trazodone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 µM/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

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 1256.40 10.08 1465 119419 144208 63223930
Drug abuse 549.82 10.08 684 120200 71834 63296304
Sopor 500.02 10.08 381 120503 21783 63346355
Toxicity to various agents 440.04 10.08 1246 119638 246004 63122134
Serotonin syndrome 377.69 10.08 362 120522 28320 63339818
Pemphigus 328.43 10.08 4 120880 183722 63184416
Polycystic ovaries 294.71 10.08 152 120732 4319 63363819
Hand deformity 270.58 10.08 7 120877 159450 63208688
Systemic lupus erythematosus 248.78 10.08 48 120836 208870 63159268
Sensitisation 243.23 10.08 122 120762 3264 63364874
Suicide attempt 229.12 10.08 414 120470 60504 63307634
Rhinitis allergic 218.11 10.08 180 120704 11547 63356591
Pericarditis 215.22 10.08 8 120876 131571 63236567
Glossodynia 211.05 10.08 42 120842 178834 63189304
Anti-cyclic citrullinated peptide antibody positive 205.56 10.08 3 120881 116209 63251929
Maternal exposure during pregnancy 205.36 10.08 81 120803 219981 63148157
Swelling 200.07 10.08 140 120744 275238 63092900
Ejection fraction 197.65 10.08 95 120789 2311 63365827
Wound 193.30 10.08 38 120846 163225 63204913
Sleep disorder due to a general medical condition 191.83 10.08 170 120714 12018 63356120
Gastrooesophageal reflux disease 189.58 10.08 502 120382 95137 63273001
Blood test abnormal 188.41 10.08 188 120696 15441 63352697
Hypomania 179.49 10.08 125 120759 6205 63361933
Suicidal ideation 168.16 10.08 369 120515 62052 63306086
Cardio-respiratory arrest 163.29 10.08 356 120528 59603 63308535
Sleep apnoea syndrome 154.14 10.08 231 120653 28902 63339236
Schizophrenia 153.03 10.08 137 120747 9815 63358323
Synovitis 146.64 10.08 87 120797 186831 63181307
Contraindicated product administered 142.35 10.08 123 120761 217525 63150613
Helicobacter infection 140.99 10.08 9 120875 92776 63275362
Exposure during pregnancy 134.34 10.08 64 120820 155483 63212655
Alopecia 133.95 10.08 276 120608 337260 63030878
Jaundice cholestatic 133.24 10.08 111 120773 7213 63360925
Abdominal discomfort 129.35 10.08 260 120624 320625 63047513
Product dose omission issue 127.68 10.08 823 120061 233490 63134648
Drug interaction 127.44 10.08 809 120075 228322 63139816
Overdose 124.59 10.08 491 120393 114587 63253551
Presbyacusis 121.83 10.08 73 120811 2792 63365346
Joint swelling 119.24 10.08 281 120603 327385 63040753
Infusion related reaction 116.99 10.08 179 120705 245342 63122796
Carpal tunnel syndrome 114.34 10.08 168 120716 20649 63347489
Folliculitis 112.52 10.08 5 120879 70312 63297826
Impaired healing 111.06 10.08 29 120855 102513 63265625
Pleural fibrosis 108.96 10.08 73 120811 3399 63364739
Psychotic disorder 107.33 10.08 183 120701 25529 63342609
Arthropathy 107.29 10.08 176 120708 234616 63133522
Pleural thickening 106.13 10.08 67 120817 2816 63365322
Rash 103.60 10.08 635 120249 560236 62807902
Muscle injury 103.41 10.08 5 120879 65340 63302798
Blood magnesium increased 102.92 10.08 67 120817 2971 63365167
Lung diffusion test abnormal 101.04 10.08 34 120850 309 63367829
Migraine 100.03 10.08 426 120458 102920 63265218
Depression 97.24 10.08 674 120210 195818 63172320
Electrocardiogram QT prolonged 96.85 10.08 291 120593 59239 63308899
Withdrawal syndrome 95.17 10.08 151 120733 19846 63348292
Anxiety 92.12 10.08 719 120165 216822 63151316
Deafness neurosensory 87.11 10.08 73 120811 4782 63363356
Loss of personal independence in daily activities 86.51 10.08 391 120493 96899 63271239
Asthma 83.37 10.08 470 120414 127091 63241047
Insomnia 83.30 10.08 697 120187 214555 63153583
Suspected suicide 80.99 10.08 80 120804 6488 63361650
Tremor 80.41 10.08 478 120406 131761 63236377
Ejection fraction abnormal 79.86 10.08 47 120837 1738 63366400
Blepharospasm 79.51 10.08 76 120808 5920 63362218
General physical health deterioration 77.01 10.08 168 120716 201234 63166904
Memory impairment 76.14 10.08 396 120488 103862 63264276
Discomfort 75.92 10.08 126 120758 167248 63200890
Nephrectomy 73.56 10.08 42 120842 1466 63366672
Neutropenia 71.10 10.08 141 120743 174864 63193274
Drug intolerance 70.46 10.08 325 120559 308336 63059802
Thrombocytopenia 70.23 10.08 112 120772 151045 63217093
Hypersensitivity 68.70 10.08 305 120579 292380 63075758
Epigastric discomfort 68.14 10.08 74 120810 6706 63361432
Sputum discoloured 67.76 10.08 116 120768 16231 63351907
Blister 67.36 10.08 89 120795 129725 63238413
Neovascularisation 67.13 10.08 36 120848 1109 63367029
Therapeutic product effect decreased 66.78 10.08 170 120714 193017 63175121
Respiratory arrest 66.30 10.08 173 120711 32472 63335666
Stomatitis 65.19 10.08 102 120782 138623 63229515
Confabulation 64.78 10.08 24 120860 296 63367842
Pyrexia 64.09 10.08 580 120304 469898 62898240
Hyper IgE syndrome 63.76 10.08 27 120857 483 63367655
C-reactive protein abnormal 63.09 10.08 7 120877 46089 63322049
Myocardial stunning 62.46 10.08 20 120864 153 63367985
Haemoglobin decreased 61.90 10.08 114 120770 145371 63222767
Burning sensation 61.16 10.08 235 120649 54172 63313966
Pancytopenia 60.66 10.08 57 120827 96876 63271262
Irritability 59.36 10.08 163 120721 31531 63336607
Intentional overdose 57.87 10.08 287 120597 73865 63294273
Agitation 57.54 10.08 246 120638 59511 63308627
Skin lesion 57.54 10.08 158 120726 30563 63337575
Wheezing 57.10 10.08 344 120540 95251 63272887
Asthma-chronic obstructive pulmonary disease overlap syndrome 56.80 10.08 40 120844 2021 63366117
Ill-defined disorder 54.87 10.08 45 120839 81710 63286428
Bradyphrenia 54.69 10.08 67 120817 6913 63361225
Anaemia 54.64 10.08 331 120553 293099 63075039
Irritable bowel syndrome 52.11 10.08 48 120836 82364 63285774
Febrile neutropenia 52.01 10.08 91 120793 118358 63249780
Lower respiratory tract infection 51.69 10.08 109 120775 132198 63235940
Bone cyst 51.37 10.08 39 120845 2215 63365923
Extrapyramidal disorder 50.82 10.08 91 120793 13193 63354945
Poor quality sleep 50.46 10.08 115 120769 19820 63348318
Hypothyroidism 50.28 10.08 187 120697 42445 63325693
Taste disorder 50.25 10.08 92 120792 13570 63354568
Paradoxical drug reaction 50.14 10.08 50 120834 4102 63364036
Hyperreflexia 49.83 10.08 59 120825 5875 63362263
Drug withdrawal syndrome 49.09 10.08 138 120746 27056 63341082
Leukopenia 48.89 10.08 45 120839 77245 63290893
Cardiac disorder 48.77 10.08 209 120675 50607 63317531
Total lung capacity increased 48.35 10.08 38 120846 2272 63365866
Adjustment disorder with mixed anxiety and depressed mood 48.00 10.08 15 120869 105 63368033
Asphyxia 47.89 10.08 59 120825 6122 63362016
Mucosal inflammation 47.61 10.08 15 120869 46913 63321225
Visual perseveration 45.79 10.08 13 120871 62 63368076
Cyst 45.74 10.08 90 120794 14009 63354129
Nightmare 45.59 10.08 108 120776 19086 63349052
Arteriosclerosis coronary artery 45.15 10.08 67 120817 8306 63359832
Abnormal behaviour 43.97 10.08 114 120770 21312 63346826
Malignant neoplasm progression 43.94 10.08 55 120829 82066 63286072
Liver injury 43.56 10.08 31 120853 60489 63307649
Accidental poisoning 43.27 10.08 22 120862 606 63367532
Total lung capacity decreased 41.62 10.08 34 120850 2149 63365989
Oral discomfort 40.40 10.08 67 120817 9134 63359004
Injection site mass 40.08 10.08 101 120783 18555 63349583
Sleep disorder due to general medical condition, insomnia type 39.93 10.08 25 120859 52192 63315946
Rheumatoid factor positive 39.70 10.08 62 120822 84344 63283794
Somatic delusion 38.65 10.08 20 120864 572 63367566
Persistent genital arousal disorder 38.63 10.08 16 120868 270 63367868
Restrictive pulmonary disease 38.59 10.08 30 120854 1765 63366373
Obstructive airways disorder 38.31 10.08 106 120778 20593 63347545
Disorganised speech 38.27 10.08 26 120858 1239 63366899
Product use issue 37.32 10.08 256 120628 220264 63147874
Body tinea 37.29 10.08 30 120854 1855 63366283
Fall 36.92 10.08 993 119891 391341 62976797
Somnolence 36.80 10.08 510 120374 178175 63189963
Intentional self-injury 36.63 10.08 120 120764 25567 63342571
Bone marrow failure 36.40 10.08 6 120878 29284 63338854
Restless legs syndrome 36.40 10.08 97 120787 18434 63349704
Blood cholesterol increased 36.27 10.08 78 120806 93954 63274184
Hereditary angioedema 35.84 10.08 57 120827 7505 63360633
Hostility 35.36 10.08 29 120855 1843 63366295
Headache 35.01 10.08 1506 119378 631735 62736403
Vertigo 34.79 10.08 214 120670 59673 63308465
Treatment failure 34.71 10.08 229 120655 198814 63169324
Pleurothotonus 34.46 10.08 25 120859 1324 63366814
Cardiac failure 34.34 10.08 74 120810 89068 63279070
