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 1082.36 10.20 1309 97511 130580 50375724
Drug abuse 451.14 10.20 570 98250 59276 50447028
Sopor 377.43 10.20 312 98508 19567 50486737
Toxicity to various agents 370.27 10.20 1080 97740 211419 50294885
Serotonin syndrome 355.02 10.20 331 98489 24382 50481922
Hand deformity 172.52 10.20 5 98815 100194 50406110
Systemic lupus erythematosus 157.82 10.20 40 98780 140582 50365722
Suicide attempt 154.87 10.20 324 98496 51408 50454896
Polycystic ovaries 143.53 10.20 78 98742 2406 50503898
Suicidal ideation 143.19 10.20 327 98493 55058 50451246
Cardio-respiratory arrest 141.34 10.20 320 98500 53572 50452732
Maternal exposure during pregnancy 139.19 10.20 69 98751 159709 50346595
Pericarditis 131.65 10.20 5 98815 78684 50427620
Swelling 130.50 10.20 120 98700 200752 50305552
Synovitis 121.40 10.20 45 98775 123820 50382484
Presbyacusis 117.09 10.20 71 98749 2705 50503599
Wound 116.95 10.20 31 98789 105763 50400541
Glossodynia 116.65 10.20 40 98780 115529 50390775
Hypomania 114.36 10.20 84 98736 4421 50501883
Overdose 108.83 10.20 434 98386 99293 50407011
Pleural thickening 105.84 10.20 65 98755 2534 50503770
Pleural fibrosis 104.21 10.20 71 98749 3313 50502991
Sensitisation 103.60 10.20 54 98766 1528 50504776
Drug interaction 103.05 10.20 705 98115 198916 50307388
Exposure during pregnancy 101.30 10.20 55 98765 120960 50385344
Infusion related reaction 101.25 10.20 109 98711 169448 50336856
Blood magnesium increased 99.72 10.20 65 98755 2815 50503489
Schizophrenia 98.42 10.20 95 98725 7302 50499002
Joint swelling 97.03 10.20 209 98611 245077 50261227
Depression 96.80 10.20 603 98217 164820 50341484
Product dose omission issue 95.91 10.20 651 98169 183187 50323117
Contraindicated product administered 95.51 10.20 90 98730 148868 50357436
Electrocardiogram QT prolonged 95.12 10.20 269 98551 51617 50454687
Anxiety 93.28 10.20 630 98190 176976 50329328
Migraine 91.44 10.20 339 98481 74941 50431363
Withdrawal syndrome 88.32 10.20 138 98682 17452 50488852
Deafness neurosensory 86.14 10.20 71 98749 4430 50501874
Ejection fraction 84.47 10.20 43 98777 1157 50505147
Jaundice cholestatic 78.30 10.20 71 98749 5040 50501264
Rash 78.21 10.20 517 98303 436954 50069350
Alopecia 73.20 10.20 240 98580 244807 50261497
Sleep apnoea syndrome 73.16 10.20 151 98669 23717 50482587
Abdominal discomfort 72.60 10.20 222 98598 231419 50274885
Helicobacter infection 71.69 10.20 7 98813 49695 50456609
Arthropathy 70.66 10.20 125 98695 157781 50348523
Neutropenia 70.01 10.20 113 98707 147852 50358452
Epigastric discomfort 69.96 10.20 71 98749 5799 50500505
Memory impairment 67.86 10.20 321 98499 79039 50427265
Blood test abnormal 67.12 10.20 96 98724 11223 50495081
Gastrooesophageal reflux disease 65.25 10.20 309 98511 76119 50430185
Suspected suicide 64.21 10.20 65 98755 5292 50501012
Folliculitis 63.91 10.20 3 98817 39222 50467082
Myocardial stunning 63.62 10.20 20 98800 139 50506165
Irritability 62.84 10.20 158 98662 28268 50478036
Impaired healing 62.46 10.20 29 98791 69757 50436547
Confabulation 62.30 10.20 23 98797 273 50506031
Rhinitis allergic 61.32 10.20 73 98747 7127 50499177
Insomnia 59.23 10.20 561 98259 174304 50332000
Neovascularisation 59.06 10.20 32 98788 981 50505323
Sleep disorder due to a general medical condition 56.72 10.20 71 98749 7300 50499004
Drug intolerance 55.92 10.20 229 98591 218875 50287429
Thrombocytopenia 55.37 10.20 103 98717 127570 50378734
Psychotic disorder 54.38 10.20 127 98693 21685 50484619
Muscle injury 54.12 10.20 5 98815 37106 50469198
Hyper IgE syndrome 53.77 10.20 23 98797 411 50505893
Asphyxia 52.91 10.20 59 98761 5368 50500936
Anaemia 52.58 10.20 284 98536 252172 50254132
Bone cyst 51.96 10.20 38 98782 1986 50504318
General physical health deterioration 51.70 10.20 127 98693 142307 50363997
Haemoglobin decreased 51.40 10.20 107 98713 127109 50379195
Agitation 50.89 10.20 223 98597 53161 50453143
Tremor 50.67 10.20 391 98429 114512 50391792
Lung diffusion test abnormal 50.34 10.20 17 98803 152 50506152
Respiratory arrest 49.63 10.20 150 98670 29859 50476445
Pyrexia 49.15 10.20 490 98330 379713 50126591
Rheumatoid factor positive 49.01 10.20 18 98802 49841 50456463
Skin lesion 48.41 10.20 138 98682 26589 50479715
Pancytopenia 47.95 10.20 56 98764 83974 50422330
Febrile neutropenia 47.69 10.20 73 98747 97594 50408710
Nightmare 47.23 10.20 100 98720 15986 50490318
Hyperreflexia 47.10 10.20 54 98766 5064 50501240
Paradoxical drug reaction 46.94 10.20 46 98774 3601 50502703
Hypersensitivity 46.49 10.20 239 98581 214922 50291382
Arteriosclerosis coronary artery 45.62 10.20 65 98755 7571 50498733
Visual perseveration 45.47 10.20 13 98807 62 50506242
Extrapyramidal disorder 45.30 10.20 82 98738 11688 50494616
Cyst 44.50 10.20 83 98737 12104 50494200
Accidental poisoning 43.62 10.20 22 98798 580 50505724
Oral discomfort 43.20 10.20 65 98755 7952 50498352
Leukopenia 43.01 10.20 41 98779 67487 50438817
Malignant neoplasm progression 42.65 10.20 42 98778 68082 50438222
Therapeutic product effect decreased 42.14 10.20 131 98689 135919 50370385
Intentional overdose 41.73 10.20 236 98584 62268 50444036
Carpal tunnel syndrome 41.71 10.20 98 98722 16795 50489509
Mucosal inflammation 40.29 10.20 14 98806 40128 50466176
Persistent genital arousal disorder 40.20 10.20 16 98804 236 50506068
Nephrectomy 39.50 10.20 23 98797 812 50505492
Adjustment disorder with mixed anxiety and depressed mood 39.40 10.20 12 98808 74 50506230
Fall 39.11 10.20 892 97928 334040 50172264
Lower respiratory tract infection 38.51 10.20 80 98740 95121 50411183
Drug withdrawal syndrome 38.35 10.20 122 98698 24959 50481345
Sleep disorder 38.05 10.20 216 98604 57067 50449237
Osteopenia 38.04 10.20 95 98725 16923 50489381
Injection site mass 37.67 10.20 90 98730 15590 50490714
Discomfort 37.49 10.20 99 98721 108281 50398023
C-reactive protein abnormal 37.39 10.20 5 98815 27804 50478500
Stomatitis 37.04 10.20 90 98730 101254 50405050
Fibromyalgia 36.32 10.20 179 98641 44799 50461505
Somatic delusion 36.15 10.20 19 98801 547 50505757
Blister 36.07 10.20 70 98750 85348 50420956
Intentional self-injury 35.87 10.20 113 98707 22999 50483305
Poor quality sleep 35.20 10.20 91 98729 16555 50489749
Bone marrow failure 34.78 10.20 6 98814 27618 50478686
Bradyphrenia 34.76 10.20 51 98769 6101 50500203
Osteosclerosis 34.33 10.20 38 98782 3429 50502875
Abnormal behaviour 34.15 10.20 100 98720 19558 50486746
Blood potassium increased 34.02 10.20 89 98731 16309 50489995
Hostility 33.87 10.20 28 98792 1754 50504550
Encephalopathy 33.80 10.20 143 98677 33568 50472736
Dry eye 33.63 10.20 138 98682 31957 50474347
Muscle rigidity 33.49 10.20 65 98755 9764 50496540
Psoriasis 33.35 10.20 240 98580 68760 50437544
Multiple sclerosis relapse 33.28 10.20 169 98651 42795 50463509
Asthma 32.93 10.20 292 98528 89045 50417259
Pleurothotonus 32.44 10.20 24 98796 1277 50505027
Listless 32.37 10.20 31 98789 2359 50503945
Loss of personal independence in daily activities 32.33 10.20 241 98579 69809 50436495
Sputum discoloured 32.31 10.20 77 98743 13318 50492986
Blepharospasm 32.14 10.20 34 98786 2914 50503390
Depressed level of consciousness 31.97 10.20 192 98628 51761 50454543
Alcoholism 31.93 10.20 26 98794 1594 50504710
Akathisia 31.25 10.20 57 98763 8172 50498132
Hereditary angioedema 30.58 10.20 45 98775 5397 50500907
Ill-defined disorder 30.56 10.20 37 98783 54617 50451687
Restrictive pulmonary disease 30.51 10.20 24 98796 1400 50504904
