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

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 3323.90 9.92 2686 122561 129203 50350674
Toxicity to various agents 805.92 9.92 1683 123564 210816 50269061
Overdose 460.58 9.92 859 124388 98868 50381009
Intentional overdose 450.32 9.92 658 124589 61846 50418031
Seizure 412.78 9.92 905 124342 116969 50362908
Generalised tonic-clonic seizure 409.98 9.92 410 124837 25900 50453977
Depression 371.03 9.92 1072 124175 164351 50315526
Anxiety 366.13 9.92 1117 124130 176489 50303388
Suicidal ideation 353.31 9.92 551 124696 54834 50425043
Cardio-respiratory arrest 332.47 9.92 528 124719 53364 50426513
Suspected suicide 326.58 9.92 189 125058 5168 50474709
Product substitution issue 293.92 9.92 258 124989 13799 50466078
Serotonin syndrome 269.30 9.92 319 124928 24394 50455483
Electrocardiogram QRS complex prolonged 237.34 9.92 154 125093 5190 50474687
Suicide attempt 234.07 9.92 442 124805 51290 50428587
Cardiac arrest 231.30 9.92 586 124661 83065 50396812
Temperature regulation disorder 220.79 9.92 135 125112 4092 50475785
Status epilepticus 203.44 9.92 206 125041 13200 50466677
Agitation 197.03 9.92 419 124828 52965 50426912
Respiratory arrest 178.12 9.92 289 124958 29720 50450157
Mydriasis 171.77 9.92 169 125078 10458 50469419
Irritability 170.41 9.92 275 124972 28151 50451726
Pemphigus 167.68 9.92 45 125202 120121 50359756
Drug withdrawal syndrome 167.52 9.92 255 124992 24826 50455051
Coeliac disease 162.98 9.92 150 125097 8535 50471342
Systemic lupus erythematosus 152.18 9.92 79 125168 140543 50339334
Food allergy 151.65 9.92 140 125107 7997 50471880
Neutropenia 143.32 9.92 95 125152 147870 50332007
Swelling 141.96 9.92 173 125074 200699 50279178
Asthma 141.05 9.92 514 124733 88823 50391054
Poisoning 139.63 9.92 163 125084 12266 50467611
Tremor 138.79 9.92 608 124639 114295 50365582
Thrombocytopenia 137.74 9.92 72 125175 127601 50352276
Anaemia 134.77 9.92 263 124984 252193 50227684
Electrocardiogram QT prolonged 134.60 9.92 355 124892 51531 50428346
Hyperhidrosis 134.06 9.92 506 124741 88920 50390957
Sinus tachycardia 128.55 9.92 207 125040 21147 50458730
Sleep apnoea syndrome 127.13 9.92 219 125028 23649 50456228
White blood cell count abnormal 126.22 9.92 106 125141 5334 50474543
Pyrexia 124.35 9.92 502 124745 379701 50100176
Acute kidney injury 123.96 9.92 235 125012 227823 50252054
Glossodynia 123.44 9.92 66 125181 115503 50364374
Insomnia 121.75 9.92 795 124452 174070 50305807
Hand deformity 121.33 9.92 48 125199 100151 50379726
Arthropathy 116.90 9.92 131 125116 157775 50322102
Febrile neutropenia 114.67 9.92 49 125198 97618 50382259
Immunodeficiency 112.35 9.92 160 125087 14668 50465209
Maternal exposure during pregnancy 110.34 9.92 140 125107 159638 50320239
Joint swelling 105.48 9.92 287 124960 244999 50234878
Helicobacter infection 105.36 9.92 4 125243 49698 50430179
Treatment failure 100.97 9.92 115 125132 137522 50342355
Pancytopenia 100.51 9.92 41 125206 83989 50395888
Withdrawal syndrome 98.44 9.92 165 125082 17425 50462452
General physical health deterioration 97.10 9.92 126 125121 142308 50337569
Sensitisation 96.91 9.92 56 125191 1526 50478351
Duodenal ulcer perforation 95.57 9.92 4 125243 45607 50434270
Peripheral swelling 95.40 9.92 232 125015 205704 50274173
Infusion related reaction 95.38 9.92 171 125076 169386 50310491
Headache 92.80 9.92 1763 123484 504772 49975105
Therapeutic response unexpected 92.70 9.92 152 125095 15763 50464114
Polycystic ovaries 92.10 9.92 64 125183 2420 50477457
Anger 89.88 9.92 125 125122 11208 50468669
Cardiac failure 89.49 9.92 38 125209 76002 50403875
Drug hypersensitivity 88.47 9.92 980 124267 250030 50229847
Drug abuse 88.30 9.92 337 124910 59509 50420368
Feeling abnormal 88.16 9.92 572 124675 124920 50354957
Malignant neoplasm progression 83.50 9.92 32 125215 68092 50411785
Bursitis 83.09 9.92 175 125072 21960 50457917
Exposure via ingestion 82.94 9.92 63 125184 2740 50477137
Memory impairment 80.36 9.92 399 124848 78961 50400916
Myoclonus 79.99 9.92 135 125112 14335 50465542
Infarction 79.41 9.92 57 125190 2271 50477606
Product odour abnormal 79.25 9.92 43 125204 1034 50478843
Ejection fraction 77.59 9.92 44 125203 1156 50478721
Crying 77.32 9.92 162 125085 20254 50459623
Blister 75.93 9.92 60 125187 85358 50394519
Pericarditis 74.17 9.92 52 125195 78637 50401240
Sympathomimetic effect 73.97 9.92 19 125228 39 50479838
Dyspnoea 73.92 9.92 935 124312 546673 49933204
Psoriasis 73.50 9.92 352 124895 68648 50411229
Muscle injury 72.33 9.92 5 125242 37106 50442771
Rash 72.00 9.92 714 124533 436757 50043120
Mental status changes 71.58 9.92 225 125022 36047 50443830
Tardive dyskinesia 71.21 9.92 89 125158 7190 50472687
Lower respiratory tract infection 70.39 9.92 79 125168 95122 50384755
Alopecia 69.42 9.92 341 124906 244706 50235171
Diarrhoea 68.62 9.92 1035 124212 587441 49892436
Pulseless electrical activity 67.49 9.92 84 125163 6757 50473120
Anti-cyclic citrullinated peptide antibody positive 67.38 9.92 46 125201 70541 50409336
Abdominal discomfort 66.97 9.92 320 124927 231321 50248556
Migraine 66.89 9.92 365 124882 74915 50404962
Postmortem blood drug level increased 65.58 9.92 31 125216 551 50479326
Atrial fibrillation 65.29 9.92 94 125153 101651 50378226
Postictal state 64.59 9.92 36 125211 914 50478963
Disturbance in attention 63.90 9.92 196 125051 30990 50448887
Sepsis 62.90 9.92 148 125099 132777 50347100
Panic attack 62.50 9.92 144 125103 19198 50460679
Folliculitis 62.16 9.92 11 125236 39214 50440663
Cholecystitis chronic 59.93 9.92 95 125152 9574 50470303
Cerebral venous thrombosis 59.70 9.92 44 125203 1827 50478050
Weight increased 59.08 9.92 761 124486 201130 50278747
Product residue present 58.60 9.92 58 125189 3614 50476263
Synovitis 57.73 9.92 139 125108 123726 50356151
Platelet count decreased 57.13 9.92 101 125146 100625 50379252
Renal impairment 56.79 9.92 62 125185 75599 50404278
Pneumonia 56.34 9.92 632 124615 377769 50102108
Bone marrow failure 56.01 9.92 3 125244 27621 50452256
Bronchial neoplasm 54.82 9.92 25 125222 408 50479469
Disease progression 54.48 9.92 96 125151 95770 50384107
Hyperkalaemia 53.50 9.92 26 125221 48063 50431814
Brain injury 53.27 9.92 70 125177 5944 50473933
Hyponatraemia 53.09 9.92 98 125149 96041 50383836
Gastrointestinal disorder 52.41 9.92 96 125151 94360 50385517
Areflexia 52.13 9.92 48 125199 2732 50477145
Hepatocellular injury 52.04 9.92 3 125244 25944 50453933
Sleep-related eating disorder 51.93 9.92 29 125218 739 50479138
Mental disorder 51.54 9.92 145 125102 21846 50458031
Wound 51.48 9.92 116 125131 105678 50374199
Bipolar disorder 51.31 9.92 73 125174 6684 50473193
Tachycardia 51.22 9.92 422 124825 99341 50380536
Haemoglobin decreased 50.83 9.92 154 125093 127062 50352815
Nicotine dependence 50.57 9.92 27 125220 628 50479249
Multiple organ dysfunction syndrome 50.50 9.92 31 125216 50306 50429571
Bronchial haemorrhage 50.45 9.92 25 125222 495 50479382
Persistent genital arousal disorder 49.98 9.92 20 125227 232 50479645
Discomfort 48.64 9.92 124 125123 108256 50371621
Asthma exercise induced 48.22 9.92 20 125227 256 50479621
Factor V Leiden mutation 48.08 9.92 18 125229 172 50479705
Cardiogenic shock 48.06 9.92 114 125133 15485 50464392
Rash erythematous 47.93 9.92 192 125055 34660 50445217
Stomatitis 47.00 9.92 114 125133 101230 50378647
Multiple sclerosis relapse 46.33 9.92 220 125027 42744 50437133
Mucosal inflammation 45.74 9.92 21 125226 40121 50439756
Neutrophil count decreased 45.27 9.92 29 125218 45997 50433880
Leukopenia 44.69 9.92 61 125186 67467 50412410
Nasal turbinate hypertrophy 44.49 9.92 25 125222 645 50479232
Emotional distress 44.41 9.92 164 125083 28499 50451378
Hepatic function abnormal 44.14 9.92 13 125234 32668 50447209
Infection 43.74 9.92 250 124997 172704 50307173
Rubber sensitivity 43.52 9.92 36 125211 1773 50478104
Intentional product misuse 43.13 9.92 229 125018 46505 50433372
Hyperreflexia 42.92 9.92 58 125189 5060 50474817
Hallucination 42.63 9.92 228 125019 46429 50433448
Product complaint 42.27 9.92 90 125157 11376 50468501
Mood altered 42.26 9.92 96 125151 12677 50467200
Hostility 41.91 9.92 35 125212 1747 50478130
Septic shock 41.65 9.92 48 125199 57127 50422750
Brugada syndrome 41.61 9.92 19 125228 311 50479566
Multiple sclerosis 41.24 9.92 128 125119 20365 50459512
Pleural effusion 40.70 9.92 88 125159 81366 50398511
Cholestasis 40.51 9.92 7 125240 25394 50454483
Gastrointestinal haemorrhage 40.24 9.92 75 125172 73246 50406631
Hypokalaemia 40.00 9.92 100 125147 87892 50391985
Drug intolerance 39.62 9.92 349 124898 218755 50261122
Foot deformity 39.60 9.92 121 125126 19089 50460788
Depressed mood 39.48 9.92 178 125069 33845 50446032
Affective disorder 39.38 9.92 56 125191 5125 50474752
Libido increased 39.14 9.92 29 125218 1214 50478663
Joint dislocation 38.94 9.92 91 125156 12242 50467635
Impaired healing 38.64 9.92 71 125176 69715 50410162
Endometrial ablation 38.64 9.92 25 125222 838 50479039
White blood cell count decreased 37.45 9.92 155 125092 116567 50363310
Muscle twitching 37.40 9.92 103 125144 15328 50464549
Arthralgia 36.99 9.92 816 124431 437886 50041991
Rhinitis allergic 36.94 9.92 65 125182 7135 50472742
Nephrectomy 36.92 9.92 24 125223 811 50479066
Vertigo 36.81 9.92 237 125010 51595 50428282
Hallucinations, mixed 36.72 9.92 48 125199 4055 50475822
Nightmare 36.66 9.92 105 125142 15981 50463896
Impulse-control disorder 36.54 9.92 22 125225 648 50479229
Pre-existing condition improved 36.32 9.92 64 125183 7033 50472844
Lung disorder 35.54 9.92 35 125212 44764 50435113
Pupil fixed 35.51 9.92 30 125217 1522 50478355
Hepatic failure 35.09 9.92 18 125229 32265 50447612
Fluid retention 34.99 9.92 230 125017 50419 50429458
Sleep disorder due to general medical condition, insomnia type 34.98 9.92 17 125230 31430 50448447
Exostosis 34.65 9.92 84 125163 11569 50468308
Nasopharyngitis 34.57 9.92 308 124939 192619 50287258
Retinitis 34.26 9.92 32 125215 1855 50478022
Pruritus 34.18 9.92 495 124752 283073 50196804
Abnormal dreams 33.87 9.92 73 125174 9304 50470573
Mania 33.87 9.92 80 125167 10836 50469041
