321 150697 673141 62663863
Drug tolerance 28.61 9.93 56 151962 6893 63330111
Neoplasm progression 28.57 9.93 27 151991 36401 63300603
Hepatotoxicity 28.42 9.93 28 151990 37013 63299991
Sexual dysfunction 28.32 9.93 43 151975 4316 63332688
Blood lactate dehydrogenase increased 28.25 9.93 10 152008 23106 63313898
Melaena 28.22 9.93 19 151999 30346 63306658
Hypomagnesaemia 28.05 9.93 17 152001 28720 63308284
Muscle twitching 27.92 9.93 107 151911 19561 63317443
Automatism 27.54 9.93 9 152009 57 63336947
Somnolence 27.54 9.93 590 151428 178095 63158909
Foreign body in reproductive tract 27.37 9.93 19 151999 742 63336262
Labelled drug-drug interaction issue 27.32 9.93 22 151996 1079 63335925
Drug intolerance 27.27 9.93 548 151470 308113 63028891
Binge eating 27.22 9.93 16 152002 466 63336538
Septic shock 27.20 9.93 76 151942 66553 63270451
Musculoskeletal pain 27.12 9.93 121 151897 92156 63244848
Urine sodium increased 27.08 9.93 10 152008 95 63336909
Heart rate decreased 27.02 9.93 42 151976 45518 63291486
Central nervous system necrosis 26.93 9.93 11 152007 140 63336864
Swollen joint count increased 26.81 9.93 28 151990 36026 63300978
Osteonecrosis of jaw 26.43 9.93 27 151991 35096 63301908
Electroencephalogram abnormal 26.42 9.93 38 151980 3634 63333370
Parkinsonism 26.07 9.93 69 151949 10370 63326634
Feeling of despair 25.95 9.93 30 151988 2309 63334695
Rheumatoid arthritis 25.85 9.93 793 151225 253026 63083978
Interstitial lung disease 25.73 9.93 70 151948 61838 63275166
Syncope 25.63 9.93 170 151848 117215 63219789
Dystonia 25.52 9.93 82 151936 13737 63323267
Nervousness 25.06 9.93 143 151875 30836 63306168
Secondary immunodeficiency 24.89 9.93 23 151995 1360 63335644
Product quality issue 24.84 9.93 159 151859 35706 63301298
Tinnitus 24.71 9.93 158 151860 35470 63301534
Urine osmolarity increased 24.57 9.93 10 152008 126 63336878
Hip arthroplasty 24.54 9.93 48 151970 47598 63289406
Device dislocation 24.42 9.93 124 151894 25581 63311423
Thalamic infarction 24.34 9.93 15 152003 477 63336527
Infection 24.30 9.93 394 151624 228779 63108225
Blood pressure systolic increased 24.20 9.93 48 151970 47349 63289655
Drug tolerance decreased 24.19 9.93 6 152012 17467 63319537
Hypertension 24.18 9.93 856 151162 278447 63058557
Posterior reversible encephalopathy syndrome 23.93 9.93 6 152012 17339 63319665
Decreased interest 23.89 9.93 34 151984 3220 63333784
Large intestine anastomosis 23.87 9.93 7 152011 29 63336975
Mucosal dryness 23.67 9.93 31 151987 2713 63334291
Neuropathy peripheral 23.64 9.93 167 151851 113500 63223504
Haemoglobin urine 23.63 9.93 10 152008 140 63336864
Rhonchi 23.63 9.93 30 151988 2546 63334458
Erythema dyschromicum perstans 23.55 9.93 8 152010 58 63336946
Ill-defined disorder 23.55 9.93 108 151910 81647 63255357
Peritonitis 23.54 9.93 6 152012 17148 63319856
Pneumonitis 23.34 9.93 30 151988 35192 63301812
Soft tissue injury 23.23 9.93 24 151994 1628 63335376
Respiratory failure 23.01 9.93 146 151872 101712 63235292
Liver function test increased 22.73 9.93 27 151991 32784 63304220
Dysphemia 22.73 9.93 30 151988 2645 63334359
Drug specific antibody 22.51 9.93 28 151990 2327 63334677
Myoglobinuria 22.51 9.93 12 152006 288 63336716
Unresponsive to stimuli 22.25 9.93 148 151870 33668 63303336
Blood bilirubin increased 22.25 9.93 34 151984 37106 63299898
Oppositional defiant disorder 22.17 9.93 7 152011 39 63336965
Dissociation 22.17 9.93 31 151987 2888 63334116
Contusion 22.09 9.93 241 151777 149803 63187201
Disseminated intravascular coagulation 22.01 9.93 9 152009 19042 63317962
Inadequate analgesia 21.97 9.93 31 151987 2912 63334092
Apathy 21.83 9.93 58 151960 8736 63328268
Accidental exposure to product by child 21.78 9.93 20 151998 1173 63335831
Upper gastrointestinal haemorrhage 21.63 9.93 9 152009 18843 63318161
Oedema 21.50 9.93 141 151877 97481 63239523
Ankle arthroplasty 21.38 9.93 24 151994 1789 63335215
Accidental death 21.35 9.93 25 151993 1951 63335053
Nausea 21.30 9.93 2346 149672 852125 62484879
Paranoia 21.29 9.93 69 151949 11610 63325394
Post-traumatic stress disorder 21.23 9.93 42 151976 5209 63331795
Orthostatic hypertension 21.17 9.93 14 152004 504 63336500
Narcolepsy 21.17 9.93 21 151997 1357 63335647
Liver function test abnormal 21.15 9.93 53 151965 48128 63288876
Drug dependence 21.12 9.93 115 151903 24368 63312636
Ventricular tachycardia 20.85 9.93 99 151919 19880 63317124
Embedded device 20.73 9.93 33 151985 3450 63333554
Anticholinergic syndrome 20.68 9.93 27 151991 2355 63334649
Compulsive shopping 20.62 9.93 16 152002 743 63336261
Mass excision 20.59 9.93 12 152006 344 63336660
Supraventricular tachycardia 20.55 9.93 78 151940 14193 63322811
Corneal reflex decreased 20.53 9.93 9 152009 138 63336866
Affect lability 20.44 9.93 66 151952 11085 63325919
Metastases to liver 20.39 9.93 16 152002 23623 63313381
Ear infection 20.38 9.93 159 151859 38054 63298950
Urine amphetamine positive 20.35 9.93 7 152011 53 63336951
Sensitivity to weather change 20.32 9.93 50 151968 7187 63329817
Blood creatinine increased 20.31 9.93 125 151893 87719 63249285
Sternal fracture 20.28 9.93 26 151992 2228 63334776
Dyspnoea exertional 20.28 9.93 75 151943 60227 63276777
Amnesia 20.28 9.93 213 151805 55372 63281632
Insurance issue 20.14 9.93 45 151973 6076 63330928
Sputum discoloured 20.06 9.93 85 151933 16262 63320742
Cannabinoid hyperemesis syndrome 19.91 9.93 7 152011 57 63336947
Sedation 19.88 9.93 160 151858 38649 63298355
Premature delivery 19.85 9.93 26 151992 30255 63306749
Caput succedaneum 19.72 9.93 5 152013 10 63336994
Bronchiectasis 19.69 9.93 7 152011 16135 63320869
Dysgraphia 19.66 9.93 31 151987 3215 63333789
Cough 19.65 9.93 542 151476 292201 63044803
Urinary tract infection 19.35 9.93 484 151534 264200 63072804
Lactic acidosis 19.35 9.93 39 151979 38248 63298756
Biliary dyskinesia 19.28 9.93 28 151990 2701 63334303
Skin ulcer 19.17 9.93 47 151971 42998 63294006
Femur fracture 19.07 9.93 45 151973 41711 63295293
Haematemesis 19.04 9.93 27 151991 30385 63306619
Device expulsion 19.00 9.93 146 151872 34776 63302228
Mood swings 18.74 9.93 90 151928 18158 63318846
Tenosynovitis 18.59 9.93 5 152013 13790 63323214
Sexually inappropriate behaviour 18.52 9.93 8 152010 118 63336886
Somnambulism 18.52 9.93 41 151977 5502 63331502
Knee arthroplasty 18.50 9.93 67 151951 54139 63282865
Solar urticaria 18.47 9.93 7 152011 72 63336932
Emotional disorder 18.35 9.93 72 151946 13307 63323697
Chorea 18.31 9.93 21 151997 1603 63335401
Cardiomyopathy acute 18.28 9.93 10 152008 253 63336751
Cardiac failure congestive 18.16 9.93 138 151880 92295 63244709
Hepatitis 18.07 9.93 43 151975 39745 63297259
Abnormal behaviour 18.05 9.93 100 151918 21326 63315678
Vomiting 18.05 9.93 1127 150891 558490 62778514
Dysphoria 18.04 9.93 38 151980 4928 63332076
Forced expiratory volume decreased 18.03 9.93 38 151980 4930 63332074
Hypertensive crisis 18.03 9.93 7 152011 15279 63321725
Device placement issue 18.00 9.93 19 151999 1321 63335683
Gallbladder disorder 17.97 9.93 91 151927 18751 63318253
Haemangioma congenital 17.95 9.93 12 152006 440 63336564
Haemorrhage 17.94 9.93 80 151938 60942 63276062
Premature baby 17.93 9.93 14 152004 20721 63316283
Loss of libido 17.90 9.93 19 151999 1330 63335674
Self esteem decreased 17.88 9.93 14 152004 659 63336345
Wrong technique in product usage process 17.87 9.93 228 151790 62112 63274892
Live birth 17.85 9.93 21 151997 25609 63311395
Rectal haemorrhage 17.82 9.93 59 151959 48971 63288033
Illusion 17.73 9.93 17 152001 1053 63335951
Tongue biting 17.72 9.93 20 151998 1500 63335504
Angina pectoris 17.57 9.93 28 151990 30050 63306954
Oscillopsia 17.55 9.93 8 152010 135 63336869
Clonus 17.46 9.93 36 151982 4600 63332404
Drug titration error 17.42 9.93 15 152003 808 63336196
Uterine perforation 17.36 9.93 46 151972 6917 63330087
Foot operation 17.25 9.93 47 151971 7184 63329820
Post-traumatic neck syndrome 17.22 9.93 23 151995 2051 63334953
Colitis 17.22 9.93 59 151959 48469 63288535
Hypotonic urinary bladder 17.19 9.93 5 152013 20 63336984
Metastases to bone 17.17 9.93 15 152003 21004 63316000
Skin necrosis 17.10 9.93 6 152012 13944 63323060
Rhinitis 17.10 9.93 63 151955 11303 63325701
Palmar-plantar erythrodysaesthesia syndrome 16.97 9.93 18 152000 22997 63314007
Acute myeloid leukaemia 16.94 9.93 10 152008 17137 63319867
Depressive symptom 16.82 9.93 33 151985 4069 63332935
Polyneuropathy 16.68 9.93 7 152011 14582 63322422
Iron deficiency anaemia 16.62 9.93 14 152004 19955 63317049
Tearfulness 16.61 9.93 33 151985 4106 63332898
Substance abuse 16.56 9.93 36 151982 4771 63332233
Ulcer 16.52 9.93 23 151995 26084 63310920
Dermatillomania 16.41 9.93 8 152010 158 63336846
Arthritis 16.34 9.93 378 151640 115543 63221461
CSWS syndrome 16.29 9.93 5 152013 25 63336979
Haematuria 16.24 9.93 28 151990 29129 63307875
Obesity 16.18 9.93 125 151893 29827 63307177
Pulmonary hypertension 16.17 9.93 41 151977 37082 63299922
Poor personal hygiene 16.12 9.93 10 152008 322 63336682
Cortisol increased 16.11 9.93 11 152007 418 63336586
Gastrointestinal sounds abnormal 15.90 9.93 32 151986 4019 63332985
Drug reaction with eosinophilia and systemic symptoms 15.82 9.93 36 151982 33800 63303204
Pericardial effusion 15.73 9.93 30 151988 30028 63306976
Suicidal behaviour 15.70 9.93 25 151993 2614 63334390
Impaired work ability 15.70 9.93 83 151935 17392 63319612
Rheumatoid nodule 15.59 9.93 11 152007 17144 63319860
Pallor 15.57 9.93 31 151987 30537 63306467
Deep vein thrombosis postoperative 15.55 9.93 4 152014 11365 63325639
Encephalopathy 15.53 9.93 151 151867 38469 63298535
Diabetes mellitus 15.53 9.93 203 151815 55607 63281397
Diverticulitis 15.50 9.93 46 151972 39511 63297493
Myoclonic epilepsy 15.48 9.93 17 152001 1237 63335767
Tubulointerstitial nephritis 15.32 9.93 15 152003 19888 63317116
Cerebrovascular accident 15.30 9.93 175 151843 107849 63229155
Lymphoedema 15.30 9.93 62 151956 11630 63325374
Hypervolaemia 15.18 9.93 28 151990 28385 63308619
Cerebral infarction 15.17 9.93 21 151997 23872 63313132
Executive dysfunction 15.12 9.93 8 152010 189 63336815
Snoring 15.09 9.93 32 151986 4170 63332834
Product coating issue 15.08 9.93 6 152012 71 63336933
Euphoric mood 15.05 9.93 35 151983 4852 63332152
Right ventricular systolic pressure decreased 15.00 9.93 5 152013 34 63336970
Herpes zoster 14.87 9.93 126 151892 82336 63254668
Ankle fracture 14.82 9.93 83 151935 17772 63319232
Gestational diabetes 14.76 9.93 49 151969 8347 63328657
Visual impairment 14.70 9.93 284 151734 84162 63252842
Pain in jaw 14.69 9.93 54 151964 43442 63293562
Drug screen false positive 14.57 9.93 14 152004 870 63336134
Shock haemorrhagic 14.49 9.93 3 152015 9892 63327112
Osteoporosis 14.49 9.93 205 151813 57133 63279871
Blood pressure diastolic decreased 14.37 9.93 20 151998 22686 63314318
Subacute cutaneous lupus erythematosus 14.32 9.93 24 151994 2619 63334385
Restlessness 14.32 9.93 120 151898 29333 63307671
Decorticate posture 14.28 9.93 9 152009 298 63336706
Generalised anxiety disorder 14.25 9.93 21 151997 2053 63334951
Wound infection fungal 14.19 9.93 7 152011 142 63336862
Infusion site scar 14.14 9.93 11 152007 513 63336491
Ventricular tachyarrhythmia 14.10 9.93 7 152011 144 63336860
Haemophagocytic lymphohistiocytosis 14.05 9.93 4 152014 10623 63326381
Yawning 13.96 9.93 15 152003 1065 63335939
Lip dry 13.95 9.93 10 152008 15460 63321544
