bupropion 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 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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 3641.95 9.87 2856 125574 135345 53085291
Toxicity to various agents 864.89 9.87 1738 126692 217860 53002776
Depression 624.58 9.87 1367 127063 181685 53038951
Overdose 551.09 9.87 955 127475 106781 53113855
Intentional overdose 508.99 9.87 714 127716 66491 53154145
Generalised tonic-clonic seizure 456.49 9.87 447 127983 28311 53192325
Seizure 446.72 9.87 972 127458 128537 53092099
Product substitution issue 430.97 9.87 335 128095 15531 53205105
Anxiety 415.07 9.87 1225 127205 195479 53025157
Suicidal ideation 411.53 9.87 611 127819 59900 53160736
Poisoning 334.59 9.87 273 128157 13577 53207059
Cardio-respiratory arrest 324.12 9.87 539 127891 58219 53162417
Cardiac arrest 299.11 9.87 682 127748 92985 53127651
Suicide attempt 289.76 9.87 510 127920 57658 53162978
Respiratory arrest 288.13 9.87 379 128051 33161 53187475
Serotonin syndrome 283.97 9.87 334 128096 26072 53194564
Electrocardiogram QRS complex prolonged 265.52 9.87 168 128262 5574 53215062
Agitation 229.78 9.87 464 127966 58162 53162474
Suspected suicide 220.16 9.87 135 128295 4233 53216403
Temperature regulation disorder 199.31 9.87 125 128305 4082 53216554
Status epilepticus 193.82 9.87 210 128220 14974 53205662
Irritability 185.62 9.87 295 128135 30658 53189978
Mydriasis 173.99 9.87 173 128257 11153 53209483
Pemphigus 170.36 9.87 24 128406 104007 53116629
Tremor 166.38 9.87 671 127759 125065 53095571
Drug withdrawal syndrome 165.19 9.87 265 128165 27757 53192879
Anaemia 153.84 9.87 269 128161 276449 52944187
Neutropenia 151.90 9.87 98 128332 159087 53061549
Feeling abnormal 148.95 9.87 683 127747 134618 53086018
Systemic lupus erythematosus 146.82 9.87 59 128371 125355 53095281
Pyrexia 145.91 9.87 491 127939 402702 52817934
Electrocardiogram QT prolonged 145.02 9.87 378 128052 56025 53164611
Coeliac disease 144.60 9.87 139 128291 8596 53212040
Insomnia 144.11 9.87 855 127575 186217 53034419
Therapeutic response unexpected 143.42 9.87 192 128238 17078 53203558
Acute kidney injury 140.90 9.87 247 128183 253621 52967015
Food allergy 136.47 9.87 131 128299 8087 53212549
Thrombocytopenia 135.66 9.87 83 128347 138644 53081992
Sinus tachycardia 132.26 9.87 218 128212 23354 53197282
Swelling 130.37 9.87 161 128269 190944 53029692
Hyperhidrosis 128.35 9.87 517 127913 96276 53124360
Hand deformity 124.79 9.87 26 128404 84823 53135813
Maternal exposure during pregnancy 116.04 9.87 122 128308 155517 53065119
Febrile neutropenia 113.92 9.87 55 128375 104881 53115755
Glossodynia 112.85 9.87 50 128380 100241 53120395
Headache 106.86 9.87 1849 126581 534972 52685664
General physical health deterioration 106.41 9.87 118 128312 146824 53073812
Pancytopenia 104.42 9.87 44 128386 90884 53129752
Cardiac failure 104.42 9.87 38 128392 85806 53134830
Treatment failure 103.39 9.87 94 128336 128309 53092327
White blood cell count abnormal 101.67 9.87 92 128338 5266 53215370
Anger 97.19 9.87 134 128296 12256 53208380
Product complaint 96.81 9.87 133 128297 12124 53208512
Joint swelling 96.64 9.87 269 128161 234369 52986267
Arthropathy 95.56 9.87 120 128310 141333 53079303
Drug abuse 94.13 9.87 359 128071 65167 53155469
Crying 90.52 9.87 179 128251 22083 53198553
Immunodeficiency 90.20 9.87 143 128287 14824 53205812
Sleep apnoea syndrome 89.24 9.87 195 128235 25807 53194829
Infusion related reaction 88.02 9.87 150 128280 155807 53064829
Withdrawal syndrome 86.84 9.87 162 128268 19139 53201497
Peripheral swelling 86.57 9.87 234 128196 205874 53014762
Dyspnoea 85.71 9.87 951 127479 585281 52635355
Malignant neoplasm progression 84.77 9.87 33 128397 71508 53149128
Myoclonus 84.70 9.87 143 128287 15621 53205015
Mental status changes 81.78 9.87 245 128185 39326 53181310
Helicobacter infection 80.75 9.87 3 128427 39066 53181570
Pneumonia 79.52 9.87 614 127816 406555 52814081
Product odour abnormal 79.01 9.87 45 128385 1227 53219409
Tardive dyskinesia 78.43 9.87 97 128333 7973 53212663
Exposure via ingestion 78.26 9.87 64 128366 3191 53217445
Diarrhoea 77.73 9.87 1051 127379 624495 52596141
Memory impairment 74.80 9.87 402 128028 84355 53136281
Atrial fibrillation 74.06 9.87 96 128334 111556 53109080
Infarction 74.01 9.87 56 128374 2491 53218145
Panic attack 73.93 9.87 161 128269 21257 53199379
Pulseless electrical activity 73.09 9.87 90 128340 7364 53213272
Bursitis 73.05 9.87 165 128265 22327 53198309
Product residue present 72.34 9.87 68 128362 4088 53216548
Duodenal ulcer perforation 71.70 9.87 3 128427 35180 53185456
Hyponatraemia 71.41 9.87 94 128336 108513 53112123
Sepsis 71.13 9.87 154 128276 146275 53074361
Sympathomimetic effect 70.88 9.87 18 128412 36 53220600
Lower respiratory tract infection 70.41 9.87 69 128361 90912 53129724
Anti-cyclic citrullinated peptide antibody positive 70.04 9.87 25 128405 57147 53163489
Postmortem blood drug level increased 67.44 9.87 31 128399 531 53220105
Weight increased 67.38 9.87 771 127659 203796 53016840
Renal impairment 67.04 9.87 61 128369 83257 53137379
Migraine 66.00 9.87 374 128056 80043 53140593
Pericarditis 65.09 9.87 37 128393 64369 53156267
Disturbance in attention 64.66 9.87 206 128224 34177 53186459
Postictal state 64.63 9.87 37 128393 1019 53219617
Cardiogenic shock 64.47 9.87 135 128295 17347 53203289
Polycystic ovaries 63.84 9.87 49 128381 2227 53218409
Sensitisation 63.80 9.87 40 128390 1305 53219331
Drug hypersensitivity 62.78 9.87 941 127489 264301 52956335
Cholecystitis chronic 62.70 9.87 100 128330 10418 53210218
Rash 62.66 9.87 730 127700 445461 52775175
Platelet count decreased 61.86 9.87 103 128327 107996 53112640
Hyperkalaemia 61.09 9.87 27 128403 54229 53166407
Blister 60.62 9.87 60 128370 78693 53141943
Alopecia 60.38 9.87 325 128105 234258 52986378
Bone marrow failure 59.96 9.87 3 128427 30112 53190524
Areflexia 59.32 9.87 53 128377 2983 53217653
Brain injury 59.07 9.87 75 128355 6330 53214306
Bipolar disorder 58.60 9.87 82 128348 7604 53213032
Hepatocellular injury 56.63 9.87 4 128426 29982 53190654
Disease progression 56.59 9.87 99 128331 101821 53118815
Abdominal discomfort 56.48 9.87 307 128123 220755 52999881
Mental disorder 56.23 9.87 157 128273 24219 53196417
Infection 55.95 9.87 219 128211 171986 53048650
Haemoglobin decreased 55.30 9.87 159 128271 137148 53083488
