trazodone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
2717 19794-93-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • trazodone
  • trazodon
  • trazodone hydrochloride
  • trazodone HCl
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
  • Molecular weight: 371.87
  • Formula: C19H22ClN5O
  • CLOGP: 3.65
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 0
  • TPSA: 42.39
  • ALOGS: -3.11
  • ROTB: 5

  • 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) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.20 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) 23.05 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 81 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.52 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.08 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.30 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,KIT,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PDK2,PDK4,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,TEK,TTK 43
kinase-selectivity-class AXL,EIF2AK3,GRK2,SIK2,STK33 5
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.441 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
rat-kpuu-brain Rat brain Kpuu 0.853 % High 1

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1981 FDA

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 2014.32 9.28 1868 167702 143190 90315687
Drug abuse 709.67 9.28 822 168748 81525 90377352
Toxicity to various agents 664.44 9.28 1582 167988 286264 90172613
Sopor 647.01 9.28 461 169109 24183 90434694
Serotonin syndrome 579.73 9.28 516 169054 37371 90421506
Suicide attempt 349.50 9.28 557 169013 74842 90384035
Schizophrenia 346.12 9.28 259 169311 14655 90444222
Cardio-respiratory arrest 300.29 9.28 472 169098 62668 90396209
Polycystic ovaries 293.43 9.28 163 169407 5491 90453386
Rhinitis allergic 271.51 9.28 236 169334 16549 90442328
Pemphigus 261.42 9.28 143 169427 326721 90132156
Hypomania 260.51 9.28 178 169392 8719 90450158
Systemic lupus erythematosus 246.37 9.28 190 169380 361706 90097171
Sensitisation 246.22 9.28 131 169439 4044 90454833
Suicidal ideation 237.75 9.28 465 169105 73390 90385487
Drug interaction 229.58 9.28 1075 168495 275378 90183499
Hand deformity 225.09 9.28 138 169432 296224 90162653
Gastrooesophageal reflux disease 217.07 9.28 745 168825 165592 90293285
Blood test abnormal 210.97 9.28 227 169343 20725 90438152
Glossodynia 205.26 9.28 180 169390 321599 90137278
Ejection fraction 199.07 9.28 102 169468 2909 90455968
Jaundice cholestatic 190.90 9.28 155 169415 9888 90448989
Intentional overdose 186.73 9.28 488 169082 93346 90365531
Pericarditis 174.83 9.28 149 169421 270002 90188875
Swelling 174.36 9.28 324 169246 418734 90040143
Suspected suicide 170.02 9.28 142 169428 9426 90449451
Exposure during pregnancy 163.64 9.28 124 169446 238286 90220591
Impaired healing 163.08 9.28 120 169450 234079 90224798
Infusion related reaction 158.98 9.28 339 169231 416441 90042436
Dissociation 158.90 9.28 118 169452 6597 90452280
Product dose omission issue 158.08 9.28 1010 168560 290677 90168200
Psychotic disorder 157.59 9.28 240 169330 30990 90427887
Folliculitis 156.71 9.28 94 169476 204259 90254618
Sleep apnoea syndrome 156.02 9.28 241 169329 31506 90427371
Wound 153.76 9.28 205 169365 302775 90156102
Electrocardiogram QT prolonged 147.41 9.28 380 169190 72076 90386801
Anti-cyclic citrullinated peptide antibody positive 146.24 9.28 136 169434 236297 90222580
Ill-defined disorder 146.10 9.28 82 169488 184809 90274068
Joint swelling 142.96 9.28 474 169096 502826 89956051
Tremor 142.27 9.28 616 168954 152557 90306320
Helicobacter infection 137.36 9.28 133 169437 226717 90232160
Sleep disorder due to a general medical condition 135.91 9.28 275 169295 44463 90414414
Depression 130.49 9.28 986 168584 299615 90159262
Abdominal discomfort 130.47 9.28 457 169113 476871 89982006
Duodenal ulcer perforation 125.75 9.28 137 169433 221151 90237726
Carpal tunnel syndrome 123.73 9.28 186 169384 23742 90435135
Presbyacusis 121.52 9.28 74 169496 2968 90455909
Muscle injury 118.50 9.28 94 169476 176560 90282317
Overdose 118.33 9.28 596 168974 157113 90301764
Asthma-chronic obstructive pulmonary disease overlap syndrome 117.97 9.28 87 169483 4812 90454065
Pyrexia 117.04 9.28 740 168830 659745 89799132
Hypersensitivity 116.55 9.28 447 169123 454230 90004647
Respiratory arrest 112.38 9.28 214 169356 33097 90425780
Maternal exposure during pregnancy 111.42 9.28 326 169244 359737 90099140
Bronchiectasis 110.40 9.28 170 169400 22160 90436717
Pleural fibrosis 110.18 9.28 74 169496 3522 90455355
Total lung capacity increased 109.43 9.28 84 169486 4937 90453940
Alopecia 107.72 9.28 518 169052 494553 89964324
Withdrawal syndrome 105.13 9.28 167 169403 22357 90436520
Loss of personal independence in daily activities 103.25 9.28 516 169054 135589 90323288
Pleural thickening 102.31 9.28 68 169502 3180 90455697
Irritable bowel syndrome 101.54 9.28 144 169426 207304 90251573
Contraindicated product administered 101.12 9.28 287 169283 319852 90139025
Swollen joint count increased 100.56 9.28 41 169529 111165 90347712
Blood magnesium increased 99.34 9.28 68 169502 3340 90455537
Synovitis 98.81 9.28 303 169267 329449 90129428
Stomatitis 96.08 9.28 234 169336 274464 90184413
Arthropathy 95.79 9.28 357 169213 365885 90092992
Lung diffusion test abnormal 95.53 9.28 32 169538 292 90458585
Discomfort 94.93 9.28 235 169335 274100 90184777
Sputum discoloured 94.92 9.28 151 169419 20240 90438637
Persistent genital arousal disorder 94.67 9.28 39 169531 661 90458216
Cholelithiasis 94.31 9.28 263 169307 52243 90406634
Sleep disorder due to general medical condition, insomnia type 93.42 9.28 63 169507 128631 90330246
Liver injury 93.17 9.28 109 169461 170458 90288419
Neovascularisation 92.90 9.28 50 169520 1580 90457297
Cardiac murmur 89.23 9.28 138 169432 18056 90440821
Ejection fraction abnormal 87.89 9.28 56 169514 2435 90456442
C-reactive protein abnormal 85.20 9.28 68 169502 127361 90331516
Nephrectomy 83.81 9.28 50 169520 1931 90456946
Breath sounds abnormal 81.55 9.28 121 169449 15265 90443612
Somnolence 81.39 9.28 669 168901 208415 90250462
Thrombocytopenia 80.96 9.28 168 169402 208557 90250320
Irritability 79.82 9.28 194 169376 35468 90423409
Total lung capacity decreased 79.46 9.28 62 169508 3733 90455144
Deafness neurosensory 79.42 9.28 80 169490 6761 90452116
Sedation 77.54 9.28 232 169338 47939 90410938
Blister 77.30 9.28 233 169337 254765 90204112
Lower respiratory tract infection 75.29 9.28 230 169340 250429 90208448
Rheumatic fever 75.20 9.28 106 169464 153015 90305862
Anxiety 75.07 9.28 898 168672 308874 90150003
Infection 74.60 9.28 386 169184 361708 90097169
Rash 72.25 9.28 1052 168518 795048 89663829
Dermatitis atopic 72.14 9.28 145 169425 23327 90435550
Bronchopulmonary aspergillosis allergic 71.31 9.28 58 169512 3708 90455169
Depressed level of consciousness 70.84 9.28 297 169273 72487 90386390
Insomnia 70.71 9.28 943 168627 332531 90126346
Sarcoidosis 70.06 9.28 93 169477 10580 90448297
General physical health deterioration 69.03 9.28 386 169184 354729 90104148
Confabulation 68.90 9.28 25 169545 295 90458582
Agitation 68.61 9.28 278 169292 66820 90392057
Poor quality sleep 68.22 9.28 146 169424 24547 90434330
Obstructive airways disorder 68.10 9.28 150 169420 25719 90433158
Paradoxical drug reaction 67.99 9.28 68 169502 5698 90453179
Liver disorder 66.75 9.28 77 169493 121192 90337685
Burning sensation 66.57 9.28 265 169305 63187 90395690
Drug withdrawal syndrome 65.09 9.28 157 169413 28566 90430311
Hyper IgE syndrome 64.47 9.28 27 169543 478 90458399
Tardive dyskinesia 63.83 9.28 90 169480 10840 90448037
Febrile neutropenia 63.49 9.28 125 169445 158224 90300653
Hyperreflexia 63.31 9.28 70 169500 6587 90452290
Mobility decreased 63.19 9.28 248 169322 250486 90208391
Epigastric discomfort 62.54 9.28 74 169496 7494 90451383
Neutropenia 62.23 9.28 214 169356 224690 90234187
Extrapyramidal disorder 61.61 9.28 110 169460 16193 90442684
Distributive shock 61.21 9.28 51 169519 3373 90455504
Nasal polyps 59.74 9.28 87 169483 10793 90448084
Bradyphrenia 58.92 9.28 72 169498 7540 90451337
Nightmare 58.35 9.28 127 169443 21598 90437279
Abnormal behaviour 58.20 9.28 130 169440 22498 90436379
Oedema 57.87 9.28 187 169383 200108 90258769
Aspiration 56.91 9.28 104 169466 15589 90443288
Blood bilirubin increased 56.89 9.28 195 169375 43275 90415602
Pancytopenia 56.36 9.28 86 169484 120177 90338700
Migraine 56.20 9.28 574 168996 189818 90269059
Lung opacity 56.03 9.28 63 169507 6039 90452838
Blood cholesterol increased 55.49 9.28 201 169369 207811 90251066
Chronic obstructive pulmonary disease 55.32 9.28 279 169291 73550 90385327
Fall 55.25 9.28 1234 168336 480576 89978301
Akathisia 55.22 9.28 85 169485 11074 90447803
Malignant neoplasm progression 54.46 9.28 72 169498 106798 90352079
Taste disorder 52.93 9.28 242 169328 61304 90397573
Vertigo 52.44 9.28 264 169306 69547 90389330
Deep vein thrombosis postoperative 52.27 9.28 34 169536 70775 90388102
Sinusitis 51.96 9.28 402 169168 342686 90116191
Memory impairment 51.85 9.28 581 168989 196663 90262214
Cardiac disorder 51.44 9.28 227 169343 56645 90402232
Autoimmune disorder 51.23 9.28 41 169529 76703 90382174
Myocardial stunning 51.20 9.28 20 169550 293 90458584
Restless legs syndrome 51.10 9.28 123 169447 22347 90436530
Prescription drug used without a prescription 51.09 9.28 45 169525 3210 90455667
Intentional self-injury 50.78 9.28 145 169425 29189 90429688
Adjustment disorder with mixed anxiety and depressed mood 50.63 9.28 16 169554 119 90458758
Asthma 50.14 9.28 682 168888 241478 90217399
Bone cyst 50.11 9.28 39 169531 2339 90456538
Haemoglobin decreased 49.76 9.28 147 169423 161809 90297068
Rheumatoid factor positive 49.76 9.28 160 169410 171490 90287387
Myelosuppression 49.69 9.28 19 169551 53572 90405305
Hostility 49.48 9.28 38 169532 2235 90456642
Anaemia 49.47 9.28 422 169148 352380 90106497
Skin lesion 49.23 9.28 168 169402 37197 90421680
Cardiac arrest 48.74 9.28 350 169220 104585 90354292
Injury 48.57 9.28 197 169373 197152 90261725
Hallucination, auditory 48.27 9.28 98 169472 15877 90443000
Granuloma skin 48.22 9.28 78 169492 10602 90448275
Hip arthroplasty 48.07 9.28 43 169527 76165 90382712
Urticaria 48.02 9.28 365 169205 312369 90146508
Nasopharyngitis 47.31 9.28 510 169060 406594 90052283
Sciatica 47.02 9.28 73 169497 101309 90357568
Impaired quality of life 46.66 9.28 121 169449 23023 90435854
Libido increased 46.62 9.28 33 169537 1711 90457166
Restlessness 46.53 9.28 160 169410 35560 90423317
Hypothyroidism 46.50 9.28 210 169360 52917 90405960
Visual perseveration 46.01 9.28 13 169557 62 90458815
Arteriosclerosis coronary artery 45.92 9.28 72 169498 9531 90449346
Cognitive disorder 45.64 9.28 253 169317 69154 90389723
Encephalopathy 45.56 9.28 190 169380 46254 90412623
Hepatotoxicity 45.34 9.28 188 169382 45654 90413223
Mucosal inflammation 44.86 9.28 26 169544 57599 90401278
Disease progression 44.69 9.28 147 169423 156468 90302409
Leukopenia 44.38 9.28 75 169495 100635 90358242
Macular degeneration 43.46 9.28 9 169561 37961 90420916
Neuroleptic malignant syndrome 42.56 9.28 90 169480 15006 90443871
Psoriatic arthropathy 42.29 9.28 252 169318 228083 90230794
Asphyxia 42.24 9.28 59 169511 7044 90451833
Blood parathyroid hormone decreased 41.84 9.28 79 169491 12137 90446740
Prescribed overdose 41.83 9.28 74 169496 97551 90361326
Alcoholism 41.18 9.28 31 169539 1769 90457108
Somatic delusion 41.17 9.28 21 169549 593 90458284
Product use in unapproved indication 41.00 9.28 869 168701 335367 90123510