Vertigo 29.66 10.20 188 98632 51644 50454660
Rheumatoid arthritis 29.58 10.20 253 98567 202297 50304007
Somnolence 29.30 10.20 445 98375 154540 50351764
Disorganised speech 28.65 10.20 20 98800 971 50505333
Muscle twitching 28.26 10.20 80 98740 15351 50490953
Sleep disorder due to general medical condition, insomnia type 28.24 10.20 13 98807 31434 50474870
Cardiac failure 28.20 10.20 67 98753 75973 50430331
Platelet count decreased 27.76 10.20 102 98718 100624 50405680
Sedation 27.76 10.20 126 98694 30484 50475820
Cardiac failure congestive 27.74 10.20 79 98741 84303 50422001
Sternal fracture 27.17 10.20 26 98794 1976 50504328
Cholestasis 27.01 10.20 8 98812 25393 50480911
Hyperhidrosis 26.88 10.20 280 98540 89146 50417158
Libido increased 26.74 10.20 21 98799 1222 50505082
Mental disorder 26.65 10.20 99 98721 21892 50484412
Cognitive disorder 26.47 10.20 162 98658 43961 50462343
Treatment failure 26.37 10.20 159 98661 137478 50368826
Middle insomnia 26.09 10.20 59 98761 9862 50496442
Sensation of foreign body 25.75 10.20 35 98785 3901 50502403
Cardiac arrest 25.66 10.20 263 98557 83388 50422916
Restless legs syndrome 24.92 10.20 78 98742 15819 50490485
Tonic clonic movements 24.69 10.20 20 98800 1217 50505087
Psychomotor hyperactivity 24.11 10.20 55 98765 9246 50497058
Intentional product misuse 24.01 10.20 165 98655 46569 50459735
Apallic syndrome 23.68 10.20 15 98805 618 50505686
Compartment syndrome 23.67 10.20 24 98796 1958 50504346
Soft tissue injury 23.49 10.20 21 98799 1463 50504841
Torsade de pointes 23.30 10.20 63 98757 11772 50494532
Gambling disorder 23.19 10.20 19 98801 1175 50505129
Acute kidney injury 23.13 10.20 310 98510 227748 50278556
Sinus bradycardia 22.84 10.20 67 98753 13116 50493188
Major depression 22.82 10.20 45 98775 6839 50499465
Sense of a foreshortened future 22.75 10.20 5 98815 5 50506299
Irritable bowel syndrome 22.73 10.20 41 98779 51400 50454904
Post-traumatic neck syndrome 22.57 10.20 23 98797 1887 50504417
Cytomegalovirus infection 22.40 10.20 4 98816 17958 50488346
Solar urticaria 22.22 10.20 7 98813 49 50506255
Vasoplegia syndrome 22.21 10.20 18 98802 1096 50505208
Mood altered 22.21 10.20 65 98755 12708 50493596
Exostosis 21.91 10.20 61 98759 11592 50494712
Meningitis streptococcal 21.89 10.20 9 98811 145 50506159
Dyskinesia 21.86 10.20 110 98710 27751 50478553
Mental status changes 21.65 10.20 133 98687 36139 50470165
Toxic epidermal necrolysis 21.63 10.20 7 98813 20985 50485319
Body tinea 21.45 10.20 19 98801 1308 50504996
Clonus 21.30 10.20 33 98787 4142 50502162
Periorbital swelling 21.09 10.20 22 98798 1855 50504449
Tardive dyskinesia 21.08 10.20 45 98775 7234 50499070
Coma 21.00 10.20 186 98634 56693 50449611
Disease progression 20.95 10.20 106 98714 95760 50410544
Product use issue 20.80 10.20 189 98631 149286 50357018
Unresponsive to stimuli 20.70 10.20 116 98704 30493 50475811
Abortion spontaneous 20.59 10.20 31 98789 41741 50464563
Abnormal dreams 20.59 10.20 52 98768 9325 50496979
Post-traumatic stress disorder 20.55 10.20 33 98787 4270 50502034
Infantile vomiting 20.41 10.20 8 98812 113 50506191
Reduced facial expression 20.32 10.20 20 98800 1574 50504730
Alanine aminotransferase increased 20.29 10.20 96 98724 88263 50418041
Perseveration 20.20 10.20 10 98810 253 50506051
Initial insomnia 20.15 10.20 36 98784 5079 50501225
Peripheral swelling 20.14 10.20 282 98538 205654 50300650
Autonomic nervous system imbalance 20.01 10.20 24 98796 2361 50503943
Liver function test abnormal 19.90 10.20 35 98785 44304 50462000
Affect lability 19.87 10.20 50 98770 8948 50497356
Accommodation disorder 19.82 10.20 11 98809 354 50505950
Drug ineffective for unapproved indication 19.59 10.20 88 98732 21193 50485111
Heart rate abnormal 19.59 10.20 31 98789 3961 50502343
Premature delivery 19.43 10.20 11 98809 23652 50482652
Dysphoria 19.32 10.20 34 98786 4740 50501564
Oppositional defiant disorder 19.30 10.20 6 98814 40 50506264
Hospitalisation 19.14 10.20 210 98610 67727 50438577
Dissociation 19.13 10.20 23 98797 2268 50504036
Head discomfort 19.09 10.20 56 98764 10963 50495341
Purple glove syndrome 19.09 10.20 9 98811 204 50506100
Anger 19.06 10.20 57 98763 11276 50495028
Headache 18.97 10.20 1188 97632 505347 50000957
Multiple organ dysfunction syndrome 18.94 10.20 44 98776 50293 50456011
Accidental death 18.81 10.20 20 98800 1724 50504580
Skin texture abnormal 18.75 10.20 11 98809 394 50505910
Tachyphrenia 18.49 10.20 17 98803 1228 50505076
Renal failure 18.47 10.20 127 98693 106506 50399798
Hepatic function abnormal 18.40 10.20 22 98798 32659 50473645
Burning mouth syndrome 18.31 10.20 11 98809 412 50505892
Slow speech 18.07 10.20 17 98803 1265 50505039
Burning sensation 18.02 10.20 151 98669 45295 50461009
Total lung capacity decreased 17.97 10.20 17 98803 1274 50505030
Haemangioma congenital 17.93 10.20 11 98809 428 50505876
Hepatic failure 17.89 10.20 22 98798 32261 50474043
C-reactive protein increased 17.86 10.20 68 98752 66406 50439898
Septic shock 17.72 10.20 55 98765 57120 50449184
Product physical issue 17.72 10.20 31 98789 4301 50502003
Psychomotor skills impaired 17.70 10.20 21 98799 2043 50504261
Hip arthroplasty 17.65 10.20 20 98800 30409 50475895
Therapy interrupted 17.56 10.20 82 98738 20070 50486234
Ejection fraction abnormal 17.56 10.20 14 98806 833 50505471
Substance abuse 17.51 10.20 30 98790 4094 50502210
Drug screen positive 17.51 10.20 27 98793 3375 50502929
Concussion 17.49 10.20 43 98777 7585 50498719
Myoclonus 17.41 10.20 65 98755 14405 50491899
Premature baby 17.39 10.20 7 98813 18330 50487974
Haematocrit decreased 17.20 10.20 26 98794 34950 50471354
Bradycardia 17.18 10.20 197 98623 64229 50442075
Disseminated intravascular coagulation 17.15 10.20 6 98814 17129 50489175
Taste disorder 17.08 10.20 45 98775 8279 50498025
Liver disorder 17.05 10.20 29 98791 37193 50469111
Oedema peripheral 17.01 10.20 212 98608 157749 50348555
Eczema eyelids 16.96 10.20 7 98813 114 50506190
Nystagmus 16.82 10.20 35 98785 5526 50500778
Tongue discolouration 16.81 10.20 24 98796 2800 50503504
Depressed mood 16.81 10.20 119 98701 33904 50472400
Plasma cell mastitis 16.67 10.20 5 98815 29 50506275
Wound infection fungal 16.63 10.20 7 98813 120 50506184
Personality disorder 16.48 10.20 30 98790 4294 50502010
Inhibitory drug interaction 16.37 10.20 21 98799 2212 50504092
Delirium 16.28 10.20 129 98691 38063 50468241
Obstructive airways disorder 16.16 10.20 67 98753 15585 50490719
Affective disorder 16.14 10.20 33 98787 5148 50501156
Body height decreased 16.13 10.20 46 98774 8862 50497442
Sepsis 16.01 10.20 174 98646 132751 50373553
Screaming 15.84 10.20 24 98796 2954 50503350
Hyperkalaemia 15.82 10.20 45 98775 48044 50458260
Priapism 15.76 10.20 6 98814 78 50506226
Anaphylactic shock 15.66 10.20 10 98810 20145 50486159
Pleural effusion 15.64 10.20 94 98726 81360 50424944
Small for dates baby 15.55 10.20 26 98794 3479 50502825
Aspartate aminotransferase increased 15.51 10.20 89 98731 77909 50428395
Drug dependence 15.49 10.20 78 98742 19681 50486623
Restlessness 15.46 10.20 93 98727 25080 50481224
Mitral valve thickening 15.44 10.20 4 98816 12 50506292
Personal relationship issue 15.41 10.20 5 98815 39 50506265
Hallucination, auditory 15.33 10.20 51 98769 10677 50495627
Lung opacity 15.17 10.20 19 98801 1954 50504350
Blood calcium decreased 15.12 10.20 11 98809 20695 50485609
Blood prolactin increased 15.12 10.20 24 98796 3075 50503229
Hepatocellular injury 15.11 10.20 17 98803 25930 50480374