Hypoglycaemia 33.87 9.92 50 125197 53531 50426346
Choreoathetosis 33.54 9.92 18 125229 423 50479454
Fibromyalgia 33.38 9.92 208 125039 44770 50435107
Liver disorder 33.25 9.92 26 125221 37196 50442681
Sleep paralysis 33.04 9.92 19 125228 513 50479364
Thinking abnormal 32.88 9.92 73 125174 9494 50470383
International normalised ratio increased 32.78 9.92 35 125212 43117 50436760
Renal failure 32.74 9.92 144 125103 106489 50373388
Drug eruption 32.60 9.92 9 125238 23597 50456280
C-reactive protein abnormal 32.54 9.92 14 125233 27795 50452082
Amnesia 32.35 9.92 197 125050 42063 50437814
Upper respiratory tract infection 32.34 9.92 276 124971 65622 50414255
Bronchial disorder 32.33 9.92 25 125222 1117 50478760
Lupus-like syndrome 32.15 9.92 72 125175 9419 50470458
Akathisia 31.98 9.92 66 125181 8163 50471714
Stress 31.71 9.92 235 125012 53558 50426319
Libido decreased 31.54 9.92 34 125213 2342 50477535
Epistaxis 31.20 9.92 70 125177 63884 50415993
Bruxism 31.07 9.92 38 125209 3002 50476875
Drug screen positive 30.76 9.92 40 125207 3362 50476515
Ascites 29.64 9.92 27 125220 35834 50444043
Endometriosis 29.44 9.92 43 125204 4032 50475845
Thermal burn 29.23 9.92 47 125200 4794 50475083
Gambling disorder 29.23 9.92 24 125223 1170 50478707
Death 29.20 9.92 599 124648 324780 50155097
Carpal tunnel syndrome 29.03 9.92 100 125147 16793 50463084
Economic problem 28.69 9.92 29 125218 1853 50478024
Gamma-glutamyltransferase increased 28.67 9.92 19 125228 29604 50450273
Hypercalcaemia 28.56 9.92 11 125236 23341 50456536
Feeling jittery 28.56 9.92 76 125171 11084 50468793
Rheumatic fever 28.37 9.92 4 125243 16863 50463014
Urine sodium increased 28.05 9.92 10 125237 82 50479795
Vision blurred 28.04 9.92 308 124939 78339 50401538
Affect lability 27.98 9.92 66 125181 8932 50470945
Automatism 27.94 9.92 9 125238 52 50479825
Product quality issue 27.65 9.92 150 125097 30708 50449169
Central nervous system necrosis 27.46 9.92 11 125236 128 50479749
Toxic epidermal necrolysis 27.18 9.92 9 125238 20983 50458894
Brain death 27.18 9.92 34 125213 2749 50477128
Anorgasmia 27.14 9.92 17 125230 538 50479339
Sputum purulent 27.08 9.92 21 125226 942 50478935
Anti-neutrophil cytoplasmic antibody positive vasculitis 26.99 9.92 31 125216 2291 50477586
Jaundice 26.89 9.92 16 125231 26413 50453464
Myelodysplastic syndrome 26.88 9.92 3 125244 15129 50464748
Electroencephalogram abnormal 26.86 9.92 38 125209 3461 50476416
Obsessive-compulsive disorder 26.72 9.92 37 125210 3303 50476574
Hypothyroidism 26.71 9.92 160 125087 33965 50445912
Somnolence 26.67 9.92 535 124712 154450 50325427
Cerebral haemorrhage 26.66 9.92 17 125230 27035 50452842
Anhedonia 26.57 9.92 67 125180 9457 50470420
Restless legs syndrome 26.36 9.92 93 125154 15804 50464073
Tachyphrenia 26.32 9.92 23 125224 1222 50478655
Dyskinesia 26.03 9.92 137 125110 27724 50452153
Mucosal dryness 25.99 9.92 31 125216 2386 50477491
Off label use 25.98 9.92 937 124310 473489 50006388
Syncope 25.96 9.92 149 125098 102853 50377024
Hallucination, auditory 25.39 9.92 71 125176 10657 50469220
Major depression 25.34 9.92 54 125193 6830 50473047
Feeling of despair 25.27 9.92 28 125219 1990 50477887
Thalamic infarction 25.21 9.92 15 125232 432 50479445
Urine osmolarity increased 24.99 9.92 10 125237 116 50479761
Melaena 24.98 9.92 18 125229 26846 50453031
Unresponsive to stimuli 24.91 9.92 145 125102 30464 50449413
Tinnitus 24.70 9.92 136 125111 27996 50451881
Hepatotoxicity 24.34 9.92 19 125228 27207 50452670
Blood lactate dehydrogenase increased 24.28 9.92 9 125238 19553 50460324
Binge eating 24.18 9.92 14 125233 383 50479494
Posterior reversible encephalopathy syndrome 24.06 9.92 4 125243 14924 50464953
Osteonecrosis of jaw 24.02 9.92 27 125220 32499 50447378
Gastrooesophageal reflux disease 23.98 9.92 292 124955 76136 50403741
Haematemesis 23.97 9.92 20 125227 27705 50452172
Supraventricular tachycardia 23.97 9.92 78 125169 12723 50467154
Swollen joint count increased 23.94 9.92 4 125243 14869 50465008
Decreased interest 23.86 9.92 33 125214 2943 50476934
Dysphemia 23.85 9.92 29 125218 2277 50477600
Nervousness 23.83 9.92 133 125114 27518 50452359
Large intestine anastomosis 23.64 9.92 7 125240 29 50479848
Post-traumatic stress disorder 23.59 9.92 40 125207 4263 50475614
Accidental exposure to product by child 23.58 9.92 20 125227 1020 50478857
Dyspnoea exertional 23.45 9.92 58 125189 51175 50428702
Adrenergic syndrome 23.45 9.92 7 125240 30 50479847
Asthenia 23.37 9.92 606 124641 318436 50161441
Hepatitis 23.34 9.92 26 125221 31427 50448450
Haemorrhage 23.31 9.92 62 125185 53379 50426498
Rash maculo-papular 23.30 9.92 19 125228 26622 50453255
Erythema dyschromicum perstans 23.29 9.92 8 125239 58 50479819
Secondary immunodeficiency 23.23 9.92 21 125226 1167 50478710
Product use issue 23.23 9.92 247 125000 149228 50330649
Agranulocytosis 23.20 9.92 12 125235 21409 50458468
Irritable bowel syndrome 22.96 9.92 59 125188 51382 50428495
Complication of device insertion 22.94 9.92 48 125199 5993 50473884
Soft tissue injury 22.87 9.92 23 125224 1461 50478416
Hip arthroplasty 22.75 9.92 25 125222 30404 50449473
Treatment noncompliance 22.73 9.92 140 125107 30010 50449867
Sexual dysfunction 22.72 9.92 34 125213 3258 50476619
Attention deficit hyperactivity disorder 22.65 9.92 29 125218 2400 50477477
Oesophageal pain 22.36 9.92 31 125216 2771 50477106
Lactic acidosis 22.20 9.92 30 125217 33325 50446552
Blood creatinine increased 22.09 9.92 105 125142 76055 50403822
Oppositional defiant disorder 21.95 9.92 7 125240 39 50479838
Hepatic cirrhosis 21.94 9.92 94 125153 17483 50462394
Drug dependence 21.90 9.92 102 125145 19657 50460220
Therapeutic product effect incomplete 21.88 9.92 333 124914 91182 50388695
Neoplasm progression 21.75 9.92 24 125223 29133 50450744
Ventricular tachycardia 21.62 9.92 87 125160 15734 50464143
Interstitial lung disease 21.49 9.92 64 125183 53112 50426765
Oedema 21.40 9.92 95 125152 70086 50409791
Peritonitis 21.21 9.92 6 125241 15480 50464397
Impaired work ability 21.09 9.92 78 125169 13562 50466315
Compulsive shopping 20.94 9.92 16 125231 702 50479175
Anticholinergic syndrome 20.93 9.92 24 125223 1771 50478106
Oesophageal spasm 20.76 9.92 27 125220 2269 50477608
Corneal reflex decreased 20.66 9.92 9 125238 131 50479746
Hypotonic urinary bladder 20.66 9.92 5 125242 7 50479870
Solar urticaria 20.59 9.92 7 125240 49 50479828
Cardiomyopathy acute 20.51 9.92 10 125237 191 50479686
Heart rate decreased 20.32 9.92 37 125210 36460 50443417
Emotional disorder 20.28 9.92 70 125177 11766 50468111
Urine amphetamine positive 20.24 9.92 7 125240 52 50479825
Paranoia 20.23 9.92 64 125183 10284 50469593
Liver injury 20.12 9.92 19 125228 24787 50455090
Biliary dyskinesia 20.03 9.92 28 125219 2522 50477355
Dystonia 19.97 9.92 70 125177 11856 50468021
Product dose omission issue 19.97 9.92 596 124651 183242 50296635
Rhinitis 19.71 9.92 55 125192 8246 50471631
Hypomagnesaemia 19.66 9.92 17 125230 23139 50456738
Self esteem decreased 19.56 9.92 14 125233 555 50479322
Caput succedaneum 19.55 9.92 5 125242 10 50479867
Dizziness 19.54 9.92 1046 124201 345323 50134554
Alcoholism 19.46 9.92 22 125225 1598 50478279
Disseminated intravascular coagulation 19.46 9.92 9 125238 17126 50462751
Cerebral infarction 19.41 9.92 15 125232 21589 50458288
Rhonchi 19.13 9.92 26 125221 2281 50477596
Cough 19.07 9.92 453 124794 240811 50239066
Bone erosion 19.06 9.92 68 125179 11619 50468258
Sexually inappropriate behaviour 19.04 9.92 8 125239 106 50479771
Gallbladder disorder 18.98 9.92 87 125160 16655 50463222
Liver function test abnormal 18.92 9.92 52 125195 44287 50435590
Apathy 18.91 9.92 51 125196 7497 50472380
Upper gastrointestinal haemorrhage 18.88 9.92 8 125239 16027 50463850
Sternal fracture 18.82 9.92 24 125223 1978 50477899
Blood test abnormal 18.58 9.92 66 125181 11253 50468624
Somnambulism 18.56 9.92 39 125208 4885 50474992
Injury 18.55 9.92 194 125053 48731 50431146
Neuropathy peripheral 18.41 9.92 152 125095 96605 50383272
Femur fracture 18.28 9.92 41 125206 37423 50442454
Infusion site scar 18.24 9.92 11 125236 325 50479552
Dysphoria 18.21 9.92 38 125209 4736 50475141
Pneumonitis 18.20 9.92 28 125219 29482 50450395
Ventricular tachyarrhythmia 18.16 9.92 7 125240 73 50479804
Burning sensation 18.08 9.92 182 125065 45264 50434613
Clonus 18.04 9.92 35 125212 4140 50475737
Metastases to liver 18.01 9.92 14 125233 20090 50459787
Uterine perforation 17.76 9.92 45 125202 6370 50473507
Knee arthroplasty 17.67 9.92 39 125208 35807 50444070
Tongue biting 17.60 9.92 19 125228 1311 50478566
Cortisol increased 17.54 9.92 11 125236 349 50479528
Oscillopsia 17.52 9.92 8 125239 131 50479746
Respiratory failure 17.46 9.92 143 125104 91038 50388839
Blood bilirubin increased 17.37 9.92 33 125214 32005 50447872
Product coating issue 17.18 9.92 6 125241 46 50479831
Loss of libido 17.12 9.92 18 125229 1205 50478672
Premature delivery 17.08 9.92 20 125227 23643 50456234
Liver function test increased 17.07 9.92 23 125224 25583 50454294
Herpes zoster 16.98 9.92 104 125143 70682 50409195
Subacute cutaneous lupus erythematosus 16.92 9.92 24 125223 2191 50477686
C-reactive protein increased 16.83 9.92 96 125151 66378 50413499
Dermatillomania 16.68 9.92 8 125239 147 50479730
Ill-defined disorder 16.65 9.92 74 125173 54580 50425297
Ejection fraction abnormal 16.62 9.92 15 125232 832 50479045
Post-traumatic neck syndrome 16.56 9.92 22 125225 1888 50477989
Gastrointestinal sounds abnormal 16.36 9.92 31 125216 3603 50476274
Dissociation 16.30 9.92 24 125223 2267 50477610
Device dislocation 16.21 9.92 100 125147 21446 50458431
Premature baby 16.14 9.92 13 125234 18324 50461553
Right ventricular systolic pressure decreased 16.12 9.92 5 125242 25 50479852
Narcolepsy 16.11 9.92 17 125230 1143 50478734
Nausea 16.04 9.92 1986 123261 703412 49776465
Iron deficiency anaemia 16.02 9.92 11 125236 16823 50463054
Mood swings 15.98 9.92 80 125167 15874 50464003
Sedation 15.97 9.92 130 125117 30480 50449397
Abnormal behaviour 15.91 9.92 93 125154 19565 50460312
Road traffic accident 15.86 9.92 109 125138 24243 50455634