Feeling jittery 55.08 9.87 102 128328 11981 53208655
Cerebral venous thrombosis 54.08 9.87 45 128385 2299 53218337
Muscle injury 53.36 9.87 5 128425 29761 53190875
Septic shock 53.18 9.87 43 128387 62186 53158450
Asthma 52.10 9.87 444 127986 108528 53112108
Intentional product misuse 51.81 9.87 246 128184 49146 53171490
Pleural effusion 51.05 9.87 84 128346 88495 53132141
Hepatic function abnormal 50.87 9.87 13 128417 36886 53183750
Neutrophil count decreased 49.90 9.87 28 128402 49070 53171566
Synovitis 48.72 9.87 118 128312 107775 53112861
Tachycardia 48.66 9.87 435 127995 107777 53112859
Mood altered 48.55 9.87 105 128325 13796 53206840
Leukopenia 47.85 9.87 64 128366 73399 53147237
Pupil fixed 47.76 9.87 37 128393 1705 53218931
Sleep-related eating disorder 46.60 9.87 27 128403 761 53219875
Hypokalaemia 46.44 9.87 102 128328 96415 53124221
Death 46.09 9.87 595 127835 356637 52863999
Persistent genital arousal disorder 45.97 9.87 20 128410 299 53220337
Multiple organ dysfunction syndrome 45.70 9.87 40 128390 55637 53164999
Multiple sclerosis relapse 45.32 9.87 221 128209 44632 53176004
Drug intolerance 44.80 9.87 300 128130 205193 53015443
Depressed mood 44.68 9.87 192 128238 36772 53183864
White blood cell count decreased 44.57 9.87 152 128278 124323 53096313
Hyperreflexia 44.08 9.87 60 128370 5420 53215216
Mucosal inflammation 44.06 9.87 24 128406 42760 53177876
Folliculitis 44.04 9.87 11 128419 31698 53188938
Cholestasis 43.85 9.87 8 128422 28687 53191949
Major depression 43.71 9.87 71 128359 7511 53213125
Renal failure 43.54 9.87 143 128287 118309 53102327
Discomfort 43.43 9.87 104 128326 95368 53125268
Nausea 43.07 9.87 2227 126203 753864 52466772
Ejection fraction 42.78 9.87 28 128402 985 53219651
Hallucination 42.59 9.87 248 128182 53590 53167046
Brugada syndrome 41.89 9.87 19 128411 315 53220321
Gastrointestinal haemorrhage 41.08 9.87 82 128348 80248 53140388
Wound 40.65 9.87 101 128329 91456 53129180
Bronchial neoplasm 40.53 9.87 20 128410 404 53220232
Amnesia 40.07 9.87 215 128215 45073 53175563
Drug screen positive 39.99 9.87 48 128382 3824 53216812
Affective disorder 39.15 9.87 57 128373 5482 53215154
Akathisia 38.63 9.87 72 128358 8499 53212137
Stomatitis 38.54 9.87 115 128315 98043 53122593
Rash erythematous 38.45 9.87 186 128244 37437 53183199
Nicotine dependence 38.16 9.87 22 128408 614 53220022
Muscle twitching 38.08 9.87 106 128324 16320 53204316
Liver disorder 37.88 9.87 25 128405 40130 53180506
Gastrointestinal disorder 37.88 9.87 102 128328 89902 53130734
Vertigo 37.87 9.87 248 128182 55833 53164803
Nervousness 37.44 9.87 158 128272 30020 53190616
Drug reaction with eosinophilia and systemic symptoms 37.44 9.87 16 128414 32784 53187852
Lung disorder 37.39 9.87 36 128394 47843 53172793
Drug titration error 37.32 9.87 22 128408 641 53219995
Unresponsive to stimuli 36.90 9.87 169 128261 33257 53187379
Hostility 36.88 9.87 31 128399 1606 53219030
Ventricular tachycardia 36.72 9.87 110 128320 17652 53202984
Bronchial haemorrhage 36.68 9.87 20 128410 500 53220136
Rubber sensitivity 36.42 9.87 33 128397 1892 53218744
Thinking abnormal 36.27 9.87 79 128351 10429 53210207
Emotional distress 36.13 9.87 164 128266 32153 53188483
Nasopharyngitis 36.02 9.87 293 128137 192002 53028634
Nightmare 35.82 9.87 109 128321 17642 53202994
Abnormal dreams 35.80 9.87 79 128351 10522 53210114
Automatism 35.77 9.87 11 128419 55 53220581
Choreoathetosis 35.69 9.87 19 128411 452 53220184
Asthma exercise induced 35.48 9.87 17 128413 321 53220315
Dizziness 35.26 9.87 1158 127272 371101 52849535
Factor V Leiden mutation 34.92 9.87 15 128415 217 53220419
Hypoglycaemia 34.90 9.87 55 128375 58958 53161678
Bruxism 34.33 9.87 41 128389 3250 53217386
Sleep paralysis 34.32 9.87 20 128410 570 53220066
Brain death 33.91 9.87 39 128391 2969 53217667
Cerebral haemorrhage 33.65 9.87 15 128415 29981 53190655
Epistaxis 33.56 9.87 72 128358 68638 53151998
Arthralgia 33.42 9.87 805 127625 438978 52781658
Peritonitis 33.24 9.87 6 128424 21681 53198955
Toxic epidermal necrolysis 33.04 9.87 8 128422 23542 53197094
Gamma-glutamyltransferase increased 32.87 9.87 20 128410 33535 53187101
Feeling of despair 32.82 9.87 32 128398 2013 53218623
Off label use 32.77 9.87 876 127554 471336 52749300
Sleep disorder due to general medical condition, insomnia type 32.76 9.87 9 128421 24340 53196296
Somnolence 32.51 9.87 576 127854 167158 53053478
Vision blurred 32.46 9.87 332 128098 85272 53135364
Stress 32.41 9.87 242 128188 56842 53163794
Mania 32.16 9.87 81 128349 11748 53208888
Libido decreased 32.03 9.87 36 128394 2673 53217963
Affect lability 31.81 9.87 70 128360 9305 53211331
Hepatic failure 31.53 9.87 24 128406 35782 53184854
Nasal turbinate hypertrophy 31.48 9.87 20 128410 668 53219968
Libido increased 31.15 9.87 24 128406 1097 53219539
Electroencephalogram abnormal 30.99 9.87 42 128388 3779 53216857
Plasma cell myeloma 30.87 9.87 42 128388 47832 53172804
Hallucinations, mixed 30.80 9.87 45 128385 4341 53216295
Impaired work ability 30.79 9.87 89 128341 14001 53206635
Impulse-control disorder 30.51 9.87 21 128409 804 53219832
Gambling disorder 30.49 9.87 26 128404 1374 53219262
Pre-existing condition improved 30.45 9.87 63 128367 8026 53212610
Economic problem 30.30 9.87 31 128399 2067 53218569
Oedema 29.98 9.87 86 128344 74260 53146376
Tinnitus 29.85 9.87 149 128281 30370 53190266
Jaundice 29.79 9.87 18 128412 30295 53190341
International normalised ratio increased 29.71 9.87 43 128387 47718 53172918
Restless legs syndrome 29.52 9.87 100 128330 17123 53203513
Drug eruption 29.02 9.87 12 128418 25082 53195554
Psoriasis 28.96 9.87 329 128101 86760 53133876
C-reactive protein abnormal 28.92 9.87 13 128417 25857 53194779
Urine osmolarity increased 28.64 9.87 11 128419 117 53220519
Ascites 28.63 9.87 32 128398 39703 53180933
Osteonecrosis of jaw 28.43 9.87 27 128403 36119 53184517
Impaired healing 28.36 9.87 71 128359 64134 53156502
Cough 28.10 9.87 442 127988 256451 52964185
Haematemesis 28.05 9.87 20 128410 30837 53189799
Joint dislocation 27.96 9.87 79 128351 12266 53208370
Food craving 27.87 9.87 26 128404 1548 53219088
Pruritus 27.80 9.87 519 127911 293313 52927323
Hypercalcaemia 27.59 9.87 12 128418 24336 53196300
Dyskinesia 27.40 9.87 150 128280 31683 53188953
Anti-neutrophil cytoplasmic antibody positive vasculitis 27.38 9.87 31 128399 2320 53218316
Product use issue 27.37 9.87 210 128220 139374 53081262