Akathisia 34.15 10.08 62 120822 9084 63359054
Rheumatoid arthritis 34.00 10.08 314 120570 253505 63114633
Alcoholism 34.00 10.08 28 120856 1790 63366348
Listless 33.72 10.08 34 120850 2826 63365312
Hip arthroplasty 33.51 10.08 25 120859 47621 63320517
Osteopenia 33.38 10.08 98 120786 19687 63348451
Cardiac arrest 33.28 10.08 295 120589 92250 63275888
Muscle rigidity 33.26 10.08 70 120814 11430 63356708
Osteosclerosis 33.21 10.08 39 120845 3849 63364289
Breath sounds abnormal 33.15 10.08 68 120816 10905 63357233
Dissociation 33.14 10.08 34 120850 2885 63365253
Blood potassium increased 33.13 10.08 93 120791 18216 63349922
Hospitalisation 33.11 10.08 276 120608 84805 63283333
Encephalopathy 32.66 10.08 153 120731 38467 63329671
Cardiac murmur 32.55 10.08 80 120804 14472 63353666
Cholestasis 32.48 10.08 8 120876 29426 63338712
Bronchiectasis 32.21 10.08 85 120799 16057 63352081
Tardive dyskinesia 32.21 10.08 58 120826 8444 63359694
Multiple sclerosis relapse 31.89 10.08 179 120705 48299 63319839
Dry eye 31.25 10.08 157 120727 40604 63327534
Disease progression 31.18 10.08 124 120760 122634 63245504
Psoriasis 31.17 10.08 277 120607 86680 63281458
Lung opacity 30.83 10.08 34 120850 3134 63365004
Mental disorder 30.82 10.08 114 120770 25805 63342333
Bronchopulmonary aspergillosis allergic 30.66 10.08 29 120855 2229 63365909
Renal disorder 30.40 10.08 134 120750 32840 63335298
Macular degeneration 30.28 10.08 5 120879 24371 63343767
Inhibitory drug interaction 30.22 10.08 32 120852 2817 63365321
Libido increased 30.05 10.08 23 120861 1322 63366816
Acute kidney injury 29.87 10.08 339 120545 263076 63105062
Fibromyalgia 29.77 10.08 258 120626 80162 63287976
Platelet count decreased 29.68 10.08 117 120767 116005 63252133
Infection susceptibility increased 29.55 10.08 35 120849 3486 63364652
Live birth 28.21 10.08 7 120877 25623 63342515
Toxic epidermal necrolysis 27.73 10.08 7 120877 25327 63342811
Cardiac failure congestive 27.73 10.08 87 120797 92346 63275792
Hallucination, auditory 27.10 10.08 69 120815 12755 63355383
Sternal fracture 26.95 10.08 27 120857 2227 63365911
Premature delivery 26.83 10.08 12 120872 30269 63337869
Aspiration 26.80 10.08 62 120822 10789 63357349
Cognitive disorder 26.70 10.08 190 120694 55625 63312513
Muscle twitching 26.38 10.08 90 120794 19578 63348560
Coma 26.23 10.08 211 120673 64153 63303985
Infection 25.95 10.08 295 120589 228878 63139260
Soft tissue injury 25.91 10.08 23 120861 1629 63366509
Major depression 25.79 10.08 51 120833 7967 63360171
Dyskinesia 25.77 10.08 125 120759 31877 63336261
Peripheral swelling 25.74 10.08 354 120530 265588 63102550
Prescription drug used without a prescription 25.67 10.08 27 120857 2359 63365779
Dermatitis atopic 25.62 10.08 57 120827 9667 63358471
Sedation 25.33 10.08 143 120741 38666 63329472
Knee arthroplasty 25.31 10.08 40 120844 54166 63313972
Blood bilirubin increased 25 10.08 138 120746 37002 63331136
Sarcoidosis 24.99 10.08 47 120837 7075 63361063
Impaired quality of life 24.93 10.08 70 120814 13713 63354425
Hypertonia 24.85 10.08 37 120847 4600 63363538
Sleep disorder 24.84 10.08 251 120633 81315 63286823
Depressed level of consciousness 24.48 10.08 202 120682 61876 63306262
Sinus bradycardia 24.48 10.08 72 120812 14479 63353659
Intentional product misuse 24.44 10.08 199 120685 60718 63307420
Psychomotor hyperactivity 24.25 10.08 59 120825 10604 63357534
Sensation of foreign body 24.20 10.08 37 120847 4708 63363430
Post-traumatic stress disorder 24.09 10.08 39 120845 5212 63362926
Drug screen positive 23.96 10.08 32 120852 3597 63364541
Mood altered 23.90 10.08 72 120812 14671 63353467
Autonomic nervous system imbalance 23.63 10.08 28 120856 2790 63365348
Bone erosion 23.48 10.08 3 120881 17714 63350424
Post-traumatic neck syndrome 23.26 10.08 24 120860 2050 63366088
Hepatotoxicity 23.20 10.08 135 120749 36906 63331232
Perseveration 23.02 10.08 11 120873 264 63367874
Liver disorder 22.88 10.08 42 120842 53645 63314493
Sense of a foreshortened future 22.87 10.08 5 120879 5 63368133
Product physical issue 22.86 10.08 37 120847 4943 63363195
Gambling disorder 22.82 10.08 19 120865 1233 63366905
Full blood count abnormal 22.81 10.08 120 120764 31597 63336541
Epilepsy 22.72 10.08 107 120777 26958 63341180
Abnormal dreams 22.66 10.08 57 120827 10459 63357679
Glucose tolerance impaired 22.57 10.08 43 120841 6534 63361604
Tonic clonic movements 22.55 10.08 20 120864 1415 63366723
Cytomegalovirus infection 22.53 10.08 6 120878 20946 63347192
Unresponsive to stimuli 22.33 10.08 125 120759 33691 63334447
Apallic syndrome 22.24 10.08 15 120869 706 63367432
Mental status changes 22.06 10.08 140 120744 39459 63328679
Clonus 22.04 10.08 35 120849 4601 63363537
Productive cough 21.96 10.08 200 120684 63008 63305130
Meningitis streptococcal 21.94 10.08 9 120875 148 63367990
Concussion 21.94 10.08 52 120832 9192 63358946
Abortion spontaneous 21.87 10.08 35 120849 47160 63320978
Middle insomnia 21.69 10.08 63 120821 12580 63355558
Therapy non-responder 21.68 10.08 73 120811 75828 63292310
Neuroleptic malignant syndrome 21.58 10.08 61 120823 11995 63356143
Nasal polyps 21.37 10.08 40 120844 5999 63362139
Urinary retention 21.35 10.08 114 120770 30187 63337951
Compartment syndrome 21.35 10.08 24 120860 2260 63365878
Affective disorder 20.87 10.08 40 120844 6106 63362032
Reduced facial expression 20.71 10.08 22 120862 1944 63366194
Psychomotor skills impaired 20.64 10.08 24 120860 2344 63365794
Torsade de pointes 20.52 10.08 64 120820 13287 63354851
Depressed mood 20.51 10.08 139 120745 40052 63328086
Haemangioma congenital 20.48 10.08 12 120872 440 63367698
Pregnancy 20.41 10.08 24 120860 36812 63331326
Head discomfort 20.34 10.08 64 120820 13351 63354787
Multiple organ dysfunction syndrome 20.32 10.08 49 120835 56703 63311435
Restlessness 20.20 10.08 110 120774 29343 63338795
Cholelithiasis 20.12 10.08 148 120736 43777 63324361
Infantile vomiting 20.11 10.08 8 120876 121 63368017
Solar urticaria 20.03 10.08 7 120877 72 63368066
Inappropriate schedule of product administration 19.89 10.08 293 120591 103672 63264466
Blood calcium decreased 19.76 10.08 13 120871 26438 63341700
Accommodation disorder 19.63 10.08 11 120873 370 63367768
Chronic obstructive pulmonary disease 19.62 10.08 194 120690 62492 63305646
Skin texture abnormal 19.61 10.08 12 120872 477 63367661
Bursitis 19.61 10.08 25 120859 37016 63331122
Initial insomnia 19.60 10.08 39 120845 6118 63362020
Oppositional defiant disorder 19.45 10.08 6 120878 40 63368098
Mobility decreased 19.33 10.08 143 120741 121016 63247122
Tachyphrenia 19.33 10.08 18 120866 1356 63366782
Purple glove syndrome 19.30 10.08 9 120875 204 63367934
Burning mouth syndrome 19.12 10.08 12 120872 499 63367639
Hyperhidrosis 19.12 10.08 300 120584 107536 63260602
Lung disorder 19.10 10.08 58 120826 62203 63305935
Septic shock 19.09 10.08 64 120820 66565 63301573
Dysphoria 18.97 10.08 34 120850 4932 63363206
Urticaria 18.93 10.08 213 120671 165589 63202549
Premature baby 18.71 10.08 8 120876 20727 63347411
Anger 18.49 10.08 59 120825 12397 63355741
Nasopharyngitis 18.44 10.08 357 120527 253900 63114238
Haematocrit decreased 18.39 10.08 29 120855 39311 63328827
Joint range of motion decreased 18.10 10.08 21 120863 32407 63335731
Ejection fraction decreased 18.05 10.08 10 120874 22322 63345816
Drug withdrawal syndrome neonatal 17.99 10.08 21 120863 2060 63366078
Hepatic failure 17.92 10.08 25 120859 35631 63332507
Heart rate abnormal 17.80 10.08 33 120851 4914 63363224
Hepatic function abnormal 17.73 10.08 27 120857 37115 63331023
Delirium 17.60 10.08 160 120724 50381 63317757
Maximal voluntary ventilation abnormal 17.42 10.08 5 120879 25 63368113
Apathy 17.24 10.08 46 120838 8748 63359390
Substance abuse 17.21 10.08 32 120852 4775 63363363
Accidental death 17.18 10.08 20 120864 1956 63366182
Nystagmus 17.00 10.08 37 120847 6183 63361955
Hyperkalaemia 16.98 10.08 50 120834 54153 63313985
Liver function test abnormal 16.94 10.08 42 120842 48139 63319999
Nervousness 16.93 10.08 109 120775 30870 63337268
Affect lability 16.72 10.08 53 120831 11098 63357040
Bradycardia 16.71 10.08 213 120671 73014 63295124
Musculoskeletal pain 16.66 10.08 105 120779 92172 63275966
Myoclonus 16.58 10.08 67 120817 15801 63352337
Deep vein thrombosis 16.37 10.08 93 120791 83707 63284431
Mydriasis 16.29 10.08 55 120829 11901 63356237
Priapism 16.14 10.08 7 120877 133 63368005
Vasoplegia syndrome 16.13 10.08 18 120866 1681 63366457
Body height decreased 16.13 10.08 49 120835 10029 63358109
Hepatocellular injury 16.09 10.08 17 120867 27364 63340774