Cardiac failure congestive 15.85 9.92 133 125114 84249 50395628
Drug specific antibody 15.79 9.92 21 125226 1804 50478073
Urinary tract infection 15.72 9.92 428 124819 223592 50256285
Macular degeneration 15.67 9.92 8 125239 14380 50465497
Drug reaction with eosinophilia and systemic symptoms 15.66 9.92 29 125218 28395 50451482
Haemangioma congenital 15.55 9.92 11 125236 428 50479449
Haemoglobin urine 15.42 9.92 7 125240 113 50479764
Balance disorder 15.41 9.92 253 124994 70337 50409540
Snoring 15.40 9.92 29 125218 3355 50476522
Encephalopathy 15.39 9.92 139 125108 33572 50446305
Hypertonic bladder 15.28 9.92 27 125220 2973 50476904
Skin necrosis 15.28 9.92 4 125243 10863 50469014
Vomiting 15.21 9.92 960 124287 459798 50020079
Euphoric mood 15.14 9.92 32 125215 4023 50475854
Device placement issue 15.13 9.92 14 125233 802 50479075
Decreased appetite 15.12 9.92 380 124867 200543 50279334
Wound infection fungal 15.04 9.92 7 125240 120 50479757
Orgasmic sensation decreased 15.01 9.92 3 125244 0 50479877
Hypervolaemia 14.97 9.92 25 125222 25474 50454403
Drug tolerance 14.93 9.92 36 125211 4940 50474937
Contraindicated product administered 14.92 9.92 269 124978 148689 50331188
Rheumatoid factor positive 14.89 9.92 68 125179 49791 50430086
Personality disorder 14.87 9.92 33 125214 4291 50475586
Dysgraphia 14.85 9.92 25 125222 2648 50477229
Blood pressure systolic increased 14.80 9.92 42 125205 35407 50444470
Hypertensive crisis 14.80 9.92 7 125240 13147 50466730
Sleep disorder due to a general medical condition 14.79 9.92 46 125201 7325 50472552
Exposure via breast milk 14.68 9.92 19 125228 1589 50478288
Tenosynovitis 14.64 9.92 4 125243 10561 50469316
Skin ulcer 14.64 9.92 42 125205 35276 50444601
Impaired driving ability 14.49 9.92 31 125216 3930 50475947
Sensitivity to weather change 14.48 9.92 40 125207 5961 50473916
Gestational diabetes 14.44 9.92 46 125201 7419 50472458
Polyneuropathy 14.37 9.92 6 125241 12125 50467752
Metastases to bone 14.34 9.92 14 125233 17981 50461896
Generalised anxiety disorder 14.32 9.92 20 125227 1800 50478077
Haematuria 14.23 9.92 26 125221 25587 50454290
Acute myeloid leukaemia 14.15 9.92 10 125237 15064 50464813
Cholelithiasis 14.12 9.92 150 125097 37823 50442054
Decorticate posture 14.12 9.92 9 125238 294 50479583
Chronic fatigue syndrome 14.07 9.92 15 125232 1020 50478857
Pelvic pain 14.02 9.92 60 125187 11153 50468724
Obesity 14.00 9.92 80 125167 16695 50463182
Rheumatoid arthritis 13.98 9.92 624 124623 201926 50277951
Bipolar I disorder 13.96 9.92 18 125229 1500 50478377
Mental impairment 13.96 9.92 63 125184 11981 50467896
Homicidal ideation 13.84 9.92 19 125228 1683 50478194
Pupillary reflex impaired 13.81 9.92 20 125227 1861 50478016
False positive investigation result 13.80 9.92 11 125236 514 50479363
Cerebrovascular accident 13.69 9.92 159 125088 94521 50385356
Pulmonary hypertension 13.66 9.92 40 125207 33377 50446500
Drug tolerance decreased 13.61 9.92 3 125244 9157 50470720
Haematoma 13.61 9.92 35 125212 30475 50449402
Poor personal hygiene 13.54 9.92 9 125238 316 50479561
Abscess sterile 13.52 9.92 5 125242 46 50479831
Oedema peripheral 13.49 9.92 293 124954 157668 50322209
Palmar-plantar erythrodysaesthesia syndrome 13.45 9.92 18 125229 20080 50459797
Forced expiratory volume decreased 13.41 9.92 32 125215 4362 50475515
Muscle rigidity 13.39 9.92 54 125193 9775 50470102
Pallor 13.38 9.92 23 125224 23176 50456701
Hypocalcaemia 13.37 9.92 29 125218 26787 50453090
Executive dysfunction 13.34 9.92 7 125240 157 50479720
Angina pectoris 13.32 9.92 28 125219 26160 50453717
Antidepressant discontinuation syndrome 13.24 9.92 4 125243 18 50479859
Bone pain 13.18 9.92 66 125181 47163 50432714
Brain stem syndrome 13.15 9.92 9 125238 332 50479545
Food craving 13.13 9.92 17 125230 1422 50478455
Insurance issue 13.07 9.92 23 125224 2525 50477352
Dyspareunia 12.94 9.92 21 125226 2158 50477719
Mobility decreased 12.86 9.92 131 125116 79817 50400060
Flat affect 12.83 9.92 16 125231 1289 50478588
Bipolar II disorder 12.81 9.92 8 125239 252 50479625
Gait disturbance 12.62 9.92 472 124775 149533 50330344
Myoglobinuria 12.58 9.92 8 125239 260 50479617
Musculoskeletal pain 12.57 9.92 116 125131 72061 50407816
Mass excision 12.56 9.92 8 125239 261 50479616
Stoma site ulcer 12.50 9.92 8 125239 263 50479614
Blood pressure fluctuation 12.48 9.92 46 125201 35777 50444100
Pericardial effusion 12.48 9.92 28 125219 25561 50454316
Ankle fracture 12.48 9.92 74 125173 15648 50464229
Bezoar 12.42 9.92 16 125231 1332 50478545
Parkinsonism 12.37 9.92 49 125198 8798 50471079
Tooth fracture 12.34 9.92 52 125195 9599 50470278
Galactorrhoea 12.34 9.92 28 125219 3695 50476182
Bronchiectasis 12.32 9.92 5 125242 10278 50469599
Carbon monoxide poisoning 12.31 9.92 7 125240 185 50479692
Essential tremor 12.27 9.92 13 125234 878 50478999
Device expulsion 12.23 9.92 117 125130 28705 50451172
Panniculitis 12.20 9.92 3 125244 8500 50471377
Coagulopathy 12.08 9.92 16 125231 17928 50461949
Haemolytic anaemia 12.00 9.92 4 125243 9288 50470589
Acute myocardial infarction 11.99 9.92 35 125212 29238 50450639
Intentional self-injury 11.97 9.92 98 125149 23014 50456863
Malaise 11.95 9.92 694 124553 334838 50145039
Right ventricular failure 11.95 9.92 13 125234 15880 50463997
Fear 11.89 9.92 69 125178 14480 50465397
Suicidal behaviour 11.88 9.92 21 125226 2313 50477564
Shock haemorrhagic 11.87 9.92 3 125244 8341 50471536
Social anxiety disorder 11.84 9.92 9 125238 392 50479485
Colitis 11.83 9.92 52 125195 38477 50441400
Clostridium difficile colitis 11.76 9.92 16 125231 17726 50462151
Blood pressure orthostatic abnormal 11.73 9.92 3 125244 6 50479871
Pain in jaw 11.72 9.92 52 125195 38376 50441501
Distractibility 11.72 9.92 9 125238 398 50479479
Ulcer 11.68 9.92 20 125227 20180 50459697
Anaphylactic shock 11.61 9.92 20 125227 20135 50459742
Restlessness 11.60 9.92 104 125143 25069 50454808
Middle insomnia 11.58 9.92 52 125195 9869 50470008
Tri-iodothyronine free decreased 11.52 9.92 8 125239 302 50479575
Clostridium difficile infection 11.48 9.92 29 125218 25410 50454467
Partner stress 11.48 9.92 8 125239 304 50479573
Impulsive behaviour 11.44 9.92 16 125231 1442 50478435
Nystagmus 11.43 9.92 35 125212 5526 50474351
Homeless 11.40 9.92 5 125242 74 50479803
Drug screen false positive 11.37 9.92 12 125235 807 50479070
Injection site mass 11.31 9.92 72 125175 15608 50464269
Disorientation 11.31 9.92 136 125111 35348 50444529
Diverticulitis 11.31 9.92 43 125204 33139 50446738
Bankruptcy 11.31 9.92 4 125243 32 50479845
Incorrect route of product administration 11.25 9.92 82 125165 18584 50461293
Rheumatoid nodule 11.24 9.92 9 125238 12726 50467151
Electrocardiogram QRS complex shortened 11.21 9.92 9 125238 425 50479452
Therapeutic product effect decreased 11.14 9.92 254 124993 135796 50344081
Priapism 11.11 9.92 5 125242 79 50479798
Hepatic encephalopathy 11.04 9.92 5 125242 9631 50470246
Basal cell carcinoma 11.04 9.92 26 125221 23330 50456547
Gaze palsy 11.02 9.92 15 125232 1318 50478559
Abnormal sleep-related event 10.96 9.92 11 125236 697 50479180
Pancreatitis acute 10.86 9.92 27 125220 23785 50456092
Orthostatic hypotension 10.85 9.92 37 125210 29444 50450433
Hyperphagia 10.83 9.92 16 125231 1516 50478361
Tubulointerstitial nephritis 10.83 9.92 13 125234 15198 50464679
Panic disorder 10.81 9.92 20 125227 2283 50477594
Diabetes mellitus 10.80 9.92 176 125071 48857 50431020
Metastases to lung 10.76 9.92 7 125240 11013 50468864
Convulsive threshold lowered 10.75 9.92 8 125239 337 50479540
Diabetes mellitus inadequate control 10.74 9.92 10 125237 13135 50466742
Vocal cord thickening 10.71 9.92 4 125243 38 50479839
Rectal haemorrhage 10.69 9.92 54 125193 38504 50441373
Device related infection 10.69 9.92 22 125225 20713 50459164
Infusion site discomfort 10.68 9.92 12 125235 866 50479011
Live birth 10.67 9.92 15 125232 16393 50463484
Haemophagocytic lymphohistiocytosis 10.67 9.92 4 125243 8629 50471248
Blood potassium increased 10.66 9.92 15 125232 16383 50463494
Intermenstrual bleeding 10.56 9.92 39 125208 6775 50473102
Serum sickness-like reaction 10.56 9.92 9 125238 462 50479415
Poor quality sleep 10.54 9.92 74 125173 16572 50463305
Formication 10.54 9.92 26 125221 3620 50476257
Hangover 10.54 9.92 15 125232 1374 50478503
Accidental poisoning 10.53 9.92 10 125237 592 50479285
Depressive symptom 10.53 9.92 24 125223 3176 50476701
Blood pressure systolic abnormal 10.52 9.92 3 125244 7703 50472174
Drug-induced liver injury 10.51 9.92 35 125212 28060 50451817
Inadequate analgesia 10.51 9.92 21 125226 2537 50477340
Psychotic disorder 10.51 9.92 91 125156 21721 50458156
Postmortem blood drug level abnormal 10.49 9.92 8 125239 350 50479527
Ankle operation 10.43 9.92 14 125233 1213 50478664
Mouth ulceration 10.43 9.92 35 125212 27989 50451888
Drug titration error 10.42 9.92 10 125237 600 50479277
Plasma cell myeloma 10.41 9.92 41 125206 31281 50448596
Heavy menstrual bleeding 10.39 9.92 70 125177 15467 50464410
Multiple fractures 10.38 9.92 38 125209 6573 50473304
Product solubility abnormal 10.38 9.92 11 125236 743 50479134
Tearfulness 10.35 9.92 26 125221 3661 50476216
Pulmonary oedema 10.18 9.92 75 125172 48863 50431014
Embedded device 10.15 9.92 22 125225 2815 50477062
Blood triglycerides increased 10.14 9.92 55 125192 11257 50468620
Haemodialysis 10.12 9.92 4 125243 8358 50471519
Pineal gland cyst 10.02 9.92 3 125244 13 50479864
Dry mouth 10.01 9.92 195 125052 55983 50423894
Pneumothorax 9.98 9.92 12 125235 14022 50465855
Sputum discoloured 9.97 9.92 62 125185 13333 50466544
Drug ineffective 9.93 9.92 1832 123415 817501 49662376

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 2117.34 11.18 1508 48510 88738 29435771
Depression 1069.80 11.18 990 49028 84157 29440352
Toxicity to various agents 600.10 11.18 1060 48958 172601 29351908
Serotonin syndrome 467.29 11.18 318 49700 17194 29507315
Drug interaction 426.59 11.18 992 49026 196393 29328116
Intentional overdose 335.17 11.18 368 49650 38160 29486349
Suicidal ideation 304.38 11.18 333 49685 34383 29490126
Overdose 298.96 11.18 506 49512 79313 29445196