Balance disorder 15.03 10.20 207 98613 70383 50435921
Nausea 14.98 10.20 1584 97236 703814 49802490
Wheezing 14.91 10.20 186 98634 61861 50444443
Polyglandular autoimmune syndrome type II 14.78 10.20 5 98815 45 50506259
Mydriasis 14.73 10.20 50 98770 10577 50495727
Large for dates baby 14.71 10.20 10 98810 465 50505839
Inappropriate schedule of product administration 14.64 10.20 209 98611 71622 50434682
Thyroglobulin increased 14.49 10.20 5 98815 48 50506256
International normalised ratio increased 14.47 10.20 40 98780 43112 50463192
Macular degeneration 14.47 10.20 5 98815 14383 50491921
Productive cough 14.44 10.20 162 98658 52532 50453772
Acute respiratory distress syndrome 14.40 10.20 12 98808 21087 50485217
Weight decreased 14.40 10.20 548 98272 220697 50285607
Live birth 14.40 10.20 7 98813 16401 50489903
Urinary retention 14.37 10.20 94 98726 26096 50480208
Red blood cell sedimentation rate increased 14.34 10.20 22 98798 29394 50476910
Myoglobin blood increased 14.25 10.20 15 98805 1278 50505026
Tracheitis 14.24 10.20 12 98808 772 50505532
Neonatal seizure 14.16 10.20 9 98811 373 50505931
Aspiration 14.10 10.20 45 98775 9219 50497085
Drug reaction with eosinophilia and systemic symptoms 14.10 10.20 21 98799 28403 50477901
Prescription drug used without a prescription 14.09 10.20 17 98803 1683 50504621
Drug resistance 13.98 10.20 10 98810 18979 50487325
Bone erosion 13.74 10.20 3 98817 11684 50494620
Patient restraint 13.65 10.20 3 98817 3 50506301
Gamma-glutamyltransferase increased 13.64 10.20 23 98797 29600 50476704
Pregnancy 13.59 10.20 23 98797 29554 50476750
Bronchopulmonary aspergillosis allergic 13.46 10.20 14 98806 1177 50505127
Generalised oedema 13.42 10.20 5 98815 13726 50492578
Deformity 13.42 10.20 40 98780 7900 50498404
Peritoneal perforation 13.41 10.20 6 98814 120 50506184
Anticholinergic syndrome 13.35 10.20 17 98803 1778 50504526
Hepatotoxicity 13.32 10.20 95 98725 27131 50479173
Ejection fraction decreased 13.31 10.20 10 98810 18510 50487794
Pneumocystis jirovecii pneumonia 13.26 10.20 6 98814 14657 50491647
Hyperthermia 13.22 10.20 39 98781 7657 50498647
Arthralgia 13.08 10.20 712 98108 437990 50068314
Metastases to liver 13.04 10.20 12 98808 20092 50486212
Feeling abnormal 13.01 10.20 329 98491 125163 50381141
Gastroenteritis radiation 12.96 10.20 9 98811 433 50505871
Heterophoria 12.95 10.20 4 98816 26 50506278
Tension 12.94 10.20 21 98799 2741 50503563
Postural tremor 12.94 10.20 7 98813 214 50506090
Confusional state 12.94 10.20 464 98356 185464 50320840
Infection 12.88 10.20 249 98571 172705 50333599
Product shape issue 12.80 10.20 5 98815 70 50506234
Hypotension 12.76 10.20 572 98248 234897 50271407
Economic problem 12.71 10.20 17 98803 1865 50504439
Impaired quality of life 12.69 10.20 33 98787 6023 50500281
Nervousness 12.68 10.20 95 98725 27556 50478748
Coagulopathy 12.50 10.20 10 98810 17934 50488370
Skin sensitisation 12.48 10.20 11 98809 752 50505552
Deep vein thrombosis 12.35 10.20 88 98732 73216 50433088
Holmes-Adie pupil 12.35 10.20 4 98816 31 50506273
Hypothyroidism 12.29 10.20 111 98709 34014 50472290
Urticaria 12.09 10.20 179 98641 129382 50376922
Apraxia 12.07 10.20 15 98805 1530 50504774
Rash maculo-papular 11.98 10.20 21 98799 26620 50479684
Intervertebral disc degeneration 11.90 10.20 55 98765 13406 50492898
Glucose tolerance impaired 11.89 10.20 29 98791 5089 50501215
Palmar-plantar erythrodysaesthesia syndrome 11.89 10.20 13 98807 20085 50486219
Wandering pacemaker 11.84 10.20 3 98817 8 50506296
Inappropriate antidiuretic hormone secretion 11.84 10.20 54 98766 13089 50493215
Device expulsion 11.83 10.20 24 98796 28798 50477506
Apathy 11.80 10.20 37 98783 7511 50498793
Decreased interest 11.79 10.20 21 98799 2955 50503349
Serum serotonin increased 11.67 10.20 6 98814 165 50506139
Immune-mediated lung disease 11.63 10.20 8 98812 379 50505925
Hyponatriuria 11.58 10.20 3 98817 9 50506295
Product complaint 11.50 10.20 4 98816 11462 50494842
Knee deformity 11.47 10.20 12 98808 1015 50505289
Knee arthroplasty 11.45 10.20 34 98786 35812 50470492
Borderline personality disorder 11.42 10.20 10 98810 678 50505626
Therapy non-responder 11.38 10.20 56 98764 50966 50455338
Genital infection female 11.36 10.20 5 98815 96 50506208
Morbid thoughts 11.32 10.20 9 98811 533 50505771
Lung disorder 11.29 10.20 47 98773 44752 50461552
Infection susceptibility increased 11.24 10.20 19 98801 2565 50503739
Respiratory distress 11.19 10.20 27 98793 30462 50475842
Injection site induration 11.19 10.20 39 98781 8358 50497946
Angioedema 11.15 10.20 37 98783 37639 50468665
Mood swings 11.15 10.20 61 98759 15893 50490411
Immobile 11.07 10.20 28 98792 5026 50501278
Compulsive shopping 11.05 10.20 10 98810 708 50505596
Malignant melanoma 11.01 10.20 44 98776 10064 50496240
Extra dose administered 10.99 10.20 28 98792 5048 50501256
Hypertonia 10.86 10.20 24 98796 3949 50502355
Parkinsonism 10.86 10.20 40 98780 8807 50497497
Jaundice 10.86 10.20 22 98798 26407 50479897
Alcohol withdrawal syndrome 10.76 10.20 10 98810 733 50505571
Product size issue 10.72 10.20 7 98813 304 50506000
Thinking abnormal 10.71 10.20 42 98778 9525 50496779
Depressive symptom 10.71 10.20 21 98799 3179 50503125
Product administered at inappropriate site 10.67 10.20 18 98802 2425 50503879
Cross sensitivity reaction 10.66 10.20 16 98804 1953 50504351
Electrocardiogram T wave peaked 10.62 10.20 6 98814 200 50506104
Long QT syndrome 10.57 10.20 20 98800 2947 50503357
Drug diversion 10.51 10.20 10 98810 755 50505549
Gastrointestinal haemorrhage 10.50 10.20 92 98728 73229 50433075
Cardiomyopathy 10.47 10.20 9 98811 15577 50490727
Dementia 10.40 10.20 60 98760 15937 50490367
Interstitial lung disease 10.40 10.20 61 98759 53115 50453189
Aspartate aminotransferase decreased 10.39 10.20 9 98811 601 50505703
Autoimmune nephritis 10.38 10.20 7 98813 321 50505983
Product packaging difficult to open 10.37 10.20 4 98816 54 50506250
Impaired gastric emptying 10.36 10.20 39 98781 8679 50497625
Rheumatoid nodule 10.34 10.20 6 98814 12729 50493575
Alcohol poisoning 10.28 10.20 15 98805 1785 50504519
Dizziness 10.24 10.20 797 98023 345572 50160732
Kluver-Bucy syndrome 10.22 10.20 3 98817 16 50506288

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 473.33 11.49 620 42684 89626 29441597
Serotonin syndrome 401.44 11.49 274 43030 17238 29513985
Priapism 357.63 11.49 160 43144 4328 29526895
Toxicity to various agents 354.04 11.49 782 42522 172879 29358344
Drug abuse 288.23 11.49 460 42844 79423 29451800
Sopor 245.56 11.49 169 43135 10765 29520458
Overdose 121.70 11.49 322 42982 79497 29451726
Suicidal ideation 119.59 11.49 196 43108 34520 29496703
Intentional overdose 109.77 11.49 200 43104 38328 29492895
Suicide attempt 88.34 11.49 170 43134 33940 29497283
Drug interaction 80.47 11.49 529 42775 196856 29334367
Cardio-respiratory arrest 77.92 11.49 205 43099 50396 29480827
Somnolence 76.53 11.49 306 42998 93649 29437574
Electrocardiogram QT prolonged 75.71 11.49 165 43139 35972 29495251
Intrusive thoughts 72.15 11.49 23 43281 232 29530991
Agitation 71.15 11.49 200 43104 51104 29480119
Insomnia 69.82 11.49 286 43018 88475 29442748
Anxiety 68.69 11.49 277 43027 85088 29446135
Depression 65.11 11.49 272 43032 84875 29446348
Febrile neutropenia 63.86 11.49 43 43261 112197 29419026
Ventricular tachyarrhythmia 49.40 11.49 18 43286 280 29530943
Pancytopenia 48.46 11.49 31 43273 83137 29448086
Anaemia 47.60 11.49 144 43160 200807 29330416