Urine sodium increased 27.03 9.87 10 128420 95 53220541
Myelodysplastic syndrome 26.89 9.87 4 128426 16656 53203980
Syncope 26.69 9.87 159 128271 111834 53108802
Endometrial ablation 26.68 9.87 20 128410 877 53219759
Central nervous system necrosis 26.66 9.87 11 128419 143 53220493
Decreased interest 26.58 9.87 36 128394 3237 53217399
Interstitial lung disease 26.54 9.87 64 128366 58558 53162078
Tachyphrenia 26.47 9.87 24 128406 1377 53219259
Agranulocytosis 26.45 9.87 12 128418 23737 53196899
Hallucination, auditory 26.34 9.87 75 128355 11698 53208938
Anorgasmia 26.13 9.87 17 128413 592 53220044
Rash maculo-papular 26.12 9.87 20 128410 29729 53190907
Foot deformity 26.04 9.87 101 128329 18467 53202169
Posterior reversible encephalopathy syndrome 25.81 9.87 4 128426 16156 53204480
Lactic acidosis 25.76 9.87 31 128399 37222 53183414
Dyspnoea exertional 25.73 9.87 59 128371 54941 53165695
C-reactive protein increased 25.60 9.87 81 128349 67805 53152831
Accidental exposure to product by child 25.43 9.87 22 128408 1186 53219450
Thalamic infarction 25.30 9.87 16 128414 530 53220106
Mood swings 25.25 9.87 96 128334 17390 53203246
Melaena 25.04 9.87 20 128410 29109 53191527
Haemorrhage 24.93 9.87 65 128365 57922 53162714
Thermal burn 24.89 9.87 45 128385 5188 53215448
Decreased appetite 24.82 9.87 366 128064 214608 53006028
Mucosal dryness 24.60 9.87 31 128399 2597 53218039
Fluid retention 24.59 9.87 219 128211 54182 53166454
Product quality issue 24.55 9.87 163 128267 36860 53183776
Blood lactate dehydrogenase increased 24.26 9.87 11 128419 21770 53198866
Post-traumatic stress disorder 24.03 9.87 42 128388 4716 53215920
Hypomagnesaemia 24.01 9.87 15 128415 24796 53195840
Dysphemia 23.98 9.87 30 128400 2494 53218142
Paranoia 23.85 9.87 71 128359 11353 53209283
Exostosis 23.85 9.87 71 128359 11353 53209283
Large intestine anastomosis 23.83 9.87 7 128423 29 53220607
Neuropathy peripheral 23.80 9.87 148 128282 103039 53117597
Apathy 23.74 9.87 58 128372 8254 53212382
Hepatitis 23.66 9.87 28 128402 33866 53186770
Adrenergic syndrome 23.64 9.87 7 128423 30 53220606
Erythema dyschromicum perstans 23.63 9.87 8 128422 57 53220579
Dystonia 23.56 9.87 77 128353 12944 53207692
Binge eating 23.29 9.87 14 128416 423 53220213
Nephrectomy 23.28 9.87 17 128413 716 53219920
Sexual dysfunction 23.18 9.87 34 128396 3292 53217344
Impaired driving ability 23.04 9.87 39 128391 4268 53216368
Fibromyalgia 22.87 9.87 183 128247 43892 53176744
Anhedonia 22.86 9.87 67 128363 10620 53210016
Asthenia 22.86 9.87 641 127789 342949 52877687
Neoplasm progression 22.78 9.87 23 128407 29896 53190740
Supraventricular tachycardia 22.66 9.87 81 128349 14244 53206392
Blood creatinine increased 22.65 9.87 112 128318 82550 53138086
Obsessive-compulsive disorder 22.45 9.87 35 128395 3575 53217061
Upper gastrointestinal haemorrhage 22.43 9.87 7 128423 17423 53203213
Corneal reflex decreased 22.43 9.87 10 128420 159 53220477
Oppositional defiant disorder 22.14 9.87 7 128423 39 53220597
Clonus 21.83 9.87 38 128392 4253 53216383
Drug dependence 21.83 9.87 106 128324 21366 53199270
Attention deficit hyperactivity disorder 21.80 9.87 29 128401 2563 53218073
Upper respiratory tract infection 21.62 9.87 258 128172 68839 53151797
Euphoric mood 21.61 9.87 39 128391 4490 53216146
Toxic skin eruption 21.57 9.87 3 128427 13136 53207500
Anticholinergic syndrome 21.36 9.87 25 128405 1939 53218697
Solar urticaria 21.16 9.87 7 128423 46 53220590
Bronchial disorder 21.08 9.87 20 128410 1216 53219420
Herpes zoster 21.03 9.87 99 128331 73920 53146716
Lupus-like syndrome 20.91 9.87 59 128371 9153 53211483
Emotional disorder 20.89 9.87 74 128356 12956 53207680
Liver function test increased 20.82 9.87 20 128410 26608 53194028
Hypotonic urinary bladder 20.80 9.87 5 128425 7 53220629
Multiple sclerosis 20.77 9.87 124 128306 27029 53193607
Respiratory failure 20.76 9.87 149 128281 100363 53120273
Hypocalcaemia 20.73 9.87 24 128406 29313 53191323
Gastrointestinal sounds abnormal 20.55 9.87 35 128395 3849 53216787
Rheumatic fever 20.40 9.87 3 128427 12601 53208035
Urinary tract infection 20.19 9.87 432 127998 239471 52981165
Gallbladder disorder 20.17 9.87 92 128338 18073 53202563
Anuria 20.05 9.87 3 128427 12437 53208199
Self esteem decreased 20.02 9.87 14 128416 550 53220086
Premature delivery 19.95 9.87 20 128410 26084 53194552
Sedation 19.89 9.87 131 128299 29544 53191092
Oesophageal pain 19.75 9.87 30 128400 2996 53217640
Malaise 19.69 9.87 684 127746 356933 52863703
Caput succedaneum 19.69 9.87 5 128425 10 53220626
Cardiomyopathy acute 19.57 9.87 10 128420 218 53220418
Hip arthroplasty 19.46 9.87 23 128407 27839 53192797
Metastases to liver 19.45 9.87 14 128416 21482 53199154
Rheumatoid factor positive 19.43 9.87 44 128386 41154 53179482
Compulsive shopping 19.35 9.87 16 128414 810 53219826
Pneumonitis 19.02 9.87 28 128402 30860 53189776
Injury 18.99 9.87 197 128233 50774 53169862
Biliary dyskinesia 18.95 9.87 28 128402 2729 53217907
Cortisol increased 18.94 9.87 12 128418 399 53220237
Cerebrovascular accident 18.88 9.87 162 128268 105012 53115624
Rhinitis allergic 18.85 9.87 51 128379 7722 53212914
Tongue biting 18.60 9.87 20 128410 1413 53219223
Pupillary reflex impaired 18.45 9.87 24 128406 2075 53218561
Hepatotoxicity 18.44 9.87 24 128406 27856 53192780
Fluid overload 18.37 9.87 24 128406 27807 53192829
Hunger 18.37 9.87 36 128394 4411 53216225
Iron deficiency anaemia 18.30 9.87 11 128419 18569 53202067
Dysgraphia 18.19 9.87 28 128402 2829 53217807
Abnormal behaviour 18.12 9.87 102 128328 21764 53198872
Ventricular tachyarrhythmia 18.01 9.87 7 128423 77 53220559
Parkinsonism 17.86 9.87 55 128375 8958 53211678
Mobility decreased 17.79 9.87 109 128321 76162 53144474
Oscillopsia 17.67 9.87 8 128422 132 53220504
Liver function test abnormal 17.67 9.87 58 128372 48013 53172623
Retinitis 17.66 9.87 18 128412 1195 53219441
Disseminated intravascular coagulation 17.64 9.87 13 128417 19706 53200930
Restlessness 17.63 9.87 122 128308 27965 53192671
Oedema peripheral 17.61 9.87 297 128133 170490 53050146
Swollen joint count increased 17.57 9.87 3 128427 11287 53209349
Oesophageal spasm 17.53 9.87 26 128404 2542 53218094
Urine amphetamine positive 17.46 9.87 6 128424 45 53220591
Dissociation 17.28 9.87 24 128406 2210 53218426
Cerebral infarction 17.27 9.87 20 128410 24424 53196212
Complication of device insertion 17.20 9.87 42 128388 5975 53214661
