amitriptyline 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antidepressants, dibenzo[a,d]cycloheptane or cyclopheptene derivatives 180 50-48-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amitriptyline
  • amitriprolidine
  • amitriptylin
  • damitriptyline
  • amitriptyline hydrochloride
  • amitryptiline
  • amitryptiline hydrochloride
  • amitriptyline HCl
  • amitryptiline HCl
Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.
  • Molecular weight: 277.41
  • Formula: C20H23N
  • CLOGP: 4.85
  • LIPINSKI: 0
  • HAC: 1
  • HDO: 0
  • TPSA: 3.24
  • ALOGS: -4.79
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
75 mg O
75 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 15.45 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 48 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 8.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.07 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 17 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 7, 1961 FDA ASTRAZENECA

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
Toxicity to various agents 537.29 9.97 1352 112197 211147 50280428
Completed suicide 403.06 9.97 904 112645 130985 50360590
Sedation complication 295.33 9.97 205 113344 8561 50483014
Sedation 272.82 9.97 340 113209 30270 50461305
Cognitive disorder 262.13 9.97 403 113146 43720 50447855
Orthostatic hypotension 255.63 9.97 323 113226 29158 50462417
Creatinine renal clearance decreased 252.31 9.97 211 113338 11670 50479905
Systemic lupus erythematosus 206.13 9.97 34 113515 140588 50350987
Glossodynia 204.72 9.97 14 113535 115555 50376020
Depressed level of consciousness 203.96 9.97 395 113154 51558 50440017
Blood calcium decreased 194.17 9.97 236 113313 20470 50471105
Balance disorder 193.52 9.97 464 113085 70126 50421449
Drug abuse 178.92 9.97 407 113142 59439 50432136
Serotonin syndrome 165.77 9.97 239 113310 24474 50467101
Coma 151.71 9.97 370 113179 56509 50435066
Hand deformity 149.57 9.97 23 113526 100176 50391399
Electrocardiogram QRS complex prolonged 148.05 9.97 111 113438 5233 50486342
Arthropathy 129.37 9.97 99 113450 157807 50333768
Wound 121.09 9.97 43 113506 105751 50385824
Pericarditis 119.89 9.97 17 113532 78672 50412903
Migraine 116.58 9.97 403 113146 74877 50416698
Abdominal discomfort 115.39 9.97 215 113334 231426 50260149
Overdose 109.62 9.97 479 113070 99248 50392327
Alopecia 107.20 9.97 245 113304 244802 50246773
Poisoning deliberate 97.64 9.97 104 113445 7808 50483767
Fall 94.04 9.97 1156 112393 333776 50157799
Contraindicated product administered 93.59 9.97 118 113431 148840 50342735
Mydriasis 92.98 9.97 117 113432 10510 50481065
Anticholinergic syndrome 90.21 9.97 54 113495 1741 50489834
Impaired work ability 90.13 9.97 131 113418 13509 50478066
Hepatic enzyme increased 89.28 9.97 106 113443 137274 50354301
Maternal exposure during pregnancy 88.98 9.97 138 113411 159640 50331935
Rheumatoid factor positive 88.37 9.97 6 113543 49853 50441722
Derealisation 84.40 9.97 43 113506 1003 50490572
Fibromyalgia 84.25 9.97 257 113292 44721 50446854
Hypersensitivity 81.78 9.97 231 113318 214930 50276645
Constipation 80.68 9.97 701 112848 185007 50306568
Gastric pH decreased 80.25 9.97 36 113513 626 50490949
Suicidal ideation 75.11 9.97 284 113265 55101 50436474
Somnolence 74.75 9.97 599 112950 154386 50337189
Neutropenia 73.02 9.97 138 113411 147827 50343748
Infusion related reaction 71.31 9.97 173 113376 169384 50322191