Small for dates baby 16.05 10.08 27 120857 3724 63364414
Renal failure 15.97 10.08 145 120739 117507 63250631
Slow speech 15.91 10.08 17 120867 1512 63366626
Anaphylactic shock 15.86 10.08 13 120871 23620 63344518
Sedative therapy 15.80 10.08 3 120881 0 63368138
Wound infection fungal 15.72 10.08 7 120877 142 63367996
Plasma cell mastitis 15.53 10.08 5 120879 39 63368099
Coagulopathy 15.48 10.08 10 120874 20534 63347604
Rash maculo-papular 15.40 10.08 23 120861 31873 63336265
Hepatitis 15.34 10.08 33 120851 39755 63328383
Tongue discolouration 15.32 10.08 24 120860 3119 63365019
Hypercholesterolaemia 15.25 10.08 11 120873 21323 63346815
Eczema eyelids 15.25 10.08 7 120877 153 63367985
Angioedema 15.20 10.08 44 120840 47921 63320217
Creatinine renal clearance decreased 15.19 10.08 6 120878 16302 63351836
International normalised ratio increased 15.15 10.08 42 120842 46383 63321755
Sepsis 15.10 10.08 203 120681 152920 63215218
Drug resistance 14.92 10.08 13 120871 22920 63345218
Polyglandular autoimmune syndrome type II 14.80 10.08 5 120879 46 63368092
Large for dates baby 14.78 10.08 10 120874 473 63367665
Oedema 14.74 10.08 117 120767 97505 63270633
Disseminated intravascular coagulation 14.73 10.08 9 120875 19042 63349096
Blood prolactin increased 14.70 10.08 25 120859 3478 63364660
Screaming 14.65 10.08 24 120860 3238 63364900
Balance disorder 14.64 10.08 234 120650 84188 63283950
Thyroglobulin increased 14.62 10.08 5 120879 48 63368090
Feeling abnormal 14.60 10.08 378 120506 148014 63220124
Acute respiratory distress syndrome 14.53 10.08 14 120870 23520 63344618
Hyponatriuria 14.28 10.08 4 120880 18 63368120
Tracheitis 14.20 10.08 12 120872 795 63367343
Arthralgia 14.15 10.08 915 119969 568795 62799343
Personality disorder 14.13 10.08 33 120851 5778 63362360
Drug ineffective for unapproved indication 14.05 10.08 112 120772 33951 63334187
Lip dry 13.91 10.08 6 120878 15464 63352674
Drug dependence 13.91 10.08 87 120797 24396 63343742
Economic problem 13.87 10.08 18 120866 1968 63366170
Periorbital swelling 13.83 10.08 22 120862 2896 63365242
Mitral valve thickening 13.77 10.08 4 120880 21 63368117
Patient restraint 13.72 10.08 3 120881 3 63368135
Serum serotonin increased 13.60 10.08 7 120877 198 63367940
Pain 13.59 10.08 1220 119664 739408 62628730
Peritoneal perforation 13.56 10.08 6 120878 120 63368018
Therapy interrupted 13.55 10.08 107 120777 32348 63335790
Myoglobin blood increased 13.54 10.08 15 120869 1390 63366748
Therapeutic response shortened 13.07 10.08 51 120833 11837 63356301
Pneumocystis jirovecii pneumonia 13.07 10.08 8 120876 16906 63351232
Interstitial lung disease 13.04 10.08 67 120817 61841 63306297
Respiratory acidosis 13.03 10.08 35 120849 6680 63361458
Personal relationship issue 12.73 10.08 5 120879 73 63368065
C-reactive protein increased 12.73 10.08 117 120767 94590 63273548
Gait apraxia 12.68 10.08 4 120880 29 63368109
Gastroenteritis radiation 12.64 10.08 9 120875 463 63367675
Immobile 12.58 10.08 32 120852 5911 63362227
Myelosuppression 12.54 10.08 16 120868 23687 63344451
Holmes-Adie pupil 12.45 10.08 4 120880 31 63368107
Heterophoria 12.45 10.08 4 120880 31 63368107
Mood swings 12.41 10.08 68 120816 18180 63349958
Gastrointestinal haemorrhage 12.38 10.08 97 120787 81079 63287059
Nausea 12.35 10.08 1830 119054 852641 62515497
Product size issue 12.34 10.08 8 120876 352 63367786
Anuria 12.33 10.08 52 120832 12499 63355639
Infusion site pruritus 12.27 10.08 32 120852 6003 63362135
Extra dose administered 12.23 10.08 33 120851 6317 63361821
Accidental overdose 12.12 10.08 81 120803 23228 63344910
Facet joint syndrome 12.10 10.08 4 120880 12134 63356004
Foetal death 12.08 10.08 3 120881 10977 63357161
Obsessive-compulsive disorder 12.08 10.08 25 120859 4035 63364103
Decreased interest 12.08 10.08 22 120862 3232 63364906
Human herpesvirus 6 infection reactivation 12.06 10.08 8 120876 366 63367772
Weight decreased 11.97 10.08 643 120241 276155 63091983
Alcohol withdrawal syndrome 11.96 10.08 11 120873 816 63367322
Wandering pacemaker 11.92 10.08 3 120881 8 63368130
Psoriatic arthropathy 11.90 10.08 114 120770 91406 63276732
Grip strength decreased 11.84 10.08 15 120869 22272 63345866
Neonatal seizure 11.82 10.08 9 120875 513 63367625
Disorientation 11.81 10.08 121 120763 39331 63328807
Sinusitis 11.75 10.08 335 120549 226318 63141820
Sympathomimetic effect 11.73 10.08 5 120879 91 63368047
Foreign body 11.60 10.08 18 120866 2320 63365818
Hyperbilirubinaemia neonatal 11.59 10.08 8 120876 391 63367747
Toxic skin eruption 11.58 10.08 5 120879 12880 63355258
Pericardial effusion 11.53 10.08 25 120859 30033 63338105
Haemophagocytic lymphohistiocytosis 11.51 10.08 3 120881 10624 63357514
Jaundice 11.50 10.08 24 120860 29227 63338911
Product complaint 11.47 10.08 5 120879 12804 63355334
Product shape issue 11.44 10.08 5 120879 97 63368041
Hyperlipidaemia 11.40 10.08 70 120814 19501 63348637
Genital infection female 11.34 10.08 5 120879 99 63368039
Injection site induration 11.32 10.08 41 120843 9185 63358953
Suicidal behaviour 11.30 10.08 19 120865 2620 63365518
Skin sensitisation 11.28 10.08 11 120873 878 63367260
Presyncope 11.27 10.08 91 120793 27694 63340444
Tension 11.20 10.08 21 120863 3154 63364984
Product substitution issue 11.14 10.08 60 120824 15936 63352202
Malignant melanoma 11.12 10.08 47 120837 11309 63356829
Exostosis 11.12 10.08 65 120819 17797 63350341
Device expulsion 11.09 10.08 32 120852 34890 63333248
Dyslipidaemia 10.96 10.08 35 120849 7358 63360780
Intervertebral disc degeneration 10.95 10.08 59 120825 15673 63352465
Speech disorder 10.95 10.08 122 120762 40507 63327631
Illness 10.89 10.08 142 120742 48917 63319221
Acute myeloid leukaemia 10.82 10.08 10 120874 17137 63351001
Compulsive shopping 10.79 10.08 10 120874 749 63367389
Lupus-like syndrome 10.79 10.08 8 120876 15287 63352851
Hypoaesthesia 10.74 10.08 407 120477 167986 63200152
Long QT syndrome 10.72 10.08 21 120863 3258 63364880
Joint effusion 10.70 10.08 10 120874 17050 63351088
Injection site necrosis 10.69 10.08 13 120871 1331 63366807
Knee deformity 10.68 10.08 13 120871 1332 63366806
Hyperthermia 10.66 10.08 40 120844 9116 63359022
Rapid eye movement sleep behaviour disorder 10.58 10.08 7 120877 319 63367819
Osteonecrosis of jaw 10.57 10.08 33 120851 35090 63333048
Galactorrhoea 10.55 10.08 24 120860 4131 63364007
Multiple sclerosis 10.53 10.08 81 120803 24291 63343847
Metastases to liver 10.52 10.08 18 120866 23621 63344517
Drug detoxification 10.46 10.08 7 120877 325 63367813
Juvenile melanoma benign 10.45 10.08 3 120881 15 63368123
Apraxia 10.44 10.08 15 120869 1806 63366332
Neoplasm progression 10.43 10.08 35 120849 36393 63331745
Morbid thoughts 10.43 10.08 9 120875 614 63367524
Thinking abnormal 10.38 10.08 44 120840 10599 63357539
Hypotension 10.38 10.08 626 120258 271978 63096160
Electrocardiogram T wave peaked 10.32 10.08 6 120878 217 63367921
Impaired gastric emptying 10.30 10.08 43 120841 10289 63357849
Kluver-Bucy syndrome 10.29 10.08 3 120881 16 63368122
Generalised oedema 10.25 10.08 9 120875 15809 63352329
Cardiomyopathy 10.24 10.08 11 120873 17573 63350565
Borderline personality disorder 10.23 10.08 10 120874 801 63367337
Hypokinesia 10.21 10.08 53 120831 13883 63354255
Urine odour abnormal 10.17 10.08 31 120853 6358 63361780
Immune-mediated lung disease 10.14 10.08 9 120875 637 63367501
Postural tremor 10.11 10.08 7 120877 344 63367794
Inappropriate antidiuretic hormone secretion 10.10 10.08 57 120827 15405 63352733
Compulsive sexual behaviour 10.09 10.08 4 120880 60 63368078

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 580.72 11.26 708 49325 97460 34809438
Serotonin syndrome 470.87 11.26 315 49718 19618 34887280
Priapism 401.71 11.26 178 49855 4816 34902082
Toxicity to various agents 389.10 11.26 873 49160 199489 34707409
Drug abuse 306.72 11.26 526 49507 98570 34808328
Sopor 277.42 11.26 188 49845 11948 34894950
Intentional overdose 147.05 11.26 241 49792 43433 34863465
Suicidal ideation 137.50 11.26 224 49809 40164 34866734
Suicide attempt 117.28 11.26 205 49828 38911 34867987
Overdose 114.87 11.26 338 49695 90721 34816177
Drug interaction 105.20 11.26 616 49417 225330 34681568
Agitation 89.16 11.26 230 49803 57169 34849729
Intrusive thoughts 88.07 11.26 28 50005 287 34906611
Cardio-respiratory arrest 80.26 11.26 216 49817 55057 34851841
Electrocardiogram QT prolonged 79.60 11.26 179 49854 40773 34866125
Insomnia 78.89 11.26 326 49707 103581 34803317
Head discomfort 76.02 11.26 56 49977 4060 34902838
Somnolence 72.43 11.26 333 49700 110783 34796115