Therapeutic product effect decreased 13.91 9.93 354 151664 192833 63144171
Homicidal ideation 13.90 9.93 19 151999 1733 63335271
Panniculitis 13.78 9.93 5 152013 11380 63325624
Posture abnormal 13.75 9.93 22 151996 2310 63334694
Hypertonic bladder 13.67 9.93 28 151990 3560 63333444
Blood pressure diastolic abnormal 13.65 9.93 9 152009 14533 63322471
Abscess sterile 13.59 9.93 5 152013 47 63336957
Hepatic encephalopathy 13.58 9.93 5 152013 11277 63325727
Chronic fatigue syndrome 13.53 9.93 15 152003 1103 63335901
Infusion site discomfort 13.52 9.93 17 152001 1429 63335575
Eosinophilia 13.47 9.93 21 151997 22735 63314269
Device related infection 13.46 9.93 22 151996 23370 63313634
Blood pressure fluctuation 13.45 9.93 61 151957 46256 63290748
Symptom recurrence 13.42 9.93 19 151999 1791 63335213
Red blood cells urine 13.41 9.93 11 152007 554 63336450
Haematoma 13.28 9.93 41 151977 34779 63302225
Pulmonary oedema 13.25 9.93 77 151941 54796 63282208
Cytokine release syndrome 13.24 9.93 9 152009 14305 63322699
Metastases to lung 13.22 9.93 7 152011 12743 63324261
Adjustment disorder with depressed mood 13.20 9.93 4 152014 10200 63326804
Plasma cell myeloma 13.19 9.93 43 151975 35862 63301142
Right ventricular failure 13.18 9.93 13 152005 17175 63319829
Product solubility abnormal 13.14 9.93 13 152005 837 63336167
Injection site mass 13.10 9.93 83 151935 18573 63318431
Balance disorder 13.07 9.93 279 151739 84143 63252861
Clostridium difficile infection 13.07 9.93 33 151985 29889 63307115
Orgasmic sensation decreased 13.04 9.93 3 152015 3 63337001
Pupillary reflex impaired 13.03 9.93 20 151998 2027 63334977
Bone pain 13.02 9.93 77 151941 54564 63282440
Haematochezia 13.00 9.93 75 151943 53469 63283535
Exposure via breast milk 12.95 9.93 20 151998 2037 63334967
Blood pressure systolic abnormal 12.95 9.93 8 152010 13378 63323626
Dyspareunia 12.91 9.93 22 151996 2433 63334571
Basal cell carcinoma 12.91 9.93 30 151988 27961 63309043
Anaphylactic shock 12.88 9.93 23 151995 23610 63313394
Wound complication 12.84 9.93 28 151990 3719 63333285
Orthostatic hypotension 12.80 9.93 44 151974 36116 63300888
Blood potassium increased 12.76 9.93 15 152003 18294 63318710
Stoma site ulcer 12.75 9.93 8 152010 263 63336741
Bipolar I disorder 12.72 9.93 19 151999 1880 63335124
Pelvic pain 12.69 9.93 65 151953 13454 63323550
Product use issue 12.63 9.93 417 151601 220103 63116901
Abnormal uterine bleeding 12.62 9.93 17 152001 1529 63335475
Bipolar II disorder 12.60 9.93 9 152009 368 63336636
Impaired driving ability 12.49 9.93 31 151987 4480 63332524
Blood calcium decreased 12.48 9.93 28 151990 26423 63310581
Blood parathyroid hormone decreased 12.37 9.93 4 152014 9787 63327217
Contraindicated product administered 12.36 9.93 412 151606 217236 63119768
Carbon monoxide poisoning 12.35 9.93 7 152011 190 63336814
Bacteraemia 12.32 9.93 14 152004 17334 63319670
Tooth fracture 12.29 9.93 56 151962 11054 63325950
Red blood cell sedimentation rate increased 12.24 9.93 160 151858 43822 63293182
Acute myocardial infarction 12.13 9.93 38 151980 32086 63304918
Coagulopathy 12.12 9.93 19 151999 20525 63316479
Red blood cell count decreased 12.12 9.93 53 151965 40592 63296412
Food craving 12.11 9.93 17 152001 1589 63335415
Psychotic disorder 12.10 9.93 104 151914 25608 63311396
Cystitis interstitial 12.10 9.93 17 152001 1591 63335413
Nodule 12.06 9.93 89 151929 20937 63316067
Drug ineffective 12.05 9.93 2262 149756 1042503 62294501
Abortion spontaneous 12.03 9.93 169 151849 47026 63289978
False positive investigation result 12.02 9.93 11 152007 642 63336362
Muscle rigidity 12.01 9.93 57 151961 11443 63325561
Flat affect 11.92 9.93 16 152002 1434 63335570
Vaginal odour 11.91 9.93 10 152008 520 63336484
Surgery 11.89 9.93 135 151883 35777 63301227
Pituitary hyperplasia 11.83 9.93 3 152015 6 63336998
Ankle operation 11.82 9.93 15 152003 1272 63335732
Mouth ulceration 11.77 9.93 40 151978 32944 63304060
Priapism 11.64 9.93 6 152012 134 63336870
Homeless 11.56 9.93 5 152013 74 63336930
Brain stem syndrome 11.54 9.93 9 152009 421 63336583
Social anxiety disorder 11.52 9.93 9 152009 422 63336582
Product physical issue 11.52 9.93 32 151986 4948 63332056
Cholelithiasis 11.49 9.93 158 151860 43767 63293237
Tri-iodothyronine free decreased 11.44 9.93 8 152010 316 63336688
Bankruptcy 11.44 9.93 4 152014 32 63336972
Haemolytic anaemia 11.35 9.93 5 152013 10120 63326884
Distractibility 11.29 9.93 9 152009 435 63336569
Bezoar 11.28 9.93 16 152002 1510 63335494
Confusional state 11.28 9.93 457 151561 235923 63101081
Clostridium difficile colitis 11.23 9.93 20 151998 20549 63316455
Loss of consciousness 11.20 9.93 366 151652 117755 63219249
Pulmonary renal syndrome 11.11 9.93 9 152009 445 63336559
Eosinophil count abnormal 11.01 9.93 10 152008 578 63336426
Increased appetite 11.00 9.93 49 151969 9581 63327423
Q fever 11.00 9.93 6 152012 151 63336853
Blood pressure orthostatic abnormal 10.97 9.93 3 152015 9 63336995
Perinatal depression 10.97 9.93 11 152007 720 63336284
Spinal operation 10.93 9.93 44 151974 8227 63328777
Galactorrhoea 10.92 9.93 28 151990 4127 63332877
Electrocardiogram QRS complex shortened 10.85 9.93 9 152009 460 63336544
Convulsive threshold lowered 10.85 9.93 8 152010 344 63336660
Panic reaction 10.84 9.93 28 151990 4146 63332858
Impulsive behaviour 10.83 9.93 16 152002 1567 63335437
Haemoptysis 10.83 9.93 34 151984 28692 63308312
Hyperphagia 10.79 9.93 17 152001 1762 63335242
Postmortem blood drug level abnormal 10.73 9.93 8 152010 350 63336654
Arrhythmia 10.72 9.93 139 151879 38001 63299003
Haemodialysis 10.71 9.93 4 152014 8943 63328061
Epstein-Barr virus infection 10.70 9.93 3 152015 8047 63328957
Hallucination, visual 10.68 9.93 81 151937 19217 63317787
Gaze palsy 10.66 9.93 15 152003 1405 63335599
Autoinflammatory disease 10.64 9.93 7 152011 250 63336754
Hyperbilirubinaemia 10.62 9.93 7 152011 11307 63325697
Rhinorrhoea 10.60 9.93 103 151915 65474 63271530
Mental impairment 10.59 9.93 64 151954 14087 63322917
Panic disorder 10.57 9.93 21 151997 2612 63334392
Pulmonary arterial hypertension 10.57 9.93 24 151994 22553 63314451
Concussion 10.53 9.93 47 151971 9197 63327807
Hyperglycaemia 10.52 9.93 58 151960 41809 63295195
Essential tremor 10.50 9.93 13 152005 1075 63335929
Staring 10.48 9.93 16 152002 1614 63335390
Hypoventilation 10.46 9.93 30 151988 4724 63332280
Accidental poisoning 10.45 9.93 10 152008 618 63336386
Lower gastrointestinal haemorrhage 10.37 9.93 3 152015 7887 63329117
Fear 10.37 9.93 69 151949 15697 63321307
Disorientation 10.35 9.93 142 151876 39310 63297694
Pancreatitis acute 10.35 9.93 32 151986 27134 63309870
Intermenstrual bleeding 10.34 9.93 42 151976 7884 63329120
Personality disorder 10.29 9.93 34 151984 5777 63331227
Enterococcal infection 10.29 9.93 3 152015 7845 63329159
Abnormal sleep-related event 10.22 9.93 11 152007 782 63336222
Cardiac failure acute 10.22 9.93 5 152013 9518 63327486
Long QT syndrome congenital 10.20 9.93 5 152013 100 63336904
Serum sickness-like reaction 10.20 9.93 9 152009 501 63336503
Grip strength decreased 10.19 9.93 24 151994 22263 63314741
Faeces discoloured 10.10 9.93 18 152000 18491 63318513
Road traffic accident 10.09 9.93 133 151885 36499 63300505
Heavy menstrual bleeding 10.06 9.93 75 151943 17698 63319306
Transfusion 10.04 9.93 13 152005 15204 63321800
Decreased appetite 10.01 9.93 495 151523 250557 63086447
Erythema induratum 9.99 9.93 6 152012 182 63336822
Metastases to central nervous system 9.95 9.93 10 152008 13095 63323909
Substance use 9.94 9.93 9 152009 518 63336486
Pineal gland cyst 9.94 9.93 3 152015 14 63336990

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 2289.55 11.69 1616 55758 96552 34803005
Depression 1352.99 11.69 1181 56193 95917 34803640
Toxicity to various agents 655.14 11.69 1174 56200 199188 34700369
Drug interaction 629.42 11.69 1236 56138 224710 34674847
Serotonin syndrome 532.22 11.69 358 57016 19575 34879982
Suicidal ideation 450.86 11.69 435 56939 39953 34859604
Intentional overdose 351.73 11.69 395 56979 43279 34856278
Anxiety 335.65 11.69 592 56782 98836 34800721
Psychiatric decompensation 326.53 11.69 137 57237 2800 34896757
Overdose 320.10 11.69 552 56822 90507 34809050
Seizure 258.87 11.69 547 56827 104310 34795247
Depression suicidal 249.19 11.69 108 57266 2397 34897160
Tearfulness 239.48 11.69 107 57267 2560 34896997
Drug abuse 238.85 11.69 512 56862 98584 34800973
Paranoia 215.46 11.69 170 57204 11898 34887659
Cardio-respiratory arrest 209.82 11.69 347 57027 54926 34844631
Loss of personal independence in daily activities 207.58 11.69 264 57110 32915 34866642
Depressive symptom 198.53 11.69 96 57278 2763 34896794
Psychotic disorder 193.03 11.69 219 57155 24233 34875324
Electrocardiogram QRS complex prolonged 173.01 11.69 105 57269 4789 34894768
Psychomotor skills impaired 159.54 11.69 92 57282 3814 34895743
Febrile neutropenia 149.55 11.69 23 57351 136826 34762731
Anaemia 146.72 11.69 102 57272 233233 34666324
Generalised tonic-clonic seizure 146.07 11.69 177 57197 20997 34878560
Suicide attempt 139.62 11.69 239 57135 38877 34860680
Status epilepticus 135.20 11.69 133 57241 12481 34887076
Hyperreflexia 132.24 11.69 76 57298 3130 34896427
Thrombocytopenia 118.68 11.69 54 57320 156193 34743364
Acute kidney injury 108.03 11.69 211 57163 304777 34594780
Suspected suicide 107.21 11.69 77 57297 4671 34894886
Tremor 104.92 11.69 336 57038 82251 34817306
Distributive shock 95.89 11.69 45 57329 1209 34898348
Sepsis 95.40 11.69 80 57294 166481 34733076
Neutropenia 95.20 11.69 71 57303 156707 34742850
Pyrexia 94.86 11.69 259 57115 332754 34566803
Poisoning 93.91 11.69 108 57266 12118 34887439
Insomnia 93.78 11.69 378 56996 103529 34796028
Agitation 93.35 11.69 255 57119 57144 34842413
General physical health deterioration 86.03 11.69 52 57322 128217 34771340
Malignant neoplasm progression 83.14 11.69 21 57353 88025 34811532
Depressed mood 79.64 11.69 126 57248 19191 34880366
Product substitution issue 78.92 11.69 90 57284 10005 34889552
Pneumonia 74.18 11.69 325 57049 362302 34537255
Platelet count decreased 72.92 11.69 54 57320 119663 34779894
Psychomotor retardation 70.75 11.69 54 57320 3596 34895961
Respiratory arrest 69.82 11.69 147 57227 27896 34871661
Sexual dysfunction 68.54 11.69 67 57307 6236 34893321
Pancytopenia 66.02 11.69 37 57337 95120 34804437
Postmortem blood drug level increased 65.67 11.69 22 57352 232 34899325
Disease progression 65.49 11.69 49 57325 108028 34791529
Panic attack 65.28 11.69 79 57295 9353 34890204
Interstitial lung disease 64.73 11.69 14 57360 65268 34834289
Irritability 62.13 11.69 130 57244 24560 34874997
Major depression 62.08 11.69 55 57319 4517 34895040
Septic shock 60.75 11.69 21 57353 71813 34827744
Clonus 60.72 11.69 44 57330 2706 34896851
Rhinitis perennial 60.24 11.69 22 57352 305 34899252
Cardiogenic shock 58.82 11.69 133 57241 26485 34873072
Therapeutic response unexpected 58.40 11.69 76 57298 9681 34889876
Anger 58.19 11.69 84 57290 11800 34887757
Electrocardiogram QT prolonged 57.87 11.69 173 57201 40779 34858778
Hyperkalaemia 57.46 11.69 21 57353 69368 34830189
Incorrect route of product administration 55.98 11.69 93 57281 14752 34884805
Exposure via ingestion 55.36 11.69 38 57336 2143 34897414
Dyspnoea 55.34 11.69 377 56997 376405 34523152
Tardive dyskinesia 54.64 11.69 57 57317 5733 34893824
Disturbance in attention 54.42 11.69 127 57247 25818 34873739
Diarrhoea 53.44 11.69 398 56976 389514 34510043