Overlap syndrome 40.75 9.28 64 169506 8484 90450393
Bone marrow failure 40.45 9.28 6 169564 32215 90426662
Cyst 40.21 9.28 93 169477 16468 90442409
Gastrointestinal disorder 40.15 9.28 298 169272 256389 90202488
Unresponsive to stimuli 39.81 9.28 159 169411 37962 90420915
Pleurothotonus 39.77 9.28 27 169543 1308 90457569
Dyskinesia 39.46 9.28 154 169416 36380 90422497
Panniculitis 39.38 9.28 85 169485 14373 90444504
Mood altered 39.15 9.28 94 169476 17050 90441827
Soft tissue injury 39.15 9.28 32 169538 2060 90456817
Oral discomfort 38.68 9.28 70 169500 10413 90448464
Drug intolerance 38.24 9.28 598 168972 446993 90011884
Mental disorder 38.02 9.28 140 169430 32178 90426699
Listless 37.73 9.28 38 169532 3211 90455666
Sternal fracture 37.69 9.28 36 169534 2851 90456026
Grip strength decreased 37.17 9.28 73 169497 92503 90366374
Hypertonia 37.08 9.28 47 169523 5108 90453769
Injection site mass 37.08 9.28 108 169462 21982 90436895
Anti-cyclic citrullinated peptide antibody 36.76 9.28 4 169566 27217 90431660
Dry eye 36.65 9.28 209 169361 57722 90401155
Torsade de pointes 36.58 9.28 85 169485 15097 90443780
Coma 36.51 9.28 247 169323 72385 90386492
Body tinea 36.35 9.28 31 169539 2117 90456760
Post-traumatic neck syndrome 36.00 9.28 33 169537 2481 90456396
Bone erosion 35.80 9.28 28 169542 52993 90405884
Renal disorder 35.68 9.28 153 169417 37706 90421171
Muscle rigidity 35.45 9.28 81 169489 14228 90444649
Bursitis 35.24 9.28 127 169443 131527 90327350
Accidental poisoning 34.92 9.28 22 169548 938 90457939
Knee arthroplasty 34.79 9.28 64 169506 83118 90375759
Productive cough 34.61 9.28 255 169315 76808 90382069
Major depression 34.50 9.28 65 169505 9970 90448907
Hypoxia 33.92 9.28 242 169328 72157 90386720
Therapeutic product effect decreased 33.73 9.28 344 169226 277227 90181650
Osteosclerosis 33.66 9.28 41 169529 4279 90454598
Urinary retention 32.89 9.28 149 169421 37595 90421282
Mental status changes 32.88 9.28 168 169402 44511 90414366
Lung neoplasm malignant 32.74 9.28 110 169460 24163 90434714
Drug withdrawal syndrome neonatal 32.35 9.28 30 169540 2289 90456588
Autonomic nervous system imbalance 32.33 9.28 36 169534 3414 90455463
Psychomotor hyperactivity 32.27 9.28 73 169497 12740 90446137
Hospitalisation 32.14 9.28 374 169196 127726 90331151
Muscle twitching 32.04 9.28 109 169461 24093 90434784
Peripheral swelling 31.96 9.28 562 169008 412544 90046333
Acute kidney injury 31.94 9.28 415 169155 319972 90138905
Restrictive pulmonary disease 31.88 9.28 30 169540 2332 90456545
Blepharospasm 31.83 9.28 195 169375 55250 90403627
Clonus 31.60 9.28 46 169524 5704 90453173
Skin necrosis 31.54 9.28 86 169484 16855 90442022
Disorganised speech 31.49 9.28 27 169543 1858 90457019
Lupus vulgaris 31.44 9.28 23 169547 45036 90413841
Dislocation of vertebra 31.38 9.28 35 169535 55933 90402944
Multiple sclerosis relapse 31.33 9.28 186 169384 52119 90406758
Apallic syndrome 30.87 9.28 19 169551 777 90458100
Pregnancy 30.40 9.28 43 169527 62004 90396873
Depressed mood 30.34 9.28 179 169391 50043 90408834
Adjustment disorder with depressed mood 30.19 9.28 37 169533 56716 90402161
Middle insomnia 30.16 9.28 84 169486 16667 90442210
Lip dry 30.02 9.28 93 169477 100862 90358015
Drug screen positive 29.83 9.28 36 169534 3721 90455156
Inhibitory drug interaction 29.63 9.28 33 169537 3130 90455747
Musculoskeletal pain 29.63 9.28 193 169377 171058 90287819
Accidental death 29.55 9.28 27 169543 2021 90456856
Premature delivery 29.45 9.28 18 169552 38744 90420133
Joint range of motion decreased 29.37 9.28 142 169428 135501 90323376
Osteopenia 29.06 9.28 102 169468 22900 90435977
Cytomegalovirus infection 29.05 9.28 7 169563 26595 90432282
Blood potassium increased 28.85 9.28 95 169475 20654 90438223
Concussion 28.84 9.28 64 169506 11027 90447850
Nausea 28.72 9.28 2430 167140 1107886 89350991
Affective disorder 28.70 9.28 52 169518 7741 90451136
Foot deformity 28.58 9.28 42 169528 59609 90399268
Infection susceptibility increased 28.57 9.28 36 169534 3890 90454987
Foetal death 28.10 9.28 3 169567 20720 90438157
Type 2 diabetes mellitus 28.06 9.28 244 169326 203000 90255877
Hereditary angioedema 27.76 9.28 57 169513 9308 90449569
Lower limb fracture 27.70 9.28 75 169495 84938 90373939
Platelet count decreased 27.61 9.28 147 169423 136822 90322055
Abnormal dreams 27.09 9.28 63 169507 11194 90447683
Lung disorder 26.91 9.28 167 169403 149716 90309161
Intentional product misuse 26.35 9.28 270 169300 89334 90369543
Bradycardia 26.27 9.28 256 169314 83591 90375286
X-ray abnormal 25.91 9.28 28 169542 45396 90413481
Hypercholesterolaemia 25.90 9.28 99 169471 100793 90358084
Trichoglossia 25.82 9.28 14 169556 449 90458428
Lupus-like syndrome 25.82 9.28 32 169538 48814 90410063
Initial insomnia 25.66 9.28 55 169515 9255 90449622
Multiple organ dysfunction syndrome 25.64 9.28 56 169514 68280 90390597
Blood calcium increased 25.30 9.28 64 169506 11994 90446883
Retinitis 25.10 9.28 21 169549 38437 90420440
Facet joint syndrome 24.96 9.28 97 169473 98292 90360585
Toxic epidermal necrolysis 24.86 9.28 15 169555 32513 90426364
Head discomfort 24.72 9.28 77 169493 16256 90442621
Cholestasis 24.72 9.28 19 169551 36280 90422597
Septic shock 24.69 9.28 78 169492 84082 90374795
Inappropriate schedule of product administration 24.66 9.28 406 169164 149527 90309350
Road traffic accident 24.28 9.28 111 169459 107515 90351362
Glucose tolerance impaired 24.14 9.28 49 169521 7936 90450941
Sensation of foreign body 24.11 9.28 43 169527 6323 90452554
Product physical issue 23.75 9.28 40 169530 5620 90453257
Infusion site reaction 23.69 9.28 84 169486 18955 90439922
Cholinergic rebound syndrome 23.67 9.28 6 169564 17 90458860
Hepatic cirrhosis 23.60 9.28 52 169518 63201 90395676
Delusion of parasitosis 23.54 9.28 9 169561 124 90458753
Alcohol poisoning 23.38 9.28 23 169547 1889 90456988
C-reactive protein 23.23 9.28 15 169555 31352 90427525
Skin neoplasm excision 23.23 9.28 22 169548 1724 90457153
Post-traumatic stress disorder 23.19 9.28 44 169526 6784 90452093
Gambling disorder 23.11 9.28 19 169551 1233 90457644
Rheumatoid arthritis 22.98 9.28 510 169060 362104 90096773
Gastroenteritis radiation 22.96 9.28 14 169556 563 90458314
Blood calcium decreased 22.95 9.28 14 169556 30168 90428709
Therapeutic product effect incomplete 22.92 9.28 499 169071 193397 90265480
Cardiac failure 22.92 9.28 116 169454 109380 90349497
Reduced facial expression 22.83 9.28 26 169544 2527 90456350
Perseveration 22.83 9.28 11 169559 274 90458603
Hepatic function abnormal 22.76 9.28 32 169538 46256 90412621
Therapy non-responder 22.67 9.28 156 169414 136548 90322329
Rash maculo-papular 22.51 9.28 26 169544 40907 90417970
Sense of a foreshortened future 22.49 9.28 5 169565 6 90458871
Respiratory acidosis 22.42 9.28 48 169522 8071 90450806
Purple glove syndrome 22.23 9.28 10 169560 212 90458665
Angioedema 22.08 9.28 56 169514 64820 90394057
Mydriasis 22.01 9.28 70 169500 14942 90443935
Full blood count abnormal 21.83 9.28 130 169440 36467 90422410
Myoclonus 21.68 9.28 82 169488 19086 90439791
Headache 21.60 9.28 1884 167686 860862 89598015
Feeling abnormal 21.59 9.28 436 169134 166799 90292078
Cardiac failure congestive 21.55 9.28 103 169467 98591 90360286
Hepatic cytolysis 21.29 9.28 16 169554 30900 90427977
Sinus bradycardia 21.27 9.28 75 169495 16877 90442000
Substance abuse 21.10 9.28 37 169533 5369 90453508
Anger 21.06 9.28 65 169505 13655 90445222
Pneumonia 21.04 9.28 1424 168146 636635 89822242
Tension 21.03 9.28 30 169540 3652 90455225
Haemangioma congenital 20.87 9.28 13 169557 543 90458334
Maternal exposure timing unspecified 20.79 9.28 8 169562 22475 90436402
Drug resistance 20.66 9.28 16 169554 30433 90428444
Hyperkalaemia 20.65 9.28 58 169512 64906 90393971
Food allergy 20.54 9.28 11 169559 25467 90433410
Apathy 20.51 9.28 56 169514 10984 90447893
Psychomotor skills impaired 20.37 9.28 26 169544 2846 90456031
Gait apraxia 20.23 9.28 6 169564 35 90458842
Hepatic failure 20.00 9.28 27 169543 39701 90419176
Loss of consciousness 19.93 9.28 371 169199 139867 90319010
Tachyphrenia 19.90 9.28 20 169550 1686 90457191
Anuria 19.85 9.28 67 169503 14751 90444126
Product use issue 19.78 9.28 468 169102 329451 90129426
Tonic clonic movements 19.74 9.28 20 169550 1702 90457175
Nervousness 19.69 9.28 120 169450 33936 90424941
Wheezing 19.66 9.28 584 168986 237496 90221381
Calcification of muscle 19.62 9.28 9 169561 200 90458677
Thrombotic microangiopathy 19.61 9.28 3 169567 15740 90443137
Plasma cell mastitis 19.43 9.28 6 169564 41 90458836
Ischaemic hepatitis 19.36 9.28 25 169545 2768 90456109
Meningitis streptococcal 19.34 9.28 8 169562 137 90458740
Solar urticaria 19.26 9.28 7 169563 83 90458794
Increased appetite 19.25 9.28 57 169513 11708 90447169
Illness 19.10 9.28 236 169334 81733 90377144
Accommodation disorder 18.96 9.28 11 169559 403 90458474
Female genital tract fistula 18.93 9.28 5 169565 17863 90441014
Joint dislocation 18.91 9.28 34 169536 44548 90414329
Hypotension 18.81 9.28 766 168804 324631 90134246
Oppositional defiant disorder 18.61 9.28 6 169564 48 90458829
Vomiting 18.58 9.28 1714 167856 786579 89672298
Compartment syndrome 18.54 9.28 25 169545 2887 90455990
Immunodeficiency 18.31 9.28 33 169537 43201 90415676
Infantile vomiting 18.25 9.28 8 169562 159 90458718
Musculoskeletal stiffness 18.23 9.28 419 169151 296113 90162764
Therapy interrupted 18.23 9.28 158 169412 49950 90408927
Onychomycosis 18.21 9.28 26 169544 37350 90421527
Chest pain 18.19 9.28 457 169113 319188 90139689
Hyperhidrosis 18.14 9.28 357 169213 135948 90322929
Abortion spontaneous 18.13 9.28 47 169523 54009 90404868
Fluid retention 18.05 9.28 94 169476 87997 90370880
Epilepsy 18.02 9.28 234 169336 81972 90376905
Pneumocystis jirovecii pneumonia 17.92 9.28 9 169561 21607 90437270
COVID-19 17.92 9.28 428 169142 168415 90290462
Joint stiffness 17.90 9.28 80 169490 77962 90380915
Slow speech 17.82 9.28 20 169550 1913 90456964
Disseminated intravascular coagulation 17.81 9.28 9 169561 21529 90437348
Skin texture abnormal 17.57 9.28 12 169558 587 90458290
Maximal voluntary ventilation abnormal 17.50 9.28 5 169565 25 90458852
Thinking abnormal 17.47 9.28 55 169515 11677 90447200
Coagulopathy 17.44 9.28 11 169559 23278 90435599
Aggression 17.38 9.28 97 169473 26571 90432306
Pneumococcal infection 17.16 9.28 16 169554 1229 90457648
Acute respiratory distress syndrome 17.13 9.28 17 169553 28669 90430208
Balance disorder 17.13 9.28 266 169304 96814 90362063
Rheumatoid nodule 17.11 9.28 79 169491 20087 90438790
Presyncope 17.10 9.28 110 169460 31695 90427182
Compulsive shopping 17.05 9.28 13 169557 756 90458121
Creatinine renal clearance decreased 17.03 9.28 7 169563 18892 90439985
Blood prolactin increased 17.02 9.28 27 169543 3610 90455267
Haemophagocytic lymphohistiocytosis 17.01 9.28 4 169566 15455 90443422
Walking aid user 17.01 9.28 25 169545 35481 90423396
Nystagmus 16.91 9.28 40 169530 7187 90451690
Chronic sinusitis 16.80 9.28 12 169558 23790 90435087
Mood swings 16.76 9.28 80 169490 20622 90438255
Proctitis 16.69 9.28 4 169566 15255 90443622
Dysphoria 16.55 9.28 36 169534 6118 90452759
Obsessive-compulsive disorder 16.52 9.28 30 169540 4474 90454403
Priapism 16.51 9.28 7 169563 128 90458749
Anaphylactic shock 16.41 9.28 21 169549 31596 90427281
Screaming 16.40 9.28 27 169543 3723 90455154
Ankylosing spondylitis 16.39 9.28 58 169512 13075 90445802
Economic problem 16.25 9.28 25 169545 3256 90455621
Long QT syndrome 16.24 9.28 28 169542 4009 90454868
Speech disorder 16.20 9.28 143 169427 45442 90413435