Anxiety 70.08 11.26 305 49728 99123 34807775
Depression 68.54 11.26 298 49735 96800 34810098
Febrile neutropenia 65.07 11.26 60 49973 136789 34770109
Aggression 64.51 11.26 160 49873 38804 34868094
Homicidal ideation 62.34 11.26 42 49991 2640 34904258
Antidepressant drug level above therapeutic 61.15 11.26 20 50013 226 34906672
Tachyphrenia 58.78 11.26 31 50002 1238 34905660
Mental status changes 57.46 11.26 151 49882 37932 34868966
Anaemia 56.53 11.26 160 49873 233175 34673723
Analgesic drug level above therapeutic 56.43 11.26 20 50013 293 34906605
Pancytopenia 51.08 11.26 37 49996 95120 34811778
Environmental exposure 50.15 11.26 18 50015 274 34906624
Sedation 47.91 11.26 98 49935 20908 34885990
Confusional state 47.51 11.26 361 49672 143799 34763099
Renal failure 46.33 11.26 72 49961 130485 34776413
Ventricular tachyarrhythmia 45.81 11.26 18 50015 356 34906542
Paranoia 45.26 11.26 70 49963 11998 34894900
Device dislocation 45.01 11.26 50 49983 6199 34900699
Withdrawal syndrome 44.98 11.26 71 49962 12384 34894514
Disease progression 42.91 11.26 55 49978 108022 34798876
Irritability 42.57 11.26 103 49930 24587 34882311
Anger 41.89 11.26 67 49966 11817 34895081
Pyrexia 41.41 11.26 293 49740 332720 34574178
Drug withdrawal syndrome neonatal 40.94 11.26 37 49996 3582 34903316
Neck pain 40.80 11.26 103 49930 25246 34881652
Thrombocytopenia 39.39 11.26 105 49928 156142 34750756
Parkinsonism 37.46 11.26 52 49981 8086 34898812
Bradyphrenia 37.36 11.26 40 49993 4758 34902140
Alcoholism 36.90 11.26 32 50001 2933 34903965
Interstitial lung disease 36.86 11.26 24 50009 65258 34841640
Intentional product misuse 36.86 11.26 146 49887 45465 34861433
Penis injury 36.70 11.26 14 50019 255 34906643
Symptom masked 36.61 11.26 18 50015 619 34906279
Migraine 35.75 11.26 78 49955 17400 34889498
Loss of libido 34.74 11.26 29 50004 2523 34904375
Tremor 33.13 11.26 217 49816 82370 34824528
Product dose omission issue 33.04 11.26 288 49745 119423 34787475
Sleep disorder 32.85 11.26 110 49923 31578 34875320
Hallucination, auditory 32.54 11.26 60 49973 11857 34895041
Injection site reaction 32.35 11.26 63 49970 12970 34893928
Intentional self-injury 32.29 11.26 65 49968 13706 34893192
Respiratory arrest 31.46 11.26 100 49933 27943 34878955
Dysphoria 31.01 11.26 26 50007 2276 34904622
Restless legs syndrome 30.69 11.26 48 49985 8306 34898592
Fall 30.59 11.26 433 49600 202452 34704446
Poor feeding infant 30.34 11.26 15 50018 522 34906376
Renal impairment 29.95 11.26 56 49977 94457 34812441
Mood swings 29.86 11.26 46 49987 7855 34899043
General physical health deterioration 29.52 11.26 90 49943 128179 34778719
Delusion of replacement 29.23 11.26 10 50023 131 34906767
Septic shock 29.08 11.26 36 49997 71798 34835100
Hyperreflexia 29.06 11.26 29 50004 3177 34903721
Clonus 28.93 11.26 27 50006 2723 34904175
Shock 28.77 11.26 88 49945 24091 34882807
Psychotic disorder 28.17 11.26 88 49945 24364 34882534
Device malfunction 27.87 11.26 52 49981 10369 34896529
Penile haemorrhage 27.70 11.26 15 50018 632 34906266
Delusion 27.69 11.26 58 49975 12577 34894321
Homicide 27.32 11.26 17 50016 932 34905966
Neutropenia 26.95 11.26 124 49909 156654 34750244
Persistent depressive disorder 26.92 11.26 12 50021 329 34906569
Pre-existing condition improved 26.41 11.26 25 50008 2567 34904331
Hepatic function abnormal 25.46 11.26 16 50017 44347 34862551
Hallucination, visual 25.27 11.26 69 49964 17722 34889176
Akathisia 24.93 11.26 43 49990 8066 34898832
Depressed mood 24.58 11.26 72 49961 19245 34887653
Sepsis 24.51 11.26 139 49894 166422 34740476
Cytomegalovirus infection 24.48 11.26 4 50029 26131 34880767
Suspected suicide 24.38 11.26 32 50001 4716 34902182
Foaming at mouth 24.33 11.26 15 50018 809 34906089
Initial insomnia 24.25 11.26 26 50007 3098 34903800
Polymerase chain reaction 24.10 11.26 8 50025 95 34906803
Ascites 23.83 11.26 19 50014 46552 34860346
Mucosal inflammation 23.48 11.26 13 50020 38609 34868289
Psychomotor hyperactivity 23.26 11.26 46 49987 9576 34897322
Delirium 23.04 11.26 124 49909 43867 34863031
Neuroleptic malignant syndrome 22.97 11.26 67 49966 17867 34889031
Feeling abnormal 22.87 11.26 162 49871 63073 34843825
Eye haematoma 22.73 11.26 7 50026 64 34906834
Accidental poisoning 22.36 11.26 14 50019 776 34906122
Hallucination 22.30 11.26 138 49895 51360 34855538
International normalised ratio increased 22.17 11.26 21 50012 47306 34859592
Alanine aminotransferase increased 22.14 11.26 52 49981 80763 34826135
Erectile dysfunction 21.71 11.26 72 49961 20565 34886333
Muscle rigidity 21.57 11.26 47 49986 10471 34896427
Atrial fibrillation 21.50 11.26 96 49937 122297 34784601
Catatonia 21.49 11.26 31 50002 4994 34901904
Death 21.45 11.26 732 49301 397317 34509581
Post-traumatic stress disorder 20.82 11.26 19 50014 1862 34905036
Distributive shock 20.80 11.26 16 50017 1238 34905660
Myotonia 20.65 11.26 6 50027 44 34906854
Bite 20.58 11.26 7 50026 90 34906808
Alcohol interaction 20.45 11.26 23 50010 2890 34904008
Congenital pneumonia 20.24 11.26 7 50026 95 34906803
Painful erection 20.21 11.26 9 50024 246 34906652
Dementia 20.20 11.26 54 49979 13694 34893204
Depressed level of consciousness 19.94 11.26 117 49916 42724 34864174
Illness anxiety disorder 19.87 11.26 8 50025 169 34906729
Rash maculo-papular 19.71 11.26 8 50025 28443 34878455
Tardive dyskinesia 19.53 11.26 32 50001 5758 34901140
Brain injury 19.45 11.26 33 50000 6109 34900789
Sleep sex 19.44 11.26 4 50029 4 34906894
Poor quality sleep 19.39 11.26 39 49994 8217 34898681
Psychomotor retardation 19.37 11.26 25 50008 3625 34903273
Erection increased 19.23 11.26 11 50022 516 34906382
Platelet count decreased 19.21 11.26 97 49936 119620 34787278
Accidental overdose 19.20 11.26 68 49965 20072 34886826
Headache 19.19 11.26 398 49635 200237 34706661
Pulmonary congestion 19.16 11.26 53 49980 13712 34893186
Sudden cardiac death 19.09 11.26 25 50008 3676 34903222
Bone marrow failure 19.04 11.26 9 50024 29244 34877654
Nervousness 19.02 11.26 50 49983 12556 34894342
Euphoric mood 18.79 11.26 31 50002 5610 34901288
Blood urea increased 18.78 11.26 10 50023 30354 34876544
General symptom 18.55 11.26 13 50020 871 34906027
Food aversion 18.52 11.26 10 50023 419 34906479
Procedural failure 18.41 11.26 6 50027 67 34906831
Reduced facial expression 18.27 11.26 14 50019 1077 34905821
Lactic acidosis 18.20 11.26 98 49935 34674 34872224
Sleep deficit 18.17 11.26 11 50022 574 34906324
Paedophilia 18.17 11.26 4 50029 7 34906891
C-reactive protein 18.12 11.26 7 50026 132 34906766
Drug withdrawal syndrome 18.09 11.26 66 49967 19768 34887130
Depersonalisation/derealisation disorder 18.01 11.26 11 50022 583 34906315
Cholestasis 18.00 11.26 8 50025 26940 34879958
Derealisation 17.96 11.26 11 50022 586 34906312
Delirium febrile 17.79 11.26 5 50028 32 34906866
Restlessness 17.78 11.26 78 49955 25404 34881494
Bipolar disorder 17.73 11.26 24 50009 3645 34903253
Cardiac failure 17.61 11.26 69 49964 91179 34815719
Blood cholinesterase decreased 17.47 11.26 7 50026 146 34906752
Device expulsion 17.44 11.26 6 50027 80 34906818
Generalised anxiety disorder 17.18 11.26 12 50021 800 34906098
Blood creatinine increased 16.97 11.26 74 49959 94902 34811996
Sprue-like enteropathy 16.85 11.26 10 50023 503 34906395
Amnesia 16.81 11.26 79 49954 26484 34880414
Substance abuse 16.66 11.26 35 49998 7606 34899292
Hangover 16.54 11.26 13 50020 1038 34905860
Hypertonia 16.44 11.26 25 50008 4221 34902677
Injection site mass 16.41 11.26 32 50001 6594 34900304
Drug screen positive 16.39 11.26 24 50009 3919 34902979
Product administered at inappropriate site 16.29 11.26 18 50015 2218 34904680
Hospitalisation 16.25 11.26 138 49895 56764 34850134
Drug reaction with eosinophilia and systemic symptoms 16.23 11.26 14 50019 32998 34873900
Sleep-related eating disorder 16.01 11.26 8 50025 285 34906613
Periorbital haemorrhage 15.90 11.26 6 50027 106 34906792
Myelodysplastic syndrome 15.79 11.26 4 50029 19204 34887694
Blood bilirubin increased 15.70 11.26 19 50014 38277 34868621
Obsessive thoughts 15.61 11.26 11 50022 744 34906154
Haemoglobin decreased 15.56 11.26 105 49928 120667 34786231
Drug resistance 15.37 11.26 9 50024 25918 34880980
Homeless 15.23 11.26 4 50029 19 34906879
Physical disability 15.23 11.26 14 50019 1385 34905513
Nicotine dependence 15.14 11.26 10 50023 608 34906290
Prescription drug used without a prescription 15.11 11.26 17 50016 2137 34904761
Sexual dysfunction 15.07 11.26 30 50003 6273 34900625
Diabetic foetopathy 15.06 11.26 7 50026 212 34906686
Ventricular fibrillation 15.04 11.26 7 50026 22947 34883951