Anxiety 242.17 11.18 480 49538 84885 29439624
Drug abuse 227.55 11.18 450 49568 79433 29445076
Seizure 223.62 11.18 489 49529 92634 29431875
Cardio-respiratory arrest 190.83 11.18 322 49696 50279 29474230
Loss of personal independence in daily activities 149.04 11.18 199 49819 25241 29499268
Status epilepticus 145.55 11.18 131 49887 10663 29513846
Electrocardiogram QRS complex prolonged 144.95 11.18 89 49929 4021 29520488
Febrile neutropenia 139.64 11.18 14 50004 112226 29412283
Generalised tonic-clonic seizure 125.02 11.18 158 49860 18981 29505528
Hyperreflexia 121.28 11.18 69 49949 2703 29521806
Anaemia 119.33 11.18 99 49919 200852 29323657
Acute kidney injury 115.43 11.18 169 49849 265098 29259411
Suicide attempt 115.39 11.18 207 49811 33903 29490606
Thrombocytopenia 111.97 11.18 44 49974 134779 29389730
Tremor 105.28 11.18 318 49700 73220 29451289
Psychiatric decompensation 104.48 11.18 51 49967 1453 29523056
Depression suicidal 101.70 11.18 48 49970 1267 29523242
Poisoning 100.13 11.18 103 49915 9890 29514619
Paranoia 99.33 11.18 102 49916 9775 29514734
Distributive shock 98.47 11.18 43 49975 942 29523567
Suspected suicide 93.13 11.18 67 49951 3953 29520556
Tearfulness 91.75 11.18 48 49970 1588 29522921
Insomnia 85.99 11.18 337 49681 88424 29436085
Pyrexia 84.83 11.18 230 49788 287392 29237117
Agitation 82.17 11.18 231 49787 51073 29473436
Sepsis 81.32 11.18 73 49945 142609 29381900
Psychotic disorder 81.28 11.18 133 49885 20221 29504288
Product substitution issue 75.15 11.18 85 49933 9087 29515422
Neutropenia 73.13 11.18 69 49949 131642 29392867
Malignant neoplasm progression 72.16 11.18 18 50000 73841 29450668
Sexual dysfunction 71.44 11.18 67 49951 5747 29518762
Pneumonia 67.33 11.18 296 49722 319876 29204633
Postmortem blood drug level increased 67.08 11.18 22 49996 209 29524300
General physical health deterioration 65.61 11.18 47 49971 102810 29421699
Cardiogenic shock 64.28 11.18 116 49902 19074 29505435
Platelet count decreased 63.98 11.18 50 49968 104622 29419887
Pancytopenia 62.90 11.18 31 49987 83137 29441372
Septic shock 59.66 11.18 16 50002 62544 29461965
Therapeutic response unexpected 59.09 11.18 73 49945 8565 29515944
Interstitial lung disease 58.48 11.18 13 50005 57705 29466804
Respiratory arrest 57.72 11.18 132 49886 25701 29498808
Irritability 57.22 11.18 120 49898 22032 29502477
Exposure via ingestion 57.01 11.18 38 49980 1980 29522529
Hyperkalaemia 56.14 11.18 17 50001 61375 29463134
Anger 54.49 11.18 79 49939 10811 29513698
Depressive symptom 52.56 11.18 34 49984 1683 29522826
Tardive dyskinesia 52.32 11.18 54 49964 5204 29519305
Vein of Galen aneurysmal malformation 51.62 11.18 11 50007 11 29524498
Depressed mood 50.78 11.18 96 49922 16352 29508157
Renal impairment 50.77 11.18 38 49980 81295 29443214
Memory impairment 49.59 11.18 155 49863 36315 29488194
Erectile dysfunction 49.39 11.18 100 49918 17909 29506600
Dyspnoea 48.90 11.18 338 49680 326394 29198115
Major depression 48.67 11.18 45 49973 3790 29520719
Pupil fixed 48.06 11.18 32 49986 1664 29522845
Cardiac arrest 47.05 11.18 276 49742 85315 29439194
Autonomic nervous system imbalance 46.96 11.18 36 49982 2340 29522169
C-reactive protein increased 44.77 11.18 10 50008 44253 29480256
Feeling abnormal 44.26 11.18 196 49822 54249 29470260
Diarrhoea 44.14 11.18 356 49662 332342 29192167
Haemoglobin decreased 44.14 11.18 72 49946 108303 29416206
Cardiac failure 43.42 11.18 42 49976 79245 29445264
Electrocardiogram QT prolonged 43.21 11.18 147 49871 35990 29488519
Clonus 42.61 11.18 34 49984 2344 29522165
Libido decreased 42.51 11.18 44 49974 4254 29520255
Disease progression 41.91 11.18 46 49972 81870 29442639
Intentional product misuse 41.44 11.18 141 49877 34520 29489989
Renal failure 41.04 11.18 87 49931 118512 29405997
Rhinitis perennial 40.96 11.18 15 50003 203 29524306
Disturbance in attention 40.89 11.18 103 49915 21321 29503188
Product residue present 40.65 11.18 34 49984 2505 29522004
Maternal drugs affecting foetus 40.58 11.18 41 49977 3852 29520657
Drug withdrawal syndrome 40.28 11.18 92 49926 17892 29506617
Euphoric mood 40.01 11.18 45 49973 4780 29519729
Psychomotor skills impaired 39.26 11.18 34 49984 2627 29521882
Myoclonus 39.02 11.18 76 49942 13233 29511276
Pleural effusion 38.33 11.18 39 49979 71869 29452640
Depersonalisation/derealisation disorder 38.26 11.18 19 49999 562 29523947
Panic attack 38.21 11.18 58 49960 8268 29516241
Basilar artery occlusion 37.38 11.18 11 50007 70 29524439
Electrocardiogram PR prolongation 36.91 11.18 20 49998 711 29523798
Hyponatraemic coma 36.80 11.18 9 50009 24 29524485
Multiple organ dysfunction syndrome 36.25 11.18 32 49986 63084 29461425
Hallucination, visual 36.08 11.18 79 49939 14936 29509573
Neonatal toxicity 36.03 11.18 9 50009 27 29524482
Mucosal inflammation 34.34 11.18 6 50012 31589 29492920
Drug reaction with eosinophilia and systemic symptoms 33.48 11.18 4 50014 27988 29496521
Dysphoria 33.47 11.18 28 49990 2064 29522445
Mood swings 32.55 11.18 50 49968 7201 29517308
Blood creatinine increased 32.39 11.18 59 49959 85043 29439466
Vasoplegia syndrome 32.36 11.18 24 49994 1484 29523025
Sedation 31.47 11.18 82 49936 17323 29507186
Lower respiratory tract infection 31.17 11.18 4 50014 26498 29498011
Bradyphrenia 31.08 11.18 37 49981 4177 29520332
Off label use 30.80 11.18 343 49675 300457 29224052
Tinnitus 30.77 11.18 76 49942 15538 29508971
Transposition of the great vessels 30.17 11.18 15 50003 445 29524064
Mood altered 29.70 11.18 51 49967 8060 29516449
Hypokalaemia 29.38 11.18 25 49993 50178 29474331
Leukopenia 29.34 11.18 30 49988 55173 29469336
Intentional self-injury 29.30 11.18 65 49953 12396 29512113
Talipes 28.70 11.18 24 49994 1768 29522741
Ascites 28.66 11.18 13 50005 36606 29487903
Encephalopathy neonatal 28.64 11.18 8 50010 41 29524468
Mania 28.53 11.18 52 49966 8611 29515898
Respiratory failure 28.25 11.18 78 49940 97053 29427456
Melaena 27.84 11.18 9 50009 31167 29493342
Infection 27.63 11.18 55 49963 76696 29447813
Incorrect route of product administration 27.29 11.18 58 49960 10743 29513766
Hallucination 27.05 11.18 148 49870 44564 29479945
Cholestasis 26.52 11.18 4 50014 23458 29501051
Dry mouth 26.37 11.18 89 49929 21695 29502814
Hepatic function abnormal 26.26 11.18 17 50001 39242 29485267
Cytomegalovirus infection 26.14 11.18 4 50014 23211 29501298
Abnormal behaviour 25.83 11.18 92 49926 23035 29501474
Delusion 25.81 11.18 58 49960 11158 29513351
White blood cell count decreased 25.72 11.18 65 49953 83297 29441212
Apathy 25.54 11.18 41 49977 6130 29518379
Infusion related reaction 25.50 11.18 22 49996 43864 29480645
Gastrointestinal haemorrhage 25.33 11.18 61 49957 79472 29445037
Tachycardia 25.25 11.18 209 49809 72201 29452308
Aggression 25.22 11.18 123 49895 35418 29489091
Erythema 24.87 11.18 57 49961 75549 29448960
Emotional distress 24.65 11.18 65 49953 13830 29510679
Feelings of worthlessness 24.58 11.18 11 50007 256 29524253
Eosinophilia 24.54 11.18 4 50014 22157 29502352
Bone marrow failure 24.37 11.18 8 50010 27441 29497068
Substance use disorder 24.15 11.18 11 50007 267 29524242
Adjustment disorder 23.91 11.18 17 50001 984 29523525
Weight increased 23.46 11.18 215 49803 76452 29448057
Cerebral haemorrhage 23.31 11.18 12 50006 31414 29493095
Pelvic abscess 23.26 11.18 16 50002 878 29523631
Restless legs syndrome 23.10 11.18 42 49976 6942 29517567
Sleep disorder 23.08 11.18 92 49926 24294 29500215
Drug dependence 23.04 11.18 83 49935 20898 29503611
Hypomania 22.84 11.18 23 49995 2152 29522357
Abdominal pain 22.72 11.18 135 49883 135222 29389287
Malaise 22.37 11.18 168 49850 159434 29365075
Stomatitis 22.30 11.18 18 50000 37095 29487414
Nightmare 21.89 11.18 55 49963 11362 29513147
Atrial fibrillation 21.88 11.18 98 49920 105548 29418961
Marital problem 21.78 11.18 7 50011 62 29524447
Gamma-glutamyltransferase increased 21.70 11.18 9 50009 26728 29497781
Rheumatoid arthritis 21.40 11.18 14 50004 32138 29492371
Mental status changes 21.39 11.18 116 49902 34811 29489698
Persecutory delusion 21.32 11.18 22 49996 2119 29522390
Product complaint 21.14 11.18 35 49983 5370 29519139
Dehydration 21.12 11.18 111 49907 114637 29409872
Hallucination, tactile 20.98 11.18 10 50008 270 29524239
Dyskinesia 20.88 11.18 78 49940 19983 29504526
Unresponsive to stimuli 20.81 11.18 91 49927 25035 29499474
Orgasm abnormal 20.80 11.18 8 50010 125 29524384
Alcoholism 20.68 11.18 24 49994 2637 29521872
Jaundice 20.55 11.18 12 50006 29284 29495225
Gun shot wound 20.49 11.18 16 50002 1069 29523440
Pre-existing condition improved 20.39 11.18 22 49996 2231 29522278
Lupus-like syndrome 20.31 11.18 22 49996 2240 29522269
Hallucination, auditory 20.30 11.18 48 49970 9545 29514964
Amnesia 20.30 11.18 84 49934 22559 29501950
Haematuria 20.22 11.18 27 49991 44112 29480397
Substance abuse 20.19 11.18 39 49979 6748 29517761
Dysarthria 19.84 11.18 104 49914 30807 29493702
Treatment failure 19.71 11.18 20 49998 36919 29487590
Decreased interest 19.56 11.18 21 49997 2117 29522392
Accidental poisoning 19.46 11.18 12 50006 546 29523963
Thinking abnormal 19.27 11.18 33 49985 5203 29519306
Disseminated intravascular coagulation 19.25 11.18 5 50013 19975 29504534
Road traffic accident 19.21 11.18 64 49954 15497 29509012
Ideas of reference 19.20 11.18 6 50012 48 29524461
Oedema peripheral 19.16 11.18 100 49918 103457 29421052
Akathisia 19.15 11.18 38 49980 6704 29517805
Withdrawal syndrome 19.07 11.18 51 49967 10941 29513568
Atrial septal defect 18.97 11.18 38 49980 6751 29517758
Crying 18.75 11.18 33 49985 5318 29519191
Psychomotor retardation 18.53 11.18 24 49994 2952 29521557
Injection site reaction 18.50 11.18 51 49967 11137 29513372
Obsessive-compulsive disorder 18.39 11.18 30 49988 4546 29519963
Product use in unapproved indication 18.34 11.18 80 49938 86795 29437714
Oxygen saturation decreased 18.14 11.18 30 49988 44907 29479602
Disorientation 18.05 11.18 98 49920 29417 29495092
Vomiting 17.93 11.18 252 49766 212008 29312501
Lung disorder 17.90 11.18 15 50003 30347 29494162
Drug resistance 17.89 11.18 7 50011 21533 29502976
Delirium 17.85 11.18 121 49897 39276 29485233