Cardiac arrest 52.64 11.69 303 57071 95856 34803701
Cardiac failure 51.97 11.69 44 57330 91204 34808353
Vein of Galen aneurysmal malformation 51.95 11.69 11 57363 11 34899546
C-reactive protein increased 48.98 11.69 14 57360 54084 34845473
Hallucination, visual 47.50 11.69 96 57278 17695 34881862
Renal failure 47.22 11.69 89 57285 130468 34769089
Pupil fixed 47.19 11.69 32 57342 1769 34897788
Drug withdrawal syndrome 47.09 11.69 102 57272 19732 34879825
Renal impairment 46.38 11.69 52 57322 94461 34805096
Mania 46.24 11.69 67 57307 9444 34890113
Autonomic nervous system imbalance 45.65 11.69 36 57338 2515 34897042
Pleural effusion 45.61 11.69 40 57334 81506 34818051
Feeling abnormal 45.48 11.69 215 57159 63020 34836537
Erectile dysfunction 44.36 11.69 102 57272 20535 34879022
Memory impairment 44.25 11.69 164 57210 43154 34856403
Multiple organ dysfunction syndrome 43.49 11.69 37 57337 76529 34823028
Mucosal inflammation 43.27 11.69 6 57368 38616 34860941
Haemoglobin decreased 43.08 11.69 83 57291 120689 34778868
Adjustment disorder 43.04 11.69 26 57348 1175 34898382
Off label use 42.66 11.69 462 56912 419062 34480495
Sedation 42.07 11.69 101 57273 20905 34878652
Manic symptom 41.45 11.69 13 57361 109 34899448
Bradyphrenia 41.32 11.69 45 57329 4753 34894804
Product residue present 41.26 11.69 35 57339 2711 34896846
Maternal drugs affecting foetus 40.98 11.69 41 57333 3924 34895633
Libido decreased 40.37 11.69 44 57330 4652 34894905
Euphoric mood 40.26 11.69 48 57326 5593 34893964
Myoclonus 39.96 11.69 80 57294 14645 34884912
Drug reaction with eosinophilia and systemic symptoms 39.78 11.69 4 57370 33008 34866549
Prescribed overdose 39.20 11.69 66 57308 10581 34888976
Depersonalisation/derealisation disorder 38.41 11.69 19 57355 575 34898982
Basilar artery occlusion 37.71 11.69 11 57363 70 34899487
Neonatal toxicity 36.29 11.69 9 57365 27 34899530
Leukopenia 36.16 11.69 30 57344 62826 34836731
Blood creatinine increased 35.88 11.69 63 57311 94913 34804644
Feelings of worthlessness 35.85 11.69 15 57359 304 34899253
Hyponatraemic coma 34.92 11.69 9 57365 33 34899524
Hypokalaemia 34.47 11.69 27 57347 58187 34841370
Dysphoria 33.89 11.69 29 57345 2273 34897284
Restless legs syndrome 33.75 11.69 54 57320 8300 34891257
Electrocardiogram PR prolongation 33.70 11.69 20 57354 875 34898682
Intentional product misuse 33.46 11.69 156 57218 45455 34854102
Mood swings 33.20 11.69 52 57322 7849 34891708
Dissociation 33.17 11.69 25 57349 1633 34897924
Intentional self-injury 32.89 11.69 71 57303 13700 34885857
Infection 32.83 11.69 62 57312 90853 34808704
Ascites 32.44 11.69 18 57356 46553 34853004
Delusion 32.33 11.69 67 57307 12568 34886989
Melaena 32.31 11.69 9 57365 35371 34864186
Aggression 32.14 11.69 138 57236 38826 34860731
Thinking abnormal 30.96 11.69 44 57330 6093 34893464
Psychomotor hyperactivity 30.69 11.69 56 57318 9566 34889991
Gastrointestinal haemorrhage 30.51 11.69 62 57312 88415 34811142
Substance abuse 30.33 11.69 49 57325 7592 34891965
White blood cell count decreased 30.33 11.69 70 57304 95375 34804182
Transposition of the great vessels 30.32 11.69 15 57359 454 34899103
Mood altered 29.70 11.69 53 57321 8899 34890658
Hepatic function abnormal 29.68 11.69 18 57356 44345 34855212
Eosinophilia 29.55 11.69 4 57370 26218 34873339
Drug withdrawal syndrome neonatal 29.54 11.69 33 57341 3586 34895971
Cytomegalovirus infection 29.42 11.69 4 57370 26131 34873426
Drug dependence 29.32 11.69 97 57277 24120 34875437
Vasoplegia syndrome 28.59 11.69 24 57350 1832 34897725
Abdominal pain 28.47 11.69 155 57219 163463 34736094
Encephalopathy neonatal 28.41 11.69 8 57366 44 34899513
Cholestasis 28.34 11.69 5 57369 26943 34872614
Product odour abnormal 28.33 11.69 17 57357 759 34898798
Abnormal clotting factor 28.24 11.69 9 57365 80 34899477
Malaise 28.14 11.69 184 57190 185641 34713916
Hallucination, auditory 27.96 11.69 61 57313 11856 34887701
Tachycardia 27.92 11.69 236 57138 84536 34815021
Talipes 27.85 11.69 24 57350 1899 34897658
Unresponsive to stimuli 27.83 11.69 104 57270 27465 34872092
Erythema 27.50 11.69 66 57308 88714 34810843
Dissociative disorder 27.38 11.69 14 57360 455 34899102
Decreased interest 27.38 11.69 26 57348 2334 34897223
Hallucination 27.32 11.69 161 57213 51337 34848220
Emotional distress 26.67 11.69 69 57305 14957 34884600
Vomiting 26.16 11.69 270 57104 247351 34652206
Atrial fibrillation 25.93 11.69 108 57266 122285 34777272
Hallucination, tactile 25.86 11.69 12 57362 314 34899243
Apathy 25.56 11.69 43 57331 6889 34892668
Feeling jittery 25.24 11.69 32 57342 3971 34895586
Crying 25.21 11.69 39 57335 5823 34893734
Cerebral haemorrhage 25.07 11.69 13 57361 34924 34864633
Withdrawal syndrome 25.06 11.69 60 57314 12395 34887162
Dehydration 24.94 11.69 119 57255 129850 34769707
Stomatitis 24.81 11.69 20 57354 42494 34857063
Respiratory failure 24.78 11.69 93 57281 108479 34791078
Abulia 24.15 11.69 14 57360 586 34898971
Bone marrow failure 23.96 11.69 9 57365 29244 34870313
Gamma-glutamyltransferase increased 23.93 11.69 9 57365 29222 34870335
Pre-existing condition improved 23.53 11.69 25 57349 2567 34896990
Abnormal behaviour 23.40 11.69 92 57282 24877 34874680
Oedema peripheral 23.40 11.69 109 57265 119703 34779854
Tongue biting 23.11 11.69 16 57358 915 34898642
Pelvic abscess 22.98 11.69 16 57358 923 34898634
Tinnitus 22.95 11.69 79 57295 20039 34879518
Jaundice 22.67 11.69 12 57362 31870 34867687
Infusion related reaction 22.09 11.69 33 57341 53024 34846533
Marital problem 21.98 11.69 7 57367 62 34899495
Haematuria 21.97 11.69 30 57344 50036 34849521
Hypomania 21.86 11.69 23 57351 2336 34897221
Mental status changes 21.46 11.69 121 57253 37962 34861595
Dyskinesia 21.34 11.69 83 57291 22330 34877227
Lip squamous cell carcinoma 21.09 11.69 8 57366 124 34899433
Disseminated intravascular coagulation 20.97 11.69 5 57369 21811 34877746
Lower respiratory tract infection 20.94 11.69 13 57361 31624 34867933
Depressed level of consciousness 20.86 11.69 131 57243 42710 34856847
Alcoholism 20.78 11.69 25 57349 2940 34896617
Akathisia 20.75 11.69 43 57331 8066 34891491
Orgasm abnormal 20.69 11.69 8 57366 131 34899426
Mydriasis 20.45 11.69 40 57334 7197 34892360
Gun shot wound 20.36 11.69 16 57358 1112 34898445
Prostate cancer 20.34 11.69 21 57353 39628 34859929
Oxygen saturation decreased 20.04 11.69 36 57338 53782 34845775
Liver disorder 19.91 11.69 15 57359 32982 34866575
Obsessive-compulsive disorder 19.83 11.69 34 57340 5530 34894027
Product complaint 19.70 11.69 35 57339 5855 34893702
Drug resistance 19.58 11.69 9 57365 25918 34873639
Sleep disorder 19.41 11.69 103 57271 31585 34867972
Lung disorder 19.41 11.69 17 57357 34679 34864878
Ideas of reference 19.27 11.69 6 57368 49 34899508
Dysarthria 19.26 11.69 110 57264 34672 34864885
Inadequate analgesia 19.10 11.69 24 57350 2951 34896606
Amnesia 18.85 11.69 90 57284 26473 34873084
Road traffic accident 18.60 11.69 67 57307 17383 34882174
Persecutory delusion 18.49 11.69 22 57352 2558 34896999
Dry mouth 18.45 11.69 98 57276 30067 34869490
Agranulocytosis 18.41 11.69 8 57366 23813 34875744
Disorientation 18.40 11.69 105 57269 33083 34866474
Sleep apnoea syndrome 18.34 11.69 74 57300 20247 34879310
International normalised ratio increased 18.22 11.69 31 57343 47296 34852261
Weight increased 18.22 11.69 233 57141 92800 34806757
Clonic convulsion 18.04 11.69 12 57362 642 34898915
Dependence 17.98 11.69 15 57359 1135 34898422
Sinus tachycardia 17.95 11.69 66 57308 17294 34882263
Hepatocellular injury 17.91 11.69 7 57367 22204 34877353
Obesity 17.80 11.69 54 57320 12824 34886733
Hallucinations, mixed 17.76 11.69 22 57352 2667 34896890
Rheumatoid arthritis 17.71 11.69 22 57352 38216 34861341
Poor feeding infant 17.65 11.69 11 57363 526 34899031
Mental disorder 17.59 11.69 60 57314 15149 34884408
Upper gastrointestinal haemorrhage 17.57 11.69 10 57364 25508 34874049
Atrial septal defect 17.52 11.69 38 57336 7354 34892203
Hypoglycaemia 17.41 11.69 40 57334 54600 34844957
Blood testosterone decreased 17.37 11.69 28 57346 4329 34895228
Lupus-like syndrome 17.33 11.69 22 57352 2734 34896823
Decreased appetite 17.31 11.69 182 57192 166210 34733347
Cytokine release syndrome 17.19 11.69 8 57366 22869 34876688
Toxic epidermal necrolysis 17.16 11.69 7 57367 21639 34877918
Rash maculo-papular 17.08 11.69 13 57361 28438 34871119
Foetal exposure during pregnancy 17.01 11.69 114 57260 37987 34861570
Delirium 16.95 11.69 127 57247 43864 34855693
Treatment failure 16.71 11.69 32 57342 46665 34852892
Neutrophil count decreased 16.61 11.69 37 57337 51067 34848490
Injection site reaction 16.49 11.69 53 57321 12980 34886577
Cutaneous lupus erythematosus 16.27 11.69 12 57362 758 34898799
Pulmonary fibrosis 16.21 11.69 5 57369 18391 34881166
Colitis 16.18 11.69 23 57351 37727 34861830
Substance use disorder 16.15 11.69 12 57362 767 34898790
Lip pruritus 16.13 11.69 4 57370 12 34899545
Neuropathy peripheral 16.10 11.69 76 57298 83187 34816370
Acute myeloid leukaemia 16.04 11.69 5 57369 18265 34881292
Accidental poisoning 16.00 11.69 12 57362 778 34898779
Nightmare 15.97 11.69 56 57318 14335 34885222
Hepatic failure 15.86 11.69 20 57354 34511 34865046
Pulmonary oedema 15.79 11.69 34 57340 47495 34852062
Restlessness 15.73 11.69 83 57291 25399 34874158
Inflammation 15.66 11.69 14 57360 28281 34871276
Myelodysplastic syndrome 15.58 11.69 6 57368 19202 34880355
Loss of employment 15.55 11.69 10 57364 505 34899052
Gastrooesophageal reflux disease 15.48 11.69 111 57263 37813 34861744
Loss of libido 15.46 11.69 20 57354 2532 34897025
Product quality issue 15.35 11.69 62 57312 16973 34882584
Haemoptysis 15.33 11.69 21 57353 34985 34864572
Hostility 15.24 11.69 12 57362 836 34898721
Pneumonitis 15.16 11.69 20 57354 33858 34865699
Pericardial effusion 15.15 11.69 11 57363 24651 34874906
Vision blurred 15.14 11.69 128 57246 45835 34853722
Lactic acidosis 15.09 11.69 21 57353 34751 34864806
Pulmonary embolism 15.05 11.69 86 57288 89660 34809897
Gambling disorder 15.05 11.69 16 57358 1644 34897913
Gastric hypomotility 15.05 11.69 6 57368 107 34899450
Postictal state 15.01 11.69 12 57362 855 34898702
Hypoplastic right heart syndrome 14.87 11.69 4 57370 18 34899539
Lymphadenopathy 14.68 11.69 15 57359 28448 34871109
Suicidal behaviour 14.60 11.69 15 57359 1482 34898075
Joint swelling 14.52 11.69 50 57324 59840 34839717
Cardiotoxicity 14.51 11.69 30 57344 5618 34893939
Acute lung injury 14.49 11.69 15 57359 1495 34898062
Energy increased 14.47 11.69 14 57360 1286 34898271
Blood lactate dehydrogenase increased 14.46 11.69 10 57364 22980 34876577
Hypomagnesaemia 14.43 11.69 9 57365 21842 34877715
Respiratory distress 14.06 11.69 23 57351 35642 34863915
Parkinsonism 14.06 11.69 37 57337 8101 34891456
Hypoxia 14.04 11.69 45 57329 55050 34844507
Blood triglycerides increased 13.94 11.69 53 57321 14106 34885451
Drug screen positive 13.93 11.69 24 57350 3919 34895638
Double inlet left ventricle 13.91 11.69 4 57370 24 34899533
Epistaxis 13.87 11.69 49 57325 58202 34841355
Urinary tract infection 13.87 11.69 81 57293 84000 34815557
Persistent depressive disorder 13.84 11.69 8 57366 333 34899224
Abnormal dreams 13.65 11.69 35 57339 7543 34892014
Urine amphetamine positive 13.64 11.69 4 57370 26 34899531
Pallor 13.64 11.69 13 57361 25467 34874090
Enuresis 13.57 11.69 18 57356 2335 34897222
Ejaculation disorder 13.42 11.69 12 57362 997 34898560