Drug dependence 16.12 9.28 102 169468 29225 90429652
Mental impairment 16.08 9.28 68 169502 16652 90442225
Breathing-related sleep disorder 16.07 9.28 7 169563 137 90458740
Seronegative arthritis 16.03 9.28 7 169563 18227 90440650
Premature baby 15.99 9.28 14 169556 25063 90433814
Gait inability 15.98 9.28 186 169384 146270 90312607
Myoglobin blood increased 15.95 9.28 17 169553 1535 90457342
Crying 15.88 9.28 92 169478 25553 90433324
Sedative therapy 15.85 9.28 3 169567 0 90458877
Frequent bowel movements 15.85 9.28 54 169516 56881 90401996
Skin fissures 15.84 9.28 79 169491 20730 90438147
Disturbance in attention 15.83 9.28 146 169424 46963 90411914
Liver function test abnormal 15.72 9.28 46 169524 50799 90408078
Hepatic enzyme increased 15.69 9.28 535 169035 360201 90098676
Neoplasm skin 15.64 9.28 24 169546 3118 90455759
Toxic skin eruption 15.64 9.28 5 169565 15769 90443108
Pleuritic pain 15.54 9.28 49 169521 10412 90448465
Disorientation 15.48 9.28 138 169432 43976 90414901
Rash erythematous 15.38 9.28 66 169504 65038 90393839
Treatment failure 15.34 9.28 442 169128 303486 90155391
Accidental overdose 15.33 9.28 98 169472 28175 90430702
Foreign body 15.25 9.28 21 169549 2473 90456404
Hypokinesia 15.22 9.28 64 169506 15633 90443244
Burning mouth syndrome 15.18 9.28 11 169559 592 90458285
Ejection fraction decreased 15.18 9.28 16 169554 26237 90432640
Acute myeloid leukaemia 15.11 9.28 10 169560 20630 90438247
Metastases to liver 15.09 9.28 19 169551 28788 90430089
Heart rate abnormal 15.01 9.28 34 169536 5937 90452940
Neck pain 15.00 9.28 298 169272 113665 90345212
Alcohol withdrawal syndrome 14.96 9.28 13 169557 911 90457966
Parkinsonism 14.95 9.28 59 169511 14006 90444871
Wound infection fungal 14.88 9.28 7 169563 165 90458712
Therapeutic response shortened 14.77 9.28 83 169487 22796 90436081
Pneumonia viral 14.68 9.28 43 169527 8780 90450097
Anaphylactic reaction 14.45 9.28 100 169470 87424 90371453
Electrocardiogram QRS complex prolonged 14.38 9.28 38 169532 7310 90451567
Pulseless electrical activity 14.35 9.28 43 169527 8889 90449988
Haematocrit decreased 14.32 9.28 36 169534 41796 90417081
Interstitial lung disease 14.30 9.28 84 169486 76321 90382556
Large for dates baby 14.29 9.28 10 169560 509 90458368
Polyglandular autoimmune syndrome type II 14.26 9.28 5 169565 53 90458824
Hepatocellular injury 14.25 9.28 20 169550 28938 90429939
Product quality issue 14.24 9.28 218 169352 79107 90379770
Therapeutic reaction time decreased 14.23 9.28 25 169545 3633 90455244
Vitamin B12 decreased 14.21 9.28 31 169539 5279 90453598
Bipolar disorder 14.20 9.28 43 169527 8942 90449935
Product substitution issue 14.16 9.28 69 169501 17939 90440938
Central pain syndrome 14.15 9.28 11 169559 659 90458218
Foreign body in reproductive tract 14.10 9.28 14 169556 1163 90457714
Somnambulism 14.06 9.28 34 169536 6194 90452683
Hyperlipidaemia 14.05 9.28 82 169488 22834 90436043
Mania 14.02 9.28 58 169512 14066 90444811
Respiratory depression 13.95 9.28 62 169508 15513 90443364
Neoplasm progression 13.93 9.28 40 169530 44446 90414431
Osteonecrosis of jaw 13.89 9.28 33 169537 39070 90419807
Haematochezia 13.79 9.28 77 169493 70836 90388041
Compulsive sexual behaviour 13.78 9.28 5 169565 59 90458818
Patient restraint 13.78 9.28 3 169567 3 90458874
International normalised ratio increased 13.77 9.28 44 169526 47272 90411605
Tongue discolouration 13.76 9.28 24 169546 3469 90455408
Ulcer 13.74 9.28 107 169463 32775 90426102
Hypoacusis 13.57 9.28 94 169476 27756 90431121
Aplastic anaemia 13.53 9.28 4 169566 13265 90445612
Immobile 13.46 9.28 34 169536 6364 90452513
Body height decreased 13.42 9.28 51 169519 11898 90446979
Palliative care 13.39 9.28 12 169558 876 90458001
Peritoneal perforation 13.39 9.28 6 169564 126 90458751
Galactorrhoea 13.34 9.28 28 169542 4644 90454233
Toxicologic test abnormal 13.29 9.28 11 169559 721 90458156
Illusion 13.26 9.28 14 169556 1250 90457627
Breast cancer stage II 13.22 9.28 29 169541 35305 90423572
Serum serotonin increased 13.19 9.28 7 169563 215 90458662
Depressive symptom 13.18 9.28 30 169540 5255 90453622
Sinus tachycardia 13.17 9.28 95 169475 28418 90430459
Hypersomnia 13.17 9.28 77 169493 21454 90437423
Suicidal behaviour 13.15 9.28 21 169549 2823 90456054
Tracheitis 13.14 9.28 12 169558 898 90457979
Pain 13.07 9.28 1649 167921 994692 89464185
Colitis 13.04 9.28 77 169493 69865 90389012
Personal relationship issue 13.01 9.28 6 169564 135 90458742
Needle issue 12.89 9.28 56 169514 13878 90444999
Oral herpes 12.88 9.28 107 169463 33417 90425460
Agranulocytosis 12.87 9.28 29 169541 34973 90423904
Holmes-Adie pupil 12.87 9.28 4 169566 28 90458849
Sepsis 12.83 9.28 248 169322 179566 90279311
Jaundice 12.74 9.28 26 169544 32491 90426386
Rales 12.70 9.28 61 169509 15766 90443111
Neutrophil count decreased 12.68 9.28 80 169490 71452 90387425
Nodule 12.58 9.28 19 169551 26667 90432210
Eczema eyelids 12.51 9.28 8 169562 350 90458527
Multiple sclerosis 12.43 9.28 92 169478 27748 90431129
Osteoporosis 12.40 9.28 118 169452 96413 90362464
Anticholinergic syndrome 12.34 9.28 20 169550 2723 90456154
Delusion 12.33 9.28 55 169515 13785 90445092
Hyperaesthesia 12.29 9.28 46 169524 10656 90448221
Bruxism 12.28 9.28 26 169544 4337 90454540
Anhedonia 12.19 9.28 48 169522 11383 90447494
Hyponatriuria 12.19 9.28 4 169566 34 90458843
Deafness 12.18 9.28 78 169492 22436 90436441
Rib fracture 12.17 9.28 88 169482 26347 90432530
Decreased interest 12.11 9.28 26 169544 4381 90454496
Intervertebral disc degeneration 12.05 9.28 64 169506 17210 90441667
Small for dates baby 12.03 9.28 28 169542 4979 90453898
Injection site induration 12.02 9.28 45 169525 10423 90448454
Rectal haemorrhage 12.01 9.28 98 169472 82646 90376231
Neuropathy peripheral 12.00 9.28 182 169388 136788 90322089
Wandering pacemaker 11.97 9.28 3 169567 8 90458869
Hemianopia 11.94 9.28 17 169553 2065 90456812
Atrioventricular block second degree 11.93 9.28 26 169544 4426 90454451
Spinal operation 11.85 9.28 44 169526 10152 90448725
Hyperbilirubinaemia neonatal 11.78 9.28 8 169562 388 90458489
Blood lactate dehydrogenase increased 11.71 9.28 19 169551 25913 90432964
Adrenal insufficiency 11.66 9.28 24 169546 29897 90428980
Laryngitis 11.65 9.28 52 169518 50701 90408176
Enuresis 11.60 9.28 22 169548 3392 90455485
Proteinuria 11.55 9.28 16 169554 23275 90435602
Abnormal faeces 11.53 9.28 33 169537 6649 90452228
Hyperthermia 11.51 9.28 44 169526 10291 90448586
Finger deformity 11.50 9.28 28 169542 32869 90426008
Rectal discharge 11.49 9.28 11 169559 874 90458003
Hypercalcaemia 11.45 9.28 106 169464 34134 90424743
Deep vein thrombosis 11.34 9.28 113 169457 91507 90367370
Product shape issue 11.34 9.28 5 169565 101 90458776
Palmar-plantar erythrodysaesthesia syndrome 11.33 9.28 22 169548 28001 90430876
Infusion site pruritus 11.28 9.28 33 169537 6732 90452145
Nasal congestion 11.27 9.28 219 169351 83195 90375682
Rhabdomyolysis 11.27 9.28 146 169424 51110 90407767
Hyponatraemic syndrome 11.21 9.28 9 169561 565 90458312
Food craving 11.19 9.28 16 169554 1951 90456926
Renal failure 11.17 9.28 175 169395 130832 90328045
Extra dose administered 11.15 9.28 40 169530 9078 90449799
Obesity 11.12 9.28 135 169435 105372 90353505
Dyspepsia 11.08 9.28 284 169286 197876 90261001
Product dose omission in error 11.07 9.28 71 169499 20432 90438445
Transplant rejection 11.06 9.28 5 169565 12753 90446124
Confusional arousal 11.04 9.28 7 169563 302 90458575
Crush syndrome 11.04 9.28 7 169563 302 90458575
Oral candidiasis 11.01 9.28 32 169538 35423 90423454
Incorrect dose administered 10.93 9.28 208 169362 78722 90380155
Drug screen false positive 10.90 9.28 11 169559 932 90457945
Intestinal ischaemia 10.89 9.28 39 169531 8844 90450033
Genital infection female 10.86 9.28 5 169565 112 90458765
Knee deformity 10.86 9.28 14 169556 1548 90457329
Kluver-Bucy syndrome 10.85 9.28 3 169567 13 90458864
Vasculitis 10.85 9.28 16 169554 22677 90436200
Cushingoid 10.84 9.28 3 169567 10392 90448485
Second primary malignancy 10.82 9.28 3 169567 10375 90448502
Alcohol abuse 10.79 9.28 16 169554 2017 90456860
Malaise 10.74 9.28 947 168623 585039 89873838
Sinus congestion 10.68 9.28 22 169548 27402 90431475
Mitral valve thickening 10.67 9.28 4 169566 52 90458825
Heterophoria 10.67 9.28 4 169566 52 90458825
Ventricular tachycardia 10.66 9.28 81 169489 24627 90434250
Neonatal seizure 10.64 9.28 9 169561 608 90458269
Periorbital swelling 10.63 9.28 26 169544 4772 90454105
Product size issue 10.62 9.28 8 169562 457 90458420
Hypocoagulable state 10.60 9.28 14 169556 1585 90457292
Generalised oedema 10.59 9.28 12 169558 19041 90439836
Eczema 10.56 9.28 148 169422 52722 90406155
Snoring 10.54 9.28 27 169543 5099 90453778
Juvenile melanoma benign 10.50 9.28 3 169567 15 90458862
Colitis ischaemic 10.45 9.28 5 169565 12341 90446536
Electrocardiogram T wave inversion 10.43 9.28 22 169548 3661 90455216
Human herpesvirus 6 infection reactivation 10.42 9.28 9 169561 625 90458252
Presbyopia 10.35 9.28 9 169561 631 90458246
Joint effusion 10.33 9.28 13 169557 19697 90439180
Vascular device infection 10.27 9.28 47 169523 11905 90446972
Altered state of consciousness 10.23 9.28 97 169473 31435 90427442
Skin sensitisation 10.22 9.28 11 169559 1004 90457873
Pyelonephritis 10.22 9.28 15 169555 21301 90437576
Eyelid operation 10.22 9.28 4 169566 59 90458818
AST/ALT ratio abnormal 10.18 9.28 5 169565 130 90458747
Drug detoxification 10.17 9.28 7 169563 347 90458530
Product packaging difficult to open 10.08 9.28 5 169565 133 90458744
Laryngeal hypertrophy 10.05 9.28 3 169567 18 90458859
Urinary incontinence 10.01 9.28 111 169459 37455 90421422
Night sweats 9.99 9.28 175 169395 128591 90330286
Drug diversion 9.94 9.28 11 169559 1036 90457841
Surgery 9.93 9.28 128 169442 44759 90414118
Product use complaint 9.88 9.28 21 169549 3512 90455365
Hip fracture 9.88 9.28 100 169470 32977 90425900
Electrocardiogram PR prolongation 9.78 9.28 10 169560 860 90458017
Peripheral venous disease 9.78 9.28 105 169465 83816 90375061
Product administered at inappropriate site 9.74 9.28 23 169547 4128 90454749
Injection site necrosis 9.73 9.28 13 169557 1488 90457389
Pelvic fracture 9.68 9.28 55 169515 15164 90443713
Loefgren syndrome 9.68 9.28 5 169565 145 90458732
Chondritis 9.65 9.28 4 169566 69 90458808
Rapid eye movement sleep behaviour disorder 9.64 9.28 7 169563 378 90458499
Autism spectrum disorder 9.64 9.28 12 169558 1281 90457596
Breast cancer stage I 9.63 9.28 3 169567 9621 90449256
Meningism 9.63 9.28 8 169562 527 90458350
Blood thyroid stimulating hormone decreased 9.57 9.28 28 169542 5712 90453165
Hypogammaglobulinaemia 9.54 9.28 4 169566 10670 90448207
Defiant behaviour 9.53 9.28 3 169567 22 90458855
Bronchospasm 9.51 9.28 15 169555 20694 90438183
Apraxia 9.51 9.28 16 169554 2246 90456631
Haemolytic anaemia 9.51 9.28 5 169565 11692 90447185
Electrocardiogram T wave peaked 9.50 9.28 6 169564 257 90458620
Metastases to bone 9.49 9.28 21 169549 25484 90433393
Contusion 9.47 9.28 379 169191 250837 90208040
Thyroglobulin increased 9.44 9.28 4 169566 73 90458804
Sympathomimetic effect 9.44 9.28 5 169565 153 90458724
Emotional disorder 9.41 9.28 54 169516 14943 90443934
Brachial plexopathy 9.39 9.28 6 169564 262 90458615
Vasoplegia syndrome 9.39 9.28 18 169552 2796 90456081
Sensory loss 9.39 9.28 12 169558 18063 90440814
Psychiatric symptom 9.37 9.28 32 169538 7086 90451791
Drug ineffective for unapproved indication 9.36 9.28 176 169394 66468 90392409
Nail bed inflammation 9.31 9.28 14 169556 1787 90457090
Tuberculosis 9.29 9.28 6 169564 12543 90446334