Nightmare 14.95 11.26 50 49983 14341 34892557
Malignant neoplasm progression 14.89 11.26 70 49963 87976 34818922
Lower respiratory tract infection 14.86 11.26 14 50019 31623 34875275
Panic attack 14.83 11.26 38 49995 9394 34897504
Ventricular tachycardia 14.69 11.26 10 50023 26569 34880329
Acute myeloid leukaemia 14.64 11.26 4 50029 18266 34888632
Aspartate aminotransferase increased 14.57 11.26 49 49984 67734 34839164
Premature baby 14.47 11.26 5 50028 19628 34887270
Myoclonus 14.28 11.26 50 49983 14675 34892223
Osteonecrosis of jaw 14.18 11.26 4 50029 17885 34889013
Urine amphetamine positive 14.18 11.26 4 50029 26 34906872
Acute pulmonary oedema 14.14 11.26 32 50001 7311 34899587
Multiple organ dysfunction syndrome 14.08 11.26 59 49974 76507 34830391
Hyperhidrosis 14.08 11.26 168 49865 75524 34831374
Discoloured vomit 14.05 11.26 9 50024 519 34906379
Wrong patient received product 13.80 11.26 18 50015 2636 34904262
Cardiac failure congestive 13.62 11.26 67 49966 83203 34823695
Respiratory disorder neonatal 13.42 11.26 14 50019 1616 34905282
Hanging 13.34 11.26 6 50027 168 34906730
Hepatic failure 13.25 11.26 18 50015 34513 34872385
Gambling disorder 13.21 11.26 14 50019 1646 34905252
Leukopenia 13.13 11.26 46 49987 62810 34844088
Pleural effusion 13.12 11.26 66 49967 81480 34825418
Erythema 13.09 11.26 74 49959 88706 34818192
Obsessive rumination 13.05 11.26 3 50030 7 34906891
Memory impairment 12.87 11.26 106 49927 43212 34863686
Infection 12.75 11.26 77 49956 90838 34816060
Acute kidney injury 12.68 11.26 336 49697 304652 34602246
Mental impairment 12.68 11.26 38 49995 10284 34896614
Exposure via breast milk 12.65 11.26 15 50018 1995 34904903
Drug use disorder 12.59 11.26 22 50011 4169 34902729
Withdrawal catatonia 12.54 11.26 5 50028 103 34906795
Mental disorder 12.53 11.26 49 49984 15160 34891738
Dyspnoea 12.49 11.26 428 49605 376354 34530544
Urine leukocyte esterase positive 12.47 11.26 8 50025 463 34906435
Genital haemorrhage 12.43 11.26 6 50027 198 34906700
Lung disorder 12.42 11.26 19 50014 34677 34872221
Abnormal dreams 12.41 11.26 31 50002 7547 34899351
Mixed delusion 12.33 11.26 4 50029 44 34906854
Oedema peripheral 12.24 11.26 111 49922 119701 34787197
Abnormal behaviour 12.14 11.26 69 49964 24900 34881998
Thinking abnormal 12.11 11.26 27 50006 6110 34900788
Pulmonary embolism 12.07 11.26 77 49956 89669 34817229
Needle issue 12.02 11.26 27 50006 6138 34900760
Feeling jittery 12.01 11.26 21 50012 3982 34902916
Hyperprolactinaemia 11.89 11.26 13 50020 1583 34905315
Eosinophilia 11.85 11.26 12 50021 26210 34880688
Catecholamines urine increased 11.84 11.26 3 50030 12 34906886
Back pain 11.76 11.26 242 49791 121547 34785351
Pruritus genital 11.54 11.26 15 50018 2189 34904709
Application site hypersensitivity 11.53 11.26 5 50028 128 34906770
Distractibility 11.53 11.26 7 50026 367 34906531
Tumour lysis syndrome 11.49 11.26 5 50028 17054 34889844
Stress at work 11.39 11.26 6 50027 239 34906659
Dehydration 11.37 11.26 125 49908 129844 34777054
Respiratory failure 11.35 11.26 100 49933 108472 34798426
Dry mouth 11.32 11.26 78 49955 30087 34876811
Physiotherapy chest 11.30 11.26 3 50030 15 34906883
Citrobacter test positive 11.30 11.26 3 50030 15 34906883
Prostate cancer 11.27 11.26 25 50008 39624 34867274
Toxicologic test abnormal 11.26 11.26 8 50025 548 34906350

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 1691.93 10.15 2159 143412 243608 79355209
Serotonin syndrome 785.72 10.15 654 144917 44373 79554444
Toxicity to various agents 766.76 10.15 2083 143488 419457 79179360
Sopor 753.99 10.15 562 145009 32448 79566369
Drug abuse 735.14 10.15 1171 144400 161520 79437297
Priapism 386.88 10.15 181 145390 4324 79594493
Suicide attempt 307.60 10.15 547 145024 82385 79516432
Polycystic ovaries 291.42 10.15 141 145430 3638 79595179
Cardio-respiratory arrest 228.91 10.15 568 145003 107942 79490875
Sensitisation 218.14 10.15 111 145460 3200 79595617
Overdose 212.39 10.15 779 144792 183427 79415390
Suicidal ideation 211.34 10.15 445 145126 75895 79522922
Drug interaction 202.04 10.15 1373 144198 413810 79185007
Rhinitis allergic 190.99 10.15 167 145404 12102 79586715
Intentional overdose 178.22 10.15 510 145061 105450 79493367
Hypomania 173.42 10.15 129 145442 7415 79591402
Ejection fraction 172.97 10.15 84 145487 2185 79596632
Hand deformity 166.64 10.15 5 145566 103914 79494903
Pemphigus 166.58 10.15 3 145568 99579 79499238
Electrocardiogram QT prolonged 158.80 10.15 442 145129 89944 79508873
Sleep disorder due to a general medical condition 156.47 10.15 160 145411 14117 79584700
Blood test abnormal 156.33 10.15 177 145394 17533 79581284
Withdrawal syndrome 135.98 10.15 204 145367 26650 79572167
Pericarditis 134.77 10.15 16 145555 104220 79494597
Gastrooesophageal reflux disease 133.92 10.15 457 145114 103789 79495028
Febrile neutropenia 122.16 10.15 145 145426 230854 79367963
Systemic lupus erythematosus 119.92 10.15 36 145535 121113 79477704
Maternal exposure during pregnancy 119.06 10.15 50 145521 136488 79462329
Presbyacusis 118.99 10.15 69 145502 2591 79596226
Carpal tunnel syndrome 118.96 10.15 162 145409 19366 79579451
Psychotic disorder 118.82 10.15 245 145326 41157 79557660
Agitation 115.91 10.15 423 145148 99292 79499525
Schizophrenia 114.23 10.15 141 145430 15299 79583518
Migraine 111.87 10.15 383 145188 87110 79511707
Pancytopenia 109.81 10.15 85 145486 165660 79433157
Swelling 109.36 10.15 141 145430 216570 79382247
Thrombocytopenia 108.54 10.15 199 145372 265060 79333757
Sleep apnoea syndrome 107.21 10.15 218 145353 36260 79562557
Pyrexia 103.00 10.15 771 144800 677938 78920879
Wound 102.17 10.15 42 145529 116137 79482680
General physical health deterioration 101.86 10.15 219 145352 275019 79323798
Insomnia 101.78 10.15 781 144790 244389 79354428
Glossodynia 101.74 10.15 31 145540 103306 79495511
Jaundice cholestatic 98.27 10.15 112 145459 11172 79587645
Anaemia 98.19 10.15 448 145123 444567 79154250
Pleural thickening 96.72 10.15 63 145508 2919 79595898
Depression 94.71 10.15 699 144872 216091 79382726
Lung diffusion test abnormal 94.31 10.15 33 145538 357 79598460
Neutropenia 93.66 10.15 245 145326 287465 79311352
Pleural fibrosis 92.98 10.15 70 145501 4097 79594720
Anxiety 90.84 10.15 769 144802 247743 79351074
Blood magnesium increased 89.78 10.15 64 145507 3442 79595375
Helicobacter infection 89.36 10.15 11 145560 69693 79529124
Loss of personal independence in daily activities 87.24 10.15 395 145176 102185 79496632
Rash 87.20 10.15 658 144913 577700 79021117
Tremor 87.00 10.15 570 145001 169513 79429304
Product dose omission issue 86.82 10.15 759 144812 246778 79352039
Bradyphrenia 84.96 10.15 101 145470 10539 79588278
Respiratory arrest 84.41 10.15 264 145307 57286 79541531
Folliculitis 84.21 10.15 4 145567 55376 79543441
Suspected suicide 83.80 10.15 100 145471 10476 79588341
Exposure during pregnancy 80.50 10.15 42 145529 101090 79497727
Synovitis 79.24 10.15 95 145476 150639 79448178
Intentional self-injury 78.35 10.15 179 145392 32240 79566577
Hyperreflexia 76.05 10.15 85 145486 8300 79590517
Somnolence 74.77 10.15 715 144856 238266 79360551
Mucosal inflammation 72.04 10.15 24 145547 75556 79523261
C-reactive protein abnormal 71.94 10.15 4 145567 48363 79550454
Infusion related reaction 71.93 10.15 200 145371 230037 79368780
Intrusive thoughts 70.90 10.15 29 145542 495 79598322
Mental status changes 68.68 10.15 273 145298 66686 79532131
Ejection fraction abnormal 68.21 10.15 47 145524 2393 79596424
Impaired healing 67.43 10.15 38 145533 87617 79511200
Irritability 67.16 10.15 196 145375 40948 79557869
Haemoglobin decreased 67.14 10.15 196 145375 221923 79376894
Joint swelling 66.97 10.15 285 145286 288361 79310456
Muscle injury 66.51 10.15 6 145565 48555 79550262
Memory impairment 66.23 10.15 389 145182 111345 79487472
Deafness neurosensory 66.14 10.15 72 145499 6826 79591991
Poor quality sleep 65.82 10.15 135 145436 22587 79576230
Neovascularisation 65.73 10.15 36 145535 1209 79597608
Renal failure 65.47 10.15 171 145400 200797 79398020
Head discomfort 64.79 10.15 104 145467 14398 79584419
Asthma 64.41 10.15 445 145126 134650 79464167
Nephrectomy 62.11 10.15 42 145529 2073 79596744
Malignant neoplasm progression 62.08 10.15 95 145476 135895 79462922
Hyper IgE syndrome 61.91 10.15 27 145544 544 79598273
Akathisia 61.88 10.15 97 145474 13162 79585655
Platelet count decreased 61.62 10.15 168 145403 194496 79404321
Acute kidney injury 60.96 10.15 630 144941 518774 79080043
Myocardial stunning 59.95 10.15 20 145551 185 79598632