Post-traumatic stress disorder 13.41 11.69 16 57358 1865 34897692
Drug eruption 13.41 11.69 8 57366 19890 34879667
Metastases to liver 13.39 11.69 3 57371 13660 34885897
Priapism 13.39 11.69 27 57347 4967 34894590
Hunger 13.36 11.69 15 57359 1639 34897918
Bladder cancer 13.34 11.69 5 57369 16273 34883284
Balance disorder 13.27 11.69 113 57261 40541 34859016
Impulsive behaviour 13.18 11.69 17 57357 2145 34897412
Sperm concentration decreased 13.18 11.69 6 57368 150 34899407
Tongue pruritus 13.15 11.69 4 57370 30 34899527
Toxic optic neuropathy 13.11 11.69 11 57363 839 34898718
Product solubility abnormal 13.07 11.69 9 57365 510 34899047
Haemorrhage 13.06 11.69 42 57332 51328 34848229
Ventricular hypoplasia 13.04 11.69 5 57369 80 34899477
Rash 12.94 11.69 273 57101 222479 34677078
Anaphylactic shock 12.89 11.69 5 57369 15936 34883621
Lethargy 12.75 11.69 113 57261 41009 34858548
Alanine aminotransferase increased 12.73 11.69 79 57295 80736 34818821
Muscle rigidity 12.61 11.69 42 57332 10476 34889081
Bipolar disorder 12.53 11.69 22 57352 3647 34895910
Univentricular heart 12.51 11.69 4 57370 36 34899521
Testicular pain 12.47 11.69 19 57355 2799 34896758
Congenital aortic stenosis 12.45 11.69 5 57369 91 34899466
Social avoidant behaviour 12.40 11.69 20 57354 3094 34896463
Insurance issue 12.38 11.69 16 57358 2023 34897534
Extra dose administered 12.37 11.69 23 57351 3986 34895571
Injection site mass 12.35 11.69 31 57343 6595 34892962
Hypotonia neonatal 12.26 11.69 13 57361 1332 34898225
Respiratory depression 12.23 11.69 56 57318 16189 34883368
Tubulointerstitial nephritis 12.13 11.69 10 57364 21014 34878543
Candida infection 12.11 11.69 7 57367 17708 34881849
Pain in extremity 12.11 11.69 141 57233 126372 34773185
Binge drinking 12.10 11.69 3 57371 9 34899548
Dysphemia 12.09 11.69 14 57360 1581 34897976
Blood lactic acid increased 12.05 11.69 31 57343 6697 34892860
Emotional disorder 12.00 11.69 28 57346 5688 34893869
Derealisation 11.94 11.69 9 57365 588 34898969
Cough 11.92 11.69 174 57200 149966 34749591
Nephropathy toxic 11.87 11.69 3 57371 12585 34886972
Change in sustained attention 11.86 11.69 3 57371 10 34899547
Bacteraemia 11.85 11.69 9 57365 19708 34879849
Feeling of despair 11.79 11.69 11 57363 966 34898591
Cognitive disorder 11.72 11.69 84 57290 28609 34870948
Tongue spasm 11.71 11.69 4 57370 45 34899512

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 5833.17 10.29 4519 163659 241248 79334962
Toxicity to various agents 1487.71 10.29 2948 165230 418592 79157618
Depression 1023.56 10.29 1722 166456 215068 79361142
Intentional overdose 991.41 10.29 1169 167009 104791 79471419
Overdose 768.34 10.29 1386 166792 182820 79393390
Serotonin syndrome 764.53 10.29 685 167493 44342 79531868
Seizure 673.43 10.29 1329 166849 187505 79388705
Electrocardiogram QRS complex prolonged 642.06 10.29 355 167823 10478 79565732
Cardio-respiratory arrest 573.63 10.29 908 167270 107602 79468608
Suicidal ideation 569.13 10.29 752 167426 75588 79500622
Anxiety 553.25 10.29 1451 166727 247061 79329149
Generalised tonic-clonic seizure 532.04 10.29 555 167623 43355 79532855
Suspected suicide 458.51 10.29 283 167895 10293 79565917
Status epilepticus 374.50 10.29 355 167823 24686 79551524
Anaemia 311.56 10.29 288 167890 444727 79131483
Suicide attempt 299.15 10.29 587 167591 82345 79493865
Cardiac arrest 288.46 10.29 908 167270 171188 79405022
Febrile neutropenia 287.77 10.29 67 168111 230932 79345278
Acute kidney injury 272.23 10.29 422 167756 518982 79057228
Temperature regulation disorder 270.05 10.29 163 168015 5690 79570520
Electrocardiogram QT prolonged 266.57 10.29 589 167589 89797 79486413
Agitation 255.75 10.29 615 167563 99100 79477110
Psychiatric decompensation 254.57 10.29 137 168041 3826 79572384
Respiratory arrest 253.54 10.29 444 167734 57106 79519104
Neutropenia 250.58 10.29 148 168030 287562 79288648
Product substitution issue 247.02 10.29 257 167921 19999 79556211
Thrombocytopenia 231.62 10.29 136 168042 265123 79311087
Drug abuse 231.26 10.29 812 167366 161879 79414331
Sensitisation 217.00 10.29 116 168062 3195 79573015
Polycystic ovaries 208.02 10.29 118 168060 3661 79572549
Poisoning 207.06 10.29 261 167917 25011 79551199
Pyrexia 203.93 10.29 741 167437 677968 78898242
Mydriasis 197.68 10.29 214 167964 17429 79558781
Asthma 196.92 10.29 680 167498 134415 79441795
Coeliac disease 195.14 10.29 174 168004 11177 79565033
Depression suicidal 192.91 10.29 113 168065 3729 79572481
Drug interaction 192.44 10.29 1515 166663 413668 79162542
Tearfulness 191.67 10.29 133 168045 5912 79570298
Food allergy 190.22 10.29 168 168010 10656 79565554
Tremor 183.58 10.29 778 167400 169305 79406905
Pancytopenia 182.31 10.29 61 168117 165684 79410526
Ejection fraction 167.24 10.29 86 168092 2183 79574027
Depressive symptom 164.14 10.29 124 168054 6299 79569911
Paranoia 161.28 10.29 202 167976 19230 79556980
Drug withdrawal syndrome 158.30 10.29 272 167906 34446 79541764
Sepsis 155.64 10.29 204 167974 269224 79306986
Immunodeficiency 155.29 10.29 210 167968 21558 79554652
Malignant neoplasm progression 151.39 10.29 49 168129 135941 79440269
Irritability 149.23 10.29 292 167886 40852 79535358
Cardiac failure 147.41 10.29 71 168107 154771 79421439
General physical health deterioration 145.47 10.29 222 167956 275016 79301194
Platelet count decreased 143.19 10.29 120 168058 194544 79381666
Disease progression 138.90 10.29 111 168067 184251 79391959
Foot deformity 133.36 10.29 206 167972 23868 79552342
Exposure via ingestion 132.47 10.29 100 168078 5074 79571136
Sinus tachycardia 131.51 10.29 260 167918 36648 79539562
Postmortem blood drug level increased 130.83 10.29 53 168125 756 79575454
Loss of personal independence in daily activities 130.46 10.29 494 167684 102086 79474124
Sleep apnoea syndrome 127.61 10.29 255 167923 36223 79539987
Psychomotor skills impaired 124.83 10.29 97 168081 5140 79571070
Joint dislocation 124.78 10.29 166 168012 16773 79559437
Psychotic disorder 123.35 10.29 271 167907 41131 79535079
Dyspnoea 121.63 10.29 1189 166989 855836 78720374
Hyperhidrosis 118.91 10.29 632 167546 150860 79425350
Lupus-like syndrome 118.12 10.29 146 168032 13711 79562499
Tardive dyskinesia 118.04 10.29 128 168050 10443 79565767
Hyperkalaemia 117.49 10.29 47 168131 114351 79461859
Myoclonus 117.40 10.29 210 167968 27450 79548760
Atrial fibrillation 117.16 10.29 147 168031 197739 79378471
Headache 117.15 10.29 1982 166196 651790 78924420
Renal impairment 111.50 10.29 101 168077 157682 79418528
Exostosis 107.35 10.29 154 168024 16704 79559506
Hyperreflexia 106.95 10.29 109 168069 8276 79567934
Rhinitis allergic 102.55 10.29 128 168050 12141 79564069
Retinitis 101.99 10.29 89 168089 5554 79570656
Multiple organ dysfunction syndrome 100.21 10.29 65 168113 120181 79456029
Diarrhoea 99.82 10.29 1285 166893 879204 78697006
Carpal tunnel syndrome 98.37 10.29 160 168018 19368 79556842
Feeling abnormal 93.83 10.29 616 167562 158583 79417627
Peripheral swelling 91.93 10.29 278 167900 269339 79306871
Mucosal inflammation 91.93 10.29 23 168155 75557 79500653
Pneumonia 91.82 10.29 920 167258 659326 78916884
Insomnia 91.41 10.29 853 167325 244317 79331893
Psoriasis 90.60 10.29 402 167776 89185 79487025
Anger 89.70 10.29 143 168035 17019 79559191
Withdrawal syndrome 89.49 10.29 184 167994 26670 79549540
Haemoglobin decreased 89.36 10.29 211 167967 221908 79354302
Sympathomimetic effect 88.91 10.29 24 168154 80 79576130
Panic attack 85.55 10.29 170 168008 24046 79552164
Drug hypersensitivity 84.92 10.29 984 167194 297932 79278278
White blood cell count decreased 84.73 10.29 168 168010 188120 79388090
Sleep disorder due to a general medical condition 84.50 10.29 126 168052 14151 79562059
Lower respiratory tract infection 82.91 10.29 90 168088 129130 79447080
Infarction 82.28 10.29 72 168106 4510 79571700
Crying 81.69 10.29 162 168016 22881 79553329
Therapeutic product effect incomplete 80.99 10.29 544 167634 141101 79435109
Leukopenia 80.62 10.29 76 168102 116437 79459773
Cardiogenic shock 80.32 10.29 232 167946 41682 79534528
Hepatic function abnormal 78.46 10.29 28 168150 73079 79503131
Pupil fixed 78.44 10.29 63 168115 3503 79572707
Interstitial lung disease 77.27 10.29 74 168104 112526 79463684
Migraine 76.99 10.29 377 167801 87116 79489094
Neutrophil count decreased 76.65 10.29 52 168126 93907 79482303
Mental status changes 76.63 10.29 312 167866 66647 79509563
Swelling 76.35 10.29 220 167958 216491 79359719
Bursitis 76.16 10.29 206 167972 35638 79540572
Septic shock 76.08 10.29 88 168090 122713 79453497
Renal failure 76.06 10.29 197 167981 200771 79375439
Tachycardia 75.25 10.29 636 167542 177132 79399078
Bone erosion 73.82 10.29 134 168044 17713 79558497
Cholestasis 73.61 10.29 11 168167 52098 79524112
Liver disorder 72.34 10.29 31 168147 72386 79503824
Bone marrow failure 71.71 10.29 11 168167 51096 79525114
Clonus 71.48 10.29 80 168098 6760 79569450
Gastrointestinal haemorrhage 70.68 10.29 127 168051 147592 79428618
Cytomegalovirus infection 70.51 10.29 5 168173 42639 79533571
Hyponatraemia 69.89 10.29 171 168007 177677 79398533
Pleural effusion 69.40 10.29 125 168053 145137 79431073
Hallucination 68.80 10.29 360 167818 85385 79490825
Postictal state 68.09 10.29 45 168133 1844 79574366
Depressed mood 67.95 10.29 241 167937 48239 79527971
Bronchial neoplasm 67.73 10.29 29 168149 479 79575731
Folliculitis 67.06 10.29 17 168161 55363 79520847
Blood test abnormal 67.03 10.29 128 168050 17582 79558628
Fibromyalgia 66.78 10.29 291 167887 64049 79512161
Ejection fraction abnormal 66.58 10.29 49 168129 2391 79573819
Emotional distress 66.03 10.29 210 167968 39759 79536451
Hypoglycaemia 66.01 10.29 70 168108 101524 79474686
Melaena 65.89 10.29 23 168155 60867 79515343
Disturbance in attention 65.68 10.29 246 167932 50555 79525655
Hepatocellular injury 65.08 10.29 11 168167 47582 79528628
Pulseless electrical activity 64.62 10.29 111 168067 14049 79562161
Neuropathy peripheral 64.50 10.29 125 168053 141180 79435030
Arthropathy 63.70 10.29 178 168000 176933 79399277
Intentional product misuse 62.74 10.29 379 167799 94786 79481424
Nephrectomy 61.18 10.29 44 168134 2071 79574139
Memory impairment 60.81 10.29 424 167754 111310 79464900
Distributive shock 60.23 10.29 48 168130 2639 79573571
Hypothyroidism 59.85 10.29 244 167934 52148 79524062
Stomatitis 59.32 10.29 139 168039 146618 79429592
Akathisia 59.28 10.29 103 168075 13156 79563054
Rubber sensitivity 59.04 10.29 40 168138 1709 79574501
Muscle injury 58.62 10.29 15 168163 48546 79527664
Thinking abnormal 58.53 10.29 102 168076 13059 79563151
Mania 58.37 10.29 123 168055 18137 79558073
Areflexia 58.30 10.29 65 168113 5469 79570741
C-reactive protein abnormal 58.27 10.29 15 168163 48352 79527858
Nasal turbinate hypertrophy 58.25 10.29 29 168149 686 79575524
Helicobacter infection 57.63 10.29 38 168140 69666 79506544
Lung disorder 57.56 10.29 51 168127 80506 79495704
Ascites 57.49 10.29 45 168133 75517 79500693
Oesophageal spasm 57.47 10.29 52 168126 3404 79572806
Psychomotor retardation 57.34 10.29 68 168110 6116 79570094
Gamma-glutamyltransferase increased 56.90 10.29 22 168156 54658 79521552
Pneumocystis jirovecii pneumonia 56.18 10.29 3 168175 32505 79543705
Off label use 55.91 10.29 1472 166706 905743 78670467
Cerebral haemorrhage 55.54 10.29 26 168152 57647 79518563
Endometrial ablation 54.93 10.29 30 168148 863 79575347