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 843.91 11.23 878 63931 95587 42460939
Serotonin syndrome 799.92 11.23 495 64314 25350 42531176
Priapism 516.80 11.23 233 64576 6174 42550352
Toxicity to various agents 503.57 11.23 1088 63721 228048 42328478
Drug abuse 357.79 11.23 601 64208 104170 42452356
Sopor 291.67 11.23 205 64604 12997 42543529
Intentional overdose 222.25 11.23 329 64480 51127 42505399
Drug interaction 192.35 11.23 859 63950 266140 42290386
Suicidal ideation 158.45 11.23 272 64537 47889 42508637
Suicide attempt 145.96 11.23 256 64553 45844 42510682
Overdose 135.25 11.23 409 64400 104855 42451671
Electrocardiogram QT prolonged 119.08 11.23 240 64569 47705 42508821
Neuroleptic malignant syndrome 113.01 11.23 151 64658 21321 42535205
Head discomfort 111.10 11.23 79 64730 5098 42551428
Cardio-respiratory arrest 103.39 11.23 256 64553 58380 42498146
Parkinsonism 102.18 11.23 102 64707 10521 42546005
Agitation 96.18 11.23 264 64545 64050 42492476
Insomnia 85.97 11.23 382 64427 117871 42438655
Febrile neutropenia 83.07 11.23 96 64713 185607 42370919
Mental status changes 76.48 11.23 186 64623 41929 42514597
Depression 75.91 11.23 353 64456 111010 42445516
Intrusive thoughts 75.66 11.23 28 64781 438 42556088
Anxiety 75.15 11.23 368 64441 118192 42438334
Aggression 74.88 11.23 190 64619 43973 42512553
Anaemia 74.51 11.23 201 64608 280077 42276449
Sedation 71.45 11.23 149 64660 30326 42526200
Pancytopenia 66.68 11.23 49 64760 117694 42438832
Somnolence 66.50 11.23 404 64405 140701 42415825
Disease progression 63.42 11.23 75 64734 143581 42412945
Cogwheel rigidity 62.08 11.23 37 64772 1764 42554762
Antidepressant drug level above therapeutic 61.74 11.23 21 64788 253 42556273
Pyrexia 61.49 11.23 350 64459 393692 42162834
Homicidal ideation 60.79 11.23 43 64766 2751 42553775
Fall 59.60 11.23 581 64228 233939 42322587
Analgesic drug level above therapeutic 57.86 11.23 21 64788 310 42556216
Confusional state 54.31 11.23 438 64371 167159 42389367
Device dislocation 53.88 11.23 63 64746 7768 42548758
Tachyphrenia 53.37 11.23 31 64778 1408 42555118
Neck pain 52.83 11.23 131 64678 29883 42526643
Tremor 52.47 11.23 288 64521 96641 42459885
Environmental exposure 50.53 11.23 18 64791 251 42556275
Thrombocytopenia 49.35 11.23 138 64671 190141 42366385
Interstitial lung disease 47.95 11.23 30 64779 78432 42478094
Electrocardiogram PR prolongation 46.33 11.23 25 64784 983 42555543
Intentional product misuse 45.71 11.23 201 64608 61699 42494827
Suspected suicide 44.55 11.23 51 64758 6148 42550378
Restless legs syndrome 43.67 11.23 63 64746 9551 42546975
Ventricular tachyarrhythmia 42.95 11.23 18 64791 397 42556129
Electrocardiogram QRS complex prolonged 42 11.23 48 64761 5775 42550751
Paranoia 41.93 11.23 76 64733 13950 42542576
Product dose omission issue 41.41 11.23 387 64422 153978 42402548
Substance use 40.55 11.23 28 64781 1723 42554803
Neutropenia 40.47 11.23 161 64648 199270 42357256
Eyelid function disorder 40.41 11.23 14 64795 179 42556347
Withdrawal syndrome 40.34 11.23 77 64732 14698 42541828
Renal failure 38.93 11.23 102 64707 143624 42412902
Irritability 38.62 11.23 112 64697 28016 42528510
Anger 38.23 11.23 70 64739 12948 42543578
Alcoholism 37.54 11.23 33 64776 2897 42553629
Hyperreflexia 37.23 11.23 36 64773 3571 42552955
Hyperthyroidism 37.03 11.23 73 64736 14268 42542258
Psychotic disorder 36.98 11.23 113 64696 29095 42527431
Migraine 36.65 11.23 103 64706 25311 42531215
Accidental poisoning 35.49 11.23 23 64786 1273 42555253
Respiratory arrest 35.08 11.23 109 64700 28315 42528211
Narcolepsy 34.89 11.23 18 64791 645 42555881
Mucosal inflammation 34.37 11.23 16 64793 49358 42507168
Drug withdrawal syndrome neonatal 34.27 11.23 38 64771 4423 42552103
Clonus 34.22 11.23 34 64775 3486 42553040
Intentional self-injury 34.08 11.23 73 64736 15129 42541397
Penis injury 32.85 11.23 13 64796 246 42556280
Hepatic function abnormal 32.51 11.23 19 64790 51548 42504978
Bradyphrenia 32.38 11.23 40 64769 5222 42551304
Septic shock 32.38 11.23 56 64753 91616 42464910
Renal impairment 31.57 11.23 76 64733 110152 42446374
Sepsis 31.56 11.23 176 64633 199158 42357368
Drug screen positive 31.41 11.23 35 64774 4096 42552430
Multiple drug therapy 30.83 11.23 20 64789 1109 42555417
Antidepressant drug level increased 30.68 11.23 12 64797 220 42556306
Akathisia 30.44 11.23 56 64753 10395 42546131
Delirium 30.40 11.23 159 64650 52360 42504166
Symptom masked 30.11 11.23 18 64791 863 42555663
Platelet count decreased 29.95 11.23 109 64700 138472 42418054
Rash maculo-papular 29.63 11.23 10 64799 37493 42519033
Hallucination, auditory 29.52 11.23 68 64741 14796 42541730
Sleep disorder 28.81 11.23 147 64662 47948 42508578
Dissociation 28.57 11.23 32 64777 3766 42552760
Pulmonary embolism 27.93 11.23 91 64718 119521 42437005
Ascites 27.87 11.23 27 64782 56651 42499875
Malignant neoplasm progression 27.79 11.23 79 64730 108321 42448205
Pre-existing condition improved 27.66 11.23 28 64781 2935 42553591
General physical health deterioration 27.65 11.23 127 64682 151119 42405407
Hepatic cytolysis 27.54 11.23 4 64805 26840 42529686
Delusion of replacement 27.52 11.23 11 64798 214 42556312
Device malfunction 27.41 11.23 59 64750 12268 42544258
Cholestasis 27.35 11.23 8 64801 32871 42523655
Dysphoria 27.30 11.23 27 64782 2753 42553773
Initial insomnia 27.03 11.23 32 64777 3998 42552528
Homicide 26.94 11.23 17 64792 898 42555628
Loss of libido 26.83 11.23 28 64781 3042 42553484
Andropause 26.64 11.23 9 64800 106 42556420
Restlessness 26.34 11.23 101 64708 29148 42527378
Depressed level of consciousness 26.25 11.23 143 64666 47827 42508699
Psychomotor hyperactivity 26.17 11.23 54 64755 10904 42545622
Brain injury 26.16 11.23 44 64765 7611 42548915
Hallucination 26.00 11.23 163 64646 57344 42499182
Muscle rigidity 26.00 11.23 57 64752 12002 42544524
Dementia 25.96 11.23 69 64740 16411 42540115
Prescription drug used without a prescription 25.86 11.23 26 64783 2704 42553822
Poor feeding infant 25.69 11.23 16 64793 826 42555700
Amnesia 25.45 11.23 98 64711 28339 42528187
Reduced facial expression 25.32 11.23 20 64789 1513 42555013
Tardive dyskinesia 25.28 11.23 41 64768 6883 42549643
Shock 24.96 11.23 99 64710 29022 42527504
Nervousness 24.80 11.23 60 64749 13472 42543054
Persistent depressive disorder 24.69 11.23 13 64796 486 42556040
Cytotoxic oedema 24.40 11.23 10 64799 208 42556318
Troponin increased 24.36 11.23 74 64735 18988 42537538
Polymerase chain reaction 24.34 11.23 8 64801 86 42556440
Catatonia 24.23 11.23 38 64771 6201 42550325
Bone marrow failure 24.18 11.23 10 64799 33083 42523443
Mood swings 24.09 11.23 46 64763 8780 42547746
Injection site reaction 23.94 11.23 65 64744 15656 42540870
Delusion 23.53 11.23 62 64747 14672 42541854
Psychomotor retardation 23.23 11.23 31 64778 4368 42552158
Depressed mood 22.93 11.23 83 64726 23301 42533225
Painful erection 22.82 11.23 11 64798 340 42556186
Ventricular fibrillation 22.17 11.23 9 64800 30114 42526412
Post-traumatic stress disorder 22.08 11.23 22 64787 2263 42554263
Myelodysplastic syndrome 21.96 11.23 4 64805 22741 42533785
Bite 21.92 11.23 8 64801 120 42556406
Leukopenia 21.82 11.23 51 64758 74695 42481831
Cytomegalovirus infection 21.67 11.23 11 64798 32295 42524231
Orthostatic hypotension 21.60 11.23 98 64711 30472 42526054
Alanine aminotransferase increased 21.51 11.23 66 64743 88340 42468186
Product administered at inappropriate site 21.44 11.23 25 64784 3073 42553453
Sleep deficit 21.42 11.23 15 64794 944 42555582
Pneumocystis jirovecii pneumonia 21.18 11.23 6 64803 25175 42531351
Adrenal insufficiency 21.02 11.23 70 64739 18854 42537672
Unresponsive to stimuli 20.96 11.23 99 64710 31304 42525222
Needle issue 20.83 11.23 43 64766 8684 42547842
Psychotic disorder due to a general medical condition 20.68 11.23 7 64802 83 42556443
Myotonia 20.65 11.23 6 64803 41 42556485
C-reactive protein 20.61 11.23 7 64802 84 42556442
Hypotension 20.60 11.23 525 64284 257106 42299420
Cardiac failure 20.56 11.23 88 64721 106768 42449758
Foaming at mouth 20.54 11.23 15 64794 1009 42555517
Distributive shock 20.46 11.23 22 64787 2474 42554052
Headache 20.39 11.23 492 64317 238877 42317649
Penile haemorrhage 20.36 11.23 15 64794 1023 42555503
Panic attack 20.27 11.23 49 64760 10996 42545530
Device expulsion 19.89 11.23 7 64802 94 42556432
Drug withdrawal syndrome 19.89 11.23 75 64734 21474 42535052
Mutism 19.81 11.23 17 64792 1445 42555081
Bipolar disorder 19.74 11.23 27 64782 3895 42552631
Congenital pneumonia 19.62 11.23 7 64802 98 42556428
Alcohol interaction 19.61 11.23 20 64789 2115 42554411
Generalised anxiety disorder 19.46 11.23 14 64795 920 42555606
Mental disorder 19.41 11.23 66 64743 17963 42538563
International normalised ratio increased 19.32 11.23 27 64782 48141 42508385
Death 19.30 11.23 888 63921 470297 42086229
Hallucination, visual 19.27 11.23 73 64736 20947 42535579
Aspartate aminotransferase increased 19.21 11.23 57 64752 77106 42479420
Feeling abnormal 19.20 11.23 176 64633 69610 42486916
Paedophilia 19.19 11.23 4 64805 4 42556522
Sleep sex 19.19 11.23 4 64805 4 42556522
Illness anxiety disorder 19.02 11.23 8 64801 178 42556348
Erection increased 18.93 11.23 11 64798 500 42556026
Blood cholinesterase decreased 18.78 11.23 8 64801 184 42556342
Food aversion 18.73 11.23 11 64798 510 42556016
Delirium febrile 18.70 11.23 5 64804 24 42556502
Blood bilirubin increased 18.68 11.23 22 64787 42230 42514296
Pulse pressure decreased 18.66 11.23 8 64801 187 42556339
Sudden cardiac death 18.24 11.23 26 64783 3898 42552628
Procedural failure 18.22 11.23 6 64803 65 42556461
Pulmonary congestion 18.20 11.23 59 64750 15671 42540855
Obsessive thoughts 18.19 11.23 13 64796 845 42555681
Sexual dysfunction 18.11 11.23 35 64774 6740 42549786
Pulmonary fibrosis 18.03 11.23 9 64800 26672 42529854
Pneumonia aspiration 17.91 11.23 134 64675 49944 42506582
Cardiac arrest 17.90 11.23 249 64560 109071 42447455
Acute kidney injury 17.84 11.23 424 64385 366913 42189613
Haemoglobin decreased 17.81 11.23 123 64686 132348 42424178
Anion gap abnormal 17.78 11.23 10 64799 427 42556099
Erythema 17.77 11.23 95 64714 108698 42447828
General symptom 17.75 11.23 14 64795 1057 42555469
Psychotic symptom 17.74 11.23 20 64789 2370 42554156
Urine amphetamine positive 17.63 11.23 5 64804 31 42556495
Bronchopulmonary aspergillosis 17.55 11.23 4 64805 19425 42537101
Eye haematoma 17.43 11.23 7 64802 138 42556388
Encephalopathy 17.35 11.23 115 64694 41218 42515308
Apathy 17.29 11.23 39 64770 8367 42548159
Hospitalisation 17.29 11.23 181 64628 74149 42482377
C-reactive protein increased 17.27 11.23 45 64764 63515 42493011
Gait disturbance 17.19 11.23 226 64583 97774 42458752
Infection 17.14 11.23 100 64709 111968 42444558
Hangover 17.00 11.23 14 64795 1124 42555402
Erectile dysfunction 16.96 11.23 79 64730 24834 42531692
Euphoric mood 16.84 11.23 33 64776 6420 42550106
Injection site mass 16.77 11.23 39 64770 8536 42547990
Sprue-like enteropathy 16.54 11.23 11 64798 636 42555890
Sleep-related eating disorder 16.47 11.23 9 64800 363 42556163
Poor quality sleep 16.39 11.23 41 64768 9399 42547127
Myoclonus 16.25 11.23 60 64749 17005 42539521
Depersonalisation/derealisation disorder 16.16 11.23 11 64798 661 42555865
Blood lactate dehydrogenase increased 15.89 11.23 10 64799 26071 42530455
Bruxism 15.85 11.23 18 64791 2151 42554375
Acute myeloid leukaemia 15.82 11.23 7 64802 22249 42534277
Substance abuse 15.80 11.23 39 64770 8866 42547660
Blood urea increased 15.69 11.23 16 64793 32777 42523749
Cognitive disorder 15.53 11.23 97 64712 34075 42522451
Haemodynamic instability 15.35 11.23 48 64761 12509 42544017
Hypersomnia 15.29 11.23 53 64756 14565 42541961
Osteonecrosis of jaw 15.19 11.23 5 64804 19044 42537482
Candida infection 15.04 11.23 7 64802 21603 42534923
Hypertonia 14.82 11.23 27 64782 4974 42551552
Diabetic foetopathy 14.81 11.23 7 64802 207 42556319
Pleural effusion 14.70 11.23 87 64722 97079 42459447
White blood cell count decreased 14.59 11.23 103 64706 110293 42446233
Hyperprolactinaemia 14.47 11.23 17 64792 2106 42554420
Periorbital haemorrhage 14.41 11.23 6 64803 130 42556396
Feeling jittery 14.25 11.23 25 64784 4473 42552053
Homeless 14.21 11.23 4 64805 24 42556502
Dyskinesia 14.09 11.23 76 64733 25314 42531212
Toxic epidermal necrolysis 14.03 11.23 12 64797 26738 42529788
Hyperhidrosis 13.95 11.23 204 64605 90308 42466218
Premature baby 13.94 11.23 9 64800 23144 42533382
Blood creatinine increased 13.88 11.23 104 64705 109899 42446627
Dermatitis atopic 13.88 11.23 46 64763 12358 42544168
Appendicitis 13.86 11.23 7 64802 20606 42535920
Derealisation 13.79 11.23 11 64798 844 42555682
Neutrophil count decreased 13.61 11.23 50 64759 63365 42493161
Nicotine dependence 13.56 11.23 10 64799 683 42555843
Respiratory failure 13.52 11.23 127 64682 128005 42428521
Anaphylactic reaction 13.43 11.23 28 64781 42715 42513811
Gambling disorder 13.42 11.23 15 64794 1761 42554765
Lactic acidosis 13.40 11.23 116 64693 45145 42511381
Rash 13.33 11.23 320 64489 276634 42279892
Hepatocellular injury 13.20 11.23 10 64799 23668 42532858
Sinus bradycardia 13.13 11.23 51 64758 14802 42541724
Pain 13.10 11.23 475 64334 244373 42312153
Neutropenic sepsis 13.04 11.23 4 64805 15942 42540584
Expired product administered 13.01 11.23 23 64786 4140 42552386
Lower respiratory tract infection 12.94 11.23 27 64782 41179 42515347
Obsessive rumination 12.87 11.23 3 64806 7 42556519
Coagulopathy 12.82 11.23 9 64800 22153 42534373
Haemophagocytic lymphohistiocytosis 12.53 11.23 6 64803 18216 42538310
Binocular eye movement disorder 12.49 11.23 7 64802 297 42556229
Yawning 12.48 11.23 10 64799 772 42555754
Product administration interrupted 12.48 11.23 25 64784 4941 42551585
Hanging 12.46 11.23 6 64803 185 42556341
Atrial fibrillation 12.43 11.23 144 64665 139449 42417077
Palmar-plantar erythrodysaesthesia syndrome 12.39 11.23 8 64801 20574 42535952
Urine leukocyte esterase positive 12.29 11.23 8 64801 446 42556080
Accidental death 12.28 11.23 19 64790 3064 42553462
Alcohol withdrawal syndrome 12.26 11.23 13 64796 1438 42555088
Cardiac failure congestive 12.24 11.23 78 64731 85524 42471002
Back pain 12.22 11.23 292 64517 141484 42415042
Basal cell carcinoma 12.17 11.23 10 64799 22723 42533803
Lymphopenia 12.16 11.23 9 64800 21554 42534972
Multiple organ dysfunction syndrome 12.12 11.23 92 64717 96943 42459583
Mixed delusion 12.09 11.23 4 64805 44 42556482
Toxic skin eruption 12.06 11.23 3 64806 13727 42542799
Colitis microscopic 12.05 11.23 19 64790 3114 42553412
Hormone-dependent prostate cancer 12.01 11.23 4 64805 45 42556481
Dopamine transporter scintigraphy abnormal 11.87 11.23 3 64806 11 42556515
Dyspnoea 11.72 11.23 552 64257 442069 42114457
Rhabdomyolysis 11.69 11.23 175 64634 77844 42478682
Epistaxis 11.68 11.23 57 64752 66769 42489757
Catecholamines urine increased 11.66 11.23 3 64806 12 42556514
Tumour lysis syndrome 11.63 11.23 10 64799 22221 42534305
Pulmonary alveolar haemorrhage 11.62 11.23 4 64805 14812 42541714
Neuropathy peripheral 11.60 11.23 99 64710 101754 42454772
Toxicologic test abnormal 11.59 11.23 8 64801 492 42556034
Thrombotic microangiopathy 11.58 11.23 4 64805 14778 42541748
Abdominal distension 11.51 11.23 63 64746 71672 42484854
Acute pulmonary oedema 11.44 11.23 34 64775 8617 42547909
Prostatic pain 11.41 11.23 7 64802 352 42556174
Myocardial infarction 11.40 11.23 127 64682 123882 42432644
Abnormal behaviour 11.35 11.23 74 64735 26377 42530149
Heat stroke 11.32 11.23 11 64798 1097 42555429
Vasculitis 11.28 11.23 7 64802 18387 42538139
Inability to afford medication 11.23 11.23 15 64794 2115 42554411