Disease progression 58.43 10.15 159 145412 184203 79414614
Tachyphrenia 57.99 10.15 40 145531 2040 79596777
Burning sensation 57.70 10.15 236 145335 58396 79540421
Alopecia 56.42 10.15 224 145347 231131 79367686
Accidental poisoning 56.19 10.15 36 145535 1621 79597196
Confabulation 55.47 10.15 24 145547 474 79598343
Epigastric discomfort 55.05 10.15 70 145501 7826 79590991
Headache 55.04 10.15 1572 143999 652200 78946617
Cardiac failure 54.94 10.15 126 145445 154716 79444101
Alcoholism 54.60 10.15 49 145522 3674 79595143
Sedation 54.36 10.15 213 145358 51682 79547135
Blepharospasm 52.53 10.15 59 145512 5792 79593025
Sputum discoloured 52.48 10.15 120 145451 21623 79577194
Cholestasis 52.44 10.15 15 145556 52094 79546723
Septic shock 51.19 10.15 91 145480 122710 79476107
Bone marrow failure 50.90 10.15 15 145556 51092 79547725
Stomatitis 50.80 10.15 121 145450 146636 79452181
Injection site mass 50.50 10.15 113 145458 20071 79578746
Total lung capacity increased 49.94 10.15 38 145533 2260 79596557
Leukopenia 49.79 10.15 85 145486 116428 79482389
Homicidal ideation 49.72 10.15 45 145526 3412 79595405
Cytomegalovirus infection 49.44 10.15 9 145562 42635 79556182
Blister 49.39 10.15 89 145482 119387 79479430
Paradoxical drug reaction 48.99 10.15 63 145508 7122 79591695
Nightmare 48.92 10.15 130 145441 25731 79573086
Restless legs syndrome 48.61 10.15 111 145460 19981 79578836
Clonus 48.26 10.15 61 145510 6779 79592038
Sepsis 48.25 10.15 291 145280 269137 79329680
Extrapyramidal disorder 48.07 10.15 119 145452 22560 79576257
Hepatic function abnormal 47.75 10.15 38 145533 73069 79525748
Adjustment disorder with mixed anxiety and depressed mood 47.55 10.15 15 145556 114 79598703
Asthma-chronic obstructive pulmonary disease overlap syndrome 46.46 10.15 42 145529 3179 79595638
Fall 46.23 10.15 1191 144380 486438 79112379
Contraindicated product administered 46.16 10.15 141 145430 157397 79441420
Delirium 45.93 10.15 288 145283 84339 79514478
Cyst 45.85 10.15 87 145484 13753 79585064
Aggression 45.39 10.15 199 145372 50759 79548058
Visual perseveration 45.18 10.15 13 145558 69 79598748
Intentional product misuse 45.07 10.15 313 145258 94852 79503965
Drug withdrawal syndrome 44.37 10.15 152 145419 34566 79564251
Lower respiratory tract infection 44.36 10.15 107 145464 129113 79469704
Depressed level of consciousness 44.08 10.15 315 145256 96337 79502480
Hallucination, auditory 43.25 10.15 108 145463 20585 79578232
Analgesic drug level above therapeutic 43.08 10.15 20 145551 469 79598348
Anger 42.85 10.15 96 145475 17066 79581751
Penis injury 42.21 10.15 14 145557 127 79598690
Interstitial lung disease 41.27 10.15 90 145481 112510 79486307
Hospitalisation 41.18 10.15 304 145267 93932 79504885
Irritable bowel syndrome 41.09 10.15 32 145539 62209 79536608
Muscle rigidity 40.75 10.15 103 145468 19779 79579038
Psychomotor hyperactivity 40.67 10.15 93 145478 16756 79582061
Environmental exposure 40.33 10.15 18 145553 384 79598433
Multiple organ dysfunction syndrome 40.15 10.15 101 145470 120145 79478672
Sleep disorder 40.10 10.15 281 145290 85396 79513421
Antidepressant drug level above therapeutic 39.76 10.15 21 145550 655 79598162
Persistent genital arousal disorder 39.56 10.15 16 145555 265 79598552
Toxic epidermal necrolysis 39.37 10.15 16 145555 44565 79554252
Abdominal discomfort 39.23 10.15 282 145289 250445 79348372
Drug resistance 39.20 10.15 14 145557 42199 79556618
Arthropathy 39.15 10.15 178 145393 176933 79421884
Hostility 39.12 10.15 33 145538 2277 79596540
Liver disorder 38.73 10.15 45 145526 72372 79526445
Bone cyst 38.57 10.15 39 145532 3394 79595423
Oral discomfort 38.25 10.15 66 145505 9694 79589123
Tardive dyskinesia 38.22 10.15 69 145502 10502 79588315
Neuroleptic malignant syndrome 38.19 10.15 124 145447 27435 79571382
Prescription drug used without a prescription 38.06 10.15 42 145529 4043 79594774
Cardiac failure congestive 37.88 10.15 133 145438 142269 79456548
Fibromyalgia 37.47 10.15 223 145348 64117 79534700
International normalised ratio increased 36.94 10.15 61 145510 84660 79514157
Body tinea 36.68 10.15 29 145542 1825 79596992
Reduced facial expression 35.91 10.15 34 145537 2731 79596086
Rash maculo-papular 35.57 10.15 30 145541 56048 79542769
Hypersensitivity 35.43 10.15 307 145264 261932 79336885
Abnormal behaviour 35.35 10.15 146 145425 36275 79562542
Hypertonia 35.27 10.15 54 145517 7178 79591639
Dry eye 35.03 10.15 147 145424 36784 79562033
Multiple sclerosis relapse 35.03 10.15 173 145398 46360 79552457
Drug screen positive 34.97 10.15 49 145522 6014 79592803
Drug intolerance 34.89 10.15 311 145260 263808 79335009
Libido increased 34.74 10.15 29 145542 1972 79596845
Total lung capacity decreased 34.48 10.15 34 145537 2871 79595946
Infection 34.44 10.15 279 145292 241433 79357384
Lung disorder 34.20 10.15 59 145512 80498 79518319
Initial insomnia 34.12 10.15 52 145519 6886 79591931
Nervousness 34.06 10.15 136 145435 33279 79565538
Osteosclerosis 33.88 10.15 39 145532 3932 79594885
Osteopenia 33.41 10.15 91 145480 18273 79580544
Pneumocystis jirovecii pneumonia 33.38 10.15 9 145562 32499 79566318
Cardiac disorder 33.35 10.15 220 145351 65537 79533280
Myelosuppression 33.16 10.15 16 145555 40280 79558537
Somatic delusion 33.12 10.15 19 145552 699 79598118
Hepatic failure 32.77 10.15 38 145533 61174 79537643
Sinus bradycardia 32.67 10.15 111 145460 25136 79573681
Accidental overdose 32.58 10.15 151 145420 39430 79559387
Cardiac murmur 32.45 10.15 82 145489 15742 79583075
Mental disorder 32.39 10.15 128 145443 31174 79567643
Neck pain 32.21 10.15 242 145329 75175 79523642
Parkinsonism 32.01 10.15 84 145487 16500 79582317
Anaphylactic shock 31.66 10.15 13 145558 35983 79562834
Wheezing 31.61 10.15 339 145232 116325 79482492
Pleurothotonus 30.90 10.15 30 145541 2486 79596331
Alanine aminotransferase increased 30.46 10.15 173 145398 162397 79436420
Discomfort 30.36 10.15 122 145449 125495 79473322
Restlessness 30.26 10.15 166 145405 46326 79552491
Dissociation 30.19 10.15 37 145534 3984 79594833
Cardiac arrest 29.64 10.15 460 145111 171636 79427181
Ejection fraction decreased 29.59 10.15 13 145558 34564 79564253
Hepatocellular injury 29.53 10.15 26 145545 47567 79551250
Hypothyroidism 29.49 10.15 180 145391 52212 79546605
Skin lesion 29.00 10.15 152 145419 41692 79557125
Therapeutic product effect decreased 28.78 10.15 178 145393 163685 79435132
Asphyxia 28.63 10.15 65 145506 11655 79587162
Restrictive pulmonary disease 28.28 10.15 29 145542 2566 79596251
Concussion 28.16 10.15 57 145514 9446 79589371
Autonomic nervous system imbalance 27.58 10.15 38 145533 4592 79594225
Infection susceptibility increased 27.55 10.15 34 145537 3687 79595130
Loss of libido 27.46 10.15 29 145542 2656 79596161
Cognitive disorder 27.44 10.15 220 145351 69706 79529111
Disorganised speech 27.43 10.15 26 145545 2091 79596726
Acute myeloid leukaemia 27.41 10.15 11 145560 30874 79567943
Mood swings 27.14 10.15 89 145482 19791 79579026
Coagulopathy 27.13 10.15 16 145555 35990 79562827
Penile haemorrhage 26.90 10.15 15 145556 522 79598295
Listless 26.55 10.15 34 145537 3827 79594990
Abnormal dreams 26.46 10.15 62 145509 11350 79587467
Taste disorder 26.42 10.15 76 145495 15747 79583070
Drug reaction with eosinophilia and systemic symptoms 26.41 10.15 48 145523 64196 79534621
Symptom masked 25.92 10.15 21 145550 1369 79597448
Urticaria 25.81 10.15 215 145356 184986 79413831
Post-traumatic neck syndrome 25.77 10.15 25 145546 2069 79596748
Depressed mood 25.69 10.15 164 145407 48316 79550501
Sleep disorder due to general medical condition, insomnia type 25.60 10.15 25 145546 43531 79555286
Ascites 25.59 10.15 63 145508 75499 79523318
Dysphoria 25.45 10.15 37 145534 4697 79594120
Therapy non-responder 25.36 10.15 85 145486 92220 79506597
Substance abuse 25.30 10.15 58 145513 10468 79588349
Angioedema 25.27 10.15 64 145507 75971 79522846
Soft tissue injury 25.25 10.15 23 145548 1758 79597059
Delusion of replacement 25.10 10.15 10 145561 159 79598658
Vasoplegia syndrome 25.02 10.15 32 145539 3598 79595219
Renal impairment 24.89 10.15 177 145394 157606 79441211
Hereditary angioedema 24.85 10.15 39 145532 5296 79593521
Hyperkalaemia 24.66 10.15 116 145455 114282 79484535
Injection site reaction 24.65 10.15 178 145393 54607 79544210
Gambling disorder 24.58 10.15 24 145547 2002 79596815
Bronchopulmonary aspergillosis allergic 24.34 10.15 29 145542 3032 79595785
Feeling abnormal 24.24 10.15 417 145154 158782 79440035
Haematocrit decreased 24.16 10.15 47 145524 61265 79537552
Gastrointestinal haemorrhage 24.14 10.15 164 145407 147555 79451262