Environmental exposure 47.53 11.49 17 43287 250 29530973
Homicidal ideation 47.39 11.49 35 43269 2489 29528734
Intentional product misuse 46.93 11.49 134 43170 34527 29496696
Antidepressant drug level above therapeutic 45.81 11.49 15 43289 166 29531057
Mental status changes 45.34 11.49 133 43171 34794 29496429
Paranoia 44.20 11.49 63 43241 9814 29521409
Tachyphrenia 43.75 11.49 25 43279 1144 29530079
Aggression 42.05 11.49 131 43173 35410 29495813
Renal failure 42.03 11.49 68 43236 118531 29412692
Analgesic drug level above therapeutic 40.60 11.49 15 43289 243 29530980
Drug withdrawal syndrome neonatal 40.26 11.49 36 43268 3359 29527864
Thrombocytopenia 40.10 11.49 86 43218 134737 29396486
Confusional state 39.48 11.49 321 42983 127556 29403667
Symptom masked 38.64 11.49 18 43286 535 29530688
Irritability 38.50 11.49 94 43210 22058 29509165
Product dose omission issue 38.33 11.49 257 43047 96126 29435097
Sedation 37.03 11.49 80 43224 17325 29513898
Anger 36.81 11.49 61 43243 10829 29520394
Parkinsonism 36.43 11.49 49 43255 7229 29523994
Head discomfort 35.74 11.49 33 43271 3209 29528014
Alcoholism 35.14 11.49 30 43274 2631 29528592
Interstitial lung disease 34.32 11.49 21 43283 57697 29473526
Withdrawal syndrome 33.76 11.49 59 43245 10933 29520290
Bradyphrenia 33.68 11.49 36 43268 4178 29527045
Penis injury 33.33 11.49 13 43291 246 29530977
Intentional self-injury 32.11 11.49 62 43242 12399 29518824
Restless legs syndrome 31.92 11.49 45 43259 6939 29524284
Respiratory arrest 31.28 11.49 96 43208 25737 29505486
Pyrexia 30.94 11.49 271 43033 287351 29243872
Dysphoria 30.55 11.49 25 43279 2067 29529156
Shock 30.19 11.49 84 43220 21320 29509903
Delusion of replacement 29.88 11.49 10 43294 119 29531104
Poor feeding infant 29.33 11.49 14 43290 440 29530783
Septic shock 29.29 11.49 29 43275 62531 29468692
Injection site reaction 29.23 11.49 56 43248 11132 29520091
Sleep disorder 28.94 11.49 90 43214 24296 29506927
Renal impairment 28.45 11.49 47 43257 81286 29449937
Persistent depressive disorder 28.29 11.49 12 43292 284 29530939
Tremor 27.39 11.49 193 43111 73345 29457878
Homicide 27.31 11.49 17 43287 911 29530312
Pruritus genital 27.03 11.49 14 43290 526 29530697
Delusion 26.72 11.49 54 43250 11162 29520061
Loss of libido 26.54 11.49 24 43280 2272 29528951
Initial insomnia 26.33 11.49 26 43278 2749 29528474
Hallucination, auditory 26.28 11.49 49 43255 9544 29521679
Disease progression 26.25 11.49 50 43254 81866 29449357
Foaming at mouth 26.02 11.49 15 43289 698 29530525
Neutropenia 25.98 11.49 102 43202 131609 29399614
Penile haemorrhage 25.55 11.49 14 43290 590 29530633
Pre-existing condition improved 24.97 11.49 23 43281 2230 29528993
Hyperreflexia 24.51 11.49 25 43279 2747 29528476
General physical health deterioration 24.09 11.49 74 43230 102783 29428440
Distributive shock 23.95 11.49 16 43288 969 29530254
Polymerase chain reaction 23.92 11.49 8 43296 95 29531128
Clonus 23.91 11.49 23 43281 2355 29528868
Accidental poisoning 23.79 11.49 13 43291 545 29530678
Cytomegalovirus infection 23.72 11.49 3 43301 23212 29508011
Eye haematoma 23.08 11.49 7 43297 59 29531164
Psychomotor retardation 23.04 11.49 25 43279 2951 29528272
Neck pain 22.60 11.49 76 43228 21371 29509852
Hallucination, visual 22.24 11.49 60 43244 14955 29516268
Bite 22.10 11.49 7 43297 69 29531154
Fall 22.01 11.49 373 42931 176805 29354418
Hallucination 22.00 11.49 126 43178 44586 29486637
Death 21.87 11.49 655 42649 341429 29189794
Nightmare 21.51 11.49 50 43254 11367 29519856
Alcohol interaction 21.44 11.49 23 43281 2680 29528543
International normalised ratio increased 21.43 11.49 20 43284 44352 29486871
Painful erection 21.25 11.49 9 43295 212 29531011
Restlessness 21.18 11.49 76 43228 22069 29509154
Mood swings 21.08 11.49 38 43266 7213 29524010
Hepatic function abnormal 21.04 11.49 16 43288 39243 29491980
Reduced facial expression 20.95 11.49 13 43291 693 29530530
Accidental overdose 20.94 11.49 65 43239 17528 29513695
Sleep deficit 20.77 11.49 11 43293 433 29530790
Nervousness 20.74 11.49 49 43255 11257 29519966
Myotonia 20.51 11.49 6 43298 44 29531179
Alanine aminotransferase increased 20.45 11.49 46 43258 70898 29460325
Food aversion 20.28 11.49 10 43294 338 29530885
Brain injury 20.16 11.49 32 43272 5480 29525743
Congenital pneumonia 20.08 11.49 7 43297 95 29531128
Erectile dysfunction 20.03 11.49 65 43239 17944 29513279
Illness anxiety disorder 19.97 11.49 8 43296 163 29531060
Tardive dyskinesia 19.89 11.49 31 43273 5227 29525996
Poor quality sleep 19.88 11.49 37 43267 7196 29524027
Sepsis 19.80 11.49 125 43179 142557 29388666
Migraine 19.76 11.49 51 43253 12379 29518844
Muscle rigidity 19.72 11.49 43 43261 9368 29521855
Psychotic disorder 19.59 11.49 70 43234 20284 29510939
Atrial fibrillation 19.46 11.49 84 43220 105562 29425661
Platelet count decreased 19.42 11.49 83 43221 104589 29426634
Dry mouth 19.36 11.49 73 43231 21711 29509512
Sleep sex 19.35 11.49 4 43300 4 29531219
Feeling abnormal 19.17 11.49 141 43163 54304 29476919
Blood cholinesterase decreased 19.03 11.49 7 43297 112 29531111
Substance abuse 19.01 11.49 35 43269 6752 29524471
C-reactive protein 18.91 11.49 7 43297 114 29531109
Delirium 18.72 11.49 110 43194 39287 29491936
Procedural failure 18.27 11.49 6 43298 67 29531156
Mucosal inflammation 18.08 11.49 12 43292 31583 29499640
Paedophilia 18.08 11.49 4 43300 7 29531216
Sprue-like enteropathy 18.07 11.49 10 43294 430 29530793
Derealisation 18.04 11.49 11 43293 568 29530655
Depersonalisation/derealisation disorder 18.01 11.49 11 43293 570 29530653
Hypertonia 17.98 11.49 25 43279 3804 29527419
Akathisia 17.93 11.49 34 43270 6708 29524515
Hyperhidrosis 17.76 11.49 158 43146 64382 29466841
Bone marrow failure 17.74 11.49 9 43295 27440 29503783
Neuroleptic malignant syndrome 17.70 11.49 58 43246 16090 29515133
Delirium febrile 17.68 11.49 5 43299 32 29531191
Obsessive thoughts 17.32 11.49 11 43293 611 29530612
Hangover 17.12 11.49 13 43291 964 29530259
Ascites 17.11 11.49 17 43287 36602 29494621
Depressed mood 17.07 11.49 58 43246 16390 29514833
Blood urea increased 17.02 11.49 10 43294 28102 29503121
Post-traumatic stress disorder 16.90 11.49 16 43288 1606 29529617
Erection increased 16.84 11.49 10 43294 492 29530731
General symptom 16.72 11.49 12 43292 816 29530407
Generalised anxiety disorder 16.71 11.49 11 43293 650 29530573
Catatonia 16.42 11.49 26 43278 4442 29526781
Euphoric mood 16.27 11.49 27 43277 4798 29526425
Amnesia 16.24 11.49 71 43233 22572 29508651
Cholestasis 16.23 11.49 7 43297 23455 29507768
Bipolar disorder 16.21 11.49 22 43282 3273 29527950
Product administered at inappropriate site 16.10 11.49 16 43288 1704 29529519
Sleep-related eating disorder 16.02 11.49 8 43296 278 29530945
Periorbital haemorrhage 15.76 11.49 6 43298 106 29531117
Drug withdrawal syndrome 15.76 11.49 60 43244 17924 29513299
Wrong patient received product 15.66 11.49 18 43286 2264 29528959
Rash maculo-papular 15.64 11.49 8 43296 24281 29506942
Acute pulmonary oedema 15.39 11.49 32 43272 6747 29524476
Drug screen positive 15.20 11.49 23 43281 3778 29527445
Homeless 15.14 11.49 4 43300 19 29531204
Injection site mass 15.11 11.49 28 43276 5427 29525796
Hanging 15.08 11.49 6 43298 120 29531103
Sexual dysfunction 15.06 11.49 29 43275 5785 29525438
Diabetic foetopathy 14.94 11.49 7 43297 211 29531012
Discoloured vomit 14.90 11.49 9 43295 457 29530766
Dementia 14.74 11.49 44 43260 11614 29519609
Respiratory disorder neonatal 14.74 11.49 14 43290 1411 29529812