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 2653.45 9.84 2726 202029 239655 110144889
Serotonin syndrome 1305.40 9.84 992 203763 58161 110326383
Toxicity to various agents 1139.53 9.84 2650 202105 477905 109906639
Drug abuse 927.69 9.84 1377 203378 176034 110208510
Sopor 902.68 9.84 656 204099 35890 110348654
Priapism 501.74 9.84 236 204519 5625 110378919
Suicide attempt 448.67 9.84 737 204018 102657 110281887
Intentional overdose 407.21 9.84 813 203942 131688 110252856
Drug interaction 371.67 9.84 1869 202886 498314 109886230
Cardio-respiratory arrest 370.72 9.84 723 204032 115113 110269431
Schizophrenia 296.75 9.84 277 204478 21549 110362995
Polycystic ovaries 285.79 9.84 151 204604 4645 110379899
Suicidal ideation 282.10 9.84 571 204184 93366 110291178
Hypomania 255.96 9.84 185 204570 10025 110374519
Electrocardiogram QT prolonged 249.58 9.84 594 204161 108366 110276178
Overdose 244.62 9.84 968 203787 232826 110151718
Rhinitis allergic 238.94 9.84 225 204530 17697 110366847
Sensitisation 214.75 9.84 119 204636 4032 110380512
Suspected suicide 184.09 9.84 181 204574 15018 110369526
Dissociation 176.08 9.84 146 204609 9696 110374848
Psychotic disorder 172.78 9.84 326 204429 50611 110333933
Ejection fraction 170.32 9.84 91 204664 2864 110381680
Pyrexia 161.73 9.84 988 203767 897277 109487267
Gastrooesophageal reflux disease 161.41 9.84 711 204044 179265 110205279
Febrile neutropenia 160.13 9.84 211 204544 316556 110067988
Blood test abnormal 156.72 9.84 227 204528 28327 110356217
Tremor 156.37 9.84 765 203990 201467 110183077
Jaundice cholestatic 147.96 9.84 158 204597 14450 110370094
Neuroleptic malignant syndrome 134.65 9.84 233 204522 33826 110350718
Withdrawal syndrome 133.76 9.84 222 204533 31158 110353386
Agitation 132.05 9.84 485 204270 112566 110271978
Thrombocytopenia 130.55 9.84 282 204473 348603 110035941
Respiratory arrest 130.41 9.84 315 204440 57984 110326560
Sedation 124.46 9.84 346 204409 69337 110315207
Pancytopenia 123.93 9.84 123 204632 209490 110175054
Carpal tunnel syndrome 123.00 9.84 179 204576 22431 110362113
Depression 122.45 9.84 1005 203750 316330 110068214
Hand deformity 120.48 9.84 136 204619 218370 110166174
Systemic lupus erythematosus 119.94 9.84 178 204577 254160 110130384
Presbyacusis 116.96 9.84 70 204685 2749 110381795
Total lung capacity increased 113.26 9.84 86 204669 5026 110379518
Product dose omission issue 111.48 9.84 995 203760 320787 110063757
Myelosuppression 111.39 9.84 20 204735 94320 110290224
Anaemia 111.12 9.84 578 204177 546508 109838036
Sleep apnoea syndrome 109.84 9.84 236 204519 40211 110344333
Pemphigus 109.34 9.84 142 204613 214428 110170116
Asthma-chronic obstructive pulmonary disease overlap syndrome 107.07 9.84 91 204664 6253 110378291
Folliculitis 105.43 9.84 93 204662 167560 110216984
Somnolence 104.70 9.84 923 203832 296526 110088018
Persistent genital arousal disorder 103.31 9.84 41 204714 635 110383909
Neutropenia 103.14 9.84 352 204403 374268 110010276
Sleep disorder due to a general medical condition 101.33 9.84 267 204488 51845 110332699
Pericarditis 99.79 9.84 157 204598 218957 110165587
Exposure during pregnancy 99.24 9.84 98 204657 167326 110217218
Hyperreflexia 98.56 9.84 104 204651 9381 110375163
Infusion related reaction 98.38 9.84 368 204387 380794 110003750
Impaired healing 98.38 9.84 132 204623 196585 110187959
Loss of personal independence in daily activities 98.26 9.84 542 204213 149478 110235066
Depressed level of consciousness 97.93 9.84 440 204315 111838 110272706
Mental status changes 97.81 9.84 337 204418 75785 110308759
Ill-defined disorder 95.08 9.84 90 204665 156763 110227781
Swelling 94.50 9.84 333 204422 350708 110033836
Intentional self-injury 93.28 9.84 211 204544 37218 110347326
Disease progression 93.13 9.84 195 204560 243839 110140705
Pleural fibrosis 92.21 9.84 71 204684 4237 110380307
C-reactive protein abnormal 91.58 9.84 64 204691 129631 110254913
Glossodynia 91.09 9.84 170 204585 221834 110162710
Pleural thickening 90.74 9.84 64 204691 3335 110381209
Blood magnesium increased 90.68 9.84 67 204688 3756 110380788
Cholelithiasis 90.59 9.84 291 204464 63131 110321413
Neovascularisation 90.42 9.84 50 204705 1687 110382857
Lung diffusion test abnormal 89.65 9.84 32 204723 363 110384181
Akathisia 89.50 9.84 133 204622 16980 110367564
Parkinsonism 89.30 9.84 153 204602 22034 110362510
Malignant neoplasm progression 86.41 9.84 118 204637 174449 110210095
Head discomfort 84.46 9.84 137 204618 18863 110365681
Bradyphrenia 83.79 9.84 106 204649 11622 110372922
Insomnia 83.67 9.84 1028 203727 359562 110024982
Mucosal inflammation 81.37 9.84 38 204717 96103 110288441
General physical health deterioration 80.42 9.84 460 204295 424835 109959709
Joint swelling 80.02 9.84 486 204269 442359 109942185
Anti-cyclic citrullinated peptide antibody positive 79.49 9.84 134 204621 181850 110202694
Distributive shock 78.46 9.84 74 204681 5830 110378714
Irritability 78.19 9.84 230 204525 47579 110336965
Anxiety 78 9.84 979 203776 344099 110040445
Sputum discoloured 75.82 9.84 163 204592 27782 110356762
Helicobacter infection 75.74 9.84 138 204617 181739 110202805
Liver disorder 75.73 9.84 91 204664 142152 110242392
Poor quality sleep 75.29 9.84 163 204592 27914 110356630
Restless legs syndrome 74.25 9.84 150 204605 24476 110360068
Prescription drug used without a prescription 73.26 9.84 69 204686 5427 110379117
Wound 73.17 9.84 208 204547 234229 110150315
Acute kidney injury 72.64 9.84 789 203966 634641 109749903
Fall 72.51 9.84 1542 203213 601940 109782604
Paradoxical drug reaction 72.16 9.84 90 204665 9727 110374817
Infection 72.16 9.84 385 204370 361815 110022729
Duodenal ulcer perforation 71.20 9.84 138 204617 177562 110206982
Stomatitis 70.95 9.84 259 204496 269983 110114561
Muscle injury 70.88 9.84 94 204661 140713 110243831
Platelet count decreased 70.79 9.84 206 204549 230237 110154307
Ejection fraction abnormal 69.67 9.84 55 204700 3405 110381139
Migraine 69.60 9.84 550 204205 171102 110213442
Nephrectomy 68.84 9.84 49 204706 2591 110381953
Rash 68.00 9.84 1090 203665 819874 109564670
Hypersensitivity 65.54 9.84 458 204297 403540 109981004
Cardiac murmur 63.79 9.84 141 204614 24487 110360057
Haemoglobin decreased 63.57 9.84 241 204514 248486 110136058
Aggression 63.31 9.84 247 204508 58963 110325581
Tardive dyskinesia 63.22 9.84 100 204655 13479 110371065
Bone marrow failure 62.64 9.84 15 204740 57833 110326711
Clonus 62.62 9.84 79 204676 8637 110375907
Dermatitis atopic 62.55 9.84 143 204612 25398 110359146
Septic shock 62.53 9.84 123 204632 157405 110227139
Accidental poisoning 62.19 9.84 45 204710 2442 110382102
Bronchiectasis 62.02 9.84 178 204577 36315 110348229
Intrusive thoughts 61.61 9.84 29 204726 692 110383852
Sleep disorder due to general medical condition, insomnia type 61.27 9.84 63 204692 105580 110278964
Hepatic function abnormal 60.52 9.84 46 204709 89249 110295295
Alcoholism 60.17 9.84 52 204703 3655 110380889
Swollen joint count increased 59.43 9.84 41 204714 83620 110300924
Sarcoidosis 59.07 9.84 93 204662 12486 110372058
Rash maculo-papular 58.81 9.84 32 204723 74190 110310354
Restlessness 58.79 9.84 233 204522 56026 110328518
Burning sensation 58.67 9.84 269 204486 68943 110315601
Hallucination, auditory 58.35 9.84 142 204613 26255 110358289
Irritable bowel syndrome 57.90 9.84 137 204618 164078 110220466
Confabulation 57.34 9.84 25 204730 496 110384048
Hyper IgE syndrome 56.99 9.84 27 204728 654 110383890
Lower respiratory tract infection 56.81 9.84 244 204511 242862 110141682
Intentional product misuse 56.73 9.84 431 204324 132473 110252071
Electrocardiogram QRS complex prolonged 56.67 9.84 93 204662 12928 110371616
Cholestasis 55.38 9.84 25 204730 64493 110320051
Cytomegalovirus infection 55.37 9.84 16 204739 54428 110330116
Extrapyramidal disorder 55.20 9.84 147 204608 28720 110355824
Total lung capacity decreased 55.16 9.84 67 204688 7047 110377497
Deafness neurosensory 55.02 9.84 78 204677 9541 110375003
Leukopenia 54.99 9.84 121 204634 148670 110235874
Nasal polyps 54.40 9.84 92 204663 13108 110371436
Drug screen positive 54.04 9.84 63 204692 6347 110378197
Encephalopathy 53.83 9.84 294 204461 80761 110303783
Drug withdrawal syndrome 53.79 9.84 174 204581 37880 110346664
Tachyphrenia 53.00 9.84 40 204715 2316 110382228
Cardiac arrest 52.76 9.84 577 204178 196176 110188368
Blister 52.64 9.84 229 204526 227147 110157397
Interstitial lung disease 52.58 9.84 112 204643 139222 110245322
Hostility 52.45 9.84 42 204713 2654 110381890
Sepsis 52.15 9.84 373 204382 326973 110057571
Renal failure 51.97 9.84 229 204526 226345 110158199
Adjustment disorder with mixed anxiety and depressed mood 51.15 9.84 16 204739 116 110384428
Electrocardiogram PR prolongation 49.89 9.84 35 204720 1808 110382736
Muscle rigidity 49.67 9.84 126 204629 23905 110360639
Myocardial stunning 49.46 9.84 20 204735 326 110384218
Hepatic cytolysis 49.38 9.84 20 204735 55033 110329511
Cognitive disorder 49.37 9.84 304 204451 87207 110297337
Bronchopulmonary aspergillosis allergic 49.20 9.84 69 204686 8357 110376187
Psychomotor hyperactivity 49.07 9.84 113 204642 20164 110364380
Libido increased 48.22 9.84 39 204716 2500 110382044
Cardiac failure 47.80 9.84 182 204573 187444 110197100
Injection site mass 47.73 9.84 126 204629 24487 110360057
Homicidal ideation 47.32 9.84 45 204710 3582 110380962
Breath sounds abnormal 47.20 9.84 128 204627 25276 110359268
Oedema 47.08 9.84 214 204541 209762 110174782
Epigastric discomfort 47.05 9.84 70 204685 8945 110375599
Abdominal discomfort 46.98 9.84 484 204271 393374 109991170
Urticaria 46.67 9.84 372 204383 318485 110066059
Hypertonia 46.37 9.84 67 204688 8339 110376205
Sinusitis 45.84 9.84 341 204414 296347 110088197
Unresponsive to stimuli 45.51 9.84 236 204519 63554 110320990
Analgesic drug level above therapeutic 45.12 9.84 21 204734 488 110384056
Asthma 45.06 9.84 682 204073 249609 110134935
Visual perseveration 45.00 9.84 13 204742 69 110384475
Pneumocystis jirovecii pneumonia 44.50 9.84 12 204743 42723 110341821
Maternal exposure during pregnancy 44.29 9.84 283 204472 254600 110129944
Memory impairment 44.13 9.84 558 204197 196386 110188158
Mental disorder 44.08 9.84 165 204590 38626 110345918
Neck pain 43.22 9.84 382 204373 122748 110261796
Granuloma skin 43.05 9.84 76 204679 11207 110373337
Synovitis 42.83 9.84 314 204441 273778 110110766
Multiple organ dysfunction syndrome 42.76 9.84 141 204614 151569 110232975
Delirium 42.40 9.84 409 204346 134616 110249928
Cyst 42.23 9.84 94 204661 16402 110368142
Dyskinesia 41.43 9.84 197 204558 51249 110333295
Toxic epidermal necrolysis 41.37 9.84 27 204728 56700 110327844
Anaphylactic shock 41.17 9.84 22 204733 51524 110333020
Environmental exposure 40.88 9.84 18 204737 366 110384178
Hospitalisation 40.58 9.84 423 204332 142070 110242474
Alopecia 39.98 9.84 457 204298 364296 110020248
Antidepressant drug level above therapeutic 39.98 9.84 22 204733 735 110383809
Overlap syndrome 39.83 9.84 65 204690 8994 110375550
Reduced facial expression 39.67 9.84 41 204714 3610 110380934
Anger 39.64 9.84 100 204655 18907 110365637
Rheumatic fever 39.53 9.84 107 204648 122472 110262072
Autonomic nervous system imbalance 39.34 9.84 51 204704 5729 110378815
Penis injury 38.91 9.84 13 204742 119 110384425
Lung disorder 38.88 9.84 186 204569 179861 110204683
Nervousness 38.80 9.84 153 204602 36698 110347846
Mobility decreased 38.06 9.84 270 204485 237152 110147392
Headache 37.82 9.84 1996 202759 880381 109504163
Apathy 37.66 9.84 89 204666 16150 110368394
Liver injury 37.61 9.84 147 204608 150266 110234278
Cogwheel rigidity 37.45 9.84 40 204715 3658 110380886
Post-traumatic neck syndrome 37.34 9.84 34 204721 2561 110381983
Nasopharyngitis 37.26 9.84 510 204245 393851 109990693
Soft tissue injury 37.09 9.84 32 204723 2244 110382300
Abnormal behaviour 37.08 9.84 157 204598 38882 110345662
Concussion 36.85 9.84 72 204683 11466 110373078
Taste disorder 36.79 9.84 227 204528 65160 110319384