Burning sensation 54.73 10.29 257 167921 58375 79517835
Gastrooesophageal reflux disease 54.64 10.29 392 167786 103854 79472356
Jaundice 54.63 10.29 22 168156 53327 79522883
International normalised ratio increased 54.34 10.29 59 168119 84662 79491548
Sexual dysfunction 54.01 10.29 74 168104 7689 79568521
Hypokalaemia 53.87 10.29 142 168036 143898 79432312
Laryngitis 53.56 10.29 110 168068 15929 79560281
Major depression 52.78 10.29 79 168099 8901 79567309
Blood creatinine increased 52.72 10.29 160 168018 154897 79421313
Mental disorder 52.20 10.29 165 168013 31137 79545073
Blister 51.69 10.29 109 168069 119367 79456843
Unresponsive to stimuli 51.68 10.29 244 167934 55544 79520666
Asthenia 51.24 10.29 765 167413 510924 79065286
Persistent genital arousal disorder 50.97 10.29 20 168158 261 79575949
Duodenal ulcer perforation 50.92 10.29 39 168139 66172 79510038
Brain injury 50.88 10.29 89 168089 11428 79564782
Incorrect route of product administration 50.12 10.29 175 168003 34754 79541456
Rash maculo-papular 49.95 10.29 28 168150 56050 79520160
Rhinitis perennial 49.82 10.29 21 168157 333 79575877
Epistaxis 49.72 10.29 100 168078 111415 79464795
Cholecystitis chronic 49.67 10.29 81 168097 9825 79566385
Hostility 49.09 10.29 40 168138 2270 79573940
Cerebral venous thrombosis 48.91 10.29 43 168135 2710 79573500
Product residue present 48.84 10.29 48 168130 3488 79572722
Product quality issue 48.66 10.29 170 168008 33770 79542440
Hepatic failure 48.44 10.29 35 168143 61177 79515033
Product odour abnormal 48.40 10.29 32 168146 1312 79574898
Respiratory failure 48.05 10.29 207 167971 180704 79395506
Nicotine dependence 47.71 10.29 28 168150 927 79575283
Hepatic cirrhosis 47.61 10.29 172 168006 34734 79541476
Therapeutic response unexpected 46.83 10.29 119 168059 19827 79556383
Drug reaction with eosinophilia and systemic symptoms 46.72 10.29 40 168138 64204 79512006
Joint stiffness 46.51 10.29 190 167988 40640 79535570
Infusion related reaction 46.20 10.29 290 167888 229947 79346263
Fluid retention 45.99 10.29 278 167900 69531 79506679
Impaired healing 45.96 10.29 71 168107 87584 79488626
Brugada syndrome 45.86 10.29 30 168148 1208 79575002
Agranulocytosis 45.41 10.29 19 168159 45011 79531199
Libido increased 45.40 10.29 36 168142 1965 79574245
Pneumonitis 45.35 10.29 37 168141 60823 79515387
Reversible cerebral vasoconstriction syndrome 45.05 10.29 43 168135 3014 79573196
Hallucination, auditory 45.04 10.29 120 168058 20573 79555637
Multiple sclerosis relapse 44.92 10.29 206 167972 46327 79529883
Complication of device insertion 44.89 10.29 61 168117 6289 79569921
Toxic epidermal necrolysis 44.65 10.29 19 168159 44562 79531648
Sedation 44.49 10.29 222 167956 51673 79524537
Hallucination, visual 44.41 10.29 161 168017 32568 79543642
Upper gastrointestinal haemorrhage 44.14 10.29 16 168162 41364 79534846
Haematuria 44.08 10.29 48 168130 68788 79507422
Hypomagnesaemia 43.88 10.29 22 168156 46889 79529321
Gastrointestinal disorder 43.80 10.29 123 168055 122082 79454128
Endometriosis 43.75 10.29 46 168132 3622 79572588
Joint swelling 43.04 10.29 395 167783 288251 79287959
Vertigo 42.31 10.29 270 167908 68812 79507398
Upper respiratory tract infection 42.23 10.29 333 167845 90835 79485375
Restless legs syndrome 42.21 10.29 115 168063 19977 79556233
Libido decreased 42.07 10.29 54 168124 5267 79570943
Drug eruption 42.01 10.29 20 168158 43915 79532295
Dissociation 41.97 10.29 47 168131 3974 79572236
Syncope 41.96 10.29 215 167963 179234 79396976
Bronchial haemorrhage 41.75 10.29 29 168149 1291 79574919
Disseminated intravascular coagulation 41.52 10.29 12 168166 35830 79540380
Mood altered 40.38 10.29 105 168073 17742 79558468
Autonomic nervous system imbalance 39.81 10.29 49 168129 4581 79571629
Oesophageal pain 39.59 10.29 47 168131 4232 79571978
Hallucinations, mixed 39.56 10.29 60 168118 6839 79569371
Pruritus 39.47 10.29 590 167588 394058 79182152
Osteonecrosis of jaw 39.35 10.29 21 168157 43205 79533005
Device expulsion 39.23 10.29 132 168046 25729 79550481
Rash 39.15 10.29 925 167253 577433 78998777
Blood lactate dehydrogenase increased 38.75 10.29 17 168161 39153 79537057
Sleep-related eating disorder 38.51 10.29 22 168156 692 79575518
Impulse-control disorder 38.30 10.29 31 168147 1743 79574467
Decreased interest 38.22 10.29 43 168135 3654 79572556
Rash erythematous 37.38 10.29 229 167949 57540 79518670
Myelodysplastic syndrome 37.27 10.29 9 168169 30292 79545918
Vision blurred 37.20 10.29 364 167814 105534 79470676
Eosinophilia 37.11 10.29 25 168153 45320 79530890
Manic symptom 37.06 10.29 13 168165 121 79576089
Intentional self-injury 37.03 10.29 151 168027 32268 79543942
Colitis 36.90 10.29 61 168117 73246 79502964
Polyneuropathy 36.76 10.29 4 168174 24147 79552063
Multiple sclerosis 36.73 10.29 117 168061 22165 79554045
Substance abuse 36.11 10.29 73 168105 10453 79565757
Obsessive-compulsive disorder 36.07 10.29 53 168125 5874 79570336
Renal disorder 36.01 10.29 180 167998 41925 79534285
Lactic acidosis 35.93 10.29 58 168120 70301 79505909
Bronchopulmonary aspergillosis 35.77 10.29 3 168175 22291 79553919
Affective disorder 35.09 10.29 63 168115 8256 79567954
Anaphylactic shock 35.01 10.29 16 168162 35980 79540230
Abortion spontaneous 34.95 10.29 139 168039 29368 79546842
Product complaint 34.90 10.29 83 168095 13266 79562944
Haemophagocytic lymphohistiocytosis 34.87 10.29 3 168175 21834 79554376
Bipolar disorder 34.62 10.29 60 168118 7647 79568563
Weight increased 34.60 10.29 797 167381 276589 79299621
Foetal death 34.04 10.29 61 168117 7983 79568227
Heart rate decreased 34.03 10.29 60 168118 70256 79505954
Prescribed overdose 33.86 10.29 164 168014 37719 79538491
Cough 33.76 10.29 557 167621 366232 79209978
Haemoptysis 33.74 10.29 41 168137 55958 79520252
Vomiting 33.73 10.29 1109 167069 664719 78911491
Prostate cancer 33.61 10.29 14 168164 33254 79542956
Obesity 33.54 10.29 155 168023 34970 79541240
Cytokine release syndrome 33.49 10.29 17 168161 35981 79540229
Euphoric mood 33.22 10.29 59 168119 7667 79568543
Hypercalcaemia 33.07 10.29 20 168158 38410 79537800
Acute myeloid leukaemia 32.85 10.29 12 168166 30873 79545337
Feelings of worthlessness 32.46 10.29 18 168160 534 79575676
Neoplasm progression 32.04 10.29 37 168141 51645 79524565
Inadequate analgesia 32.02 10.29 44 168134 4585 79571625
Drug tolerance 31.97 10.29 62 168116 8613 79567597
Posterior reversible encephalopathy syndrome 31.95 10.29 8 168170 26273 79549937
Foreign body in reproductive tract 31.76 10.29 19 168159 652 79575558
Thrombotic microangiopathy 31.59 10.29 3 168175 20166 79556044
Tongue biting 31.57 10.29 30 168148 2091 79574119
Decreased appetite 31.50 10.29 520 167658 341898 79234312
Pericarditis 31.01 10.29 114 168064 104122 79472088
Pericardial effusion 31 10.29 31 168147 46206 79530004
Bradyphrenia 30.95 10.29 69 168109 10571 79565639
Blood pressure systolic increased 30.78 10.29 59 168119 66927 79509283
Brain death 30.63 10.29 48 168130 5629 79570581
Skin ulcer 30.20 10.29 42 168136 54108 79522102
Dysphemia 30.16 10.29 37 168141 3447 79572763
Attention deficit hyperactivity disorder 30.05 10.29 36 168142 3273 79572937
Sleep paralysis 30.03 10.29 18 168160 620 79575590
Nightmare 29.97 10.29 121 168057 25740 79550470
Cardiac failure congestive 29.79 10.29 177 168001 142225 79433985
Alcoholism 29.78 10.29 38 168140 3685 79572525
Device dislocation 29.69 10.29 121 168057 25849 79550361
Haematemesis 29.69 10.29 40 168138 52224 79523986
Muscle twitching 29.61 10.29 117 168061 24647 79551563
Nephropathy toxic 29.56 10.29 4 168174 20415 79555795
Ankle arthroplasty 29.49 10.29 25 168153 1500 79574710
Tinnitus 29.48 10.29 177 168001 44156 79532054
Ear infection 29.30 10.29 147 168031 34285 79541925
Dermatitis atopic 29.02 10.29 65 168113 9991 79566219
Blood bilirubin increased 29.00 10.29 60 168118 66172 79510038
Shock haemorrhagic 28.88 10.29 4 168174 20056 79556154
Tubulointerstitial nephritis 28.79 10.29 23 168155 38212 79537998
Dehydration 28.76 10.29 360 167818 247827 79328383
Rectal haemorrhage 28.68 10.29 75 168103 76225 79499985
Drug resistance 28.65 10.29 28 168150 42185 79534025
Abnormal behaviour 28.57 10.29 152 168026 36269 79539941
Feeling jittery 28.49 10.29 75 168103 12766 79563444
Pneumothorax 28.48 10.29 12 168166 28311 79547899
Metastases to liver 28.46 10.29 12 168166 28302 79547908
Urine amphetamine positive 28.42 10.29 10 168168 94 79576116
Anuria 28.32 10.29 5 168173 20958 79555252
Psychomotor hyperactivity 28.26 10.29 89 168089 16760 79559450
Anti-neutrophil cytoplasmic antibody positive vasculitis 28.16 10.29 37 168141 3692 79572518
Hyponatraemic coma 28.02 10.29 9 168169 62 79576148
Peritonitis 28.00 10.29 12 168166 28024 79548186
Apathy 27.98 10.29 75 168103 12902 79563308
Bladder cancer 27.86 10.29 4 168174 19522 79556688
Bronchial disorder 27.55 10.29 30 168148 2459 79573751
Haemorrhage 27.53 10.29 99 168079 91019 79485191
Hepatitis 27.47 10.29 47 168131 55680 79520530
Job dissatisfaction 27.30 10.29 9 168169 68 79576142
Parkinsonism 27.26 10.29 87 168091 16497 79559713
Corneal reflex decreased 27.24 10.29 14 168164 355 79575855
Dyskinesia 26.80 10.29 174 168004 44599 79531611
Pallor 26.77 10.29 40 168138 50022 79526188
Abnormal dreams 26.70 10.29 68 168110 11344 79564866
Haematoma 26.67 10.29 43 168135 52152 79524058
Pulmonary oedema 26.59 10.29 96 168082 88158 79488052
Economic problem 26.24 10.29 28 168150 2242 79573968
Drug dependence 25.99 10.29 161 168017 40608 79535602
Sputum purulent 25.85 10.29 22 168156 1327 79574883
Systemic lupus erythematosus 25.65 10.29 150 168028 120999 79455211
Dystonia 25.50 10.29 101 168077 21298 79554912
Transplant rejection 25.48 10.29 5 168173 19432 79556778
Device related infection 25.36 10.29 21 168157 34273 79541937
Electroencephalogram abnormal 25.32 10.29 43 168135 5391 79570819
Metastases to lung 25.27 10.29 4 168174 18159 79558051
Nervousness 25.23 10.29 138 168040 33277 79542933
Gambling disorder 25.23 10.29 26 168152 2000 79574210
Angina pectoris 25.16 10.29 44 168134 51688 79524522
Skin necrosis 25.13 10.29 4 168174 18083 79558127
Sleep disorder due to general medical condition, insomnia type 25.09 10.29 33 168145 43523 79532687
Cardiac disorder 25.07 10.29 230 167948 65527 79510683
Aspergillus infection 24.97 10.29 5 168173 19156 79557054
Basilar artery occlusion 24.93 10.29 11 168167 196 79576014
Palmar-plantar erythrodysaesthesia syndrome 24.87 10.29 20 168158 33114 79543096
Hepatic encephalopathy 24.69 10.29 10 168168 24156 79552054
Hepatotoxicity 24.68 10.29 44 168134 51308 79524902
Cardiotoxicity 24.66 10.29 69 168109 12170 79564040
Adrenergic syndrome 24.53 10.29 10 168168 145 79576065
Drug screen positive 24.41 10.29 45 168133 6018 79570192
Uterine perforation 24.40 10.29 46 168132 6257 79569953
Bacteraemia 24.40 10.29 20 168158 32804 79543406
Erythema dyschromicum perstans 24.20 10.29 8 168170 61 79576149
Disorientation 24.14 10.29 220 167958 62556 79513654
Dyspnoea exertional 24.11 10.29 98 168080 86975 79489235
Haemoglobin urine 24.05 10.29 10 168168 153 79576057
Delusion 24.02 10.29 96 168082 20327 79555883
Dizziness 23.98 10.29 1348 166830 525093 79051117
Urinary tract infection 23.90 10.29 421 167757 274091 79302119
Hyperglycaemia 23.59 10.29 73 168105 70262 79505948
Clostridium difficile colitis 23.59 10.29 20 168158 32263 79543947
Alanine aminotransferase increased 23.55 10.29 224 167954 162346 79413864