Exposure during pregnancy 70.78 9.97 101 113448 120914 50370661
Muscle injury 70.33 9.97 3 113546 37108 50454467
Folliculitis 68.70 9.97 5 113544 39220 50452355
Synovitis 67.03 9.97 109 113440 123756 50367819
Intentional overdose 66.96 9.97 298 113251 62206 50429369
Synovial fluid analysis 66.44 9.97 43 113506 1595 50489980
Drug ineffective for unapproved indication 66.09 9.97 147 113402 21134 50470441
Nightmare 65.16 9.97 124 113425 15962 50475613
Disturbance in attention 64.89 9.97 185 113364 31001 50460574
Hallucinations, mixed 63.57 9.97 61 113488 4042 50487533
Feeling jittery 63.53 9.97 100 113449 11060 50480515
Platelet count decreased 63.02 9.97 80 113469 100646 50390929
Febrile neutropenia 62.75 9.97 76 113473 97591 50393984
Agitation 61.37 9.97 260 113289 53124 50438451
Tenosynovitis stenosans 61.17 9.97 46 113503 2178 50489397
Cogwheel rigidity 60.89 9.97 42 113507 1735 50489840
Feeling of despair 60.59 9.97 44 113505 1974 50489601
Swelling 60.30 9.97 239 113310 200633 50290942
Dissociation 59.96 9.97 46 113503 2245 50489330
Withdrawal syndrome 59.76 9.97 126 113423 17464 50474111
Restless legs syndrome 58.87 9.97 118 113431 15779 50475796
Therapeutic product effect decreased 57.83 9.97 138 113411 135912 50355663
Scleritis 57.77 9.97 52 113497 3175 50488400
H1N1 influenza 57.69 9.97 39 113510 1558 50490017
Electrocardiogram QT prolonged 57.56 9.97 250 113299 51636 50439939
Dystonia 57.30 9.97 99 113450 11827 50479748
Product use issue 57.11 9.97 160 113389 149315 50342260
Anaemia 56.79 9.97 333 113216 252123 50239452
Drug interaction 53.31 9.97 683 112866 198938 50292637
Somatic symptom disorder 53.01 9.97 40 113509 1904 50489671
Sacroiliitis 52.82 9.97 45 113504 2552 50489023
Lip pruritus 52.66 9.97 28 113521 715 50490860
Hypotension 52.47 9.97 780 112769 234689 50256886
Pleuritic pain 51.57 9.97 68 113481 6398 50485177
Mobility decreased 51.25 9.97 331 113218 79617 50411958
Dizziness 50.33 9.97 1072 112477 345297 50146278
Bradypnoea 50.10 9.97 47 113502 3027 50488548
Depersonalisation/derealisation disorder 49.95 9.97 32 113517 1166 50490409
Hyperhidrosis 48.87 9.97 356 113193 89070 50402505
Rubber sensitivity 48.83 9.97 37 113512 1772 50489803
Aspartate aminotransferase increased 48.73 9.97 62 113487 77936 50413639
Impaired healing 48.43 9.97 51 113498 69735 50421840
Discomfort 48.42 9.97 107 113442 108273 50383302
Depressed mood 48.23 9.97 177 113372 33846 50457729
Eye pain 48.17 9.97 157 113392 28292 50463283
Feeling of body temperature change 47.97 9.97 54 113495 4313 50487262
Anxiety 47.97 9.97 609 112940 176997 50314578
Bursitis 47.70 9.97 133 113416 22002 50469573
Emotional disorder 47.65 9.97 91 113458 11745 50479830
Hallucination, visual 47.56 9.97 111 113438 16471 50475104
Body tinea 46.97 9.97 32 113517 1295 50490280
Parosmia 45.60 9.97 53 113496 4383 50487192
Persistent genital arousal disorder 44.86 9.97 18 113531 234 50491341
Crystal nephropathy 44.85 9.97 26 113523 789 50490786
Crepitations 41.48 9.97 60 113489 6159 50485416
Tinnitus 41.27 9.97 148 113401 27984 50463591
Poor quality sleep 40.90 9.97 105 113444 16541 50475034
Inhibitory drug interaction 40.01 9.97 36 113513 2197 50489378
Photophobia 39.83 9.97 97 113452 14790 50476785
Medication overuse headache 39.64 9.97 22 113527 613 50490962
Neovascularisation 39.64 9.97 26 113523 987 50490588
Atrial fibrillation 38.04 9.97 110 113439 101635 50389940
Thrombocytopenia 37.59 9.97 153 113396 127520 50364055