Dissociation 17.83 11.18 15 50003 1114 29523395
Feeling jittery 17.66 11.18 26 49992 3607 29520902
International normalised ratio increased 17.56 11.18 30 49988 44342 29480167
Drug withdrawal syndrome neonatal 17.52 11.18 25 49993 3370 29521139
Blood testosterone decreased 17.50 11.18 27 49991 3903 29520606
Hepatocellular injury 17.49 11.18 7 50011 21236 29503273
Liver disorder 17.25 11.18 13 50005 27736 29496773
Dependence 16.86 11.18 14 50004 1021 29523488
Vision blurred 16.80 11.18 121 49897 40055 29484454
Neutrophil count decreased 16.75 11.18 30 49988 43537 29480972
Cutaneous lupus erythematosus 16.56 11.18 12 50006 716 29523793
Tongue biting 16.48 11.18 12 50006 721 29523788
Poor feeding infant 16.44 11.18 10 50008 444 29524065
Postictal state 16.38 11.18 12 50006 728 29523781
Agranulocytosis 16.26 11.18 7 50011 20333 29504176
Product quality issue 15.88 11.18 61 49957 15834 29508675
Hyperhidrosis 15.87 11.18 173 49845 64367 29460142
Loss of employment 15.79 11.18 10 50008 477 29524032
Mydriasis 15.75 11.18 33 49985 6052 29518457
Hunger 15.53 11.18 15 50003 1334 29523175
COVID-19 15.52 11.18 23 49995 35991 29488518
Decreased appetite 15.51 11.18 164 49854 145178 29379331
Suicidal behaviour 15.38 11.18 15 50003 1350 29523159
Abulia 15.35 11.18 10 50008 501 29524008
Foetal exposure during pregnancy 15.33 11.18 104 49914 33763 29490746
Hostility 15.32 11.18 12 50006 805 29523704
Sinus tachycardia 15.19 11.18 58 49960 15011 29509498
Blood triglycerides increased 15.15 11.18 52 49966 12782 29511727
Loss of libido 15.05 11.18 19 49999 2277 29522232
Sleep apnoea syndrome 14.77 11.18 64 49954 17535 29506974
Hypoplastic right heart syndrome 14.75 11.18 4 50014 18 29524491
Depressed level of consciousness 14.72 11.18 110 49908 36832 29487677
Persistent depressive disorder 14.67 11.18 8 50010 288 29524221
Hypoglycaemia 14.67 11.18 38 49980 48308 29476201
Injection site mass 14.61 11.18 30 49988 5425 29519084
Balance disorder 14.59 11.18 108 49910 36062 29488447
Myelodysplastic syndrome 14.43 11.18 6 50012 17788 29506721
Colitis 14.42 11.18 19 49999 31229 29493280
Lactic acidosis 14.37 11.18 18 50000 30229 29494280
Acute myeloid leukaemia 14.33 11.18 5 50013 16508 29508001
Multiple sclerosis 14.23 11.18 30 49988 5524 29518985
Tubulointerstitial nephritis 14.22 11.18 6 50012 17637 29506872
Hallucinations, mixed 14.18 11.18 19 49999 2414 29522095
Toxic optic neuropathy 14.15 11.18 11 50007 730 29523779
Dissociative disorder 14.13 11.18 7 50011 206 29524303
Clonic convulsion 14.12 11.18 10 50008 575 29523934
Slow speech 14.12 11.18 12 50006 904 29523605
Binge drinking 14.08 11.18 3 50015 3 29524506
Upper gastrointestinal haemorrhage 13.97 11.18 10 50008 21904 29502605
Urine amphetamine positive 13.94 11.18 4 50014 23 29524486
Product solubility abnormal 13.83 11.18 9 50009 450 29524059
Double inlet left ventricle 13.79 11.18 4 50014 24 29524485
Bipolar disorder 13.79 11.18 22 49996 3273 29521236
Prescribed overdose 13.78 11.18 39 49979 8644 29515865
Testicular pain 13.73 11.18 19 49999 2490 29522019
Hepatic failure 13.70 11.18 20 49998 31492 29493017
Priapism 13.61 11.18 26 49992 4462 29520047
Blood pressure decreased 13.60 11.18 36 49982 45441 29479068
Extra dose administered 13.50 11.18 21 49997 3056 29521453
Migraine 13.50 11.18 49 49969 12381 29512128
Obesity 13.47 11.18 42 49976 9821 29514688
Energy increased 13.38 11.18 13 50005 1165 29523344
Ventricular hypoplasia 13.37 11.18 5 50013 72 29524437
Blood cholesterol increased 13.31 11.18 57 49961 15538 29508971
Gastrooesophageal reflux disease 13.25 11.18 95 49923 31401 29493108
Cytokine release syndrome 13.19 11.18 3 50015 13116 29511393
Restlessness 13.18 11.18 73 49945 22072 29502437
Psychomotor hyperactivity 13.15 11.18 37 49981 8176 29516333
Rash maculo-papular 13.13 11.18 13 50005 24276 29500233
Emotional disorder 13.06 11.18 27 49991 4904 29519605
Pulmonary fibrosis 13.05 11.18 5 50013 15577 29508932
Sperm concentration decreased 13.05 11.18 6 50012 149 29524360
Cognitive disorder 13.03 11.18 76 49942 23423 29501086
Pneumonitis 13.00 11.18 17 50001 28027 29496482
Drug tolerance 12.84 11.18 17 50001 2136 29522373
Pulmonary oedema 12.65 11.18 34 49984 42701 29481808
Epistaxis 12.57 11.18 45 49973 51659 29472850
Brugada syndrome 12.51 11.18 10 50008 691 29523818
Inflammation 12.48 11.18 12 50006 22716 29501793
Respiratory distress 12.43 11.18 22 49996 32084 29492425
Univentricular heart 12.39 11.18 4 50014 36 29524473
Symptom masked 12.31 11.18 9 50009 544 29523965
Psoriasis 12.30 11.18 95 49923 32132 29492377
Congenital aortic stenosis 12.30 11.18 5 50013 91 29524418
Tongue spasm 12.01 11.18 4 50014 40 29524469
Cough 11.94 11.18 147 49871 126580 29397929
Blood lactate dehydrogenase increased 11.94 11.18 9 50009 19200 29505309
Cerebral disorder 11.92 11.18 17 50001 2291 29522218
Gambling disorder 11.90 11.18 14 50004 1561 29522948
Pericardial effusion 11.87 11.18 11 50007 21197 29503312
Life expectancy shortened 11.84 11.18 4 50014 42 29524467
Antidepressant drug level increased 11.82 11.18 5 50013 101 29524408
Lymphadenopathy 11.80 11.18 15 50003 25034 29499475
Nervousness 11.80 11.18 44 49974 11262 29513247
Haemorrhage 11.79 11.18 38 49980 45034 29479475
Haemoptysis 11.77 11.18 21 49997 30529 29493980
Male orgasmic disorder 11.73 11.18 5 50013 103 29524406
Ejaculation disorder 11.59 11.18 11 50007 957 29523552
Genital discomfort 11.59 11.18 4 50014 45 29524464
Congenital tricuspid valve atresia 11.51 11.18 5 50013 108 29524401
Drug screen positive 11.50 11.18 22 49996 3779 29520730
Inadequate analgesia 11.49 11.18 18 50000 2636 29521873
Social avoidant behaviour 11.44 11.18 19 49999 2923 29521586
Inability to afford medication 11.36 11.18 11 50007 981 29523528
Metastases to liver 11.36 11.18 3 50015 11853 29512656
Neuropathy peripheral 11.29 11.18 72 49946 70955 29453554
Lethargy 11.29 11.18 105 49913 37475 29487034
Intercepted medication error 11.24 11.18 8 50010 464 29524045

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 5384.45 10.31 4190 135031 220224 64139287
Toxicity to various agents 1422.07 10.31 2690 136531 360823 63998688
Intentional overdose 838.93 10.31 1002 138219 88942 64270569
Depression 838.18 10.31 1454 137767 181837 64177674
Overdose 750.53 10.31 1282 137939 158284 64201227
Serotonin syndrome 693.36 10.31 617 138604 38665 64320846
Seizure 576.79 10.31 1175 138046 165717 64193794
Cardio-respiratory arrest 534.34 10.31 844 138377 97549 64261962
Generalised tonic-clonic seizure 511.28 10.31 525 138696 39332 64320179
Anxiety 462.78 10.31 1212 138009 201437 64158074
Suicidal ideation 453.35 10.31 635 138586 65907 64293604
Electrocardiogram QRS complex prolonged 409.77 10.31 253 138968 8991 64350520
Suspected suicide 389.07 10.31 239 138982 8415 64351096
Status epilepticus 373.68 10.31 336 138885 21327 64338184
Suicide attempt 286.33 10.31 534 138687 70473 64289038
Cardiac arrest 265.35 10.31 833 138388 153231 64206280
Acute kidney injury 256.31 10.31 358 138863 448882 63910629
Drug abuse 255.45 10.31 745 138476 131629 64227882
Anaemia 251.62 10.31 268 138953 378412 63981099
Febrile neutropenia 242.69 10.31 54 139167 187603 64171908
Product substitution issue 239.40 10.31 241 138980 17620 64341891
Thrombocytopenia 239.06 10.31 92 139129 223709 64135802
Temperature regulation disorder 233.01 10.31 133 139088 4078 64355433
Agitation 225.78 10.31 552 138669 87815 64271696
Poisoning 224.08 10.31 256 138965 21623 64337888
Respiratory arrest 223.05 10.31 406 138815 52579 64306932
Mydriasis 196.82 10.31 202 139019 15110 64344401
Neutropenia 194.78 10.31 140 139081 239484 64120027
Electrocardiogram QT prolonged 193.15 10.31 487 138734 78961 64280550
Pyrexia 188.37 10.31 600 138621 558044 63801467
Coeliac disease 186.27 10.31 143 139078 7269 64352242
Tremor 182.07 10.31 717 138504 147513 64211998
Food allergy 164.23 10.31 136 139085 7715 64351796
Pancytopenia 161.32 10.31 54 139167 143255 64216256
Asthma 149.44 10.31 499 138722 94726 64264785
Drug withdrawal syndrome 148.79 10.31 253 138968 31038 64328473
Sepsis 148.39 10.31 167 139054 230174 64129337
General physical health deterioration 143.18 10.31 138 139083 204287 64155224
Irritability 141.42 10.31 271 138950 36475 64323036
Sinus tachycardia 138.43 10.31 249 138972 31939 64327572
Exposure via ingestion 135.22 10.31 100 139121 4802 64354709
Malignant neoplasm progression 135.18 10.31 38 139183 112833 64246678
Postmortem blood drug level increased 132.77 10.31 53 139168 708 64358803
Cardiac failure 124.66 10.31 65 139156 132308 64227203
Myoclonus 120.62 10.31 204 139017 24914 64334597
Renal impairment 120.35 10.31 71 139150 134946 64224565
Platelet count decreased 116.50 10.31 114 139107 167597 64191914
Hyperkalaemia 115.74 10.31 37 139184 101092 64258419
Hyperhidrosis 114.85 10.31 554 138667 124366 64235145
Immunodeficiency 114.38 10.31 157 139064 15967 64343544
Dyspnoea 112.41 10.31 1002 138219 717672 63641839
Insomnia 109.63 10.31 767 138454 197069 64162442
Pneumonia 108.57 10.31 735 138486 558841 63800670
Hyperreflexia 106.11 10.31 102 139119 7046 64352465
Drug interaction 105.54 10.31 1220 138001 360863 63998648
Sensitisation 99.35 10.31 56 139165 1675 64357836
Headache 98.26 10.31 1646 137575 527821 63831690
Bursitis 97.27 10.31 170 139051 21315 64338196
Tardive dyskinesia 96.70 10.31 109 139112 9069 64350442
Atrial fibrillation 95.65 10.31 138 139083 170951 64188560
Polycystic ovaries 95.54 10.31 59 139162 2096 64357415
Feeling abnormal 93.73 10.31 550 138671 133052 64226459
Cardiogenic shock 91.89 10.31 211 139010 32216 64327295
Disease progression 90.88 10.31 103 139118 141577 64217934
Anger 90.84 10.31 139 139082 15602 64343909
Septic shock 90.40 10.31 58 139163 105379 64254132
Diarrhoea 90.13 10.31 1063 138158 721641 63637870
Haemoglobin decreased 85.76 10.31 183 139038 194880 64164631
Withdrawal syndrome 85.20 10.31 169 139052 23323 64336188
Multiple organ dysfunction syndrome 83.96 10.31 58 139163 101355 64258156
Pupil fixed 82.63 10.31 63 139158 3169 64356342
Mental status changes 81.69 10.31 304 138917 60858 64298653
Paranoia 81.44 10.31 135 139086 16217 64343294