Blood parathyroid hormone decreased 36.26 9.84 77 204678 13012 110371532
Deep vein thrombosis postoperative 35.94 9.84 34 204721 59257 110325287
Initial insomnia 35.85 9.84 67 204688 10322 110374222
Acute myeloid leukaemia 35.58 9.84 13 204742 38097 110346447
Discomfort 35.48 9.84 242 204513 214465 110170079
Somatic delusion 35.47 9.84 20 204735 701 110383843
Accidental death 35.35 9.84 45 204710 4964 110379580
Impaired quality of life 35.22 9.84 129 204626 29888 110354656
Body tinea 35.00 9.84 30 204725 2085 110382459
Thrombotic microangiopathy 34.80 9.84 6 204749 29143 110355401
Bone cyst 34.79 9.84 38 204717 3565 110380979
Autoimmune disorder 34.73 9.84 42 204713 65441 110319103
Needle issue 34.26 9.84 91 204664 17749 110366795
Osteosclerosis 34.16 9.84 42 204713 4473 110380071
Cardiac disorder 33.46 9.84 249 204506 76031 110308513
Sciatica 33.43 9.84 76 204679 92323 110292221
International normalised ratio increased 33.36 9.84 69 204686 86703 110297841
Obstructive airways disorder 33.10 9.84 171 204584 45978 110338566
Bursitis 33.10 9.84 126 204629 129792 110254752
Oral discomfort 33.03 9.84 68 204687 11243 110373301
Depressed mood 32.90 9.84 209 204546 60600 110323944
Lung opacity 32.80 9.84 69 204686 11583 110372961
Neuropathy peripheral 32.72 9.84 196 204559 179081 110205463
Pleurothotonus 32.60 9.84 31 204724 2467 110382077
Haemophagocytic lymphohistiocytosis 32.60 9.84 9 204746 31550 110352994
Cardiac failure congestive 32.60 9.84 156 204599 150844 110233700
Panniculitis 32.52 9.84 82 204673 15500 110369044
Sinus bradycardia 32.34 9.84 124 204631 29359 110355185
Aspiration 32.34 9.84 127 204628 30406 110354138
Sternal fracture 32.06 9.84 35 204720 3281 110381263
Coagulopathy 31.89 9.84 18 204737 40893 110343651
Angioedema 31.75 9.84 86 204669 98414 110286130
Arthropathy 31.59 9.84 360 204395 287162 110097382
Dry eye 31.58 9.84 194 204561 55599 110328945
Nightmare 31.43 9.84 149 204606 38714 110345830
Mood altered 31.36 9.84 99 204656 21276 110363268
Drug resistance 31.15 9.84 35 204720 56339 110328205
Chronic obstructive pulmonary disease 31.06 9.84 324 204431 108834 110275710
Hypotension 30.87 9.84 1224 203531 522625 109861919
Hepatocellular injury 30.74 9.84 29 204726 50613 110333931
Vertigo 30.73 9.84 270 204485 86600 110297944
Ascites 30.69 9.84 80 204675 92728 110291816
Gastrointestinal disorder 30.64 9.84 293 204462 241659 110142885
Psychomotor retardation 30.39 9.84 53 204702 7739 110376805
Delusion of parasitosis 30.00 9.84 13 204742 254 110384290
Blood cholesterol increased 29.67 9.84 210 204545 184575 110199969
Myoclonus 29.27 9.84 130 204625 32868 110351676
Multiple sclerosis relapse 29.27 9.84 176 204579 50064 110334480
Lip dry 28.91 9.84 92 204663 99991 110284553
Haematochezia 28.81 9.84 113 204642 115411 110269133
Injury 28.69 9.84 201 204554 177064 110207480
Myelodysplastic syndrome 28.49 9.84 17 204738 37467 110347077
Neutrophil count decreased 28.47 9.84 121 204634 120820 110263724
Hyperkalaemia 28.33 9.84 142 204613 135654 110248890
Bronchopulmonary aspergillosis 28.20 9.84 10 204745 29853 110354691
Listless 27.90 9.84 38 204717 4477 110380067
Major depression 27.72 9.84 61 204694 10560 110373984
Bone erosion 27.63 9.84 27 204728 46344 110338200
Substance abuse 27.50 9.84 67 204688 12396 110372148
Blood lactate dehydrogenase increased 27.37 9.84 25 204730 44309 110340235
Contraindicated product administered 27.21 9.84 311 204444 247956 110136588
Psoriatic arthropathy 27.21 9.84 233 204522 196528 110188016
Hepatic failure 26.99 9.84 54 204701 68685 110315859
Substance use 26.97 9.84 28 204727 2478 110382066
Paranoia 26.96 9.84 97 204658 22277 110362267
Infusion site reaction 26.96 9.84 83 204672 17599 110366945
Aplastic anaemia 26.92 9.84 6 204749 24302 110360242
Mood swings 26.73 9.84 98 204657 22714 110361830
Therapy non-responder 26.63 9.84 176 204579 157131 110227413
Eyelid function disorder 26.55 9.84 15 204740 528 110384016
Abnormal dreams 26.40 9.84 67 204688 12713 110371831
Hip arthroplasty 26.34 9.84 39 204716 55774 110328770
Hypoxia 26.11 9.84 360 204395 129155 110255389
Feeling abnormal 26.09 9.84 475 204280 180236 110204308
Disseminated intravascular coagulation 25.82 9.84 23 204732 41263 110343281
Osteopenia 25.68 9.84 95 204660 22114 110362430
Middle insomnia 25.66 9.84 90 204665 20412 110364132
Jaundice 25.50 9.84 44 204711 59192 110325352
Disorganised speech 25.44 9.84 31 204724 3272 110381272
Apallic syndrome 25.38 9.84 19 204736 1087 110383457
Brain injury 25.13 9.84 68 204687 13408 110371136
Grip strength decreased 25.09 9.84 71 204684 80103 110304441
Bipolar disorder 24.96 9.84 53 204702 8954 110375590
Andropause 24.91 9.84 9 204746 106 110384438
Antidepressant drug level increased 24.79 9.84 15 204740 601 110383943
Mental impairment 24.65 9.84 95 204660 22544 110362000
Hyperhidrosis 24.52 9.84 485 204270 186813 110197731
Gambling disorder 24.52 9.84 25 204730 2166 110382378
Accidental overdose 24.34 9.84 172 204583 51662 110332882
Palmar-plantar erythrodysaesthesia syndrome 24.31 9.84 24 204731 41001 110343543
Infection susceptibility increased 24.18 9.84 35 204720 4363 110380181
Anti-cyclic citrullinated peptide antibody 24.07 9.84 4 204751 19960 110364584
Frequent bowel movements 24.02 9.84 61 204694 71329 110313215
Hepatotoxicity 23.97 9.84 200 204555 63200 110321344
White blood cell count decreased 23.73 9.84 291 204464 229099 110155445
Aspergillus infection 23.47 9.84 9 204746 25607 110358937
Mydriasis 23.33 9.84 92 204663 22065 110362479
Delusion of replacement 23.27 9.84 11 204744 265 110384279
Nodule 23.16 9.84 16 204739 32615 110351929
Toxic skin eruption 23.09 9.84 11 204744 27504 110357040
Proteinuria 23.05 9.84 24 204731 39994 110344550
Anaphylactic reaction 23.00 9.84 121 204634 114179 110270365
Sleep deficit 22.94 9.84 22 204733 1770 110382774
Asphyxia 22.87 9.84 68 204687 14147 110370397
Pregnancy 22.84 9.84 37 204718 51030 110333514
Cerebral infarction 22.78 9.84 38 204717 51800 110332744
Facet joint syndrome 22.71 9.84 97 204658 96731 110287813
Bronchospasm 22.59 9.84 14 204741 30225 110354319
Restrictive pulmonary disease 22.56 9.84 29 204726 3230 110381314
Sense of a foreshortened future 22.54 9.84 5 204750 6 110384538
Hepatitis cholestatic 22.38 9.84 3 204752 17563 110366981
Liver function test abnormal 22.37 9.84 60 204695 68890 110315654
Urinary retention 22.32 9.84 212 204543 69471 110315073
Pulmonary alveolar haemorrhage 22.26 9.84 5 204750 20145 110364399
Cytokine release syndrome 22.20 9.84 62 204693 70244 110314300
Musculoskeletal pain 22.17 9.84 224 204531 182799 110201745
Hypogammaglobulinaemia 22.14 9.84 5 204750 20071 110364473
Disorientation 22.14 9.84 214 204541 70457 110314087
Lower limb fracture 21.94 9.84 69 204686 75279 110309265
Loss of libido 21.88 9.84 28 204727 3105 110381439
Tubulointerstitial nephritis 21.87 9.84 42 204713 54242 110330302
Premature delivery 21.77 9.84 15 204740 30617 110353927
Maternal exposure timing unspecified 21.69 9.84 6 204749 21007 110363537
Death 21.66 9.84 1537 203218 697332 109687212
Gastrointestinal haemorrhage 21.56 9.84 199 204556 165319 110219225
Alcohol withdrawal syndrome 21.50 9.84 23 204732 2107 110382437
Bradycardia 21.48 9.84 406 204349 155111 110229433
Painful erection 21.46 9.84 10 204745 233 110384311
Economic problem 21.45 9.84 32 204723 4099 110380445
Perseveration 21.43 9.84 12 204743 415 110384129
Loss of consciousness 21.40 9.84 495 204260 195811 110188733
Rectal haemorrhage 21.34 9.84 132 204623 119701 110264843
Colitis 21.34 9.84 107 204648 102216 110282328
Narcolepsy 21.29 9.84 20 204735 1568 110382976
Euphoric mood 21.15 9.84 49 204706 8778 110375766
Troponin increased 21.14 9.84 110 204645 29656 110354888
Neoplasm progression 21.12 9.84 56 204699 64539 110320005
Solar urticaria 21.09 9.84 8 204747 109 110384435
Renal impairment 21.06 9.84 235 204520 188210 110196334
Homicide 21.03 9.84 17 204738 1089 110383455
Nausea 21.02 9.84 2603 202152 1233087 109151457
Post-traumatic stress disorder 20.87 9.84 41 204714 6555 110377989
Muscle twitching 20.83 9.84 110 204645 29825 110354719
Torsade de pointes 20.78 9.84 90 204665 22510 110362034
Blepharospasm 20.72 9.84 173 204582 54678 110329866
Polymerase chain reaction 20.70 9.84 8 204747 115 110384429
Female genital tract fistula 20.62 9.84 3 204752 16516 110368028
Toxicologic test abnormal 20.54 9.84 18 204737 1289 110383255
Malaise 20.42 9.84 1026 203729 670793 109713751
Dysphoria 20.39 9.84 40 204715 6388 110378156
Pulmonary embolism 20.37 9.84 277 204478 214197 110170347
Osteonecrosis of jaw 20.37 9.84 36 204719 47981 110336563
Haematocrit decreased 20.36 9.84 59 204696 66058 110318486
Calcification of muscle 20.22 9.84 9 204746 188 110384356
Product administered at inappropriate site 20.15 9.84 36 204719 5357 110379187
Erection increased 20.14 9.84 11 204744 362 110384182
Onychomycosis 20.13 9.84 25 204730 38506 110346038
Hypokinesia 20.13 9.84 87 204668 21739 110362805
Skin lesion 20.13 9.84 164 204591 51467 110333077
Vasculitis 20.12 9.84 22 204733 35851 110348693
Prostate cancer 20.11 9.84 24 204731 37617 110346927
Symptom masked 20.09 9.84 21 204734 1874 110382670
Blood calcium decreased 20.08 9.84 22 204733 35823 110348721
Epstein-Barr virus infection 20.01 9.84 5 204750 18733 110365811
Lung neoplasm malignant 20.00 9.84 119 204636 33723 110350821
Pneumonia aspiration 19.85 9.84 234 204521 80999 110303545
Prescribed overdose 19.78 9.84 89 204666 87492 110297052
Dementia 19.77 9.84 113 204642 31560 110352984
Alcohol interaction 19.73 9.84 29 204726 3665 110380879
Purple glove syndrome 19.56 9.84 10 204745 287 110384257
Bruxism 19.52 9.84 34 204721 4960 110379584
Penile haemorrhage 19.51 9.84 15 204740 893 110383651
Hypersomnia 19.45 9.84 103 204652 27958 110356586
Drug reaction with eosinophilia and systemic symptoms 19.40 9.84 82 204673 82013 110302531
Ventricular fibrillation 19.37 9.84 29 204726 41284 110343260
Affective disorder 19.26 9.84 55 204700 11186 110373358
Panic attack 19.23 9.84 105 204650 28835 110355709
Device dislocation 19.07 9.84 112 204643 31592 110352952
Coma 18.86 9.84 315 204440 117554 110266990
Joint range of motion decreased 18.81 9.84 140 204615 121692 110262852
Gastroenteritis radiation 18.80 9.84 14 204741 794 110383750
Skin neoplasm excision 18.65 9.84 21 204734 2037 110382507
Rheumatoid factor positive 18.59 9.84 155 204600 131485 110253059
Thinking abnormal 18.55 9.84 66 204689 15074 110369470
Knee arthroplasty 18.55 9.84 60 204695 64888 110319656
Device malfunction 18.54 9.84 95 204660 25463 110359081
Galactorrhoea 18.52 9.84 30 204725 4125 110380419
Tuberculosis 18.49 9.84 5 204750 17769 110366775
Tonic clonic movements 18.48 9.84 25 204730 2927 110381617
Delusion 18.43 9.84 90 204665 23665 110360879
Blood calcium increased 18.27 9.84 74 204681 17966 110366578
Drug metabolising enzyme decreased 18.26 9.84 5 204750 21 110384523
Pulseless electrical activity 17.99 9.84 70 204685 16687 110367857
Retinitis 17.93 9.84 20 204735 32307 110352237
Compulsive shopping 17.91 9.84 14 204741 854 110383690
Deep vein thrombosis 17.87 9.84 169 204586 139718 110244826
Anticholinergic syndrome 17.86 9.84 30 204725 4250 110380294
Psychomotor skills impaired 17.82 9.84 40 204715 7018 110377526
Skin necrosis 17.78 9.84 83 204672 21429 110363115
Trichoglossia 17.74 9.84 14 204741 866 110383678
Epistaxis 17.74 9.84 155 204600 130217 110254327
Agranulocytosis 17.67 9.84 57 204698 61703 110322841
Macular degeneration 17.66 9.84 9 204746 21650 110362894
Hereditary angioedema 17.61 9.84 40 204715 7074 110377470
Dyspnoea exertional 17.32 9.84 117 204638 103943 110280601
Arteriosclerosis coronary artery 17.27 9.84 92 204663 25026 110359518
Shock haemorrhagic 17.26 9.84 15 204740 27232 110357312
Cardiomyopathy 17.26 9.84 22 204733 33503 110351041
Inhibitory drug interaction 17.19 9.84 32 204723 4915 110379629
Drug intolerance 17.16 9.84 598 204157 405914 109978630
Second primary malignancy 17.14 9.84 6 204749 18062 110366482
Cholinergic rebound syndrome 17.14 9.84 6 204749 64 110384480