Road traffic accident 17.09 9.87 113 128317 25518 53195118
Treatment noncompliance 17.05 9.87 137 128293 32898 53187738
Heart rate decreased 16.99 9.87 40 128390 36907 53183729
Rheumatoid arthritis 16.98 9.87 603 127827 313928 52906708
Somnambulism 16.84 9.87 39 128391 5363 53215273
Bone pain 16.78 9.87 64 128366 50658 53169978
Mental impairment 16.75 9.87 70 128360 13239 53207397
Acute myeloid leukaemia 16.71 9.87 10 128420 16922 53203714
Homicidal ideation 16.35 9.87 21 128409 1793 53218843
Pulmonary arterial hypertension 16.30 9.87 25 128405 27097 53193539
Tearfulness 16.29 9.87 33 128397 4141 53216495
Haematuria 16.27 9.87 27 128403 28362 53192274
Right ventricular systolic pressure decreased 16.26 9.87 5 128425 25 53220611
Product coating issue 16.22 9.87 6 128424 57 53220579
Balance disorder 16.22 9.87 257 128173 72950 53147686
Subacute cutaneous lupus erythematosus 16.20 9.87 24 128406 2344 53218292
Soft tissue injury 16.18 9.87 18 128412 1321 53219315
Blood bilirubin increased 16.18 9.87 39 128391 35691 53184945
Skin necrosis 16.04 9.87 3 128427 10569 53210067
Palmar-plantar erythrodysaesthesia syndrome 16.01 9.87 17 128413 21589 53199047
Dysphoria 16.00 9.87 38 128392 5311 53215325
Loss of libido 15.92 9.87 18 128412 1345 53219291
Pulmonary hypertension 15.85 9.87 42 128388 37228 53183408
Polyneuropathy 15.84 9.87 6 128424 13227 53207409
Femur fracture 15.80 9.87 46 128384 39539 53181097
Dermatillomania 15.76 9.87 8 128422 172 53220464
Metastases to bone 15.72 9.87 14 128416 19314 53201322
Cardiac failure congestive 15.72 9.87 145 128285 92612 53128024
Knee arthroplasty 15.71 9.87 36 128394 33533 53187103
Haemoglobin urine 15.60 9.87 7 128423 113 53220523
Clostridium difficile infection 15.56 9.87 27 128403 27866 53192770
Carpal tunnel syndrome 15.47 9.87 84 128346 17683 53202953
Depressive symptom 15.44 9.87 28 128402 3236 53217400
Sexually inappropriate behaviour 15.44 9.87 7 128423 116 53220520
Pallor 15.34 9.87 23 128407 25159 53195477
Premature baby 15.33 9.87 15 128415 19786 53200850
Breast cancer metastatic 15.20 9.87 9 128421 15319 53205317
Ejection fraction abnormal 15.13 9.87 15 128415 963 53219673
Energy increased 15.10 9.87 23 128407 2302 53218334
Orgasmic sensation decreased 15.10 9.87 3 128427 0 53220636
Hepatic cirrhosis 14.89 9.87 84 128346 17938 53202698
Rheumatoid nodule 14.85 9.87 5 128425 11859 53208777
Snoring 14.82 9.87 30 128400 3762 53216874
Narcolepsy 14.82 9.87 17 128413 1291 53219345
Dry mouth 14.71 9.87 213 128217 59337 53161299
Convulsive threshold lowered 14.60 9.87 10 128420 380 53220256
Wound infection fungal 14.52 9.87 7 128423 134 53220502
Haemangioma congenital 14.50 9.87 11 128419 491 53220145
Uterine perforation 14.45 9.87 45 128385 7374 53213262
Lethargy 14.38 9.87 195 128235 53565 53167071
Anaphylactic shock 14.32 9.87 19 128411 21874 53198762
Aggression 14.30 9.87 101 128329 23302 53197334
Cholelithiasis 14.18 9.87 156 128274 40808 53179828
Pneumothorax 14.16 9.87 10 128420 15497 53205139
Clostridium difficile colitis 14.15 9.87 16 128414 19749 53200887
Bipolar II disorder 14.13 9.87 9 128421 302 53220334
Drug screen false positive 14.12 9.87 14 128416 899 53219737
Choroidal effusion 13.97 9.87 11 128419 519 53220117
Cardiotoxicity 13.96 9.87 44 128386 7255 53213381
Bipolar I disorder 13.94 9.87 19 128411 1718 53218918
Pancreatitis acute 13.91 9.87 26 128404 26083 53194553
Posturing 13.90 9.87 11 128419 523 53220113
Hypoxic-ischaemic encephalopathy 13.80 9.87 31 128399 4177 53216459
Peritonitis bacterial 13.79 9.87 3 128427 9502 53211134
Haematoma 13.75 9.87 39 128391 33805 53186831
Acute myocardial infarction 13.72 9.87 38 128392 33197 53187439
Infusion site scar 13.70 9.87 8 128422 229 53220407
Muscle rigidity 13.63 9.87 57 128373 10784 53209852
Pain in extremity 13.50 9.87 555 127875 284495 52936141
Bezoar 13.46 9.87 17 128413 1427 53219209
Poor personal hygiene 13.40 9.87 9 128421 331 53220305
Abscess sterile 13.38 9.87 5 128425 49 53220587
Colitis 13.37 9.87 53 128377 41499 53179137
Antidepressant discontinuation syndrome 13.35 9.87 4 128426 18 53220618
Generalised anxiety disorder 13.30 9.87 20 128410 1980 53218656
Angina pectoris 13.29 9.87 31 128399 28694 53191942
Red blood cell sedimentation rate abnormal 13.20 9.87 11 128419 15678 53204958
Chronic fatigue syndrome 13.13 9.87 15 128415 1134 53219502
Shock haemorrhagic 13.12 9.87 3 128427 9180 53211456
Hypertonic bladder 13.02 9.87 26 128404 3229 53217407
Brain stem syndrome 13.02 9.87 9 128421 347 53220289
Alcoholism 13.01 9.87 21 128409 2210 53218426
Skin ulcer 12.99 9.87 44 128386 36075 53184561
Musculoskeletal pain 12.98 9.87 117 128313 75083 53145553
Autonomic nervous system imbalance 12.98 9.87 23 128407 2611 53218025
Gastrooesophageal reflux disease 12.98 9.87 275 128155 82388 53138248
Decorticate posture 12.93 9.87 9 128421 351 53220285
Distractibility 12.86 9.87 9 128421 354 53220282
Electrocardiogram QRS complex shortened 12.81 9.87 10 128420 466 53220170
Sternal fracture 12.79 9.87 19 128411 1860 53218776
Device placement issue 12.78 9.87 12 128418 720 53219916
Tenosynovitis 12.77 9.87 4 128426 9935 53210701
Rectal haemorrhage 12.67 9.87 54 128376 41427 53179209
Contraindicated product administered 12.66 9.87 240 128190 135389 53085247
Sputum purulent 12.64 9.87 14 128416 1023 53219613
Psychomotor hyperactivity 12.63 9.87 53 128377 10043 53210593
Post-traumatic neck syndrome 12.57 9.87 18 128412 1705 53218931
Hallucination, visual 12.54 9.87 83 128347 18749 53201887
Bronchiectasis 12.51 9.87 5 128425 10667 53209969
Staring 12.50 9.87 17 128413 1534 53219102
Eosinophilia 12.50 9.87 20 128410 21315 53199321
False positive investigation result 12.45 9.87 11 128419 610 53220026
Hypertensive crisis 12.42 9.87 10 128420 14496 53206140
Drug-induced liver injury 12.39 9.87 33 128397 29200 53191436
Drug resistance 12.38 9.87 18 128412 19944 53200692
Product dose omission issue 12.38 9.87 572 127858 191048 53029588
Blood triglycerides increased 12.35 9.87 61 128369 12380 53208256
Exposure via breast milk 12.34 9.87 17 128413 1553 53219083
Stoma site ulcer 12.34 9.87 8 128422 277 53220359
Gestational diabetes 12.33 9.87 45 128385 7994 53212642
Disorientation 12.32 9.87 147 128283 39212 53181424
Mass excision 12.31 9.87 8 128422 278 53220358
Carbon monoxide poisoning 12.25 9.87 7 128423 192 53220444
Flat affect 12.25 9.87 16 128414 1389 53219247