Tachycardia 37.39 9.97 365 113184 99398 50392177
Pulmonary eosinophilia 37.17 9.97 15 113534 198 50491377
Suicide attempt 36.15 9.97 219 113330 51513 50440062
Device expulsion 36.02 9.97 10 113539 28812 50462763
Psychotic disorder due to a general medical condition 35.81 9.97 15 113534 219 50491356
Drooling 35.74 9.97 41 113508 3343 50488232
Vision blurred 35.73 9.97 300 113249 78347 50413228
Sensory loss 35.57 9.97 63 113486 7675 50483900
Infection susceptibility increased 35.54 9.97 36 113513 2548 50489027
Cardio-respiratory arrest 35.06 9.97 224 113325 53668 50437907
Pituitary tumour benign 34.47 9.97 30 113519 1751 50489824
Brain injury 34.38 9.97 54 113495 5960 50485615
Confusional state 34.28 9.97 597 112952 185331 50306244
Myoclonus 34.24 9.97 90 113459 14380 50477195
Irritable bowel syndrome 34.13 9.97 39 113510 51402 50440173
Akathisia 34.03 9.97 64 113485 8165 50483410
Insomnia 33.88 9.97 566 112983 174299 50317276
Autonomic dysreflexia 33.86 9.97 16 113533 315 50491260
Swollen tongue 33.33 9.97 140 113409 28490 50463085
Paraesthesia 33.16 9.97 414 113135 119829 50371746
Cestode infection 32.87 9.97 15 113534 272 50491303
Knee arthroplasty 32.62 9.97 20 113529 35826 50455749
Flank pain 32.50 9.97 83 113466 13032 50478543
Telangiectasia congenital 32.06 9.97 8 113541 16 50491559
Menstrual disorder 31.87 9.97 44 113505 4326 50487249
Delirium 31.49 9.97 169 113380 38023 50453552
Septic shock 31.20 9.97 50 113499 57125 50434450
Dry mouth 30.88 9.97 224 113325 55954 50435621
Tremor 30.57 9.97 393 113156 114510 50377065
Hip arthroplasty 30.56 9.97 15 113534 30414 50461161
Loss of consciousness 30.38 9.97 363 113186 103990 50387585
Cervix neoplasm 30.36 9.97 13 113536 201 50491374
Bone marrow failure 30.29 9.97 12 113537 27612 50463963
Dehydration 30.18 9.97 209 113340 152240 50339335
Therapeutic product ineffective 29.99 9.97 24 113525 1246 50490329
Alanine aminotransferase increased 29.86 9.97 100 113449 88259 50403316
Cardiac failure congestive 29.56 9.97 94 113455 84288 50407287
Cushingoid 29.13 9.97 53 113496 6592 50484983
Speech disorder 29.11 9.97 157 113392 35391 50456184
Muscle disorder 29.06 9.97 42 113507 4308 50487267
Clear cell renal cell carcinoma 28.98 9.97 23 113526 1180 50490395
Drug withdrawal syndrome 28.69 9.97 122 113427 24959 50466616
Tension 28.39 9.97 33 113516 2729 50488846
Malaise 28.37 9.97 968 112581 334564 50157011
Muscle twitching 27.79 9.97 87 113462 15344 50476231
Respiratory depression 27.71 9.97 74 113475 11936 50479639
Multiple organ dysfunction syndrome 27.49 9.97 44 113505 50293 50441282
Visual impairment 27.16 9.97 253 113296 68022 50423553
Paralysis 27.07 9.97 60 113489 8604 50482971
Multiple sclerosis relapse 26.98 9.97 177 113372 42787 50448788
Vestibular migraine 26.94 9.97 12 113537 205 50491370
Rash 26.85 9.97 762 112787 436709 50054866
Helicobacter infection 26.62 9.97 44 113505 49658 50441917
Impaired reasoning 26.41 9.97 9 113540 71 50491504
Dyskinesia 26.26 9.97 128 113421 27733 50463842
Condition aggravated 25.91 9.97 490 113059 296568 50195007
Injection site erythema 25.88 9.97 84 113465 74852 50416723
Disease progression 25.70 9.97 119 113430 95747 50395828
Neuralgia 25.52 9.97 107 113442 21756 50469819
Tenosynovitis 25.29 9.97 66 113483 10499 50481076
Glucose tolerance impaired 25.26 9.97 43 113506 5075 50486500
Eyelid exfoliation 25.20 9.97 10 113539 126 50491449