Vitamin B12 decreased 17.03 9.84 33 204722 5224 110379320
Blood bilirubin increased 16.90 9.84 215 204540 75757 110308787
Compulsive sexual behaviour 16.82 9.84 9 204746 284 110384260
Respiratory depression 16.70 9.84 109 204646 31892 110352652
Food allergy 16.70 9.84 8 204747 19940 110364604
X-ray abnormal 16.69 9.84 28 204727 38089 110346455
Lupus vulgaris 16.66 9.84 23 204732 33860 110350684
Maximal voluntary ventilation abnormal 16.66 9.84 5 204750 31 110384513
Obsessive thoughts 16.64 9.84 16 204739 1291 110383253
Posterior reversible encephalopathy syndrome 16.63 9.84 23 204732 33838 110350706
Dislocation of vertebra 16.61 9.84 35 204720 43686 110340858
Wheezing 16.59 9.84 603 204152 254627 110129917
Rhabdomyolysis 16.51 9.84 314 204441 120087 110264457
Hypothyroidism 16.51 9.84 207 204548 72692 110311852
Crying 16.37 9.84 92 204663 25536 110359008
Blood urea increased 16.23 9.84 50 204705 54907 110329637
Nephrotic syndrome 16.18 9.84 3 204752 13828 110370716
Ejection fraction decreased 16.15 9.84 32 204723 40848 110343696
Plasma cell mastitis 16.14 9.84 5 204750 35 110384509
Skin texture abnormal 16.12 9.84 11 204744 543 110384001
Tumour lysis syndrome 16.08 9.84 20 204735 30781 110353763
Obsessive-compulsive disorder 16.05 9.84 39 204716 7202 110377342
Injection site induration 16.04 9.84 52 204703 11331 110373213
Blood uric acid increased 16.04 9.84 10 204745 21519 110363025
Neutropenic sepsis 16.01 9.84 20 204735 30726 110353818
Pulse pressure decreased 15.89 9.84 10 204745 430 110384114
Neurotoxicity 15.86 9.84 34 204721 42173 110342371
Somnambulism 15.84 9.84 36 204719 6369 110378175
Binocular eye movement disorder 15.82 9.84 7 204748 144 110384400
Rheumatoid nodule 15.82 9.84 77 204678 20219 110364325
Product use in unapproved indication 15.82 9.84 995 203760 446382 109938162
Meningitis streptococcal 15.76 9.84 8 204747 226 110384318
Pseudomonas infection 15.71 9.84 17 204738 27836 110356708
Cytotoxic oedema 15.71 9.84 10 204745 439 110384105
Chronic sinusitis 15.66 9.84 14 204741 25070 110359474
Sensation of foreign body 15.64 9.84 41 204714 7934 110376610
Gait apraxia 15.56 9.84 5 204750 40 110384504
Metastases to liver 15.49 9.84 26 204729 35360 110349184
Product packaging difficult to open 15.48 9.84 6 204749 87 110384457
Wound infection fungal 15.48 9.84 8 204747 235 110384309
Haematotoxicity 15.42 9.84 10 204745 21072 110363472
Lymphopenia 15.39 9.84 32 204723 40138 110344406
Tension 15.39 9.84 31 204724 5047 110379497
Road traffic accident 15.37 9.84 126 204629 107272 110277272
Appendicitis 15.37 9.84 18 204737 28446 110356098
Pruritus 15.27 9.84 901 203854 580659 109803885
Rash erythematous 15.17 9.84 89 204666 81743 110302801
Adjustment disorder with depressed mood 15.15 9.84 37 204718 43846 110340698
Foot deformity 15.12 9.84 43 204712 48437 110336107
Hallucination 15.12 9.84 268 204487 101164 110283380
Creatinine renal clearance decreased 15.09 9.84 11 204744 21804 110362740
Vasoplegia syndrome 15.07 9.84 32 204723 5407 110379137
Feeling of despair 15.03 9.84 26 204729 3772 110380772
Hallucination, visual 15.01 9.84 125 204630 39480 110345064
Pericardial effusion 14.89 9.84 55 204700 57162 110327382
Increased appetite 14.82 9.84 61 204694 14916 110369628
Breathing-related sleep disorder 14.82 9.84 8 204747 257 110384287
Illness 14.81 9.84 224 204531 81947 110302597
Emotional disorder 14.59 9.84 64 204691 16096 110368448
Sleep disorder 14.58 9.84 476 204279 198168 110186376
Haematuria 14.49 9.84 92 204663 82913 110301631
Catatonia 14.49 9.84 50 204705 11250 110373294
Peripheral swelling 14.49 9.84 606 204149 403428 109981116
Alanine aminotransferase increased 14.48 9.84 246 204509 183527 110201017
Coeliac disease 14.45 9.84 37 204718 43150 110341394
Product physical issue 14.38 9.84 30 204725 5006 110379538
Central pain syndrome 14.33 9.84 12 204743 808 110383736
Confusional arousal 14.29 9.84 7 204748 183 110384361
Blood potassium increased 14.27 9.84 108 204647 33141 110351403
Cytopenia 14.26 9.84 21 204734 30095 110354449
Renal disorder 14.13 9.84 147 204608 49332 110335212
Burning mouth syndrome 14.09 9.84 11 204744 670 110383874
Discoloured vomit 14.05 9.84 18 204737 1999 110382545
Atrioventricular block second degree 13.99 9.84 40 204715 8141 110376403
Balance disorder 13.99 9.84 298 204457 116262 110268282
Heart rate abnormal 13.98 9.84 37 204718 7201 110377343
Glucose tolerance impaired 13.92 9.84 45 204710 9792 110374752
Eye haematoma 13.90 9.84 8 204747 292 110384252
Pneumococcal infection 13.89 9.84 17 204738 1802 110382742
Haemolytic anaemia 13.89 9.84 11 204744 20909 110363635
Metastases to bone 13.78 9.84 23 204732 31349 110353195
Breast cancer 13.74 9.84 120 204635 38422 110346122
Product quality issue 13.65 9.84 210 204545 77089 110307455
Lupus-like syndrome 13.61 9.84 35 204720 40757 110343787
Expired product administered 13.58 9.84 40 204715 8280 110376264
Pulmonary toxicity 13.56 9.84 8 204747 17738 110366806
Hydronephrosis 13.55 9.84 11 204744 20654 110363890
C-reactive protein 13.54 9.84 22 204733 30309 110354235
Immobile 13.51 9.84 38 204717 7664 110376880
Hanging 13.47 9.84 7 204748 208 110384336
Personal relationship issue 13.44 9.84 7 204748 209 110384335
Abortion spontaneous 13.40 9.84 27 204728 34255 110350289
Delirium febrile 13.32 9.84 5 204750 66 110384478
Laryngeal hypertrophy 13.30 9.84 4 204751 25 110384519
Orthostatic hypotension 13.29 9.84 184 204571 66065 110318479
Pneumonitis 13.27 9.84 85 204670 76446 110308098
Homeless 13.24 9.84 6 204749 131 110384413
Sleep-related eating disorder 13.08 9.84 12 204743 913 110383631
Bladder cancer 13.06 9.84 11 204744 20281 110364263
Heat stroke 13.05 9.84 17 204738 1918 110382626
Holmes-Adie pupil 13.03 9.84 4 204751 27 110384517
Normochromic normocytic anaemia 12.98 9.84 4 204751 13053 110371491
Atrial fibrillation 12.88 9.84 325 204430 229317 110155227
Skin toxicity 12.87 9.84 3 204752 11780 110372764
Immunosuppressant drug level increased 12.77 9.84 3 204752 11721 110372823
Cushingoid 12.75 9.84 3 204752 11709 110372835
Paraesthesia oral 12.75 9.84 27 204728 33644 110350900
Defiant behaviour 12.62 9.84 5 204750 77 110384467
Food craving 12.59 9.84 17 204738 1986 110382558
Therapeutic product effect decreased 12.59 9.84 350 204405 243966 110140578
Pancreatitis acute 12.58 9.84 63 204692 60211 110324333
Periorbital swelling 12.58 9.84 30 204725 5475 110379069
Alcohol poisoning 12.53 9.84 41 204714 8979 110375565
Heterophoria 12.51 9.84 5 204750 79 110384465
Oesophageal candidiasis 12.47 9.84 3 204752 11531 110373013
Hangover 12.45 9.84 19 204736 2483 110382061
Fluid retention 12.45 9.84 113 204642 94194 110290350
Dermatitis acneiform 12.42 9.84 4 204751 12691 110371853
Snoring 12.42 9.84 34 204721 6750 110377794
Productive cough 12.38 9.84 288 204467 114017 110270527
Inflammation 12.37 9.84 268 204487 192970 110191574
Accommodation disorder 12.34 9.84 10 204745 643 110383901
Procedural failure 12.31 9.84 6 204749 155 110384389
Hypoacusis 12.25 9.84 109 204646 35082 110349462
Hyponatriuria 12.23 9.84 4 204751 34 110384510
Genital infection female 12.17 9.84 5 204750 85 110384459
Haemodialysis 12.17 9.84 9 204746 17710 110366834
Product leakage 12.16 9.84 15 204740 1603 110382941
Nystagmus 12.13 9.84 48 204707 11529 110373015
Anion gap abnormal 12.12 9.84 11 204744 825 110383719
Pathogen resistance 12.10 9.84 9 204746 17663 110366881
Body height decreased 12.06 9.84 45 204710 10518 110374026
Treatment noncompliance 12.02 9.84 196 204559 72794 110311750
Wandering pacemaker 12.00 9.84 3 204752 8 110384536
Myotonia 11.79 9.84 7 204748 271 110384273
Palliative care 11.71 9.84 15 204740 1665 110382879
Pleuritic pain 11.71 9.84 60 204695 16080 110368464
Peritoneal perforation 11.65 9.84 6 204749 175 110384369
Device related infection 11.64 9.84 36 204719 39483 110345061
Rectal discharge 11.61 9.84 12 204743 1057 110383487
Mania 11.57 9.84 72 204683 20724 110363820
Multiple-drug resistance 11.56 9.84 5 204750 13230 110371314
Joint effusion 11.52 9.84 13 204742 20892 110363652
Klebsiella infection 11.52 9.84 12 204743 19997 110364547
Obsessive rumination 11.50 9.84 3 204752 10 110384534
Urine odour abnormal 11.49 9.84 35 204720 7380 110377164
Hyperthyroidism 11.43 9.84 93 204662 29168 110355376
Neuropsychiatric symptoms 11.43 9.84 13 204742 1275 110383269
Blood prolactin increased 11.38 9.84 26 204729 4616 110379928
Deformity 11.36 9.84 43 204712 10117 110374427
Therapeutic product effect incomplete 11.36 9.84 515 204240 223290 110161254
Ischaemic hepatitis 11.35 9.84 26 204729 4622 110379922
Cerebral haemorrhage 11.34 9.84 72 204683 64896 110319648
Kidney transplant rejection 11.34 9.84 4 204751 11983 110372561
Enterocolitis 11.33 9.84 11 204744 18938 110365606
Prostatic pain 11.31 9.84 7 204748 292 110384252
Eczema eyelids 11.31 9.84 8 204747 419 110384125
Presbyopia 11.26 9.84 10 204745 729 110383815
Osteoporosis 11.25 9.84 105 204650 87047 110297497
Pre-existing condition improved 11.25 9.84 32 204723 6494 110378050
Complication of device insertion 11.24 9.84 39 204716 8799 110375745
Foreign body 11.20 9.84 20 204735 2975 110381569
Cardiac failure acute 11.19 9.84 17 204738 24061 110360483
Psychotic disorder due to a general medical condition 11.17 9.84 7 204748 299 110384245
Chest discomfort 11.15 9.84 241 204514 173607 110210937
Stress at work 11.13 9.84 13 204742 1312 110383232
Proctitis 11.11 9.84 9 204746 16918 110367626
Illusion 11.08 9.84 16 204739 1991 110382553
Sedative therapy 11.08 9.84 3 204752 12 110384532
Psychotic symptom 11.00 9.84 23 204732 3844 110380700
Cytomegalovirus viraemia 10.99 9.84 10 204745 17754 110366790
Generalised anxiety disorder 10.97 9.84 19 204736 2760 110381784
Knee deformity 10.97 9.84 14 204741 1549 110382995
Foaming at mouth 10.96 9.84 17 204738 2253 110382291
Myopia 10.95 9.84 17 204738 2254 110382290
Social avoidant behaviour 10.94 9.84 28 204727 5341 110379203
Escherichia infection 10.89 9.84 17 204738 23799 110360745
Bacterial infection 10.87 9.84 46 204709 45990 110338554
Attention deficit hyperactivity disorder 10.84 9.84 25 204730 4466 110380078
Acute myopia 10.81 9.84 6 204749 204 110384340
Hip fracture 10.79 9.84 106 204649 35045 110349499
Altered state of consciousness 10.74 9.84 158 204597 57468 110327076
Vomiting 10.73 9.84 1879 202876 908796 109475748
Somatic dysfunction 10.65 9.84 4 204751 53 110384491
Pyelonephritis 10.65 9.84 19 204736 25231 110359313
Bite 10.62 9.84 9 204746 616 110383928
Blood cholinesterase decreased 10.53 9.84 8 204747 468 110384076
Freezing phenomenon 10.51 9.84 18 204737 2591 110381953
Hyperuricaemia 10.48 9.84 7 204748 14524 110370020
Respiratory acidosis 10.45 9.84 52 204703 13774 110370770
Slow speech 10.39 9.84 21 204734 3427 110381117
Dermatitis exfoliative 10.38 9.84 4 204751 11343 110373201
Infusion site urticaria 10.33 9.84 12 204743 1204 110383340
Injection site pain 10.28 9.84 415 204340 177507 110207037
Embolism 10.28 9.84 9 204746 16280 110368264
Intervertebral disc protrusion 10.27 9.84 87 204668 27611 110356933
Anhedonia 10.27 9.84 56 204699 15372 110369172
Neoplasm skin 10.24 9.84 20 204735 3184 110381360
Epididymal cyst 10.22 9.84 3 204752 17 110384527
Therapeutic reaction time decreased 10.21 9.84 27 204728 5252 110379292
Drug screen negative 10.18 9.84 7 204748 350 110384194
Tongue discolouration 10.16 9.84 23 204732 4058 110380486
Kluver-Bucy syndrome 10.08 9.84 3 204752 18 110384526
Product confusion 10.06 9.84 6 204749 234 110384310
Antipsychotic drug level above therapeutic 10.05 9.84 17 204738 2423 110382121
Persistent depressive disorder 10.00 9.84 13 204742 1464 110383080
Bronchial hyperreactivity 9.99 9.84 21 204734 3523 110381021
Autism spectrum disorder 9.99 9.84 15 204740 1933 110382611
Oppositional defiant disorder 9.93 9.84 8 204747 510 110384034
Pneumonia viral 9.93 9.84 44 204711 11113 110373431
Hypercholesterolaemia 9.86 9.84 114 204641 90723 110293821
Urine amphetamine positive 9.86 9.84 5 204750 141 110384403
Finger deformity 9.85 9.84 30 204725 33062 110351482