Blood pressure fluctuation 12.22 9.87 44 128386 35426 53185210
Thrombophlebitis superficial 12.17 9.87 33 128397 5002 53215634
Executive dysfunction 12.12 9.87 6 128424 122 53220514
Haemolytic anaemia 12.06 9.87 5 128425 10434 53210202
Pelvic pain 12.05 9.87 60 128370 12213 53208423
Diverticulitis 11.95 9.87 45 128385 35756 53184880
Poor quality sleep 11.93 9.87 77 128353 17246 53203390
Blood pressure systolic increased 11.88 9.87 44 128386 35133 53185503
Ill-defined disorder 11.88 9.87 70 128360 49374 53171262
Hypohidrosis 11.88 9.87 4 128426 28 53220608
Device related infection 11.87 9.87 23 128407 22763 53197873
Secondary immunodeficiency 11.81 9.87 14 128416 1101 53219535
Pain in jaw 11.78 9.87 54 128376 40615 53180021
Inappropriate schedule of product administration 11.72 9.87 249 128181 74629 53146007
Device dislocation 11.71 9.87 97 128333 23500 53197136
Social anxiety disorder 11.69 9.87 9 128421 411 53220225
Right ventricular failure 11.66 9.87 14 128416 16829 53203807
Priapism 11.66 9.87 5 128425 72 53220564
Patient dissatisfaction with treatment 11.66 9.87 5 128425 72 53220564
Obsessive thoughts 11.66 9.87 10 128420 533 53220103
Vocal cord thickening 11.64 9.87 4 128426 30 53220606
Accidental poisoning 11.63 9.87 11 128419 666 53219970
Essential tremor 11.60 9.87 13 128417 962 53219674
Panic reaction 11.60 9.87 28 128402 3955 53216681
Galactorrhoea 11.54 9.87 28 128402 3967 53216669
Increased appetite 11.50 9.87 48 128382 9074 53211562
Psychotic disorder 11.45 9.87 99 128331 24286 53196350
Irritable bowel syndrome 11.45 9.87 60 128370 43572 53177064
Dyspareunia 11.44 9.87 21 128409 2450 53218186
Metastases to lung 11.43 9.87 7 128423 11697 53208939
Bankruptcy 11.42 9.87 4 128426 32 53220604
Panic disorder 11.39 9.87 22 128408 2666 53217970
Rhonchi 11.35 9.87 21 128409 2465 53218171
Hepatic encephalopathy 11.31 9.87 6 128424 10853 53209783
Bone erosion 11.30 9.87 55 128375 11097 53209539
Hyperphagia 11.30 9.87 17 128413 1684 53218952
Macular degeneration 11.25 9.87 8 128422 12353 53208283
Therapeutic product effect incomplete 11.24 9.87 295 128135 91489 53129147
Impulsive behaviour 11.23 9.87 16 128414 1508 53219128
Tubulointerstitial nephritis 11.13 9.87 14 128416 16490 53204146
Homeless 11.13 9.87 5 128425 81 53220555
Multiple fractures 11.09 9.87 38 128392 6543 53214093
Rhinitis 11.06 9.87 47 128383 8954 53211682
Mouth ulceration 11.05 9.87 35 128395 29291 53191345
Intentional self-injury 11.02 9.87 101 128329 25183 53195453
Partner stress 10.99 9.87 7 128423 235 53220401
Middle insomnia 10.98 9.87 53 128377 10655 53209981
Angle closure glaucoma 10.98 9.87 20 128410 2320 53218316
Endometriosis 10.93 9.87 29 128401 4340 53216296
Personality disorder 10.93 9.87 28 128402 4103 53216533
Liver injury 10.92 9.87 23 128407 22080 53198556
Suicidal behaviour 10.92 9.87 21 128409 2537 53218099
Retinal dystrophy 10.91 9.87 4 128426 37 53220599
Sensitivity to weather change 10.89 9.87 36 128394 6086 53214550
Gastroenteritis 10.79 9.87 29 128401 25587 53195049
Tunnel vision 10.76 9.87 11 128419 733 53219903
Initial insomnia 10.72 9.87 32 128398 5123 53215513
Localised infection 10.70 9.87 31 128399 26685 53193951
Opisthotonus 10.67 9.87 8 128422 351 53220285
Blindness cortical 10.66 9.87 9 128421 469 53220167
Tooth fracture 10.63 9.87 50 128380 9948 53210688
Ulcer 10.58 9.87 21 128409 20598 53200038
Aphasia 10.55 9.87 117 128313 30661 53189975
Hypothyroidism 10.50 9.87 133 128297 35974 53184662
Purpura senile 10.49 9.87 10 128420 612 53220024
Abnormal sleep-related event 10.45 9.87 11 128419 758 53219878
Tension 10.45 9.87 24 128406 3282 53217354
Apnoea 10.43 9.87 42 128388 7811 53212825
Ankle operation 10.40 9.87 14 128416 1251 53219385
Gaze palsy 10.40 9.87 15 128415 1430 53219206
Extrapyramidal disorder 10.37 9.87 58 128372 12344 53208292
Basal cell carcinoma 10.32 9.87 26 128404 23443 53197193
Rhinorrhoea 10.31 9.87 81 128349 53497 53167139
Panniculitis 10.31 9.87 3 128427 7811 53212825
Nystagmus 10.30 9.87 35 128395 6001 53214635
Blood pressure orthostatic abnormal 10.30 9.87 3 128427 12 53220624
Hyperbilirubinaemia 10.29 9.87 7 128423 11062 53209574
Fear 10.28 9.87 72 128358 16569 53204067
Acute lung injury 10.27 9.87 15 128415 1446 53219190
Inadequate analgesia 10.26 9.87 22 128408 2873 53217763
Bronchopulmonary aspergillosis 10.26 9.87 4 128426 8661 53211975
Gait disturbance 10.22 9.87 474 127956 158368 53062268
Hangover 10.22 9.87 15 128415 1453 53219183
Agraphia 10.21 9.87 4 128426 45 53220591
Blood potassium increased 10.20 9.87 17 128413 17824 53202812
Haemoptysis 10.19 9.87 34 128396 28005 53192631
Tarsal tunnel syndrome 10.18 9.87 10 128420 635 53220001
Coagulopathy 10.16 9.87 20 128410 19678 53200958
Impatience 10.13 9.87 8 128422 379 53220257
Feeling guilty 10.10 9.87 9 128421 505 53220131
Drug abuser 10.09 9.87 23 128407 3130 53217506
Serum sickness-like reaction 10.08 9.87 9 128421 506 53220130
Face oedema 10.05 9.87 21 128409 20219 53200417
Pericardial effusion 9.97 9.87 33 128397 27245 53193391
Drug tolerance 9.96 9.87 28 128402 4335 53216301
Injection site mass 9.92 9.87 70 128360 16144 53204492
Corneal oedema 9.91 9.87 17 128413 1880 53218756

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 2383.31 11.59 1619 51803 90898 32369206
Depression 1262.88 11.59 1136 52286 95924 32364180
Toxicity to various agents 646.28 11.59 1093 52329 176948 32283156
Serotonin syndrome 476.03 11.59 329 53093 18788 32441316
Drug interaction 355.54 11.59 968 52454 217217 32242887
Intentional overdose 342.87 11.59 381 53041 41220 32418884
Overdose 335.24 11.59 550 52872 86527 32373577
Suicidal ideation 324.58 11.59 355 53067 37728 32422376
Anxiety 272.58 11.59 531 52891 95474 32364630
Seizure 259.83 11.59 545 52877 103309 32356795
Drug abuse 214.58 11.59 433 52989 79810 32380294
Poisoning 202.99 11.59 159 53263 10999 32449105
Cardio-respiratory arrest 176.42 11.59 324 53098 55665 32404439
Generalised tonic-clonic seizure 169.84 11.59 189 53233 20450 32439654
Suicide attempt 155.63 11.59 248 53174 37996 32422108
Electrocardiogram QRS complex prolonged 148.54 11.59 93 53329 4481 32455623
Status epilepticus 142.58 11.59 134 53288 11872 32448232
Febrile neutropenia 140.64 11.59 16 53406 119550 32340554
Anaemia 132.82 11.59 104 53318 223520 32236584
Tremor 120.24 11.59 349 53073 80928 32379176
Hyperreflexia 117.97 11.59 69 53353 2935 32457169