Plasma cell myeloma 23.53 10.29 48 168130 53211 79522999
Muscular weakness 23.48 10.29 221 167957 160508 79415702
Oedema 23.26 10.29 152 168026 119428 79456782
Arthralgia 23.19 10.29 978 167200 570825 79005385
Injection site mass 23.04 10.29 94 168084 20090 79556120
Treatment failure 22.99 10.29 239 167939 170247 79405963
Drug specific antibody 22.90 10.29 28 168150 2600 79573610
Feeling of despair 22.89 10.29 29 168149 2792 79573418
Nasopharyngitis 22.86 10.29 387 167791 253494 79322716
Orgasm abnormal 22.83 10.29 10 168168 175 79576035
Irritable bowel syndrome 22.77 10.29 62 168116 62179 79514031
Anhedonia 22.56 10.29 76 168102 14822 79561388
Soft tissue injury 22.44 10.29 23 168155 1758 79574452
Pemphigus 22.32 10.29 121 168057 99461 79476749
Muscle rigidity 22.23 10.29 92 168086 19790 79556420
Hyperbilirubinaemia 22.18 10.29 12 168166 24506 79551704
Pemphigoid 22.17 10.29 3 168175 15312 79560898
Cerebral infarction 22.08 10.29 39 168139 45637 79530573
Impaired work ability 21.95 10.29 91 168087 19590 79556620
Oedema peripheral 21.93 10.29 387 167791 251901 79324309
Mucosal dryness 21.91 10.29 32 168146 3527 79572683
Hypertension 21.75 10.29 879 167299 330113 79246097
C-reactive protein increased 21.71 10.29 171 168007 128856 79447354
Bronchiectasis 21.70 10.29 10 168168 22376 79553834
Liver function test abnormal 21.57 10.29 67 168111 64408 79511802
Rheumatoid arthritis 21.52 10.29 584 167594 207886 79368324
Musculoskeletal pain 21.52 10.29 127 168051 102227 79473983
Respiratory distress 21.43 10.29 58 168120 58281 79517929
Central nervous system necrosis 21.29 10.29 11 168167 282 79575928
Anorgasmia 21.11 10.29 19 168159 1235 79574975
Lymphopenia 21.05 10.29 20 168158 30537 79545673
Basal cell carcinoma 20.83 10.29 29 168149 37346 79538864
Product dose omission issue 20.82 10.29 676 167502 246861 79329349
Enterococcal infection 20.59 10.29 4 168174 15656 79560554
Self esteem decreased 20.56 10.29 17 168161 985 79575225
Haematochezia 20.48 10.29 105 168073 87540 79488670
Epstein-Barr virus infection 20.46 10.29 3 168175 14413 79561797
Sudden death 20.39 10.29 11 168167 22500 79553710
Tenosynovitis 20.39 10.29 4 168174 15550 79560660
Herpes zoster 20.37 10.29 114 168064 92969 79483241
Abdominal pain 20.36 10.29 646 167532 388923 79187287
Oxygen saturation decreased 20.35 10.29 174 168004 128873 79447337
Solar urticaria 20.35 10.29 8 168170 105 79576105
Second primary malignancy 20.33 10.29 3 168175 14347 79561863
Infection 20.31 10.29 373 167805 241339 79334871
Liver injury 20.26 10.29 57 168121 56557 79519653
Cannabinoid hyperemesis syndrome 20.26 10.29 7 168171 62 79576148
Blood pressure fluctuation 20.25 10.29 73 168105 67072 79509138
Serum sickness-like reaction 20.20 10.29 14 168164 621 79575589
Dysphoria 20.16 10.29 36 168142 4698 79571512
Accidental poisoning 20.16 10.29 21 168157 1636 79574574
Dermatitis bullous 20.13 10.29 3 168175 14242 79561968
Restlessness 19.99 10.29 167 168011 46325 79529885
Sensitivity to weather change 19.93 10.29 49 168129 7998 79568212
Mood swings 19.93 10.29 89 168089 19791 79556419
Left ventricular dysfunction 19.80 10.29 8 168170 19353 79556857
Device placement issue 19.76 10.29 18 168160 1189 79575021
Oliguria 19.76 10.29 5 168173 16304 79559906
Suicidal behaviour 19.71 10.29 29 168149 3218 79572992
Poor personal hygiene 19.71 10.29 13 168165 531 79575679
Graft versus host disease 19.41 10.29 4 168174 15022 79561188
Post-traumatic neck syndrome 19.37 10.29 23 168155 2071 79574139
Acute myocardial infarction 19.32 10.29 90 168088 76946 79499264
Metastases to bone 19.28 10.29 14 168164 24413 79551797
Arthritis 19.25 10.29 345 167833 114535 79461675
Compulsive shopping 19.20 10.29 15 168163 801 79575409
Symptom recurrence 19.11 10.29 24 168154 2290 79573920
Infusion site scar 19.08 10.29 11 168167 352 79575858
Hypertensive crisis 19.04 10.29 10 168168 20760 79555450
Mass excision 19.03 10.29 11 168167 354 79575856
Accidental exposure to product by child 19.02 10.29 27 168151 2899 79573311
Rhonchi 18.89 10.29 32 168146 4004 79572206
Staphylococcal sepsis 18.86 10.29 4 168174 14722 79561488
Urine sodium increased 18.76 10.29 9 168169 196 79576014
Accidental death 18.75 10.29 33 168145 4258 79571952
Orthostatic hypertension 18.74 10.29 15 168163 830 79575380
Enterocolitis 18.47 10.29 4 168174 14508 79561702
Blood uric acid increased 18.46 10.29 3 168175 13357 79562853
Atrioventricular block complete 18.45 10.29 6 168172 16604 79559606
Abulia 18.26 10.29 16 168162 1004 79575206
Dependence 18.24 10.29 24 168154 2398 79573812
Gallbladder disorder 18.21 10.29 85 168093 19255 79556955
Binge eating 18.04 10.29 12 168166 497 79575713
Duodenal ulcer 18.03 10.29 6 168172 16363 79559847
Marital problem 18.00 10.29 9 168169 215 79575995
Tachyphrenia 17.86 10.29 22 168156 2058 79574152
Acute lung injury 17.83 10.29 27 168151 3073 79573137
Hand deformity 17.82 10.29 137 168041 103782 79472428
Loss of libido 17.79 10.29 25 168153 2660 79573550
Pancreatitis acute 17.71 10.29 50 168128 49554 79526656
Clostridium difficile infection 17.58 10.29 40 168138 42645 79533565
Illusion 17.57 10.29 20 168158 1721 79574489
Cardiomyopathy acute 17.55 10.29 10 168168 313 79575897
Cardiac failure acute 17.52 10.29 9 168169 18920 79557290
Extra dose administered 17.51 10.29 48 168130 8367 79567843
Large intestine anastomosis 17.46 10.29 7 168171 97 79576113
Sternal fracture 17.42 10.29 24 168154 2506 79573704
Electrocardiogram PR prolongation 17.38 10.29 19 168159 1564 79574646
Labelled drug-drug interaction issue 17.35 10.29 18 168160 1395 79574815
Balance disorder 17.32 10.29 299 167879 98558 79477652
Gastric ulcer 17.26 10.29 28 168150 33877 79542333
Pre-existing condition improved 17.23 10.29 37 168141 5526 79570684
Haemolytic anaemia 17.21 10.29 8 168170 17812 79558398
Electrolyte imbalance 17.17 10.29 24 168154 30857 79545353
Red blood cell sedimentation rate increased 17.16 10.29 160 168018 45782 79530428
Acute hepatic failure 17.15 10.29 23 168155 30090 79546120
Blood pressure decreased 17.11 10.29 131 168047 99335 79476875
Partner stress 17.07 10.29 10 168168 330 79575880
Cytopenia 17.00 10.29 11 168167 20372 79555838
Homicidal ideation 16.97 10.29 28 168150 3429 79572781
Hypoxia 16.82 10.29 138 168040 103105 79473105
Contusion 16.77 10.29 217 167961 148559 79427651
Pulmonary hypertension 16.77 10.29 49 168129 48031 79528179
CSWS syndrome 16.75 10.29 5 168173 26 79576184
Amnesia 16.72 10.29 205 167973 62852 79513358
Hypomania 16.67 10.29 44 168134 7500 79568710
Osteoporosis 16.62 10.29 181 167997 53931 79522279
Malaise 16.61 10.29 854 167324 489015 79087195
Liver function test increased 16.60 10.29 37 168141 39736 79536474
Treatment noncompliance 16.60 10.29 176 168002 52092 79524118
Pseudomonas infection 16.47 10.29 12 168166 20891 79555319
Somnolence 16.47 10.29 638 167540 238343 79337867
Embedded device 16.45 10.29 27 168151 3292 79572918
Gun shot wound 16.38 10.29 16 168162 1154 79575056
Bruxism 16.36 10.29 30 168148 3996 79572214
Automatism 16.31 10.29 8 168170 183 79576027
Blood pressure diastolic decreased 16.29 10.29 24 168154 30192 79546018
Chronic fatigue syndrome 16.26 10.29 17 168161 1330 79574880
Abnormal clotting factor 16.23 10.29 8 168170 185 79576025
Hallucination, tactile 16.10 10.29 12 168166 597 79575613
Blood potassium increased 16.03 10.29 23 168155 29252 79546958
Vasoplegia syndrome 15.97 10.29 28 168150 3602 79572608
Sputum discoloured 15.88 10.29 89 168089 21654 79554556
Acute respiratory failure 15.87 10.29 68 168110 59473 79516737
Dyspareunia 15.85 10.29 20 168158 1918 79574292
Biliary dyskinesia 15.84 10.29 23 168155 2522 79573688
Pulmonary arterial hypertension 15.82 10.29 22 168156 28344 79547866
Choreoathetosis 15.79 10.29 18 168160 1552 79574658
Post-traumatic stress disorder 15.74 10.29 33 168145 4848 79571362
Erectile dysfunction 15.73 10.29 67 168111 14597 79561613
Orthostatic hypotension 15.68 10.29 63 168115 56101 79520109
Oscillopsia 15.67 10.29 8 168170 200 79576010
Persecutory delusion 15.61 10.29 33 168145 4876 79571334
Urine osmolarity increased 15.56 10.29 9 168169 290 79575920
Blood calcium decreased 15.53 10.29 27 168151 31792 79544418
Brain stem syndrome 15.50 10.29 14 168164 914 79575296
Stress 15.50 10.29 245 167933 79367 79496843
Corneal light reflex test abnormal 15.49 10.29 3 168175 0 79576210
Eczema 15.43 10.29 40 168138 40778 79535432
Premature delivery 15.43 10.29 16 168162 23451 79552759
Ischaemic stroke 15.38 10.29 29 168149 33102 79543108
Generalised anxiety disorder 15.37 10.29 21 168157 2176 79574034
Clonic convulsion 15.36 10.29 16 168162 1246 79574964
Postmortem blood drug level abnormal 15.34 10.29 12 168166 642 79575568
Cholangitis 15.32 10.29 4 168174 12772 79563438
Chorea 15.27 10.29 22 168156 2395 79573815
Lymphoma 15.15 10.29 9 168169 17451 79558759
Oculocephalogyric reflex absent 15.14 10.29 5 168173 38 79576172
Lymphoedema 15.13 10.29 59 168119 12354 79563856
Wound infection fungal 15.11 10.29 8 168170 216 79575994
Rales 15.10 10.29 12 168166 19989 79556221
Subacute cutaneous lupus erythematosus 15.06 10.29 27 168151 3534 79572676
Thermal burn 15.06 10.29 41 168137 7119 79569091
Vaginal odour 15.02 10.29 10 168168 415 79575795
Dissociative disorder 14.94 10.29 13 168165 808 79575402
Impulsive behaviour 14.93 10.29 24 168154 2876 79573334
Injection site reaction 14.91 10.29 179 167999 54606 79521604
Thalamic infarction 14.90 10.29 16 168162 1291 79574919
Emotional disorder 14.87 10.29 65 168113 14322 79561888
Anticholinergic syndrome 14.79 10.29 27 168151 3584 79572626
Partial seizures 14.67 10.29 47 168131 8931 79567279
Drug titration error 14.63 10.29 15 168163 1147 79575063
Coagulopathy 14.62 10.29 34 168144 35972 79540238
Angioedema 14.61 10.29 97 168081 75938 79500272
Panniculitis 14.59 10.29 4 168174 12367 79563843
Anaphylactic reaction 14.54 10.29 110 168068 83633 79492577
Hypervolaemia 14.54 10.29 44 168134 42646 79533564
Respiratory depression 14.52 10.29 104 168074 27526 79548684
Chills 14.49 10.29 244 167934 159990 79416220
Weight decreased 14.48 10.29 607 167571 354591 79221619
Decorticate posture 14.44 10.29 9 168169 333 79575877
Lower gastrointestinal haemorrhage 14.43 10.29 8 168170 16117 79560093
Foot operation 14.29 10.29 35 168143 5698 79570512
Hyperammonaemia 14.23 10.29 3 168175 11090 79565120
Supraventricular tachycardia 14.19 10.29 85 168093 21185 79555025
Subdural haematoma 14.17 10.29 28 168150 31406 79544804
Infusion site discomfort 14.11 10.29 16 168162 1371 79574839
Pain in jaw 14.03 10.29 50 168128 46101 79530109
Adjustment disorder 14.03 10.29 28 168150 3972 79572238
Priapism 14.00 10.29 30 168148 4475 79571735
Distractibility 13.97 10.29 12 168166 733 79575477
Peripheral sensory neuropathy 13.97 10.29 5 168173 13028 79563182
Faeces discoloured 13.96 10.29 25 168153 29102 79547108
Ileus 13.96 10.29 21 168157 26190 79550020
Red blood cell count decreased 13.95 10.29 68 168110 57445 79518765
Injection site induration 13.91 10.29 49 168129 9770 79566440
Klebsiella infection 13.78 10.29 8 168170 15712 79560498
Femur fracture 13.77 10.29 39 168139 38613 79537597
Pulmonary toxicity 13.76 10.29 5 168173 12909 79563301
Hypophosphataemia 13.75 10.29 13 168165 19900 79556310
Stoma site ulcer 13.74 10.29 8 168170 261 79575949
Compartment syndrome 13.72 10.29 32 168146 5050 79571160
Encephalitis 13.69 10.29 7 168171 14753 79561457
Lupus vulgaris 13.68 10.29 25 168153 3321 79572889