Memory impairment 80.90 10.31 383 138838 85299 64274212
Migraine 80.78 10.31 308 138913 62369 64297142
Ejection fraction 80.36 10.31 44 139177 1242 64358269
Tachycardia 78.22 10.31 572 138649 149007 64210504
Drug hypersensitivity 76.81 10.31 818 138403 236997 64122514
Depression suicidal 76.27 10.31 54 139167 2421 64357090
Tearfulness 75.71 10.31 70 139151 4603 64354908
Psychiatric decompensation 74.20 10.31 53 139168 2410 64357101
Renal failure 72.95 10.31 179 139042 181509 64178002
Sympathomimetic effect 72.74 10.31 19 139202 52 64359459
Mucosal inflammation 71.41 10.31 23 139198 62561 64296950
Bone marrow failure 70.17 10.31 10 139211 47942 64311569
Postictal state 70.11 10.31 44 139177 1609 64357902
Loss of personal independence in daily activities 69.95 10.31 326 138895 72128 64287383
Crying 69.84 10.31 142 139079 19948 64339563
Panic attack 69.19 10.31 145 139076 20808 64338703
Interstitial lung disease 68.34 10.31 66 139155 97666 64261845
Pleural effusion 67.88 10.31 105 139116 126454 64233057
Hepatic function abnormal 67.66 10.31 27 139194 64286 64295225
Infusion related reaction 67.63 10.31 160 139061 164307 64195204
Cholestasis 66.50 10.31 9 139212 44863 64314648
Intentional product misuse 65.95 10.31 320 138901 71975 64287536
Leukopenia 65.57 10.31 73 139148 101169 64258342
Neutrophil count decreased 65.44 10.31 43 139178 77153 64282358
White blood cell count decreased 65.34 10.31 153 139068 157684 64201827
Hepatocellular injury 64.88 10.31 10 139211 45225 64314286
Infarction 63.54 10.31 59 139162 3901 64355610
Gastrointestinal haemorrhage 63.40 10.31 118 139103 132194 64227317
Pulseless electrical activity 63.21 10.31 105 139116 12634 64346877
Peripheral swelling 63.20 10.31 235 138986 208918 64150593
Emotional distress 62.97 10.31 196 139025 35842 64323669
Hallucination 62.72 10.31 317 138904 72471 64287040
Distributive shock 62.67 10.31 43 139178 1832 64357679
Swelling 62.63 10.31 160 139061 160058 64199453
Areflexia 62.44 10.31 65 139156 4942 64354569
Lupus-like syndrome 61.45 10.31 85 139136 8706 64350805
Cytomegalovirus infection 61.43 10.31 5 139216 37194 64322317
Helicobacter infection 61.08 10.31 6 139215 38356 64321155
Lower respiratory tract infection 60.42 10.31 69 139152 94545 64264966
Clonus 58.77 10.31 69 139152 5998 64353513
Hypokalaemia 58.15 10.31 109 139112 121794 64237717
Hypoglycaemia 58.01 10.31 65 139156 89827 64269684
Psychotic disorder 57.61 10.31 185 139036 34393 64325118
Bronchial neoplasm 57.55 10.31 25 139196 418 64359093
Disturbance in attention 57.23 10.31 207 139014 40867 64318644
Hyponatraemia 56.55 10.31 150 139071 148189 64211322
Sleep apnoea syndrome 55.63 10.31 166 139055 29666 64329845
Melaena 55.48 10.31 23 139198 53525 64305986
Psoriasis 55.40 10.31 303 138918 71400 64288111
Lung disorder 55.38 10.31 31 139190 60669 64298842
Product quality issue 53.86 10.31 164 139057 29635 64329876
Duodenal ulcer perforation 53.62 10.31 6 139215 34619 64324892
Joint dislocation 53.57 10.31 92 139129 11373 64348138
Brain injury 53.33 10.31 85 139136 9880 64349631
Rubber sensitivity 52.87 10.31 34 139187 1298 64358213
Arthropathy 52.71 10.31 114 139107 120853 64238658
Cerebral venous thrombosis 52.55 10.31 43 139178 2398 64357113
International normalised ratio increased 52.46 10.31 56 139165 79111 64280400
Cholecystitis chronic 52.17 10.31 81 139140 9206 64350305
Ascites 51.92 10.31 35 139186 61966 64297545
Depressive symptom 51.87 10.31 56 139165 4440 64355071
Nasal turbinate hypertrophy 51.31 10.31 25 139196 550 64358961
Cerebral haemorrhage 51.25 10.31 23 139198 51067 64308444
Multiple sclerosis relapse 51.24 10.31 200 139021 40935 64318576
Unresponsive to stimuli 51.05 10.31 230 138991 50163 64309348
Foot deformity 50.80 10.31 111 139110 16393 64343118
Treatment failure 50.15 10.31 111 139110 116705 64242806
Jaundice 50.00 10.31 21 139200 48491 64311020
Persistent genital arousal disorder 49.58 10.31 19 139202 226 64359285
Neuropathy peripheral 49.37 10.31 113 139108 117412 64242099
Mental disorder 49.17 10.31 147 139074 26298 64333213
Liver disorder 49.02 10.31 27 139194 53324 64306187
Sexual dysfunction 48.92 10.31 65 139156 6406 64353105
Joint swelling 48.87 10.31 269 138952 215113 64144398
Therapeutic response unexpected 48.58 10.31 111 139110 16890 64342621
Weight increased 48.49 10.31 687 138534 212661 64146850
Gamma-glutamyltransferase increased 48.41 10.31 22 139199 48488 64311023
Blood creatinine increased 48.27 10.31 142 139079 135640 64223871
Akathisia 48.15 10.31 88 139133 11422 64348089
Hostility 47.77 10.31 39 139182 2168 64357343
Pneumocystis jirovecii pneumonia 47.69 10.31 3 139218 27631 64331880
Product residue present 47.62 10.31 46 139175 3196 64356315
Hepatic failure 46.75 10.31 31 139190 55363 64304148
Brugada syndrome 46.49 10.31 29 139192 1049 64358462
Depressed mood 45.99 10.31 193 139028 40819 64318692
Off label use 45.88 10.31 1029 138192 631777 63727734
Nicotine dependence 45.82 10.31 26 139195 788 64358723
Epistaxis 45.70 10.31 89 139132 98042 64261469
Libido decreased 45.67 10.31 54 139167 4730 64354781
Blister 45.52 10.31 65 139156 80902 64278609
Toxic epidermal necrolysis 45.44 10.31 12 139209 37154 64322357
Mania 45.07 10.31 105 139116 16181 64343330
Product odour abnormal 44.70 10.31 29 139192 1124 64358387
Stomatitis 43.95 10.31 108 139113 109497 64250014
Libido increased 43.81 10.31 34 139187 1756 64357755
Respiratory failure 43.68 10.31 189 139032 160994 64198517
Endometrial ablation 43.52 10.31 25 139196 776 64358735
Autonomic nervous system imbalance 43.40 10.31 49 139172 4083 64355428
Drug reaction with eosinophilia and systemic symptoms 42.28 10.31 33 139188 54184 64305327
Multiple sclerosis 41.77 10.31 112 139109 18829 64340682
Muscle twitching 41.56 10.31 112 139109 18886 64340625
Incorrect route of product administration 40.96 10.31 127 139094 23171 64336340
Major depression 40.91 10.31 66 139155 7750 64351761
Carpal tunnel syndrome 40.51 10.31 99 139122 15729 64343782
Decreased appetite 39.55 10.31 402 138819 280887 64078624
Intentional self-injury 39.30 10.31 145 139076 28899 64330612
Rhinitis allergic 39.30 10.31 66 139155 8012 64351499
Affective disorder 39.23 10.31 59 139162 6521 64352990
Fibromyalgia 39.17 10.31 167 139054 35564 64323947
Pemphigus 39.04 10.31 44 139177 60657 64298854
Sleep-related eating disorder 38.97 10.31 22 139199 660 64358851
Pneumonitis 38.84 10.31 31 139190 50334 64309177
Haematuria 38.71 10.31 44 139177 60427 64299084
Therapeutic product effect incomplete 38.67 10.31 367 138854 103115 64256396
Product complaint 38.63 10.31 82 139139 11872 64347639
Systemic lupus erythematosus 38.25 10.31 68 139153 77544 64281967
Rash 38.09 10.31 729 138492 457820 63901691
Hand deformity 37.71 10.31 48 139173 62723 64296788
Vision blurred 37.66 10.31 328 138893 89988 64269523
Exostosis 37.58 10.31 79 139142 11359 64348152
Muscle injury 37.56 10.31 6 139215 26431 64333080
Rash maculo-papular 37.46 10.31 28 139193 46998 64312513
Agranulocytosis 37.13 10.31 18 139203 38211 64321300
Thinking abnormal 37.03 10.31 79 139142 11477 64348034
Mood altered 36.78 10.31 96 139125 15883 64343628
Disseminated intravascular coagulation 36.70 10.31 12 139209 32336 64327175
Upper gastrointestinal haemorrhage 36.69 10.31 15 139206 35205 64324306
Drug eruption 36.67 10.31 16 139205 36120 64323391
Euphoric mood 36.35 10.31 57 139164 6534 64352977
Folliculitis 36.23 10.31 10 139211 30067 64329444
Lactic acidosis 35.82 10.31 48 139173 61362 64298149
Infection 35.61 10.31 243 138978 184637 64174874
Nightmare 35.59 10.31 113 139108 20880 64338631
Osteonecrosis of jaw 35.38 10.31 21 139200 39804 64319707
Syncope 35.13 10.31 198 139023 157437 64202074
Gastrooesophageal reflux disease 34.69 10.31 302 138919 82841 64276670
C-reactive protein increased 34.64 10.31 98 139123 94811 64264700
Vertigo 34.52 10.31 232 138989 58779 64300732
Maternal exposure during pregnancy 34.27 10.31 100 139121 95784 64263727
Hyponatraemic coma 34.10 10.31 9 139212 26 64359485
Tinnitus 33.98 10.31 155 139066 33978 64325533
Gastrointestinal disorder 33.96 10.31 91 139130 89618 64269893
Bronchial haemorrhage 33.86 10.31 25 139196 1197 64358314
Hallucination, visual 33.59 10.31 134 139087 27700 64331811
Myelodysplastic syndrome 33.54 10.31 9 139212 27570 64331941
Pericarditis 33.38 10.31 52 139169 62464 64297047
Retinitis 33.33 10.31 31 139190 2054 64357457
Rhinitis perennial 33.07 10.31 14 139207 219 64359292
Blood lactate dehydrogenase increased 33.01 10.31 15 139206 33063 64326448
Sedation 32.55 10.31 176 139045 41286 64318225
Cough 32.44 10.31 458 138763 301690 64057821
Impaired work ability 31.57 10.31 88 139133 15131 64344380
Device expulsion 31.57 10.31 109 139112 21027 64338484
Haematemesis 31.40 10.31 33 139188 46966 64312545
Complication of device insertion 31.40 10.31 46 139175 4966 64354545
Bipolar disorder 31.25 10.31 54 139167 6707 64352804
Upper respiratory tract infection 31.22 10.31 266 138955 72519 64286992
Dysphemia 31.09 10.31 36 139185 3083 64356428
Posterior reversible encephalopathy syndrome 30.87 10.31 6 139215 22940 64336571
Endometriosis 30.86 10.31 34 139187 2758 64356753
Rash erythematous 30.76 10.31 195 139026 48438 64311073
Fluid retention 30.58 10.31 227 138994 59379 64300132
Decreased interest 30.55 10.31 37 139184 3323 64356188
Urine amphetamine positive 30.52 10.31 10 139211 72 64359439
Nephrectomy 30.51 10.31 25 139196 1397 64358114
Bronchopulmonary aspergillosis 30.34 10.31 3 139218 19082 64340429
Amnesia 30.20 10.31 193 139028 48076 64311435
Asthenia 30.10 10.31 699 138522 427345 63932166
Hypomagnesaemia 30.10 10.31 22 139199 37354 64322157
Alcoholism 30.05 10.31 37 139184 3380 64356131
Anaphylactic shock 29.88 10.31 14 139207 30314 64329197
Obsessive-compulsive disorder 29.87 10.31 44 139177 4774 64354737
Obesity 29.81 10.31 105 139116 20457 64339054
Psychomotor skills impaired 29.65 10.31 39 139182 3806 64355705
Sleep disorder due to a general medical condition 29.57 10.31 59 139162 8175 64351336
Polyneuropathy 29.45 10.31 4 139217 19890 64339621
Oedema peripheral 29.37 10.31 301 138920 210016 64149495