Myelodysplastic syndrome 14.57 11.49 4 43300 17790 29513433
Nicotine dependence 14.53 11.49 9 43295 478 29530745
Urine amphetamine positive 14.51 11.49 4 43300 23 29531200
Headache 14.46 11.49 345 42959 173662 29357561
Blood bilirubin increased 14.43 11.49 17 43287 33876 29497347
Blood creatinine increased 14.28 11.49 70 43234 85032 29446191
Suspected suicide 14.24 11.49 23 43281 3997 29527226
Drug use disorder 14.11 11.49 21 43283 3401 29527822
Lactic acidosis 14.07 11.49 84 43220 30163 29501060
Malignant neoplasm progression 14.04 11.49 58 43246 73801 29457422
Erythema 13.98 11.49 60 43244 75546 29455677
Lower respiratory tract infection 13.95 11.49 11 43293 26491 29504732
Pulmonary congestion 13.93 11.49 45 43259 12391 29518832
Device malfunction 13.62 11.49 35 43269 8472 29522751
Sudden cardiac death 13.61 11.49 20 43284 3202 29528021
Gambling disorder 13.56 11.49 14 43290 1561 29529662
Device dislocation 13.51 11.49 24 43280 4503 29526720
Dyspnoea 13.47 11.49 370 42934 326362 29204861
Cardiac failure 13.42 11.49 65 43239 79222 29452001
Stress at work 13.41 11.49 6 43298 162 29531061
Urine leukocyte esterase positive 13.41 11.49 8 43296 397 29530826
Pleural effusion 13.34 11.49 57 43247 71851 29459372
Substance use disorder 13.32 11.49 7 43297 271 29530952
Eosinophilia 13.25 11.49 8 43296 22153 29509070
Haemoglobin decreased 13.02 11.49 99 43205 108276 29422947
Withdrawal catatonia 13.00 11.49 5 43299 91 29531132
Osteonecrosis of jaw 12.98 11.49 4 43300 16506 29514717
Obsessive rumination 12.98 11.49 3 43301 7 29531216
Needle issue 12.93 11.49 24 43280 4659 29526564
Leukopenia 12.71 11.49 40 43264 55163 29476060
Abnormal dreams 12.70 11.49 30 43274 6890 29524333
Depressed level of consciousness 12.62 11.49 95 43209 36847 29494376
Exposure via breast milk 12.59 11.49 14 43290 1698 29529525
Aspartate aminotransferase increased 12.57 11.49 45 43259 59680 29471543
Drug resistance 12.57 11.49 8 43296 21532 29509691
Gastrointestinal haemorrhage 12.45 11.49 67 43237 79466 29451757
Physical disability 12.36 11.49 12 43292 1242 29529981
Ventricular tachycardia 12.35 11.49 9 43295 22565 29508658
Multiple organ dysfunction syndrome 12.35 11.49 49 43255 63067 29468156
Hospitalisation 12.34 11.49 112 43192 45876 29485347
Cardiac failure congestive 12.27 11.49 64 43240 76517 29454706
Premature baby 12.20 11.49 5 43299 17275 29513948
Hepatic failure 12.18 11.49 17 43287 31495 29499728
Obsessive-compulsive disorder 12.07 11.49 23 43281 4553 29526670
Genital haemorrhage 11.96 11.49 5 43299 114 29531109
Drug reaction with eosinophilia and systemic symptoms 11.96 11.49 14 43290 27978 29503245
Blood glucose fluctuation 11.96 11.49 20 43284 3577 29527646
Pulmonary fibrosis 11.86 11.49 4 43300 15578 29515645
Oedema peripheral 11.79 11.49 96 43208 103461 29427762
Catecholamines urine increased 11.77 11.49 3 43301 12 29531211
Antipsychotic drug level above therapeutic 11.74 11.49 11 43293 1090 29530133
Application site hypersensitivity 11.72 11.49 5 43299 120 29531103
Respiratory failure 11.54 11.49 89 43215 97042 29434181
Agitated depression 11.52 11.49 6 43298 228 29530995
Heat stroke 11.50 11.49 10 43294 899 29530324

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 1416.11 10.15 1915 119093 222499 64155225
Serotonin syndrome 699.61 10.15 584 120424 38698 64339026
Toxicity to various agents 651.86 10.15 1818 119190 361695 64016029
Drug abuse 646.41 10.15 1002 120006 131372 64246352
Sopor 599.90 10.15 475 120533 29186 64348538
Priapism 350.62 10.15 164 120844 3806 64373918
Suicide attempt 214.54 10.15 436 120572 70571 64307153
Cardio-respiratory arrest 204.64 10.15 521 120487 97872 64279852
Overdose 203.22 10.15 710 120298 158856 64218868
Suicidal ideation 173.71 10.15 385 120623 66157 64311567
Polycystic ovaries 156.92 10.15 78 120930 2077 64375647
Drug interaction 155.29 10.15 1186 119822 360897 64016827
Electrocardiogram QT prolonged 148.15 10.15 404 120604 79044 64298680
Intentional overdose 135.66 10.15 424 120584 89520 64288204
Withdrawal syndrome 117.43 10.15 180 120828 23312 64354412
Presbyacusis 114.03 10.15 67 120941 2508 64375216
Febrile neutropenia 113.18 10.15 111 120897 187546 64190178
Hypomania 106.71 10.15 87 120921 5567 64372157
Sensitisation 101.06 10.15 54 120954 1677 64376047
Hand deformity 100.29 10.15 4 121004 62767 64314957
Migraine 98.70 10.15 300 120708 62377 64315347
Pancytopenia 94.49 10.15 78 120930 143231 64234493
Depression 94.43 10.15 628 120380 182663 64195061
Anxiety 94.18 10.15 677 120331 201972 64175752
Thrombocytopenia 93.74 10.15 173 120835 223628 64154096
Pleural thickening 93.19 10.15 60 120948 2650 64375074
Neutropenia 91.12 10.15 196 120812 239428 64138296
Agitation 89.01 10.15 365 120643 88002 64289722
Pleural fibrosis 88.64 10.15 68 120940 3982 64373742
Blood magnesium increased 88.23 10.15 62 120946 3169 64374555
Anaemia 86.98 10.15 390 120618 378290 63999434
Ejection fraction 83.28 10.15 43 120965 1243 64376481
Pericarditis 80.30 10.15 11 120997 62505 64315219
Pyrexia 79.80 10.15 668 120340 557976 63819748
Maternal exposure during pregnancy 78.34 10.15 41 120967 95843 64281881
Intentional self-injury 76.83 10.15 169 120839 28875 64348849
General physical health deterioration 76.22 10.15 169 120839 204256 64173468
Schizophrenia 75.71 10.15 99 120909 11069 64366655
Product dose omission issue 74.03 10.15 621 120387 194126 64183598
Insomnia 73.70 10.15 628 120380 197208 64180516
Somnolence 69.93 10.15 635 120373 203010 64174714
Respiratory arrest 69.27 10.15 238 120770 52747 64324977
Hyperreflexia 69.26 10.15 76 120932 7072 64370652
Rash 69.24 10.15 540 120468 458009 63919715
Swelling 66.92 10.15 124 120884 160094 64217630
Infusion related reaction 66.32 10.15 130 120878 164337 64213387
Psychotic disorder 65.58 10.15 177 120831 34401 64343323
Systemic lupus erythematosus 65.18 10.15 32 120976 77580 64300144
Renal failure 64.65 10.15 154 120854 181534 64196190
Memory impairment 64.65 10.15 325 120683 85357 64292367
Irritability 64.65 10.15 183 120825 36563 64341161
Deafness neurosensory 63.91 10.15 69 120939 6305 64371419
Synovitis 62.78 10.15 56 120952 99034 64278690
Bradyphrenia 61.63 10.15 82 120926 9324 64368400
Myocardial stunning 61.11 10.15 20 120988 168 64377556
Malignant neoplasm progression 61.10 10.15 73 120935 112798 64264926
Platelet count decreased 60.59 10.15 141 120867 167570 64210154
Blood test abnormal 60.26 10.15 96 120912 12847 64364877
Nightmare 58.78 10.15 125 120883 20868 64356856
Mental status changes 58.73 10.15 249 120759 60913 64316811
Tremor 58.62 10.15 477 120531 147753 64229971
Mucosal inflammation 58.61 10.15 22 120986 62562 64315162
Intrusive thoughts 58.39 10.15 23 120985 344 64377380
Wound 57.75 10.15 36 120972 76441 64301283
Neovascularisation 57.71 10.15 32 120976 1071 64376653
Suspected suicide 57.56 10.15 76 120932 8578 64369146
Sleep disorder 57.26 10.15 243 120765 59466 64318258
Intentional product misuse 57.23 10.15 278 120730 72017 64305707
Accidental poisoning 57.07 10.15 35 120973 1418 64376306
Epigastric discomfort 56.81 10.15 67 120941 6744 64370980
Rhinitis allergic 55.37 10.15 72 120936 8006 64369718
Exposure during pregnancy 55.37 10.15 39 120969 77636 64300088
Haemoglobin decreased 54.90 10.15 185 120823 194878 64182846
Sleep disorder due to a general medical condition 54.28 10.15 72 120936 8162 64369562
Sedation 53.98 10.15 186 120822 41276 64336448
Carpal tunnel syndrome 53.58 10.15 102 120906 15726 64361998