Arrhythmia 13.66 10.29 193 167985 61079 79515131
Hyperuricaemia 13.57 10.29 4 168174 11795 79564415
Bezoar 13.50 10.29 22 168156 2666 79573544
Blood lactic acid increased 13.49 10.29 58 168120 12686 79563524
Blood pressure systolic abnormal 13.46 10.29 10 168168 17237 79558973
Ankle fracture 13.43 10.29 71 168107 16898 79559312
Pharyngeal exudate 13.42 10.29 3 168175 3 79576207
Pituitary hyperplasia 13.42 10.29 3 168175 3 79576207
Drug screen false positive 13.39 10.29 14 168164 1095 79575115
Oesophagitis 13.38 10.29 19 168159 24270 79551940
Narcolepsy 13.37 10.29 15 168163 1271 79574939
Joint effusion 13.36 10.29 11 168167 18003 79558207
Enuresis 13.33 10.29 24 168154 3152 79573058
Carbon monoxide poisoning 13.31 10.29 8 168170 277 79575933
Hyperthermia 13.29 10.29 74 168104 17963 79558247
Pancreatic carcinoma 13.26 10.29 6 168172 13571 79562639
Homeless 13.25 10.29 6 168172 114 79576096
Death 13.23 10.29 1022 167156 565492 79010718
Aggression 13.22 10.29 165 168013 50793 79525417
Purpura 13.20 10.29 13 168165 19514 79556696
Diverticulitis 13.16 10.29 51 168127 45885 79530325
Erythema induratum 12.92 10.29 7 168171 198 79576012
Cerebrovascular accident 12.92 10.29 240 167938 155052 79421158
Bipolar I disorder 12.90 10.29 19 168159 2110 79574100
Wound 12.89 10.29 170 168008 116009 79460201
Forced expiratory volume decreased 12.85 10.29 41 168137 7773 79568437
Schizoaffective disorder 12.74 10.29 19 168159 2133 79574077
Respiratory tract infection 12.74 10.29 56 168122 48633 79527577
Face oedema 12.73 10.29 25 168153 28111 79548099
Gastric haemorrhage 12.72 10.29 8 168170 15042 79561168
Hypocalcaemia 12.71 10.29 58 168120 49866 79526344
Kidney transplant rejection 12.69 10.29 3 168175 10243 79565967
Mental impairment 12.65 10.29 76 168102 18960 79557250
Lip squamous cell carcinoma 12.64 10.29 8 168170 304 79575906
Hyperthyroidism 12.61 10.29 17 168161 22192 79554018
Vaginal haemorrhage 12.58 10.29 84 168094 21733 79554477
Staphylococcal bacteraemia 12.57 10.29 5 168173 12213 79563997
Body temperature decreased 12.54 10.29 31 168147 32114 79544096
Rheumatoid nodule 12.50 10.29 11 168167 17427 79558783
Abscess sterile 12.49 10.29 5 168173 69 79576141
Dermatillomania 12.46 10.29 7 168171 213 79575997
Ulcer 12.41 10.29 28 168150 29944 79546266
Cardiac failure chronic 12.40 10.29 4 168174 11131 79565079
Hypoalbuminaemia 12.40 10.29 16 168162 21281 79554929
Pupillary reflex impaired 12.40 10.29 24 168154 3329 79572881
Red blood cells urine 12.39 10.29 11 168167 702 79575508
Social anxiety disorder 12.37 10.29 10 168168 561 79575649
Hypotonic urinary bladder 12.36 10.29 5 168173 71 79576139
Right ventricular failure 12.34 10.29 19 168159 23478 79552732
Blood alkaline phosphatase increased 12.34 10.29 81 168097 63583 79512627
Gastrointestinal sounds abnormal 12.32 10.29 32 168146 5403 79570807
Body height decreased 12.32 10.29 43 168135 8537 79567673
Cachexia 12.31 10.29 4 168174 11079 79565131
Drug tolerance decreased 12.27 10.29 6 168172 12972 79563238
Insurance issue 12.23 10.29 33 168145 5700 79570510
Hypogammaglobulinaemia 12.22 10.29 6 168172 12945 79563265
Complication of device removal 12.20 10.29 26 168152 3863 79572347
Visual impairment 12.18 10.29 267 167911 91864 79484346
Hypoaesthesia 12.16 10.29 478 167700 178874 79397336
Pulmonary mass 12.13 10.29 27 168151 29007 79547203
Flat affect 12.06 10.29 18 168160 2023 79574187
Heavy menstrual bleeding 12.05 10.29 60 168118 13951 79562259
Pelvic pain 12.01 10.29 58 168120 13323 79562887
Inflammation 12.00 10.29 133 168045 93620 79482590
Abnormal uterine bleeding 11.99 10.29 13 168165 1060 79575150
Non-alcoholic steatohepatitis 11.97 10.29 19 168159 2253 79573957
Injection site abscess 11.97 10.29 16 168162 1624 79574586
Initial insomnia 11.96 10.29 37 168141 6901 79569309
Lip dry 11.96 10.29 9 168169 15409 79560801
Glossodynia 11.91 10.29 150 168028 103187 79473023
Erysipelas 11.91 10.29 4 168174 10846 79565364
Candida infection 11.89 10.29 41 168137 38173 79538037
Food craving 11.84 10.29 16 168162 1641 79574569
Pneumonia bacterial 11.81 10.29 14 168164 19317 79556893
Rhinorrhoea 11.80 10.29 103 168075 75971 79500239
Panic disorder 11.79 10.29 22 168156 2970 79573240
Deep vein thrombosis postoperative 11.74 10.29 4 168174 10748 79565462
Cutaneous lupus erythematosus 11.73 10.29 22 168156 2981 79573229
Appendicitis 11.72 10.29 16 168162 20778 79555432
Inflammatory marker increased 11.72 10.29 4 168174 10736 79565474
Heparin-induced thrombocytopenia 11.67 10.29 3 168175 9679 79566531
Gastroenteritis viral 11.66 10.29 91 168087 24740 79551470
Poor quality sleep 11.64 10.29 85 168093 22637 79553573
Renal tubular necrosis 11.55 10.29 22 168156 25017 79551193
Ejaculation failure 11.50 10.29 8 168170 357 79575853
Acute pulmonary oedema 11.44 10.29 8 168170 14222 79561988
Mouth ulceration 11.41 10.29 42 168136 38352 79537858
Injury 11.36 10.29 228 167950 77268 79498942
Bankruptcy 11.33 10.29 4 168174 38 79576172
Alopecia 11.27 10.29 387 167791 230968 79345242
Ideas of reference 11.26 10.29 6 168172 164 79576046
Haemorrhagic ovarian cyst 11.24 10.29 10 168168 640 79575570
Right ventricular systolic pressure decreased 11.24 10.29 5 168173 91 79576119
Diarrhoea haemorrhagic 11.23 10.29 7 168171 13227 79562983
Tri-iodothyronine free decreased 11.21 10.29 8 168170 372 79575838
Road traffic accident 11.16 10.29 141 168037 43523 79532687
COVID-19 pneumonia 11.12 10.29 28 168150 28821 79547389
Reactive psychosis 11.11 10.29 3 168175 10 79576200
Blood urea increased 11.09 10.29 59 168119 48731 79527479
Visuospatial deficit 11.06 10.29 4 168174 41 79576169
Galactorrhoea 11.01 10.29 24 168154 3622 79572588
Gastroenteritis 10.99 10.29 36 168142 34046 79542164
Fungal infection 10.93 10.29 48 168130 41700 79534510
Device breakage 10.86 10.29 48 168130 10627 79565583
Cerebral ischaemia 10.85 10.29 5 168173 11190 79565020
Symptom masked 10.82 10.29 14 168164 1376 79574834
Personality disorder 10.80 10.29 33 168145 6113 79570097
Pulmonary fibrosis 10.79 10.29 52 168126 44060 79532150
Bone pain 10.76 10.29 71 168107 55671 79520539
Persistent depressive disorder 10.76 10.29 13 168165 1192 79575018
Arthritis bacterial 10.74 10.29 3 168175 9163 79567047
Binge drinking 10.69 10.29 3 168175 12 79576198
Cortisol increased 10.67 10.29 9 168169 536 79575674
Concussion 10.64 10.29 44 168134 9459 79566751
Iron deficiency anaemia 10.62 10.29 24 168154 25648 79550562
Dysarthria 10.60 10.29 201 167977 67421 79508789
Blood pressure diastolic abnormal 10.60 10.29 15 168163 19187 79557023
Cataract 10.60 10.29 82 168096 62038 79514172
Feeling guilty 10.56 10.29 11 168167 857 79575353
Family stress 10.51 10.29 10 168168 698 79575512
Transfusion 10.50 10.29 18 168160 21312 79554898
Change in sustained attention 10.50 10.29 3 168175 13 79576197
Immunosuppressant drug level increased 10.50 10.29 3 168175 9024 79567186
Petechiae 10.45 10.29 17 168161 20548 79555662
Executive dysfunction 10.44 10.29 7 168171 294 79575916
Urinary incontinence 10.42 10.29 132 168046 40777 79535433
Derealisation 10.40 10.29 15 168163 1634 79574576
Pulmonary embolism 10.36 10.29 279 167899 171375 79404835
Energy increased 10.36 10.29 22 168156 3260 79572950
Tongue spasm 10.33 10.29 5 168173 111 79576099

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A08AA62 ALIMENTARY TRACT AND METABOLISM
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
Centrally acting antiobesity products
ATC N06AX12 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
FDA MoA N0000000102 Norepinephrine Uptake Inhibitors
FDA MoA N0000000114 Dopamine Uptake Inhibitors
FDA PE N0000009282 Increased Dopamine Activity
FDA PE N0000009456 Increased Norepinephrine Activity
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
FDA EPC N0000180855 Aminoketone
MeSH PA D000928 Antidepressive Agents
MeSH PA D018687 Antidepressive Agents, Second-Generation
MeSH PA D002491 Central Nervous System Agents
MeSH PA D065690 Cytochrome P-450 CYP2D6 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D015259 Dopamine Agents
MeSH PA D018765 Dopamine Uptake Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D011619 Psychotropic Drugs
MeSH PA D000077444 Smoking Cessation Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Depressive disorder indication 35489007
Nicotine dependence indication 56294008 DOID:0050742
Seasonal affective disorder indication 247803002
Major depressive disorder indication 370143000
Smoking cessation assistance indication 384742004
Obesity indication 414916001 DOID:9970
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Attention deficit hyperactivity disorder off-label use 406506008
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Mood swings contraindication 18963009
Lowered convulsive threshold contraindication 19260006
Cirrhosis of liver contraindication 19943007 DOID:5082
Myocardial infarction contraindication 22298006 DOID:5844
Feeling agitated contraindication 24199005
Hypertensive disorder contraindication 38341003 DOID:10763
Anorexia nervosa contraindication 56882008 DOID:8689
Hepatic failure contraindication 59927004
Psychotic disorder contraindication 69322001
Opioid dependence contraindication 75544000 DOID:2559
Bulimia nervosa contraindication 78004001
Hostile behavior contraindication 79351003
Injury of head contraindication 82271004
Weight loss contraindication 89362005
Kidney disease contraindication 90708001 DOID:557
Secondary malignant neoplasm of cerebrum contraindication 94248000
Neoplasm of central nervous system contraindication 126951006 DOID:3620
Seizure disorder contraindication 128613002
Bipolar affective disorder, current episode manic contraindication 191618007
Disease of liver contraindication 235856003 DOID:409
Diabetic - poor control contraindication 268519009
Alcohol withdrawal-induced convulsion contraindication 308742005
Panic disorder contraindication 371631005 DOID:594
Sedative Drug Dependence contraindication
Seizure due to Abrupt Benzodiazepine Withdrawal contraindication
Stimulant Drug Dependence contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.87 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11278544 April 21, 2024 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 7462626 July 20, 2024 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8815889 July 20, 2024 FOR EFFECT ON BLOOD GLUCOSE PARAMETERS IN PATIENTS WITH INSULIN RESISTANCE
174MG APLENZIN BAUSCH N022108 April 23, 2008 RX TABLET, EXTENDED RELEASE ORAL 7569610 June 27, 2026 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
348MG APLENZIN BAUSCH N022108 April 23, 2008 RX TABLET, EXTENDED RELEASE ORAL 7569610 June 27, 2026 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
522MG APLENZIN BAUSCH N022108 April 23, 2008 RX TABLET, EXTENDED RELEASE ORAL 7569610 June 27, 2026 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9107837 June 4, 2027 USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10307376 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8318788 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT MANAGEMENT FOR AFFECTING WEIGHT LOSS