FDA Adverse Event Reporting System (Pediatric)

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
Drug withdrawal syndrome neonatal 33.14 32.87 34 241 2396 111282

Pharmacologic Action:

SourceCodeDescription
ATC N06AX05 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
MeSH PA D000928 Antidepressive Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D017367 Selective Serotonin Reuptake Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018490 Serotonin Agents
MeSH PA D018687 Antidepressive Agents, Second-Generation
MeSH PA D049990 Membrane Transport Modulators
FDA EPC N0000175696 Serotonin Reuptake Inhibitor
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35717 sedative
CHEBI has role CHEBI:37887 adrenergic antagonist
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:50949 serotonin uptake inhibitor

Related Drugs by ATC class:

N06AX Other antidepressants 28 drugs

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

DiseaseRelationSNOMED_IDDOID
Major depressive disorder indication 370143000
Insomnia off-label use 193462001
Priapism contraindication 6273006 DOID:9286
Suicidal thoughts contraindication 6471006
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Hypokalemia contraindication 43339004
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Heart disease contraindication 56265001 DOID:114
Blood coagulation disorder contraindication 64779008 DOID:1247
Prolonged QT interval contraindication 111975006
Hypomagnesemia contraindication 190855004
Benign prostatic hyperplasia contraindication 266569009
Myocardial infarction in recovery phase contraindication 418044006
Congenital long QT syndrome contraindication 442917000




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.98 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OLEPTRO ANGELINI PHARMA N022411 Feb. 2, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 7829120 March 27, 2027 METHOD OF TREATING DEPRESSION
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OLEPTRO ANGELINI PHARMA N022411 Feb. 2, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 7829120 March 27, 2027 METHOD OF TREATING DEPRESSION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent serotonin transporter Transporter INHIBITOR Kd 6.80 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 6.65 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.35 WOMBAT-PK CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.03 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.54 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Kd 5.07 WOMBAT-PK
5-hydroxytryptamine receptor 1A GPCR Ki 7.02 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.08 WOMBAT-PK
5-hydroxytryptamine receptor 7 GPCR Ki 5.75 PDSP
Alpha-1A adrenergic receptor GPCR IC50 9.55 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR Ki 6.75 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 5.90 DRUG MATRIX
Histamine H1 receptor GPCR Ki 6.21 WOMBAT-PK
Histamine H2 receptor GPCR Ki 5.48 PDSP
5-hydroxytryptamine receptor 1D GPCR Ki 6.98 PDSP
Alpha-2C adrenergic receptor GPCR Ki 6.81 PDSP
Sodium-dependent dopamine transporter Transporter Kd 5.13 WOMBAT-PK
D(4) dopamine receptor GPCR Ki 6.15 PDSP
Alpha-1D adrenergic receptor GPCR Ki 7.33 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR Ki 6.58 WOMBAT-PK
HLA class I histocompatibility antigen, A-3 alpha chain Surface antigen Kd 5.60 CHEMBL
D(1A) dopamine receptor GPCR Ki 5.43 PDSP
D(2) dopamine receptor GPCR Ki 5.46 PDSP
Alpha-1B adrenergic receptor GPCR Ki 7.22 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 6.08 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 6.08 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 6.93 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 6.65 CHEMBL
5-hydroxytryptamine receptor 2A GPCR IC50 7.77 CHEMBL
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 6.70 IUPHAR

External reference:

IDSource
4019954 VUID
N0000148039 NUI
D00820 KEGG_DRUG
25332-39-2 SECONDARY_CAS_RN
4018812 VANDF
4019954 VANDF
C0040805 UMLSCUI
CHEBI:9654 CHEBI
CHEMBL621 ChEMBL_ID
DB00656 DRUGBANK_ID
CHEMBL1200798 ChEMBL_ID
D014196 MESH_DESCRIPTOR_UI
5533 PUBCHEM_CID
213 IUPHAR_LIGAND_ID
2878 INN_ID
YBK48BXK30 UNII
10737 RXNORM
1504 MMSL
5609 MMSL
d00395 MMSL
001511 NDDF
004610 NDDF
372829000 SNOMEDCT_US
58956008 SNOMEDCT_US
7336002 SNOMEDCT_US
YBK48BXK30 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0555-0711 TABLET 300 mg ORAL ANDA 26 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8339 TABLET 150 mg ORAL ANDA 30 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8371 TABLET 50 mg ORAL ANDA 30 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8386 TABLET 100 mg ORAL ANDA 30 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6868 TABLET 50 mg ORAL ANDA 28 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6869 TABLET 100 mg ORAL ANDA 28 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7212 TABLET 150 mg ORAL ANDA 28 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-532 TABLET 100 mg ORAL ANDA 31 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-533 TABLET 150 mg ORAL ANDA 24 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-534 TABLET 50 mg ORAL ANDA 30 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-867 TABLET 150 mg ORAL ANDA 21 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 12634-193 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
TRAZODONE HYDROCHLORIDE Human Prescription Drug Label 1 13107-079 TABLET 50 mg ORAL ANDA 30 sections
TRAZODONE HYDROCHLORIDE Human Prescription Drug Label 1 13107-080 TABLET 100 mg ORAL ANDA 30 sections
TRAZODONE HYDROCHLORIDE Human Prescription Drug Label 1 13107-081 TABLET 150 mg ORAL ANDA 30 sections
TRAZODONE HYDROCHLORIDE Human Prescription Drug Label 1 13107-082 TABLET 300 mg ORAL ANDA 30 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-330 TABLET 50 mg ORAL ANDA 22 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-331 TABLET 100 mg ORAL ANDA 22 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-332 TABLET 150 mg ORAL ANDA 22 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-333 TABLET 300 mg ORAL ANDA 22 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16590-231 TABLET 50 mg ORAL ANDA 25 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16590-232 TABLET 100 mg ORAL ANDA 25 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16590-585 TABLET 150 mg ORAL ANDA 25 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-299 TABLET 50 mg ORAL ANDA 20 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-300 TABLET 100 mg ORAL ANDA 20 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-301 TABLET 150 mg ORAL ANDA 20 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-302 TABLET 300 mg ORAL ANDA 20 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-133 TABLET 50 mg ORAL ANDA 26 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-134 TABLET 100 mg ORAL ANDA 26 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-135 TABLET 150 mg ORAL ANDA 26 sections