Abnormal behaviour 29.35 10.31 147 139074 33475 64326036
Hypothyroidism 29.27 10.31 168 139053 40289 64319222
Sleep paralysis 29.21 10.31 17 139204 541 64358970
Hepatotoxicity 29.09 10.31 26 139195 39936 64319575
Vomiting 28.94 10.31 938 138283 550179 63809332
Bradyphrenia 28.65 10.31 63 139158 9343 64350168
Apathy 28.47 10.31 70 139151 11162 64348349
Acute myeloid leukaemia 28.12 10.31 12 139209 27451 64332060
Haemoptysis 27.94 10.31 39 139182 49009 64310502
Malaise 27.88 10.31 647 138574 395600 63963911
Drug resistance 27.83 10.31 21 139200 35081 64324430
Disorientation 27.73 10.31 211 139010 55617 64303894
C-reactive protein abnormal 27.72 10.31 14 139207 29033 64330478
Corneal reflex decreased 27.67 10.31 14 139207 335 64359176
Colitis 27.50 10.31 53 139168 58621 64300890
Haemorrhage 27.46 10.31 84 139137 79267 64280244
Eosinophilia 27.45 10.31 25 139196 38051 64321460
Haemophagocytic lymphohistiocytosis 27.40 10.31 3 139218 17606 64341905
Hypercalcaemia 27.30 10.31 17 139204 31399 64328112
Hepatitis 27.23 10.31 35 139186 45547 64313964
Feeling jittery 26.66 10.31 66 139155 10569 64348942
Oesophageal spasm 26.62 10.31 30 139191 2495 64357016
Tubulointerstitial nephritis 26.48 10.31 17 139204 30892 64328619
Pruritus 26.41 10.31 495 138726 311905 64047606
Impaired healing 26.32 10.31 57 139164 60416 64299095
Electroencephalogram abnormal 25.96 10.31 43 139178 5160 64354351
Tongue biting 25.90 10.31 25 139196 1735 64357776
Injection site mass 25.74 10.31 89 139132 17181 64342330
Mucosal dryness 25.60 10.31 32 139189 2969 64356542
Dissociation 25.51 10.31 32 139189 2979 64356532
Thrombotic microangiopathy 25.50 10.31 3 139218 16652 64342859
Cardiac failure congestive 25.45 10.31 171 139050 130409 64229102
Anuria 25.43 10.31 5 139216 18959 64340552
Metastases to liver 25.26 10.31 10 139211 23931 64335580
Basilar artery occlusion 25.00 10.31 11 139210 190 64359321
Uterine perforation 24.98 10.31 45 139176 5775 64353736
Hallucinations, mixed 24.97 10.31 46 139175 6006 64353505
Nervousness 24.94 10.31 128 139093 29428 64330083
Nephropathy toxic 24.82 10.31 4 139217 17510 64342001
Pericardial effusion 24.65 10.31 29 139192 39225 64320286
Anti-neutrophil cytoplasmic antibody positive vasculitis 24.55 10.31 31 139190 2905 64356606
Drug dependence 24.54 10.31 139 139082 33173 64326338
Dehydration 24.53 10.31 325 138896 216438 64143073
Restless legs syndrome 24.47 10.31 87 139134 17029 64342482
Pneumothorax 24.27 10.31 11 139210 24287 64335224
Burning sensation 24.27 10.31 187 139034 49477 64310034
Impulse-control disorder 24.21 10.31 23 139198 1565 64357946
Haematoma 24.19 10.31 39 139182 46211 64313300
Dyspnoea exertional 24.15 10.31 80 139141 73650 64285861
Brain death 24.02 10.31 40 139181 4821 64354690
Erythema dyschromicum perstans 24.02 10.31 8 139213 61 64359450
Cerebral infarction 24.02 10.31 32 139189 41012 64318499
Peritonitis 23.97 10.31 12 139209 25011 64334500
Abnormal dreams 23.61 10.31 62 139159 10294 64349217
Oedema 23.57 10.31 110 139111 91825 64267686
Shock haemorrhagic 23.43 10.31 4 139217 16787 64342724
Solar urticaria 23.26 10.31 8 139213 68 64359443
Device dislocation 23.22 10.31 99 139122 21079 64338432
Anorgasmia 23.17 10.31 18 139203 931 64358580
Sputum purulent 23.10 10.31 20 139201 1206 64358305
Economic problem 23.08 10.31 26 139195 2161 64357350
Skin ulcer 23.07 10.31 37 139184 43937 64315574
Heart rate decreased 23.07 10.31 53 139168 55014 64304497
Anti-cyclic citrullinated peptide antibody positive 23.03 10.31 45 139176 49517 64309994
Wound 23.02 10.31 86 139135 76391 64283120
Orgasm abnormal 22.98 10.31 10 139211 168 64359343
Drug screen positive 22.96 10.31 43 139178 5686 64353825
Neoplasm progression 22.91 10.31 33 139188 40931 64318580
Blood bilirubin increased 22.84 10.31 57 139164 57496 64302015
Substance abuse 22.60 10.31 57 139164 9235 64350276
Gambling disorder 22.57 10.31 24 139197 1870 64357641
Dyskinesia 22.52 10.31 154 139067 39234 64320277
Transplant rejection 22.48 10.31 5 139216 17396 64342115
Soft tissue injury 22.44 10.31 22 139199 1557 64357954
Balance disorder 22.25 10.31 278 138943 83648 64275863
Device related infection 22.20 10.31 20 139201 30606 64328905
Infusion site scar 22.09 10.31 11 139210 254 64359257
Bronchial disorder 22.08 10.31 25 139196 2090 64357421
Accidental poisoning 22.07 10.31 21 139200 1432 64358079
Accidental exposure to product by child 22.00 10.31 27 139194 2458 64357053
Oesophageal pain 21.99 10.31 31 139190 3232 64356279
Muscle rigidity 21.79 10.31 85 139136 17388 64342123
Rectal haemorrhage 21.70 10.31 65 139156 61752 64297759
Anhedonia 21.63 10.31 72 139149 13634 64345877
Pancreatitis acute 21.61 10.31 37 139184 42818 64316693
Blood pressure decreased 21.59 10.31 104 139117 86095 64273416
Dysphoria 21.54 10.31 36 139185 4352 64355159
Self esteem decreased 21.54 10.31 17 139204 900 64358611
Arthralgia 21.48 10.31 760 138461 441500 63918011
Central nervous system necrosis 21.37 10.31 11 139210 273 64359238
Dystonia 21.32 10.31 89 139132 18776 64340735
Feeling of despair 21.29 10.31 27 139194 2541 64356970
Attention deficit hyperactivity disorder 21.21 10.31 28 139193 2742 64356769
Injury 21.12 10.31 199 139022 55793 64303718
Psychomotor retardation 21.11 10.31 39 139182 5104 64354407
Pallor 20.95 10.31 32 139189 38749 64320762
Hypomania 20.89 10.31 41 139180 5613 64353898
Angina pectoris 20.88 10.31 41 139180 45040 64314471
Hallucination, auditory 20.80 10.31 82 139139 16857 64342654
Feelings of worthlessness 20.77 10.31 13 139208 473 64359038
Nasopharyngitis 20.74 10.31 298 138923 195775 64163736
Clostridium difficile colitis 20.68 10.31 17 139204 27206 64332305
Aspergillus infection 20.58 10.31 5 139216 16374 64343137
Metastases to lung 20.52 10.31 4 139217 15260 64344251
Sleep disorder due to general medical condition, insomnia type 20.47 10.31 16 139205 26254 64333257
Hepatic encephalopathy 20.33 10.31 10 139211 21056 64338455
Psychomotor hyperactivity 20.27 10.31 73 139148 14378 64345133
Pulmonary oedema 20.24 10.31 94 139127 78580 64280931
Cardiomyopathy acute 20.04 10.31 10 139211 232 64359279
Drug tolerance 19.96 10.31 42 139179 6043 64353468
Somnolence 19.88 10.31 578 138643 203067 64156444
Stress 19.86 10.31 209 139012 60325 64299186
Urine sodium increased 19.77 10.31 9 139212 169 64359342
Gallbladder disorder 19.76 10.31 81 139140 16949 64342562
Erectile dysfunction 19.63 10.31 66 139155 12561 64346950
Blood pressure systolic increased 19.60 10.31 49 139172 49404 64310107
Compulsive shopping 19.54 10.31 15 139206 762 64358749
Palmar-plantar erythrodysaesthesia syndrome 19.52 10.31 20 139201 28799 64330712
Adrenergic syndrome 19.51 10.31 8 139213 115 64359396
Hypocalcaemia 19.32 10.31 38 139183 41715 64317796
Glossodynia 19.31 10.31 73 139148 64623 64294888
Serum sickness-like reaction 19.30 10.31 13 139208 537 64358974
Bone erosion 19.28 10.31 62 139159 11533 64347978
Oliguria 19.22 10.31 4 139217 14572 64344939
Extra dose administered 19.20 10.31 44 139177 6706 64352805
Synovitis 19.18 10.31 130 139091 98960 64260551
Binge eating 19.14 10.31 12 139209 438 64359073
Electrocardiogram PR prolongation 19.10 10.31 19 139202 1368 64358143
Dry mouth 19.07 10.31 207 139014 60211 64299300
Post-traumatic neck syndrome 19.04 10.31 22 139199 1880 64357631
Bacteraemia 19.01 10.31 18 139203 26893 64332618
Blood pressure fluctuation 18.60 10.31 54 139167 51817 64307694
Cytokine release syndrome 18.48 10.31 11 139210 20818 64338693
Dependence 18.41 10.31 23 139198 2132 64357379
Liver function test abnormal 18.40 10.31 66 139155 59335 64300176
Treatment noncompliance 18.16 10.31 158 139063 43324 64316187
Acute myocardial infarction 18.12 10.31 83 139138 69635 64289876
Cardiotoxicity 18.05 10.31 56 139165 10218 64349293
Urinary tract infection 18.03 10.31 372 138849 231224 64128287
Left ventricular dysfunction 18.02 10.31 7 139214 16947 64342564
Plasma cell myeloma 18.00 10.31 46 139175 46029 64313482
Emotional disorder 17.95 10.31 64 139157 12543 64346968
Loss of libido 17.95 10.31 24 139197 2380 64357131
Marital problem 17.91 10.31 9 139212 212 64359299
Device placement issue 17.89 10.31 14 139207 732 64358779
Enterococcal infection 17.88 10.31 4 139217 13862 64345649
Herpes zoster 17.88 10.31 99 139122 79088 64280423
Liver injury 17.86 10.31 23 139198 29909 64329602
Subacute cutaneous lupus erythematosus 17.86 10.31 27 139194 2998 64356513
Partner stress 17.83 10.31 10 139211 296 64359215
Blood test abnormal 17.83 10.31 65 139156 12878 64346633
Graft versus host disease 17.78 10.31 4 139217 13809 64345702
Product dose omission issue 17.73 10.31 548 138673 194199 64165312
Homicidal ideation 17.73 10.31 28 139193 3229 64356282
Hyperbilirubinaemia 17.71 10.31 12 139209 21193 64338318
Sternal fracture 17.65 10.31 23 139198 2224 64357287
Chronic fatigue syndrome 17.64 10.31 17 139204 1178 64358333
Oculocephalogyric reflex absent 17.51 10.31 5 139216 21 64359490
Poor personal hygiene 17.45 10.31 12 139209 513 64358998
Brain stem syndrome 17.34 10.31 14 139207 766 64358745
Delusion 17.33 10.31 81 139140 17933 64341578
Drug specific antibody 17.33 10.31 22 139199 2073 64357438
Large intestine anastomosis 17.30 10.31 7 139214 97 64359414
Automatism 17.30 10.31 8 139213 156 64359355
Sudden death 17.29 10.31 11 139210 20085 64339426
Generalised anxiety disorder 17.27 10.31 21 139200 1894 64357617
Compartment syndrome 17.25 10.31 32 139189 4200 64355311
Mood swings 17.14 10.31 79 139142 17389 64342122
Prescribed overdose 17.12 10.31 88 139133 20243 64339268
Basal cell carcinoma 17.09 10.31 25 139196 30813 64328698
Respiratory distress 16.98 10.31 57 139164 52274 64307237
Atrioventricular block complete 16.98 10.31 5 139216 14413 64345098
Dyspareunia 16.86 10.31 20 139201 1757 64357754
Thalamic infarction 16.75 10.31 16 139205 1096 64358415
Supraventricular tachycardia 16.74 10.31 83 139138 18824 64340687
Biliary dyskinesia 16.68 10.31 23 139198 2349 64357162
Choreoathetosis 16.65 10.31 18 139203 1429 64358082
Dermatitis bullous 16.54 10.31 3 139218 12051 64347460
Metastases to bone 16.49 10.31 12 139209 20423 64339088