Swelling face 25.15 9.97 203 113346 52392 50439183
Myofascial pain syndrome 25.03 9.97 27 113522 2056 50489519
Tenderness 24.99 9.97 95 113454 18470 50473105
Diaphragmatic rupture 24.91 9.97 12 113537 247 50491328
Hyperlactacidaemia 24.89 9.97 29 113520 2404 50489171
Premenstrual syndrome 24.66 9.97 16 113533 596 50490979
Dysarthria 24.66 9.97 156 113393 37247 50454328
Red blood cell sedimentation rate increased 24.63 9.97 18 113531 29398 50462177
Conjunctivitis 24.59 9.97 86 113463 16059 50475516
Biliary sepsis 24.31 9.97 18 113531 832 50490743
Heart sounds 24.24 9.97 16 113533 614 50490961
Synovial cyst 23.78 9.97 55 113494 8111 50483464
Urinary retention 23.74 9.97 119 113430 26071 50465504
Cardiac failure 23.73 9.97 89 113460 75951 50415624
Cerebellar stroke 23.68 9.97 11 113538 208 50491367
Hallucination 23.36 9.97 182 113367 46475 50445100
Bone density decreased 23.33 9.97 66 113483 11009 50480566
Oedema 23.32 9.97 80 113469 70101 50421474
Pulseless electrical activity 23.23 9.97 49 113500 6792 50484783
Oedema peripheral 22.93 9.97 235 113314 157726 50333849
Diet failure 22.93 9.97 7 113542 37 50491538
Infection 22.83 9.97 263 113286 172691 50318884
Tubulointerstitial nephritis and uveitis syndrome 22.71 9.97 10 113539 166 50491409
Hypoaesthesia oral 22.66 9.97 64 113485 10664 50480911
Magnesium deficiency 22.46 9.97 14 113535 486 50491089
Malignant neoplasm progression 22.40 9.97 78 113471 68046 50423529
Injection site swelling 22.35 9.97 37 113512 41736 50449839
Prolonged expiration 22.28 9.97 16 113533 705 50490870
Peritonitis 22.11 9.97 4 113545 15482 50476093
CYP3A4 polymorphism 21.81 9.97 8 113541 80 50491495
Drug dependence 21.75 9.97 95 113454 19664 50471911
Joint swelling 21.56 9.97 404 113145 244882 50246693
Sopor 21.44 9.97 95 113454 19784 50471791
CFTR gene mutation 21.22 9.97 8 113541 87 50491488
Neuroleptic malignant syndrome 21.21 9.97 64 113485 11066 50480509
White blood cell count decreased 21.18 9.97 164 113385 116558 50375017
Restlessness 21.17 9.97 112 113437 25061 50466514
Personality disorder 20.91 9.97 36 113513 4288 50487287
C-reactive protein abnormal 20.81 9.97 19 113530 27790 50463785
Psychotic symptom 20.66 9.97 19 113530 1193 50490382
Abortion spontaneous 20.55 9.97 39 113510 41733 50449842
Haemorrhage 20.54 9.97 57 113492 53384 50438191
Choanal stenosis 20.44 9.97 6 113543 27 50491548
Myelosuppression 20.39 9.97 3 113546 13514 50478061
Thymus disorder 20.24 9.97 10 113539 218 50491357
Anterograde amnesia 19.92 9.97 13 113536 489 50491086
Cyanosis 19.86 9.97 77 113472 15107 50476468
Circulatory collapse 19.65 9.97 93 113456 19907 50471668
Hospitalisation 19.62 9.97 82 113467 67855 50423720
Cellulitis 19.60 9.97 244 113305 70554 50421021
Blood creatinine increased 19.55 9.97 96 113453 76064 50415511
Anti-neutrophil cytoplasmic antibody positive vasculitis 19.42 9.97 25 113524 2297 50489278
Rectal cancer metastatic 19.37 9.97 10 113539 240 50491335
Mood swings 19.34 9.97 79 113470 15875 50475700
Cardiac arrest 19.32 9.97 279 113270 83372 50408203
Therapy non-responder 19.18 9.97 55 113494 50967 50440608
Tension headache 19.17 9.97 27 113522 2704 50488871
Viral diarrhoea 19.09 9.97 8 113541 117 50491458
Extrapyramidal disorder 19.07 9.97 64 113485 11706 50479869
Respiratory arrest 19.06 9.97 124 113425 29885 50461690
Sternal fracture 19.06 9.97 23 113526 1979 50489596
Naevus flammeus 18.96 9.97 8 113541 119 50491456
Blood glucose increased 18.84 9.97 89 113460 71235 50420340