Confabulation 53.42 10.15 23 120985 436 64377288
Alcoholism 53.05 10.15 47 120961 3370 64374354
Joint swelling 52.94 10.15 216 120792 215166 64162558
Sleep apnoea syndrome 51.92 10.15 148 120860 29684 64348040
Hyper IgE syndrome 51.75 10.15 23 120985 472 64377252
Jaundice cholestatic 51.39 10.15 72 120936 8598 64369126
Injection site mass 50.88 10.15 105 120903 17165 64360559
Bone cyst 50.54 10.15 38 120970 2159 64375565
Akathisia 50.36 10.15 83 120925 11427 64366297
Septic shock 50.14 10.15 75 120933 105362 64272362
Poor quality sleep 49.81 10.15 110 120898 18841 64358883
Cytomegalovirus infection 49.09 10.15 6 121002 37193 64340531
Gastrooesophageal reflux disease 48.41 10.15 294 120714 82849 64294875
Bone marrow failure 48.12 10.15 15 120993 47937 64329787
Glossodynia 48.10 10.15 31 120977 64665 64313059
Lung diffusion test abnormal 47.82 10.15 16 120992 145 64377579
Acute kidney injury 47.49 10.15 577 120431 448663 63929061
Extrapyramidal disorder 46.41 10.15 109 120899 19443 64358281
Cardiac failure 45.66 10.15 114 120894 132259 64245465
Visual perseveration 45.48 10.15 13 120995 65 64377659
Sepsis 45.46 10.15 250 120758 230091 64147633
Cholestasis 45.09 10.15 14 120994 44858 64332866
Hepatic function abnormal 44.91 10.15 33 120975 64280 64313444
Folliculitis 44.64 10.15 3 121005 30074 64347650
Leukopenia 44.38 10.15 76 120932 101166 64276558
Tachyphrenia 44.38 10.15 33 120975 1843 64375881
Depressed level of consciousness 44.30 10.15 283 120725 81153 64296571
Cyst 43.83 10.15 80 120928 11947 64365777
Fibromyalgia 43.68 10.15 157 120851 35574 64342150
Fall 43.52 10.15 1056 119952 415770 63961954
Clonus 43.03 10.15 55 120953 6012 64371712
Helicobacter infection 42.25 10.15 10 120998 38352 64339372
Muscle rigidity 42.12 10.15 98 120910 17375 64360349
Oral discomfort 41.43 10.15 64 120944 8342 64369382
Persistent genital arousal disorder 41.26 10.15 16 120992 229 64377495
Head discomfort 40.97 10.15 77 120931 11757 64365967
Alanine aminotransferase increased 40.38 10.15 130 120878 138901 64238823
C-reactive protein abnormal 40.06 10.15 4 121004 29043 64348681
Anger 39.84 10.15 90 120918 15651 64362073
Adjustment disorder with mixed anxiety and depressed mood 39.73 10.15 12 120996 75 64377649
Paradoxical drug reaction 39.55 10.15 53 120955 6067 64371657
Restless legs syndrome 39.09 10.15 94 120914 17022 64360702
Reduced facial expression 38.80 10.15 32 120976 2081 64375643
Environmental exposure 38.60 10.15 17 120991 341 64377383
Dry eye 38.49 10.15 131 120877 28888 64348836
Osteopenia 38.38 10.15 88 120920 15452 64362272
Penis injury 38.17 10.15 13 120995 125 64377599
Hostility 37.58 10.15 32 120976 2175 64375549
Drug resistance 37.02 10.15 10 120998 35092 64342632
Asphyxia 36.61 10.15 65 120943 9501 64368223
Interstitial lung disease 36.23 10.15 81 120927 97651 64280073
Impaired healing 36.16 10.15 36 120972 60437 64317287
Disease progression 36.12 10.15 140 120868 141540 64236184
Cardiac failure congestive 35.93 10.15 125 120883 130455 64247269
Homicidal ideation 35.75 10.15 37 120971 3220 64374504
Hyperhidrosis 35.71 10.15 375 120633 124545 64253179
Initial insomnia 35.59 10.15 49 120959 5755 64371969
Osteosclerosis 35.41 10.15 38 120970 3448 64374276
Multiple sclerosis relapse 35.33 10.15 162 120846 40973 64336751
Drug withdrawal syndrome 35.32 10.15 134 120874 31157 64346567
Multiple organ dysfunction syndrome 35.23 10.15 87 120921 101326 64276398
International normalised ratio increased 35.09 10.15 59 120949 79108 64298616
Parkinsonism 35.07 10.15 81 120927 14292 64363432
Loss of personal independence in daily activities 34.72 10.15 244 120764 72210 64305514
Lower respiratory tract infection 33.79 10.15 80 120928 94534 64283190
Muscle injury 33.14 10.15 5 121003 26432 64351292
Pneumocystis jirovecii pneumonia 32.92 10.15 6 121002 27628 64350096
Liver disorder 32.78 10.15 31 120977 53320 64324404
Headache 32.78 10.15 1258 119750 528209 63849515
Delirium 32.56 10.15 232 120776 68962 64308762
Asthma 32.16 10.15 296 120712 94929 64282795
Stomatitis 32.16 10.15 102 120906 109503 64268221
Confusional state 32.02 10.15 677 120331 260467 64117257
Hepatic failure 31.96 10.15 34 120974 55360 64322364
Sinus bradycardia 31.83 10.15 105 120903 22788 64354936
Vasoplegia syndrome 31.40 10.15 32 120976 2735 64374989
Blepharospasm 31.18 10.15 35 120973 3340 64374384
Somatic delusion 30.68 10.15 18 120990 672 64377052
Libido increased 30.57 10.15 26 120982 1764 64375960
Pleurothotonus 30.55 10.15 29 120979 2273 64375451
Drug reaction with eosinophilia and systemic symptoms 30.48 10.15 34 120974 54183 64323541
Mental disorder 30.47 10.15 114 120894 26331 64351393
Toxic epidermal necrolysis 30.19 10.15 16 120992 37150 64340574
Nervousness 29.67 10.15 122 120886 29434 64348290
Anaphylactic shock 29.52 10.15 10 120998 30318 64347406
Analgesic drug level above therapeutic 29.52 10.15 15 120993 419 64377305
Restlessness 29.36 10.15 150 120858 39635 64338089
Nephrectomy 29.22 10.15 23 120985 1399 64376325
Antidepressant drug level above therapeutic 28.84 10.15 16 120992 536 64377188
Arthropathy 28.65 10.15 123 120885 120844 64256880
Acute myeloid leukaemia 28.63 10.15 8 121000 27455 64350269
Blister 28.48 10.15 69 120939 80898 64296826
Tardive dyskinesia 28.46 10.15 57 120951 9121 64368603
Hepatocellular injury 28.12 10.15 26 120982 45209 64332515
Rash maculo-papular 28.11 10.15 28 120980 46998 64330726
Substance abuse 27.97 10.15 57 120951 9235 64368489
Aggression 27.87 10.15 165 120843 46067 64331657
Aspartate aminotransferase increased 27.64 10.15 123 120885 119665 64258059
Hospitalisation 27.57 10.15 238 120770 74969 64302755
Periorbital swelling 27.54 10.15 25 120983 1851 64375873
Hallucination, auditory 27.52 10.15 82 120926 16857 64360867
Drug screen positive 27.37 10.15 43 120965 5686 64372038
Skin lesion 27.23 10.15 138 120870 36344 64341380
Cardiac arrest 27.19 10.15 423 120585 153641 64224083
Abnormal behaviour 27.11 10.15 130 120878 33492 64344232
Cognitive disorder 26.68 10.15 186 120822 54901 64322823
Psychomotor hyperactivity 26.43 10.15 73 120935 14378 64363346
Exostosis 26.32 10.15 63 120945 11375 64366349
Hereditary angioedema 25.72 10.15 34 120974 3842 64373882
Delusion of replacement 25.67 10.15 10 120998 145 64377579
Liver function test abnormal 25.65 10.15 45 120963 59356 64318368
Alopecia 25.45 10.15 194 120814 165496 64212228
Gambling disorder 25.40 10.15 24 120984 1870 64375854
Neck pain 25.38 10.15 200 120808 61333 64316391
Dysphoria 25.35 10.15 36 120972 4352 64373372
Contraindicated product administered 25.32 10.15 110 120898 107719 64270005
Post-traumatic neck syndrome 25.31 10.15 24 120984 1878 64375846
Injection site reaction 25.27 10.15 162 120846 46502 64331222
Listless 25.21 10.15 31 120977 3259 64374465
Psychomotor retardation 25.12 10.15 39 120969 5104 64372620
Abnormal dreams 24.87 10.15 58 120950 10298 64367426
Disseminated intravascular coagulation 24.73 10.15 15 120993 32333 64345391
Penile haemorrhage 24.60 10.15 14 120994 493 64377231
Pleural effusion 24.59 10.15 138 120870 126421 64251303
Hyperkalaemia 24.46 10.15 102 120906 101027 64276697
Tonic clonic movements 24.40 10.15 24 120984 1965 64375759
Solar urticaria 24.36 10.15 8 121000 68 64377656
Rheumatoid factor positive 24.29 10.15 18 120990 34920 64342804
Arteriosclerosis coronary artery 24.12 10.15 74 120934 15455 64362269
C-reactive protein increased 24.04 10.15 94 120914 94815 64282909
Sputum discoloured 24.02 10.15 81 120927 17775 64359949