Thrombocytopenia 116.43 11.59 49 53373 148250 32311854
Acute kidney injury 113.26 11.59 193 53229 293275 32166829
Agitation 111.22 11.59 272 53150 56964 32403140
Product substitution issue 106.14 11.59 107 53315 10329 32449775
Loss of personal independence in daily activities 105.02 11.59 171 53251 26662 32433442
Respiratory arrest 96.97 11.59 172 53250 28736 32431368
Sepsis 92.78 11.59 75 53347 158759 32301345
Paranoia 92.46 11.59 101 53321 10698 32449406
Pyrexia 91.37 11.59 249 53173 319719 32140385
Depression suicidal 88.11 11.59 44 53378 1358 32458746
Insomnia 84.80 11.59 358 53064 99990 32360114
Sexual dysfunction 80.09 11.59 73 53349 6216 32453888
Tearfulness 79.97 11.59 44 53378 1662 32458442
Therapeutic response unexpected 77.29 11.59 87 53335 9525 32450579
Neutropenia 77.11 11.59 72 53350 142103 32318001
Psychotic disorder 75.96 11.59 136 53286 22884 32437220
General physical health deterioration 75.68 11.59 48 53374 115211 32344893
Malignant neoplasm progression 75.64 11.59 18 53404 78478 32381626
Pneumonia 75.09 11.59 315 53107 354937 32105167
Psychiatric decompensation 73.80 11.59 40 53382 1466 32458638
Irritability 72.98 11.59 139 53283 24515 32435589
Cardiac arrest 71.70 11.59 332 53090 96444 32363660
Distributive shock 70.44 11.59 33 53389 882 32459222
Postmortem blood drug level increased 68.95 11.59 22 53400 196 32459908
Platelet count decreased 68.27 11.59 53 53369 114538 32345566
Pancytopenia 67.09 11.59 33 53389 91202 32368902
Interstitial lung disease 66.51 11.59 13 53409 64988 32395116
Septic shock 66.12 11.59 16 53406 68973 32391131
Suspected suicide 63.54 11.59 47 53375 2981 32457123
Renal impairment 59.41 11.59 39 53383 91933 32368171
Major depression 57.13 11.59 52 53370 4419 32455685
Erectile dysfunction 55.23 11.59 109 53313 19730 32440374
Anger 55.12 11.59 82 53340 11822 32448282
Tardive dyskinesia 54.94 11.59 56 53366 5475 32454629
Depressive symptom 53.44 11.59 35 53387 1823 32458281
Intentional product misuse 53.42 11.59 155 53267 35896 32424208
Product complaint 52.70 11.59 56 53366 5747 32454357
Exposure via ingestion 52.66 11.59 38 53384 2319 32457785
Memory impairment 52.43 11.59 166 53256 40313 32419791
Vein of Galen aneurysmal malformation 51.94 11.59 11 53411 11 32460093
Disturbance in attention 51.64 11.59 118 53304 23635 32436469
Feeling abnormal 51.31 11.59 216 53206 60207 32399897
Cardiac failure 50.17 11.59 46 53376 91627 32368477
Dyspnoea 49.18 11.59 371 53051 361674 32098430
Diarrhoea 49.00 11.59 375 53047 364427 32095677
Cardiogenic shock 47.55 11.59 105 53317 20557 32439547
Clonus 46.98 11.59 37 53385 2577 32457527
Drug withdrawal syndrome 46.77 11.59 103 53319 20128 32439976
Haemoglobin decreased 46.64 11.59 78 53344 119593 32340511
Electrocardiogram QT prolonged 46.34 11.59 157 53265 39484 32420620
Hyperkalaemia 45.82 11.59 29 53393 69721 32390383
Autonomic nervous system imbalance 45.51 11.59 36 53386 2524 32457580
Disease progression 44.73 11.59 46 53376 86816 32373288
Product residue present 44.54 11.59 37 53385 2781 32457323
C-reactive protein increased 44.46 11.59 12 53410 48090 32412014
Renal failure 42.62 11.59 99 53323 134379 32325725
Multiple organ dysfunction syndrome 41.97 11.59 32 53390 69822 32390282
Libido decreased 41.91 11.59 45 53377 4673 32455431
Euphoric mood 41.49 11.59 47 53375 5180 32454924
Myoclonus 41.47 11.59 81 53341 14548 32445556
Hallucination, visual 40.39 11.59 88 53334 17071 32443033
Panic attack 40.33 11.59 62 53360 9199 32450905
Maternal drugs affecting foetus 40.13 11.59 42 53380 4235 32455869
Pleural effusion 38.26 11.59 44 53378 78948 32381156
Depressed mood 37.68 11.59 89 53333 18211 32441893
Aggression 37.56 11.59 146 53276 39243 32420861
Lower respiratory tract infection 36.75 11.59 3 53419 29240 32430864
Electrocardiogram PR prolongation 36.63 11.59 20 53402 744 32459360
Drug reaction with eosinophilia and systemic symptoms 36.56 11.59 5 53417 32480 32427624
Neonatal toxicity 36.28 11.59 9 53413 27 32460077
Rheumatoid arthritis 36.07 11.59 14 53408 44530 32415574
Tinnitus 35.64 11.59 84 53338 17165 32442939
Depersonalisation/derealisation disorder 35.33 11.59 18 53404 580 32459524
Mood altered 35.17 11.59 57 53365 8847 32451257
Mood swings 34.63 11.59 54 53368 8111 32451993
Off label use 34.29 11.59 330 53092 305990 32154114
Hyponatraemic coma 34.09 11.59 9 53413 37 32460067
Respiratory failure 33.87 11.59 79 53343 107103 32353001
Dysphoria 33.76 11.59 29 53393 2282 32457822
Psychomotor skills impaired 33.73 11.59 30 53392 2473 32457631
Melaena 33.28 11.59 8 53414 34657 32425447
Dry mouth 33.16 11.59 101 53321 24018 32436086
Pupil fixed 32.84 11.59 26 53396 1825 32458279
Basilar artery occlusion 32.18 11.59 10 53412 81 32460023
Leukopenia 31.90 11.59 31 53391 60091 32400013
Blood creatinine increased 31.88 11.59 69 53353 96063 32364041
Mania 31.88 11.59 57 53365 9575 32450529
Hepatic function abnormal 31.78 11.59 17 53405 44823 32415281
Mucosal inflammation 31.54 11.59 8 53414 33426 32426678
Cholestasis 30.80 11.59 4 53418 27029 32433075
Infection 30.48 11.59 58 53364 84657 32375447
Ascites 30.35 11.59 14 53408 40177 32419927
Sedation 29.73 11.59 82 53340 18444 32441660
Tachycardia 29.66 11.59 227 53195 78861 32381243
White blood cell count decreased 28.98 11.59 67 53355 91131 32368973
Encephalopathy neonatal 28.87 11.59 8 53414 41 32460063
Hypomania 28.81 11.59 27 53395 2382 32457722
Transposition of the great vessels 28.54 11.59 15 53407 516 32459588
Cytomegalovirus infection 28.46 11.59 4 53418 25460 32434644
Talipes 28.32 11.59 24 53398 1854 32458250
Hallucination 28.15 11.59 165 53257 52454 32407650
Intentional self-injury 27.97 11.59 67 53355 13833 32446271
Mental status changes 27.95 11.59 131 53291 38206 32421898
Eosinophilia 27.71 11.59 4 53418 24954 32435150
Bradyphrenia 27.58 11.59 36 53386 4593 32455511
Gastrointestinal haemorrhage 27.47 11.59 64 53358 86818 32373286
Bone marrow failure 27.32 11.59 8 53414 30396 32429708
Delusion 27.26 11.59 64 53358 13044 32447060
Atrial septal defect 26.43 11.59 44 53378 6981 32453123
Substance abuse 26.06 11.59 44 53378 7063 32453041
Hallucinations, mixed 25.98 11.59 27 53395 2700 32457404
Abnormal behaviour 25.96 11.59 99 53323 26367 32433737
Erythema 25.65 11.59 62 53360 83043 32377061
Delirium 25.46 11.59 141 53281 43905 32416199
Hypokalaemia 25.28 11.59 32 53390 55062 32405042
Thinking abnormal 24.92 11.59 38 53384 5597 32454507