Vertigo 23.74 10.15 211 145360 68871 79529946
Arteriosclerosis coronary artery 23.64 10.15 79 145492 17737 79581080
Jaundice 23.64 10.15 38 145533 53311 79545506
Mood altered 23.56 10.15 79 145492 17768 79581049
Sternal fracture 23.55 10.15 26 145545 2504 79596313
Hyperhidrosis 23.50 10.15 398 145173 151094 79447723
Liver function test abnormal 23.24 10.15 52 145519 64423 79534394
Sense of a foreshortened future 23.08 10.15 5 145566 5 79598812
Ill-defined disorder 23.04 10.15 54 145517 65821 79532996
Obstructive airways disorder 23.00 10.15 116 145455 31343 79567474
Disseminated intravascular coagulation 22.94 10.15 19 145552 35823 79562994
Hip arthroplasty 22.83 10.15 19 145552 35737 79563080
Cerebral infarction 22.72 10.15 30 145541 45646 79553171
Encephalopathy 22.72 10.15 205 145366 67192 79531625
Aplastic anaemia 22.52 10.15 3 145568 17902 79580915
Confusional state 22.48 10.15 749 144822 317248 79281569
Myoclonus 22.38 10.15 105 145466 27555 79571262
Tonic clonic movements 22.35 10.15 24 145547 2240 79596577
Economic problem 22.30 10.15 24 145547 2246 79596571
Dyskinesia 22.22 10.15 149 145422 44624 79554193
Aspartate aminotransferase increased 22.12 10.15 155 145416 138486 79460331
Impaired quality of life 22.02 10.15 67 145504 14319 79584498
Psychomotor retardation 21.90 10.15 40 145531 6144 79592673
Unresponsive to stimuli 21.60 10.15 175 145396 55613 79543204
Dermatitis atopic 21.56 10.15 53 145518 10003 79588814
Atrial fibrillation 21.55 10.15 244 145327 197642 79401175
Solar urticaria 21.47 10.15 8 145563 105 79598712
Cholelithiasis 21.38 10.15 167 145404 52497 79546320
Apathy 21.35 10.15 62 145509 12915 79585902
Blood lactate dehydrogenase increased 21.31 10.15 24 145547 39146 79559671
Epistaxis 21.25 10.15 118 145453 111397 79487420
Meningitis streptococcal 21.22 10.15 9 145562 169 79598648
Bronchiectasis 21.15 10.15 89 145482 22297 79576520
Periorbital swelling 20.70 10.15 26 145545 2870 79595947
Haemophagocytic lymphohistiocytosis 20.69 10.15 7 145564 21830 79576987
Neuropathy peripheral 20.62 10.15 162 145409 141143 79457674
Blood urea increased 20.46 10.15 36 145535 48754 79550063
Polymerase chain reaction 20.32 10.15 8 145563 123 79598694
Lung opacity 20.29 10.15 35 145536 5139 79593678
Bronchospasm 20.26 10.15 10 145561 24849 79573968
C-reactive protein increased 20.22 10.15 145 145426 128882 79469935
Homicide 20.20 10.15 17 145554 1169 79597648
White blood cell count decreased 20.17 10.15 233 145338 188055 79410762
Euphoric mood 20.17 10.15 44 145527 7682 79591135
Sarcoidosis 20.11 10.15 46 145525 8289 79590528
Erection increased 20.09 10.15 11 145560 369 79598448
Heart rate abnormal 19.97 10.15 38 145533 6019 79592798
Major depression 19.97 10.15 48 145523 8932 79589885
Death 19.95 10.15 1243 144328 565271 79033546
Thrombotic microangiopathy 19.94 10.15 6 145565 20163 79578654
Premature delivery 19.80 10.15 9 145562 23458 79575359
Joint range of motion decreased 19.68 10.15 19 145552 33263 79565554
Prostate cancer 19.66 10.15 19 145552 33249 79565568
Live birth 19.60 10.15 5 145566 18739 79580078
Dementia 19.51 10.15 93 145478 24566 79574251
Nasal polyps 19.44 10.15 42 145529 7285 79591532
Blood cholesterol increased 19.18 10.15 83 145488 83637 79515180
Post-traumatic stress disorder 19.12 10.15 33 145538 4848 79593969
Blood calcium decreased 19.00 10.15 18 145553 31801 79567016
Paranoia 18.94 10.15 78 145493 19354 79579463
Discoloured vomit 18.86 10.15 18 145553 1460 79597357
Apallic syndrome 18.85 10.15 15 145556 953 79597864
Hallucination, visual 18.77 10.15 113 145458 32616 79566201
Cardiomyopathy 18.73 10.15 15 145556 28759 79570058
Sensation of foreign body 18.65 10.15 35 145536 5487 79593330
Inhibitory drug interaction 18.63 10.15 31 145540 4422 79594395
Aspergillus infection 18.40 10.15 6 145565 19155 79579662
Eye haematoma 18.40 10.15 8 145563 160 79598657
Bursitis 18.39 10.15 23 145548 35821 79562996
Palmar-plantar erythrodysaesthesia syndrome 18.36 10.15 20 145551 33114 79565703
Myelodysplastic syndrome 18.26 10.15 17 145554 30284 79568533
Hypokinesia 18.18 10.15 76 145495 18984 79579833
Painful erection 18.17 10.15 8 145563 165 79598652
Blood potassium increased 18.03 10.15 103 145468 29172 79569645
Full blood count abnormal 17.92 10.15 131 145440 40343 79558474
Skin texture abnormal 17.88 10.15 11 145560 461 79598356
Hepatitis 17.69 10.15 48 145523 55679 79543138
Middle insomnia 17.68 10.15 67 145504 16002 79582815
Neutrophil count decreased 17.58 10.15 100 145471 93859 79504958
Purple glove syndrome 17.57 10.15 9 145562 263 79598554
Grip strength decreased 17.52 10.15 9 145562 21860 79576957
Psychomotor skills impaired 17.45 10.15 33 145538 5204 79593613
Needle issue 17.39 10.15 58 145513 13010 79585807
Disorientation 17.27 10.15 183 145388 62593 79536224
Generalised oedema 17.22 10.15 11 145560 23698 79575119
Muscle twitching 17.19 10.15 90 145481 24674 79574143
Body height decreased 17.11 10.15 44 145527 8536 79590281
Device dislocation 17.08 10.15 93 145478 25877 79572940
Pleural effusion 17.06 10.15 176 145395 145086 79453731
Breath sounds abnormal 17.05 10.15 66 145505 15918 79582899
Device malfunction 17.04 10.15 81 145490 21367 79577450
Perseveration 16.97 10.15 10 145561 387 79598430
Bipolar disorder 16.93 10.15 41 145530 7666 79591151
Maximal voluntary ventilation abnormal 16.73 10.15 5 145566 31 79598786
Exostosis 16.69 10.15 68 145503 16790 79582027
Mental impairment 16.69 10.15 74 145497 18962 79579855
Bronchopulmonary aspergillosis 16.67 10.15 10 145561 22284 79576533
Proteinuria 16.53 10.15 21 145550 32481 79566336
Dehydration 16.37 10.15 337 145234 247850 79350967
Burning mouth syndrome 16.28 10.15 11 145560 542 79598275
Wound infection fungal 16.20 10.15 8 145563 216 79598601
Abortion spontaneous 16.14 10.15 18 145553 29489 79569328
Galactorrhoea 16.09 10.15 26 145545 3620 79595197
Alcohol withdrawal syndrome 15.91 10.15 19 145552 1992 79596825
Coma 15.81 10.15 265 145306 100384 79498433
Product administered at inappropriate site 15.79 10.15 27 145544 3938 79594879
Mydriasis 15.79 10.15 69 145502 17574 79581243
Procedural failure 15.75 10.15 6 145565 84 79598733
Heterophoria 15.74 10.15 5 145566 39 79598778
Oedema 15.68 10.15 141 145430 119439 79479378
Dyspnoea exertional 15.59 10.15 94 145477 86979 79511838
Accidental death 15.50 10.15 28 145543 4263 79594554
Osteonecrosis of jaw 15.46 10.15 35 145536 43191 79555626
Thinking abnormal 15.42 10.15 56 145515 13105 79585712
Toxic skin eruption 15.31 10.15 11 145560 22282 79576535
Injection site induration 15.28 10.15 46 145525 9773 79589044
Renal disorder 15.19 10.15 130 145441 41975 79556842
Rheumatoid factor positive 15.17 10.15 57 145514 59782 79539035
Product packaging difficult to open 15.11 10.15 5 145566 45 79598772
Compulsive sexual behaviour 15.02 10.15 8 145563 254 79598563
Obsessive thoughts 14.85 10.15 14 145557 1118 79597699
Deep vein thrombosis 14.82 10.15 145 145426 120774 79478043
Knee arthroplasty 14.69 10.15 36 145535 43212 79555605
Haematotoxicity 14.66 10.15 5 145566 15514 79583303
Obsessive-compulsive disorder 14.62 10.15 33 145538 5894 79592923
Chronic obstructive pulmonary disease 14.57 10.15 228 145343 85191 79513626
Sinusitis 14.57 10.15 260 145311 195241 79403576
Catatonia 14.56 10.15 42 145529 8714 79590103
Pulmonary embolism 14.53 10.15 223 145348 171431 79427386
Urine odour abnormal 14.45 10.15 34 145537 6239 79592578
Hypogammaglobulinaemia 14.45 10.15 3 145568 12948 79585869
Hyponatriuria 14.45 10.15 4 145567 18 79598799
Sleep deficit 14.40 10.15 14 145557 1162 79597655
Nasopharyngitis 14.40 10.15 353 145218 253528 79345289
Eczema eyelids 14.35 10.15 7 145564 184 79598633
Brain injury 14.35 10.15 50 145521 11467 79587350
Tuberculosis 14.18 10.15 5 145566 15193 79583624
Transplant rejection 14.14 10.15 9 145562 19428 79579389
Panic attack 14.14 10.15 84 145487 24132 79574685
Homeless 14.08 10.15 6 145565 114 79598703
Affective disorder 13.93 10.15 40 145531 8279 79590538
Acute myopia 13.89 10.15 6 145565 118 79598699
Personality disorder 13.82 10.15 33 145538 6113 79592704
Aspiration 13.81 10.15 73 145498 20085 79578732
Pericardial effusion 13.81 10.15 41 145530 46196 79552621
Nodule 13.74 10.15 13 145558 22981 79575836
Food aversion 13.67 10.15 13 145558 1050 79597767
Glucose tolerance impaired 13.66 10.15 39 145532 8045 79590772
Hypotension 13.66 10.15 956 144615 439361 79159456
Anticholinergic syndrome 13.61 10.15 24 145547 3587 79595230
Pancreatitis acute 13.40 10.15 46 145525 49558 79549259
Delusion 13.34 10.15 73 145498 20350 79578467