Autonomic nervous system imbalance 24.02 10.15 34 120974 4098 64373626
Palmar-plantar erythrodysaesthesia syndrome 24.01 10.15 12 120996 28807 64348917
Hypersensitivity 23.99 10.15 244 120764 196208 64181516
Mood altered 23.76 10.15 75 120933 15904 64361820
Sternal fracture 23.72 10.15 25 120983 2222 64375502
Epistaxis 23.72 10.15 99 120909 98032 64279692
Lung disorder 23.58 10.15 49 120959 60651 64317073
Drug intolerance 23.16 10.15 233 120775 187759 64189965
Soft tissue injury 23.09 10.15 21 120987 1558 64376166
Sense of a foreshortened future 22.95 10.15 5 121003 5 64377719
Coagulopathy 22.78 10.15 16 120992 31904 64345820
Oedema peripheral 22.59 10.15 269 120739 210048 64167676
Ejection fraction decreased 22.39 10.15 13 120995 28694 64349030
Discoloured vomit 22.25 10.15 18 120990 1139 64376585
Gastrointestinal haemorrhage 22.21 10.15 151 120857 132161 64245563
Haematocrit decreased 22.19 10.15 43 120965 54612 64323112
Concussion 21.91 10.15 47 120961 7891 64369833
Deformity 21.83 10.15 41 120967 6256 64371468
Renal impairment 21.73 10.15 156 120852 134861 64242863
Hypertonia 21.70 10.15 41 120967 6284 64371440
Accidental overdose 21.68 10.15 122 120886 33435 64344289
Jaundice 21.64 10.15 36 120972 48476 64329248
Symptom masked 21.62 10.15 18 120990 1186 64376538
Heart rate abnormal 21.61 10.15 36 120972 4999 64372725
Mood swings 21.56 10.15 77 120931 17391 64360333
Encephalopathy 21.48 10.15 186 120822 58633 64319091
Burning sensation 21.36 10.15 163 120845 49501 64328223
Vertigo 21.24 10.15 186 120822 58825 64318899
Neuroleptic malignant syndrome 21.14 10.15 98 120910 24898 64352826
Meningitis streptococcal 21.08 10.15 9 120999 167 64377557
Drug eruption 21.04 10.15 22 120986 36114 64341610
Feeling abnormal 21.03 10.15 360 120648 133242 64244482
Dry mouth 21.00 10.15 189 120819 60229 64317495
Restrictive pulmonary disease 20.88 10.15 23 120985 2149 64375575
Death 20.86 10.15 1106 119902 481599 63896125
Depressed mood 20.76 10.15 140 120868 40872 64336852
Economic problem 20.75 10.15 23 120985 2164 64375560
Cerebral infarction 20.69 10.15 28 120980 41016 64336708
Eye haematoma 20.66 10.15 8 121000 114 64377610
Loss of libido 20.63 10.15 24 120984 2380 64375344
Middle insomnia 20.60 10.15 62 120946 12815 64364909
Haemophagocytic lymphohistiocytosis 20.60 10.15 4 121004 17605 64360119
Body tinea 20.50 10.15 18 120990 1275 64376449
Homicide 20.24 10.15 17 120991 1134 64376590
Myoclonus 20.16 10.15 97 120911 25021 64352703
Polymerase chain reaction 20.11 10.15 8 121000 123 64377601
Apallic syndrome 20.08 10.15 15 120993 844 64376880
Infection 20.03 10.15 236 120772 184644 64193080
Gamma-glutamyltransferase increased 19.83 10.15 38 120970 48472 64329252
Urticaria 19.67 10.15 179 120829 147138 64230586
Post-traumatic stress disorder 19.32 10.15 31 120977 4174 64373550
Angioedema 19.23 10.15 56 120952 61765 64315959
Sensation of foreign body 19.18 10.15 32 120976 4450 64373274
Bronchopulmonary aspergillosis 19.09 10.15 6 121002 19079 64358645
Atrial fibrillation 19.08 10.15 217 120791 170872 64206852
Dehydration 19.01 10.15 289 120719 216474 64161250
Sleep disorder due to general medical condition, insomnia type 18.97 10.15 13 120995 26257 64351467
Anticholinergic syndrome 18.62 10.15 24 120984 2645 64375079
Aspergillus infection 18.58 10.15 4 121004 16375 64361349
Disorganised speech 18.57 10.15 19 120989 1631 64376093
Blood urea increased 18.57 10.15 34 120974 44119 64333605
Psychomotor skills impaired 18.56 10.15 29 120979 3816 64373908
Generalised oedema 18.43 10.15 8 121000 20845 64356879
Painful erection 18.42 10.15 8 121000 155 64377569
Irritable bowel syndrome 18.33 10.15 26 120982 37343 64340381
Myelosuppression 18.29 10.15 11 120997 23819 64353905
Food aversion 18.15 10.15 13 120995 685 64377039
Abdominal discomfort 18.14 10.15 237 120771 182085 64195639
Bronchospasm 18.11 10.15 9 120999 21673 64356051
Ascites 17.97 10.15 58 120950 61943 64315781
Muscle twitching 17.96 10.15 77 120931 18921 64358803
Neuropathy peripheral 17.85 10.15 138 120870 117387 64260337
Dissociation 17.84 10.15 25 120983 2986 64374738
Blood potassium increased 17.82 10.15 96 120912 25884 64351840
Unresponsive to stimuli 17.70 10.15 158 120850 50235 64327489
Erection increased 17.57 10.15 10 120998 352 64377372
Purple glove syndrome 17.40 10.15 9 120999 261 64377463
Therapeutic product effect decreased 17.26 10.15 136 120872 115215 64262509
Dementia 17.25 10.15 81 120927 20685 64357039
Product administered at inappropriate site 17.21 10.15 25 120983 3085 64374639
Thrombotic microangiopathy 17.09 10.15 5 121003 16650 64361074
Posterior reversible encephalopathy syndrome 17.05 10.15 11 120997 22935 64354789
Myelodysplastic syndrome 16.97 10.15 16 120992 27563 64350161
Wound infection fungal 16.93 10.15 8 121000 190 64377534
Brain injury 16.91 10.15 49 120959 9916 64367808
Major depression 16.86 10.15 42 120966 7774 64369950
Dyskinesia 16.78 10.15 129 120879 39259 64338465
Personality disorder 16.74 10.15 31 120977 4680 64373044
Skin texture abnormal 16.72 10.15 10 120998 387 64377337
Aplastic anaemia 16.63 10.15 3 121005 13917 64363807
Distributive shock 16.56 10.15 19 120989 1856 64375868
Product packaging difficult to open 16.46 10.15 5 121003 32 64377692
Cardiomyopathy 16.45 10.15 14 120994 25342 64352382
Bipolar disorder 16.38 10.15 38 120970 6723 64371001
Hypokinesia 16.26 10.15 68 120940 16528 64361196
Blood lactate dehydrogenase increased 16.24 10.15 23 120985 33055 64344669
Injection site induration 16.21 10.15 45 120963 8887 64368837
Heterophoria 16.20 10.15 5 121003 34 64377690
Neutropenic sepsis 16.17 10.15 12 120996 23260 64354464
Apathy 16.05 10.15 52 120956 11180 64366544
Paranoia 16.02 10.15 67 120941 16285 64361439
Procedural failure 15.86 10.15 6 121002 80 64377644
Obsessive thoughts 15.81 10.15 14 120994 1003 64376721
Eczema eyelids 15.78 10.15 7 121001 143 64377581
White blood cell count decreased 15.77 10.15 205 120803 157632 64220092
Inflammation 15.70 10.15 66 120942 65234 64312490
Body height decreased 15.68 10.15 40 120968 7514 64370210
Pruritus genital 15.63 10.15 14 120994 1018 64376706
Blood calcium decreased 15.52 10.15 15 120993 25539 64352185
Lack of injection site rotation 15.39 10.15 9 120999 334 64377390
Deep vein thrombosis 15.28 10.15 125 120883 105057 64272667
Disorientation 15.20 10.15 166 120842 55662 64322062
Compulsive sexual behaviour 15.16 10.15 8 121000 242 64377482
Sleep deficit 15.09 10.15 13 120995 898 64376826
Therapy non-responder 15.00 10.15 68 120940 65831 64311893
Haematotoxicity 14.93 10.15 3 121005 12893 64364831
Acute myopia 14.86 10.15 6 121002 96 64377628
Euphoric mood 14.84 10.15 36 120972 6555 64371169
Burning mouth syndrome 14.71 10.15 10 120998 484 64377240
Taste disorder 14.70 10.15 45 120963 9388 64368336
Hypotension 14.69 10.15 864 120144 380110 63997614
Hallucination, visual 14.68 10.15 96 120912 27738 64349986
Perseveration 14.49 10.15 9 120999 373 64377351
Hanging 14.48 10.15 6 121002 103 64377621
Total lung capacity decreased 14.46 10.15 17 120991 1705 64376019
Haemolytic anaemia 14.44 10.15 6 121002 16047 64361677
Catatonia 14.44 10.15 39 120969 7581 64370143
Neuropsychiatric symptoms 14.43 10.15 13 120995 953 64376771
Accommodation disorder 14.32 10.15 10 120998 506 64377218
Osteonecrosis of jaw 13.95 10.15 34 120974 39791 64337933
Pancreatitis acute 13.93 10.15 38 120970 42817 64334907
Homeless 13.92 10.15 6 121002 114 64377610
Thyroglobulin increased 13.92 10.15 5 121003 57 64377667