Cerebral haemorrhage 24.87 11.59 13 53409 34734 32425370
Dehydration 24.31 11.59 119 53303 128839 32331265
Hallucination, auditory 24.27 11.59 53 53369 10297 32449807
Malaise 24.19 11.59 181 53241 176957 32283147
Withdrawal syndrome 23.92 11.59 58 53364 12064 32448040
Stomatitis 23.43 11.59 19 53403 40210 32419894
Drug dependence 23.16 11.59 88 53334 23396 32436708
Hallucination, tactile 23.01 11.59 11 53411 308 32459796
Atrial fibrillation 22.99 11.59 106 53316 116598 32343506
Disseminated intravascular coagulation 22.94 11.59 5 53417 23171 32436933
Weight increased 22.91 11.59 224 53198 83439 32376665
Gamma-glutamyltransferase increased 22.81 11.59 11 53411 30771 32429333
Apathy 22.56 11.59 40 53382 6675 32453429
Gun shot wound 22.56 11.59 17 53405 1109 32458995
Akathisia 22.52 11.59 41 53381 6984 32453120
Product use in unapproved indication 22.48 11.59 71 53351 87133 32372971
Unresponsive to stimuli 22.11 11.59 97 53325 27512 32432592
Pelvic abscess 22.03 11.59 16 53406 986 32459118
Neutrophil count decreased 22.02 11.59 27 53395 47112 32412992
Dysarthria 21.73 11.59 110 53312 33091 32427013
Infusion related reaction 21.43 11.59 26 53396 45573 32414531
Jaundice 21.35 11.59 15 53407 34143 32425961
Marital problem 21.13 11.59 7 53415 71 32460033
Liver disorder 21 11.59 13 53409 31641 32428463
Incorrect route of product administration 20.93 11.59 54 53368 11672 32448432
Psychomotor retardation 20.83 11.59 25 53397 2930 32457174
Abdominal pain 20.78 11.59 152 53270 149377 32310727
Feeling jittery 20.63 11.59 29 53393 3970 32456134
Dyskinesia 20.50 11.59 85 53337 23518 32436586
Orgasm abnormal 20.46 11.59 8 53414 135 32459969
Haematuria 20.26 11.59 30 53392 48331 32411773
Substance use disorder 20.22 11.59 9 53413 213 32459891
Lupus-like syndrome 20.17 11.59 22 53400 2325 32457779
Disorientation 19.98 11.59 108 53314 33317 32426787
Mydriasis 19.88 11.59 37 53385 6409 32453695
Treatment failure 19.85 11.59 21 53401 39142 32420962
Restlessness 19.61 11.59 87 53335 24794 32435310
Accidental poisoning 19.60 11.59 12 53410 555 32459549
Oedema peripheral 19.42 11.59 109 53313 113982 32346122
Sleep disorder 19.20 11.59 91 53331 26661 32433443
Drug resistance 18.95 11.59 7 53415 22958 32437146
Nightmare 18.91 11.59 56 53366 13110 32446994
Pre-existing condition improved 18.90 11.59 22 53400 2497 32457607
Road traffic accident 18.71 11.59 67 53355 17314 32442790
Plasma cell myeloma 18.56 11.59 42 53380 57572 32402532
Persecutory delusion 18.51 11.59 21 53401 2318 32457786
Crying 18.38 11.59 34 53388 5862 32454242
Ideas of reference 18.37 11.59 6 53416 58 32460046
Balance disorder 18.13 11.59 119 53303 39340 32420764
Depressed level of consciousness 18.05 11.59 122 53300 40725 32419379
Cough 17.93 11.59 144 53278 138673 32321431
Amnesia 17.84 11.59 85 53337 24951 32435153
Hunger 17.82 11.59 17 53405 1533 32458571
Hyperhidrosis 17.78 11.59 187 53235 70981 32389123
Social avoidant behaviour 17.71 11.59 24 53398 3175 32456929
Emotional distress 17.67 11.59 63 53359 16243 32443861
Tongue biting 17.62 11.59 13 53409 821 32459283
Rhinitis perennial 17.34 11.59 7 53415 129 32459975
Acute myeloid leukaemia 17.31 11.59 5 53417 19169 32440935
Dissociation 17.30 11.59 15 53407 1195 32458909
Lung disorder 17.22 11.59 18 53404 33736 32426368
Vision blurred 17.21 11.59 128 53294 44058 32416046
Decreased appetite 17.20 11.59 175 53247 160638 32299466
Drug withdrawal syndrome neonatal 17.15 11.59 25 53397 3539 32456565
Alcoholism 17.10 11.59 25 53397 3547 32456557
Lactic acidosis 16.98 11.59 18 53404 33518 32426586
Hostility 16.91 11.59 13 53409 874 32459230
Cutaneous lupus erythematosus 16.82 11.59 12 53410 719 32459385
Blood testosterone decreased 16.77 11.59 28 53394 4452 32455652
Loss of libido 16.75 11.59 20 53402 2331 32457773
Myelodysplastic syndrome 16.72 11.59 6 53416 20032 32440072
Restless legs syndrome 16.70 11.59 38 53384 7586 32452518
Sinus tachycardia 16.59 11.59 62 53360 16352 32443752
Agranulocytosis 16.48 11.59 9 53413 23468 32436636
Injection site reaction 16.42 11.59 49 53373 11520 32448584
Accidental overdose 16.29 11.59 69 53353 19270 32440834
Epistaxis 16.20 11.59 43 53379 55812 32404292
Poor feeding infant 15.98 11.59 10 53412 481 32459623
Death 15.96 11.59 493 52929 382024 32078080
Postictal state 15.75 11.59 12 53410 796 32459308
Incoherent 15.66 11.59 27 53395 4407 32455697
Dysphemia 15.55 11.59 16 53406 1581 32458523
Vomiting 15.54 11.59 283 53139 235274 32224830
Blood cholesterol increased 15.46 11.59 64 53358 17693 32442411
Loss of employment 15.46 11.59 10 53412 510 32459594
Blood triglycerides increased 15.43 11.59 56 53366 14563 32445541
Bipolar disorder 15.42 11.59 25 53397 3881 32456223
Alcohol use 15.23 11.59 23 53399 3360 32456744
Drug screen positive 15.21 11.59 26 53396 4215 32455889
Cognitive disorder 15.03 11.59 83 53339 25811 32434293
Product quality issue 14.96 11.59 67 53355 19166 32440938
Dependence 14.90 11.59 14 53408 1239 32458865
Hypoplastic right heart syndrome 14.86 11.59 4 53418 18 32460086
Obsessive-compulsive disorder 14.82 11.59 28 53394 4906 32455198
Suicidal behaviour 14.80 11.59 15 53407 1456 32458648
Impaired work ability 14.78 11.59 31 53391 5857 32454247
Hepatocellular injury 14.69 11.59 12 53410 25306 32434798
Brugada syndrome 14.64 11.59 11 53411 714 32459390
Impulsive behaviour 14.59 11.59 18 53404 2171 32457933
Hangover 14.47 11.59 13 53409 1086 32459018
Urinary tract infection 14.44 11.59 75 53347 79996 32380108
Pneumonitis 14.35 11.59 17 53405 30117 32429987
Dissociative disorder 14.29 11.59 7 53415 207 32459897
Persistent depressive disorder 14.28 11.59 8 53414 313 32459791
Sleep apnoea syndrome 14.23 11.59 65 53357 18749 32441355
Lethargy 14.16 11.59 116 53306 41112 32418992
Toxic optic neuropathy 14.12 11.59 11 53411 754 32459350
Foetal exposure during pregnancy 14.07 11.59 116 53306 41185 32418919
International normalised ratio increased 14.03 11.59 38 53384 48997 32411107
Feelings of worthlessness 14.02 11.59 7 53415 216 32459888
Exposure during pregnancy 13.97 11.59 40 53382 9189 32450915
Neuropathy peripheral 13.95 11.59 72 53350 76910 32383194
Double inlet left ventricle 13.91 11.59 4 53418 24 32460080
Bicuspid aortic valve 13.90 11.59 7 53415 220 32459884
Treatment noncompliance 13.71 11.59 84 53338 27118 32432986
Hypotonia neonatal 13.59 11.59 13 53409 1176 32458928
Migraine 13.45 11.59 52 53370 13933 32446171