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8722085 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9125868 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11324741 May 29, 2029 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8916195 Feb. 2, 2030 USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11033543 Jan. 10, 2031 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9248123 Jan. 13, 2032 USE OF NALTREXONE AND BUPROPION FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10403170 June 5, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11139056 June 5, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9633575 June 25, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 8569328 Oct. 29, 2033 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10231964 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10828294 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10835527 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10058518 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10064857 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10080727 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092560 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10092561 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10105327 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10105361 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10251879 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10463634 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10512643 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10548857 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10596167 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10772850 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10786469 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10786496 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10799497 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10806710 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10864209 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874663 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874664 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10874665 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10881624 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10881657 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10894046 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10894047 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10898453 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10933034 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10945973 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966941 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966974 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11020389 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11058648 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11090300 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11096937 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11123343 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11129826 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11141388 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11141416 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11147808 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11185515 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11191739 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11197839 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11207281 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11213521 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11229640 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11234946 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11253491 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11253492 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273133 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11273134 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285118 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11285146 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291638 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11291665 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11298351 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11298352 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11311534 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11344544 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11357744 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11364233 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11382874 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11419867 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426370 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11426401 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11433067 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11439636 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11478468 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11497721 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11510918 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11517542 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11517543 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11524007 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11524008 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11534414 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11541021 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11541048 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11596627 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11617728 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 11617747 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO INCREASE DEXTROMETHORPHAN PLASMA LEVELS
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9168234 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9198905 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9205083 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9238032 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9278095 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9314462 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9370513 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9375429 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9408815 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9421176 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457023 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9457025 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9474731 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9486450 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700528 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9700553 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9707191 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9763932 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9861595 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9867819 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 9968568 Nov. 5, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10780066 Nov. 9, 2034 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10780064 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10925842 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10940124 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL 10966942 Jan. 7, 2040 DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
105MG;45MG AUVELITY AXSOME N215430 Aug. 18, 2022 RX TABLET, EXTENDED RELEASE ORAL Aug. 18, 2025 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium-dependent dopamine transporter Transporter INHIBITOR Kd 6.28 WOMBAT-PK CHEMBL
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Ki 5.16 CHEMBL CHEMBL
Cytochrome P450 2D6 Enzyme WOMBAT-PK
Neuronal acetylcholine receptor subunit alpha-7 Ion channel IC50 4.30 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 5.70 DRUG MATRIX
Neuronal acetylcholine receptor; alpha3/beta4 Ion channel IC50 5.74 CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 5.04 WOMBAT-PK
Neuronal acetylcholine receptor; alpha3/beta2 Ion channel IC50 6 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 4.80 PDSP
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 5.85 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter IC50 5.91 CHEMBL

External reference:

IDSource
4019645 VUID
N0000147738 NUI
D00817 KEGG_DRUG
31677-93-7 SECONDARY_CAS_RN
905818-69-1 SECONDARY_CAS_RN
203204 RXNORM
C0085208 UMLSCUI
CHEBI:3219 CHEBI
CHEMBL894 ChEMBL_ID
DB01156 DRUGBANK_ID
CHEMBL1201735 ChEMBL_ID
CHEMBL1698 ChEMBL_ID
D016642 MESH_DESCRIPTOR_UI
444 PUBCHEM_CID
7135 IUPHAR_LIGAND_ID
3562 INN_ID
01ZG3TPX31 UNII
162122 MMSL
26259 MMSL
31548 MMSL
4307 MMSL
4319 MMSL
d00181 MMSL
387564004 SNOMEDCT_US
395733003 SNOMEDCT_US
431408005 SNOMEDCT_US
96199001 SNOMEDCT_US
4019483 VANDF
4019645 VANDF
4029878 VANDF
001512 NDDF
004611 NDDF
012996 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-5445 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL ANDA 30 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-5445 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL ANDA 30 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-6811 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 30 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-6811 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 30 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0135 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0135 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0135 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0135 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0722 TABLET, FILM COATED 200 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0722 TABLET, FILM COATED 200 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0722 TABLET, FILM COATED 200 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0722 TABLET, FILM COATED 200 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0947 TABLET, FILM COATED 100 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0947 TABLET, FILM COATED 100 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0947 TABLET, FILM COATED 100 mg ORAL NDA 29 sections
WELLBUTRINSR HUMAN PRESCRIPTION DRUG LABEL 1 0173-0947 TABLET, FILM COATED 100 mg ORAL NDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-0410 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-0410 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-0415 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-0415 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-1111 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-1111 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 29 sections
WELLBUTRINXL HUMAN PRESCRIPTION DRUG LABEL 1 0187-0730 TABLET, EXTENDED RELEASE 150 mg ORAL NDA 28 sections
WELLBUTRINXL HUMAN PRESCRIPTION DRUG LABEL 1 0187-0730 TABLET, EXTENDED RELEASE 150 mg ORAL NDA 28 sections
WELLBUTRINXL HUMAN PRESCRIPTION DRUG LABEL 1 0187-0731 TABLET, EXTENDED RELEASE 300 mg ORAL NDA 28 sections
WELLBUTRINXL HUMAN PRESCRIPTION DRUG LABEL 1 0187-0731 TABLET, EXTENDED RELEASE 300 mg ORAL NDA 28 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5810 TABLET, EXTENDED RELEASE 174 mg ORAL NDA 29 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5810 TABLET, EXTENDED RELEASE 174 mg ORAL NDA 29 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5811 TABLET, EXTENDED RELEASE 348 mg ORAL NDA 29 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5811 TABLET, EXTENDED RELEASE 348 mg ORAL NDA 29 sections