Erythema 13.92 10.15 257 120751 186813 64190911
Abortion spontaneous 13.88 10.15 16 120992 25127 64352597
Accidental death 13.86 10.15 25 120983 3700 64374024
Alcohol withdrawal syndrome 13.83 10.15 17 120991 1786 64375938
Galactorrhoea 13.80 10.15 23 120985 3196 64374528
Respiratory distress 13.79 10.15 51 120957 52280 64325444
Urine odour abnormal 13.71 10.15 30 120978 5106 64372618
Premature delivery 13.69 10.15 9 120999 18580 64359144
Klebsiella infection 13.60 10.15 4 121004 13277 64364447
Drug use disorder 13.56 10.15 33 120975 6021 64371703
Blood prolactin increased 13.54 10.15 24 120984 3504 64374220
Neutrophil count decreased 13.50 10.15 87 120921 77109 64300615
Needle issue 13.31 10.15 43 120965 9229 64368495
Tuberculosis 13.22 10.15 4 121004 13034 64364690
Red blood cell sedimentation rate increased 13.18 10.15 24 120984 31211 64346513
Knee deformity 13.13 10.15 12 120996 896 64376828
Delirium febrile 13.13 10.15 5 121003 68 64377656
Genital infection female 13.13 10.15 5 121003 68 64377656
Tongue discolouration 13.04 10.15 23 120985 3345 64374379
Nausea 13.00 10.15 1673 119335 784127 63593597
Holmes-Adie pupil 12.98 10.15 4 121004 27 64377697
Plasma cell mastitis 12.98 10.15 4 121004 27 64377697
Mydriasis 12.92 10.15 60 120948 15252 64362472
Blood cholinesterase decreased 12.85 10.15 7 121001 226 64377498
Affective disorder 12.79 10.15 34 120974 6546 64371178
Compartment syndrome 12.78 10.15 26 120982 4206 64373518
Foaming at mouth 12.78 10.15 16 120992 1713 64376011
Basal cell carcinoma 12.74 10.15 24 120984 30814 64346910
Pseudomonas infection 12.71 10.15 9 120999 17874 64359850
Compulsive shopping 12.69 10.15 11 120997 766 64376958
Anorgasmia 12.68 10.15 12 120996 937 64376787
Infusion site urticaria 12.66 10.15 10 120998 611 64377113
Delusion 12.65 10.15 67 120941 17947 64359777
Thinking abnormal 12.64 10.15 49 120959 11507 64366217
Pericardial effusion 12.62 10.15 35 120973 39219 64338505
Neurotoxicity 12.53 10.15 20 120988 27384 64350340
Torsade de pointes 12.48 10.15 65 120943 17298 64360426
Dyspnoea exertional 12.44 10.15 84 120924 73646 64304078
Balance disorder 12.43 10.15 224 120784 83702 64294022
Wrong patient received product 12.43 10.15 24 120984 3738 64373986
Skin sensitisation 12.41 10.15 11 120997 789 64376935
Epstein-Barr virus infection 12.36 10.15 4 121004 12484 64365240
Coma 12.34 10.15 232 120776 87383 64290341
Substance use disorder 12.31 10.15 8 121000 359 64377365
Hepatitis 12.29 10.15 44 120964 45538 64332186
Screaming 12.26 10.15 23 120985 3506 64374218
Obsessive rumination 12.24 10.15 3 121005 7 64377717
Slow speech 12.20 10.15 17 120991 2020 64375704
Toxic skin eruption 12.09 10.15 11 120997 19273 64358451
Transplant rejection 12.05 10.15 9 120999 17392 64360332
Proteinuria 11.97 10.15 21 120987 27702 64350022
Ejection fraction abnormal 11.95 10.15 14 120994 1399 64376325
Feeling of despair 11.89 10.15 19 120989 2549 64375175
Persistent depressive disorder 11.89 10.15 12 120996 1014 64376710
Toxicologic test abnormal 11.83 10.15 13 120995 1212 64376512
Peritoneal perforation 11.73 10.15 6 121002 170 64377554
Personal relationship issue 11.63 10.15 6 121002 173 64377551
Mental impairment 11.63 10.15 61 120947 16282 64361442
Heat stroke 11.62 10.15 14 120994 1441 64376283
Haemodialysis 11.61 10.15 9 120999 17068 64360656
Haematemesis 11.61 10.15 47 120961 46952 64330772
Drug screen negative 11.61 10.15 7 121001 275 64377449
Obsessive-compulsive disorder 11.59 10.15 27 120981 4791 64372933
Hangover 11.58 10.15 16 120992 1885 64375839
Ill-defined disorder 11.56 10.15 43 120965 44009 64333715
Product complaint 11.53 10.15 4 121004 11950 64365774
Nodule 11.53 10.15 10 120998 17937 64359787
Breast disorder 11.53 10.15 15 120993 1669 64376055
Bacterial vaginosis 11.50 10.15 11 120997 870 64376854
Somnambulism 11.49 10.15 28 120980 5113 64372611
Eosinophilia 11.47 10.15 35 120973 38041 64339683
Cholecystitis 11.38 10.15 12 120996 19624 64358100
Discomfort 11.35 10.15 97 120911 80781 64296943
Morbid thoughts 11.30 10.15 10 120998 716 64377008
Wandering pacemaker 11.24 10.15 3 121005 11 64377713
Bite 11.19 10.15 8 121000 420 64377304
Impaired quality of life 11.16 10.15 32 120976 6439 64371285
Tumour lysis syndrome 11.14 10.15 12 120996 19428 64358296
Shock 11.01 10.15 115 120893 38125 64339599
Bradycardia 10.96 10.15 295 120713 117924 64259800
Alcohol interaction 10.95 10.15 25 120983 4376 64373348
Device related infection 10.85 10.15 26 120982 30600 64347124
Psoriasis 10.84 10.15 192 120816 71511 64306213
Dermatitis exfoliative 10.82 10.15 3 121005 10349 64367375
White blood cell count increased 10.75 10.15 76 120932 65938 64311786
Hypogammaglobulinaemia 10.74 10.15 3 121005 10296 64367428
Expired product administered 10.71 10.15 30 120978 5957 64371767
Ventricular tachycardia 10.68 10.15 31 120977 34234 64343490
Device malfunction 10.67 10.15 63 120945 17570 64360154
Renal injury 10.66 10.15 8 121000 15421 64362303
Periorbital haemorrhage 10.65 10.15 6 121002 207 64377517
Joint effusion 10.65 10.15 6 121002 13467 64364257
Immobile 10.62 10.15 30 120978 5985 64371739
Affect lability 10.56 10.15 39 120969 8951 64368773
Second primary malignancy 10.49 10.15 5 121003 12332 64365392
Metastases to liver 10.46 10.15 18 120990 23923 64353801
Bronchopulmonary aspergillosis allergic 10.41 10.15 14 120994 1608 64376116
Alcohol poisoning 10.40 10.15 24 120984 4231 64373493
Antipsychotic drug level above therapeutic 10.36 10.15 15 120993 1846 64375878
Extra dose administered 10.33 10.15 32 120976 6718 64371006
Hip arthroplasty 10.33 10.15 15 120993 21336 64356388
Ileus 10.28 10.15 17 120991 22949 64354775
Myotonia 10.27 10.15 6 121002 222 64377502
Dermatitis allergic 10.23 10.15 8 121000 15101 64362623
Impaired gastric emptying 10.18 10.15 38 120970 8766 64368958
Transaminases increased 10.15 10.15 46 120962 44548 64333176
Haematuria 10.15 10.15 69 120939 60402 64317322

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AX05 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
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 D018490 Serotonin Agents
MeSH PA D017367 Serotonin Uptake Inhibitors
MeSH PA D014149 Tranquilizing Agents
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
FDA EPC N0000175696 Serotonin Reuptake Inhibitor

Drug Use (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
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.35 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 6.65 WOMBAT-PK CHEMBL
Sodium-dependent serotonin transporter Transporter INHIBITOR Kd 6.80 WOMBAT-PK CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 6.58 WOMBAT-PK
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 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
5-hydroxytryptamine receptor 2B GPCR Ki 7.08 WOMBAT-PK
HLA class I histocompatibility antigen, A-3 alpha chain Unclassified 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

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 0555-0733 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 0615-8371 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 29 sections
Trazodone Hydrochloride Human Prescription Drug Label 1 13107-080 TABLET 100 mg ORAL ANDA 29 sections
Trazodone Hydrochloride Human Prescription Drug Label 1 13107-081 TABLET 150 mg ORAL ANDA 29 sections
Trazodone Hydrochloride Human Prescription Drug Label 1 13107-082 TABLET 300 mg ORAL ANDA 29 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