Urine amphetamine positive 13.38 11.59 4 53418 28 32460076
Priapism 13.38 11.59 27 53395 4964 32455140
Nervousness 13.34 11.59 48 53374 12431 32447673
Colitis 13.33 11.59 22 53400 33929 32426175
Clonic convulsion 13.31 11.59 10 53412 649 32459455
Ejaculation failure 13.28 11.59 11 53411 823 32459281
Testicular pain 13.27 11.59 20 53402 2916 32457188
Ejaculation disorder 13.27 11.59 12 53410 1011 32459093
Life expectancy shortened 13.26 11.59 4 53418 29 32460075
Slow speech 13.25 11.59 12 53410 1013 32459091
Bruxism 13.25 11.59 15 53407 1652 32458452
Cytokine release syndrome 13.23 11.59 3 53419 13532 32446572
Vasoplegia syndrome 13.15 11.59 14 53408 1440 32458664
Sperm concentration decreased 13.14 11.59 6 53416 151 32459953
Upper gastrointestinal haemorrhage 12.99 11.59 12 53410 23837 32436267
Binge drinking 12.95 11.59 3 53419 6 32460098
Emotional disorder 12.91 11.59 28 53394 5413 32454691
Blood pressure decreased 12.87 11.59 42 53380 51038 32409066
Respiratory distress 12.78 11.59 24 53398 35222 32424882
Tumour lysis syndrome 12.76 11.59 4 53418 14543 32445561
Gastric ulcer 12.74 11.59 5 53417 15804 32444300
Injection site mass 12.70 11.59 28 53394 5473 32454631
Pulmonary fibrosis 12.68 11.59 6 53416 16968 32443136
Past-pointing 12.60 11.59 4 53418 35 32460069
Osteonecrosis of jaw 12.53 11.59 8 53414 19158 32440946
Obesity 12.49 11.59 41 53381 10141 32449963
Peritonitis 12.45 11.59 11 53411 22319 32437785
Cardiotoxicity 12.42 11.59 26 53396 4906 32455198
Device related infection 12.41 11.59 7 53415 17926 32442178
Univentricular heart 12.40 11.59 4 53418 37 32460067
Ventricular hypoplasia 12.39 11.59 5 53417 92 32460012
Extra dose administered 12.38 11.59 21 53401 3382 32456722
Congenital aortic stenosis 12.34 11.59 5 53417 93 32460011
Energy increased 12.33 11.59 13 53409 1322 32458782
Cerebral disorder 12.30 11.59 18 53404 2557 32457547
Compartment syndrome 12.29 11.59 18 53404 2559 32457545
Drug tolerance 12.22 11.59 17 53405 2304 32457800
Symptom masked 12.18 11.59 9 53413 570 32459534
Rash maculo-papular 12.11 11.59 17 53405 28005 32432099
Hypocalcaemia 12.09 11.59 12 53410 23042 32437062
Bacteraemia 12.03 11.59 7 53415 17626 32442478
Pericardial effusion 12.03 11.59 12 53410 22990 32437114
Genital discomfort 11.95 11.59 4 53418 42 32460062
Male orgasmic disorder 11.87 11.59 5 53417 103 32460001
Post-traumatic stress disorder 11.85 11.59 15 53407 1856 32458248
Derealisation 11.85 11.59 9 53413 594 32459510
Blood lactate dehydrogenase increased 11.84 11.59 11 53411 21794 32438310
Affective disorder 11.81 11.59 21 53401 3512 32456592
Oxygen saturation decreased 11.81 11.59 40 53382 48059 32412045
Tongue spasm 11.78 11.59 4 53418 44 32460060
Decreased interest 11.76 11.59 17 53405 2387 32457717
Homicidal ideation 11.75 11.59 18 53404 2662 32457442
Antidepressant drug level increased 11.74 11.59 5 53417 106 32459998
Anaphylactic shock 11.72 11.59 5 53417 15029 32445075
Tubulointerstitial nephritis 11.71 11.59 9 53413 19568 32440536

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 thymoanaleptics
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
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
FDA EPC N0000180855 Aminoketone

Drug Use (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

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 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 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
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

Orange Book exclusivity data (new drug applications)

None

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
C0085208 UMLSCUI
CHEBI:3219 CHEBI
CHEMBL894 ChEMBL_ID
DB01156 DRUGBANK_ID
CHEMBL1201735 ChEMBL_ID
CHEMBL1698 ChEMBL_ID
D016642 MESH_DESCRIPTOR_UI
444 PUBCHEM_CID
3562 INN_ID
7135 IUPHAR_LIGAND_ID
01ZG3TPX31 UNII
203204 RXNORM
162122 MMSL
26259 MMSL
31548 MMSL
4307 MMSL
4319 MMSL
d00181 MMSL
001512 NDDF
004611 NDDF
012996 NDDF
387564004 SNOMEDCT_US
395733003 SNOMEDCT_US
431408005 SNOMEDCT_US
96199001 SNOMEDCT_US
4019483 VANDF
4019645 VANDF
4029878 VANDF

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 0115-6811 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 0173-0722 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
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 0185-1111 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 0187-0731 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 0187-5811 TABLET, EXTENDED RELEASE 348 mg ORAL NDA 29 sections
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5812 TABLET, EXTENDED RELEASE 522 mg ORAL NDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-7200 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 28 sections
Bupropion HydrochlorideXL HUMAN PRESCRIPTION DRUG LABEL 1 0591-3331 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3540 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3541 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3542 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL ANDA 29 sections
Bupropion HydrochlorideSR HUMAN PRESCRIPTION DRUG LABEL 1 0591-3543 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7631 TABLET, FILM COATED 75 mg ORAL ANDA 27 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7632 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
Bupropion Hydrochloride(XL) HUMAN PRESCRIPTION DRUG LABEL 1 0615-8179 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 30 sections
Bupropion Hydrochloride(XL) HUMAN PRESCRIPTION DRUG LABEL 1 0615-8241 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 30 sections
bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8261 TABLET 75 mg ORAL ANDA 25 sections
bupropion HUMAN PRESCRIPTION DRUG LABEL 1 0615-8262 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 31 sections
bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8296 TABLET 100 mg ORAL ANDA 29 sections
Bupropion hydrochloride (XL) HUMAN PRESCRIPTION DRUG LABEL 1 0781-5528 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 21 sections
Bupropion hydrochloride (XL) HUMAN PRESCRIPTION DRUG LABEL 1 0781-5529 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 21 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6573 TABLET, FILM COATED, EXTENDED RELEASE 300 mg ORAL ANDA 30 sections
Bupropion Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6585 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 29 sections