Urinary retention 13.28 10.15 160 145411 56470 79542347
Accommodation disorder 13.24 10.15 10 145561 588 79598229
Neutropenic sepsis 13.23 10.15 18 145553 27046 79571771
Colitis 13.19 10.15 79 145492 73228 79525589
Somnambulism 13.17 10.15 31 145540 5690 79593127
Genital infection female 13.13 10.15 5 145566 70 79598747
Deformity 13.11 10.15 43 145528 9562 79589255
Holmes-Adie pupil 13.09 10.15 4 145567 27 79598790
Autoimmune disorder 13.06 10.15 7 145564 16605 79582212
Blood prolactin increased 13.02 10.15 25 145546 3986 79594831
Epstein-Barr virus infection 13.01 10.15 5 145566 14411 79584406
Haematochezia 13.01 10.15 100 145471 87545 79511272
Alcohol interaction 13.00 10.15 28 145543 4846 79593971
Ventricular fibrillation 12.99 10.15 24 145547 31902 79566915
Bladder cancer 12.94 10.15 10 145561 19516 79579301
Hepatotoxicity 12.89 10.15 147 145424 51205 79547612
Cholecystitis 12.76 10.15 13 145558 22199 79576618
Myotonia 12.76 10.15 7 145564 236 79598581
Delirium febrile 12.75 10.15 5 145566 76 79598741
Tumour lysis syndrome 12.66 10.15 15 145556 23924 79574893
Neoplasm progression 12.60 10.15 50 145521 51632 79547185
Breast cancer 12.56 10.15 105 145466 33676 79565141
Compulsive shopping 12.48 10.15 11 145560 805 79598012
Pulmonary toxicity 12.48 10.15 4 145567 12910 79585907
Thyroglobulin increased 12.41 10.15 5 145566 82 79598735
Plasma cell mastitis 12.39 10.15 4 145567 33 79598784
Obsessive rumination 12.32 10.15 3 145568 7 79598810
Hanging 12.32 10.15 6 145565 157 79598660
Hyperbilirubinaemia 12.30 10.15 16 145555 24502 79574315
Persistent depressive disorder 12.30 10.15 13 145558 1192 79597625
Balance disorder 12.29 10.15 251 145320 98606 79500211
Creatinine renal clearance decreased 12.25 10.15 10 145561 18992 79579825
Joint effusion 12.22 10.15 9 145562 18005 79580812
Immobile 12.14 10.15 34 145537 6939 79591878
Renal injury 12.09 10.15 8 145563 16919 79581898
Pulmonary alveolar haemorrhage 12.09 10.15 3 145568 11454 79587363
Gamma-glutamyltransferase increased 12.04 10.15 55 145516 54625 79544192
Haemolytic anaemia 11.97 10.15 9 145562 17811 79581006
Intervertebral disc protrusion 11.96 10.15 79 145492 23542 79575275
Foaming at mouth 11.95 10.15 16 145555 1881 79596936
Peritoneal perforation 11.89 10.15 6 145565 170 79598647
Pneumonitis 11.81 10.15 64 145507 60796 79538021
Blood cholinesterase decreased 11.81 10.15 7 145564 274 79598543
Sedative therapy 11.78 10.15 3 145568 9 79598808
Blood alkaline phosphatase increased 11.78 10.15 68 145503 63596 79535221
Bruxism 11.75 10.15 24 145547 4002 79594815
Tongue discolouration 11.75 10.15 23 145548 3720 79595097
Lack of injection site rotation 11.74 10.15 9 145562 541 79598276
Hypocalcaemia 11.74 10.15 49 145522 49875 79548942
Heat stroke 11.72 10.15 15 145556 1688 79597129
Sleep-related eating disorder 11.68 10.15 10 145561 704 79598113
Distributive shock 11.64 10.15 19 145552 2668 79596149
Knee deformity 11.61 10.15 13 145558 1272 79597545
Generalised anxiety disorder 11.56 10.15 17 145554 2180 79596637
Cerebral haemorrhage 11.55 10.15 60 145511 57613 79541204
Peripheral swelling 11.46 10.15 390 145181 269227 79329590
Lip dry 11.41 10.15 7 145564 15411 79583406
Autoimmune nephritis 11.38 10.15 10 145561 729 79598088
Troponin increased 11.37 10.15 67 145504 19188 79579629
Second primary malignancy 11.35 10.15 6 145565 14344 79584473
Wandering pacemaker 11.32 10.15 3 145568 11 79598806
Hyperlipidaemia 11.29 10.15 84 145487 26009 79572808
Device related infection 11.29 10.15 29 145542 34265 79564552
Impaired gastric emptying 11.25 10.15 43 145528 10310 79588507
Bronchial hyperreactivity 11.19 10.15 20 145551 3020 79595797
Haemodialysis 11.18 10.15 10 145561 18158 79580659
Personal relationship issue 11.16 10.15 6 145565 194 79598623
Infusion site urticaria 11.16 10.15 12 145559 1122 79597695
Drug screen negative 11.13 10.15 7 145564 305 79598512
Dermatitis exfoliative 11.11 10.15 3 145568 10826 79587991
Neurotoxicity 11.09 10.15 27 145544 32491 79566326
Pregnancy 11.09 10.15 20 145551 26831 79571986
Inappropriate schedule of product administration 11.08 10.15 321 145250 133307 79465510
Toxicologic test abnormal 11.01 10.15 13 145558 1347 79597470
Cardiac failure acute 10.97 10.15 11 145560 18918 79579899
Screaming 10.96 10.15 23 145548 3910 79594907
Feeling of despair 10.96 10.15 19 145552 2802 79596015
Anaphylactic reaction 10.87 10.15 99 145472 83644 79515173
Inflammation 10.84 10.15 114 145457 93639 79505178
Antipsychotic drug level above therapeutic 10.81 10.15 16 145555 2064 79596753
Rapid eye movement sleep behaviour disorder 10.78 10.15 8 145563 458 79598359
Serum serotonin increased 10.77 10.15 7 145564 323 79598494
White blood cell count increased 10.68 10.15 86 145485 74547 79524270
Morbid thoughts 10.68 10.15 10 145561 792 79598025
Osteomyelitis 10.66 10.15 28 145543 32837 79565980
Skin sensitisation 10.63 10.15 11 145560 984 79597833
Hangover 10.63 10.15 16 145555 2096 79596721
Neuropsychiatric symptoms 10.59 10.15 13 145558 1402 79597415
Hip fracture 10.59 10.15 94 145477 30667 79568150
Pyelonephritis 10.55 10.15 13 145558 20375 79578442
Bacterial vaginosis 10.54 10.15 12 145559 1196 79597621
Nausea 10.49 10.15 1941 143630 955255 78643562
Klebsiella infection 10.48 10.15 8 145563 15712 79583105
Posterior reversible encephalopathy syndrome 10.48 10.15 20 145551 26261 79572556
Emotional disorder 10.48 10.15 53 145518 14334 79584483
Metastases to lymph nodes 10.45 10.15 3 145568 10394 79588423
Crying 10.44 10.15 75 145496 22968 79575849
Ileus 10.40 10.15 20 145551 26191 79572626
Eosinophilia 10.35 10.15 45 145526 45300 79553517
Oppositional defiant disorder 10.32 10.15 8 145563 489 79598328
Enteritis 10.27 10.15 7 145564 14576 79584241
Kidney transplant rejection 10.21 10.15 3 145568 10243 79588574
Enterocolitis 10.18 10.15 7 145564 14505 79584312
Anorgasmia 10.17 10.15 12 145559 1242 79597575
Shock haemorrhagic 10.16 10.15 13 145558 20047 79578770

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AX05 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:37887 adrenergic blockers
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:50949 SSRI
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000928 Antidepressive Agents
MeSH PA D018687 Antidepressive Agents, Second-Generation
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D011619 Psychotropic Drugs
MeSH PA D017367 Selective Serotonin Reuptake Inhibitors
MeSH PA D018490 Serotonin Agents
MeSH PA D014149 Tranquilizing Agents
FDA EPC N0000175696 Serotonin Reuptake Inhibitor

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




🐶 Veterinary Drug Use

None

🐶 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
D(1A) dopamine receptor GPCR Ki 5.43 PDSP
HLA class I histocompatibility antigen, A-3 alpha chain Unclassified Kd 5.60 CHEMBL
D(2) dopamine receptor GPCR Ki 5.46 PDSP
Alpha-2A adrenergic receptor GPCR Ki 6.58 WOMBAT-PK
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

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 0555-0711 TABLET 300 mg ORAL ANDA 26 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0555-0733 TABLET 300 mg ORAL ANDA 26 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-2578 TABLET 50 mg ORAL ANDA 31 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-2579 TABLET 100 mg ORAL ANDA 31 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8339 TABLET 150 mg ORAL ANDA 30 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8339 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 0615-8371 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 0615-8386 TABLET 100 mg ORAL ANDA 30 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6554 TABLET 50 mg ORAL ANDA 21 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6555 TABLET 100 mg ORAL ANDA 21 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6868 TABLET 50 mg ORAL ANDA 27 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6868 TABLET 50 mg ORAL ANDA 27 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6869 TABLET 100 mg ORAL ANDA 27 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6869 TABLET 100 mg ORAL ANDA 27 sections
Trazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7212 TABLET 150 mg ORAL ANDA 27 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 13107-079 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 13107-080 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 13107-081 TABLET 150 mg ORAL ANDA 30 sections
Trazodone Hydrochloride Human Prescription Drug Label 1 13107-082 TABLET 300 mg ORAL ANDA 30 sections