Haemolytic anaemia 16.46 10.31 7 139214 16046 64343465
Rhonchi 16.46 10.31 28 139193 3435 64356076
Oscillopsia 16.42 10.31 8 139213 176 64359335
Liver function test increased 16.30 10.31 26 139195 30944 64328567
Abdominal pain 16.27 10.31 532 138689 311843 64047668
Injection site reaction 16.20 10.31 163 139058 46501 64313010
Hyperglycaemia 16.19 10.31 72 139149 60896 64298615
Substance use disorder 16.15 10.31 10 139211 357 64359154
Tenosynovitis 16.12 10.31 3 139218 11830 64347681
Inadequate analgesia 16.12 10.31 30 139191 3948 64355563
Haematochezia 16.09 10.31 81 139140 66292 64293219
Staphylococcal sepsis 16.08 10.31 4 139217 12895 64346616
Lymphopenia 16.06 10.31 19 139202 25638 64333873
Impulsive behaviour 16.05 10.31 24 139197 2639 64356872
Anticholinergic syndrome 16.01 10.31 24 139197 2645 64356866
Urine osmolarity increased 16.00 10.31 9 139212 268 64359243
Suicidal behaviour 15.96 10.31 25 139196 2862 64356649
Poor quality sleep 15.94 10.31 82 139139 18869 64340642
Wound infection fungal 15.86 10.31 8 139213 190 64359321
Vaginal haemorrhage 15.79 10.31 83 139138 19261 64340250
Hypertensive crisis 15.68 10.31 10 139211 18238 64341273
Haemoglobin urine 15.65 10.31 7 139214 126 64359385
Bruxism 15.53 10.31 28 139193 3596 64355915
Prostate cancer 15.49 10.31 12 139209 19783 64339728
Gun shot wound 15.45 10.31 15 139206 1049 64358462
Corneal light reflex test abnormal 15.42 10.31 3 139218 0 64359511
Cardiac failure acute 15.41 10.31 8 139213 16336 64343175
Gastric ulcer 15.34 10.31 26 139195 30208 64329303
Bipolar I disorder 15.29 10.31 19 139202 1752 64357759
Duodenal ulcer 15.28 10.31 6 139215 14429 64345082
Postmortem blood drug level abnormal 15.21 10.31 12 139209 635 64358876
Road traffic accident 15.15 10.31 116 139105 30629 64328882
Orthostatic hypotension 15.10 10.31 51 139170 46687 64312824
Oxygen saturation decreased 15.10 10.31 153 139068 107023 64252488
Injection site induration 15.07 10.31 48 139173 8884 64350627
Body height decreased 15.01 10.31 43 139178 7511 64352000
Post-traumatic stress disorder 14.94 10.31 30 139191 4175 64355336
Priapism 14.93 10.31 29 139192 3941 64355570
Premature delivery 14.89 10.31 11 139210 18578 64340933
Decorticate posture 14.87 10.31 9 139212 308 64359203
Personality disorder 14.86 10.31 32 139189 4679 64354832
Alanine aminotransferase increased 14.80 10.31 211 139010 138820 64220691
Bronchiectasis 14.76 10.31 6 139215 14134 64345377
Acute hepatic failure 14.63 10.31 21 139200 26091 64333420
Bladder cancer 14.49 10.31 3 139218 10971 64348540
Enterocolitis 14.47 10.31 4 139217 12014 64347497
Electrolyte imbalance 14.45 10.31 20 139201 25223 64334288
Lymphoma 14.42 10.31 6 139215 13935 64345576
Body temperature decreased 14.39 10.31 21 139200 25907 64333604
Restlessness 14.31 10.31 140 139081 39645 64319866
Social anxiety disorder 14.29 10.31 10 139211 440 64359071
Clostridium difficile infection 14.20 10.31 36 139185 36127 64323384
Hypophosphataemia 14.19 10.31 7 139214 14713 64344798
Sensitivity to weather change 14.10 10.31 39 139182 6675 64352836
Pulmonary hypertension 13.99 10.31 47 139174 43092 64316419
Vasoplegia syndrome 13.99 10.31 23 139198 2744 64356767
Dizziness 13.88 10.31 1093 138128 429070 63930441
Stoma site ulcer 13.88 10.31 8 139213 250 64359261
Pseudomonas infection 13.79 10.31 11 139210 17872 64341639
Pulmonary arterial hypertension 13.63 10.31 21 139200 25346 64334165
Hypotonic urinary bladder 13.56 10.31 5 139216 53 64359458
Pelvic pain 13.55 10.31 53 139168 10857 64348654
Pre-existing condition improved 13.50 10.31 31 139190 4731 64354780
Pupillary reflex impaired 13.50 10.31 24 139197 3049 64356462
Carbon monoxide poisoning 13.48 10.31 8 139213 264 64359247
Food craving 13.47 10.31 16 139205 1408 64358103
Dysarthria 13.35 10.31 191 139030 59215 64300296
Pharyngeal exudate 13.35 10.31 3 139218 3 64359508
Ankle fracture 13.32 10.31 65 139156 14645 64344866
Acute respiratory failure 13.24 10.31 59 139162 49875 64309636
Faeces discoloured 13.17 10.31 22 139199 25707 64333804
Cutaneous lupus erythematosus 13.16 10.31 22 139199 2660 64356851
Gastrointestinal sounds abnormal 13.15 10.31 31 139190 4812 64354699
Coagulopathy 13.15 10.31 31 139190 31889 64327622
Pulmonary fibrosis 13.14 10.31 28 139193 29850 64329661
Homeless 13.12 10.31 6 139215 114 64359397
Flat affect 13.05 10.31 18 139203 1839 64357672
Clonic convulsion 13.02 10.31 14 139207 1105 64358406
Joint stiffness 12.97 10.31 111 139110 30293 64329218
Ischaemic stroke 12.94 10.31 27 139194 29008 64330503
Tachyphrenia 12.90 10.31 18 139203 1858 64357653
Heavy menstrual bleeding 12.89 10.31 56 139165 12021 64347490
Hepatic cirrhosis 12.84 10.31 99 139122 26199 64333312
Dermatillomania 12.80 10.31 7 139214 197 64359314
Blood potassium increased 12.58 10.31 23 139198 25957 64333554
Blood pressure systolic abnormal 12.56 10.31 3 139218 9939 64349572
Hyperammonaemia 12.49 10.31 3 139218 9901 64349610
Initial insomnia 12.48 10.31 34 139187 5770 64353741
Abscess sterile 12.44 10.31 5 139216 68 64359443
Increased appetite 12.36 10.31 49 139172 10097 64349414
Chills 12.36 10.31 215 139006 137049 64222462
Hypoxia 12.35 10.31 126 139095 88023 64271488
Non-alcoholic steatohepatitis 12.35 10.31 18 139203 1934 64357577
Affect lability 12.26 10.31 45 139176 8945 64350566
Persistent depressive disorder 12.22 10.31 13 139208 1013 64358498
Hypervolaemia 12.22 10.31 42 139179 38243 64321268
Cortisol increased 12.17 10.31 9 139212 432 64359079
Binge drinking 12.14 10.31 3 139218 6 64359505
Eczema 12.13 10.31 29 139192 29691 64329820
Vaginal odour 12.13 10.31 8 139213 319 64359192
Encephalitis 12.08 10.31 6 139215 12565 64346946
Injection site abscess 12.07 10.31 15 139206 1383 64358128
Right ventricular systolic pressure decreased 12.06 10.31 5 139216 74 64359437
Accidental overdose 12.03 10.31 118 139103 33439 64326072
Respiratory tract infection 11.96 10.31 41 139180 37366 64322145
Face oedema 11.92 10.31 22 139199 24739 64334772
Mental impairment 11.91 10.31 68 139153 16275 64343236
Femur fracture 11.90 10.31 36 139185 34099 64325412
Abulia 11.89 10.31 12 139209 879 64358632
Disease recurrence 11.89 10.31 32 139189 31478 64328033
Kidney transplant rejection 11.76 10.31 3 139218 9508 64350003
Subdural haematoma 11.75 10.31 27 139194 28027 64331484
Tongue spasm 11.71 10.31 5 139216 80 64359431
Purpura 11.64 10.31 12 139209 17234 64342277
Multiple fractures 11.63 10.31 34 139187 6006 64353505
Peripheral sensory neuropathy 11.60 10.31 5 139216 11373 64348138
Narcolepsy 11.57 10.31 13 139208 1078 64358433
Oesophagitis 11.54 10.31 18 139203 21612 64337899
Infusion site discomfort 11.50 10.31 11 139210 755 64358756
Hyperlipidaemia 11.50 10.31 87 139134 22889 64336622
Lower gastrointestinal haemorrhage 11.49 10.31 8 139213 13931 64345580
Galactorrhoea 11.48 10.31 23 139198 3196 64356315
Blood pressure diastolic decreased 11.48 10.31 19 139202 22282 64337229
Urinary incontinence 11.47 10.31 124 139097 36027 64323484
Hallucination, tactile 11.44 10.31 9 139212 474 64359037
Ideas of reference 11.44 10.31 6 139215 155 64359356
Panic disorder 11.43 10.31 21 139200 2736 64356775
Ileus 11.42 10.31 20 139201 22946 64336565
Tri-iodothyronine free decreased 11.41 10.31 8 139213 353 64359158
Ejaculation failure 11.41 10.31 8 139213 353 64359158
Tooth fracture 11.35 10.31 47 139174 9880 64349631
Right ventricular failure 11.33 10.31 18 139203 21453 64338058
Toxic optic neuropathy 11.28 10.31 12 139209 935 64358576
Ventricular tachyarrhythmia 11.28 10.31 7 139214 251 64359260
Bankruptcy 11.24 10.31 4 139217 38 64359473
Renal tubular necrosis 11.23 10.31 19 139202 22091 64337420
Blood urea increased 11.21 10.31 53 139168 44100 64315411
Partial seizures 11.19 10.31 38 139183 7269 64352242
Hyperuricaemia 11.18 10.31 4 139217 10187 64349324
Concussion 11.05 10.31 40 139181 7898 64351613
Reactive psychosis 11.04 10.31 3 139218 10 64359501
Family stress 11.03 10.31 10 139211 641 64358870
Muscular weakness 10.98 10.31 201 139020 127137 64232374
Visuospatial deficit 10.97 10.31 4 139217 41 64359470
Aggression 10.93 10.31 150 139071 46082 64313429
Blood triglycerides increased 10.93 10.31 74 139147 18792 64340719
Pain in jaw 10.90 10.31 48 139173 40707 64318804
Cardiac failure chronic 10.90 10.31 3 139218 9038 64350473
Feeling guilty 10.83 10.31 11 139210 812 64358699
Hyperthyroidism 10.81 10.31 14 139207 18165 64341346
Erythema induratum 10.81 10.31 6 139215 174 64359337
Gastric haemorrhage 10.77 10.31 8 139213 13473 64346038
Hypoaesthesia 10.75 10.31 384 138837 138724 64220787
Dermatitis atopic 10.73 10.31 25 139196 3851 64355660
Ventricular tachycardia 10.63 10.31 117 139104 34148 64325363
Drug screen false positive 10.63 10.31 12 139209 1000 64358511
Gastroenteritis 10.60 10.31 31 139190 29680 64329831
Klebsiella infection 10.46 10.31 8 139213 13273 64346238
Bone pain 10.45 10.31 60 139161 47512 64311999
Petechiae 10.42 10.31 15 139206 18611 64340900
Blood osmolarity decreased 10.41 10.31 13 139208 1205 64358306
Ejection fraction abnormal 10.39 10.31 14 139207 1399 64358112
Mass excision 10.38 10.31 7 139214 290 64359221
Abscess 10.36 10.31 16 139205 19288 64340223
Conduction disorder 10.34 10.31 21 139200 2947 64356564

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
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
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
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 0173-0135 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 0173-0947 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
Aplenzin HUMAN PRESCRIPTION DRUG LABEL 1 0187-5812 TABLET, EXTENDED RELEASE 522 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 hydrochloride (XL) HUMAN PRESCRIPTION DRUG LABEL 1 0527-2415 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 21 sections
Bupropion hydrochloride (XL) HUMAN PRESCRIPTION DRUG LABEL 1 0527-2430 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 21 sections
Bupropion HydrochlorideXL HUMAN PRESCRIPTION DRUG LABEL 1 0591-3331 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL ANDA 29 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