Depressive symptom 18.67 9.97 29 113520 3171 50488404
Muscle spasms 18.61 9.97 390 113159 125163 50366412
Subclavian artery embolism 18.61 9.97 5 113544 15 50491560
Mood altered 18.56 9.97 67 113482 12706 50478869
Hepatic function abnormal 18.38 9.97 28 113521 32653 50458922
Coma scale abnormal 18.37 9.97 36 113513 4735 50486840
Ill-defined disorder 18.36 9.97 62 113487 54592 50436983
Libido increased 18.35 9.97 18 113531 1225 50490350
Renal failure 18.34 9.97 152 113397 106481 50385094
Muscle rigidity 18.24 9.97 56 113493 9773 50481802
Accidental death 18.20 9.97 21 113528 1723 50489852
Oesophageal spasm 18.08 9.97 24 113525 2272 50489303
Drug intolerance 17.99 9.97 365 113184 218739 50272836
Palpitations 17.95 9.97 305 113244 94201 50397374
Gastrointestinal haemorrhage 17.93 9.97 94 113455 73227 50418348
Lichen sclerosus 17.88 9.97 16 113533 969 50490606
Respiration abnormal 17.86 9.97 37 113512 5065 50486510
Poliomyelitis 17.76 9.97 6 113543 46 50491529
Neutrophil count decreased 17.75 9.97 49 113500 45977 50445598
Secondary adrenocortical insufficiency 17.72 9.97 17 113532 1126 50490449
Hyperprolactinaemia 17.58 9.97 29 113520 3336 50488239
Wrist deformity 17.58 9.97 21 113528 1788 50489787
Nodule 17.40 9.97 80 113469 16923 50474652
Sinus tachycardia 17.27 9.97 94 113455 21260 50470315
Sepsis 17.19 9.97 203 113346 132722 50358853
Vertigo 17.19 9.97 185 113364 51647 50439928
Parkinsonian rest tremor 16.98 9.97 7 113542 98 50491477
Haemoglobin decreased 16.95 9.97 193 113356 127023 50364552
Antinuclear antibody positive 16.92 9.97 41 113508 6231 50485344
Neck pain 16.81 9.97 199 113350 56868 50434707
Forced expiratory volume decreased 16.73 9.97 33 113516 4361 50487214
Abdominal pain 16.65 9.97 668 112881 235560 50256015
Renal mass 16.59 9.97 21 113528 1897 50489678
Injection site pain 16.59 9.97 164 113385 110860 50380715
Sleep disorder 16.54 9.97 199 113350 57084 50434491
Hyperaesthesia 16.53 9.97 48 113501 8125 50483450
Vulvovaginal swelling 16.51 9.97 11 113538 429 50491146
Schizophrenia 16.48 9.97 45 113504 7352 50484223
Disseminated intravascular coagulation 16.38 9.97 9 113540 17126 50474449
Vaccination site oedema 16.38 9.97 4 113545 7 50491568
Peripheral circulatory failure 16.30 9.97 12 113537 550 50491025
Leukopenia 16.27 9.97 87 113462 67441 50424134
Polymenorrhoea 16.24 9.97 16 113533 1095 50490480
Vaccination site bruising 16.03 9.97 4 113545 8 50491567
Vaccination site pruritus 16.03 9.97 4 113545 8 50491567
Pregnancy 16.01 9.97 26 113523 29551 50462024
Judgement impaired 15.94 9.97 12 113537 569 50491006
Enlarged uvula 15.88 9.97 8 113541 182 50491393
Paradoxical drug reaction 15.88 9.97 29 113520 3618 50487957
Femoral artery dissection 15.85 9.97 5 113544 30 50491545
Accidental overdose 15.81 9.97 86 113463 19447 50472128
Oesophageal pain 15.80 9.97 25 113524 2777 50488798
Multiple sclerosis 15.76 9.97 89 113460 20404 50471171
Memory impairment 15.76 9.97 258 113291 79102 50412473
Labelled drug-drug interaction issue 15.74 9.97 9 113540 266 50491309
Diarrhoea 15.73 9.97 1123 112426 587353 49904222
Soft tissue injury 15.71 9.97 18 113531 1466 50490109
Depression 15.69 9.97 484 113065 164939 50326636
Lip swelling 15.58 9.97 102 113447 24634 50466941
Environmental exposure 15.53 9.97 6 113543 70 50491505
Postural orthostatic tachycardia syndrome 15.51 9.97 14 113535 858 50490717
Illness 15.34 9.97 101 113448 24439 50467136
Seizure 15.21 9.97 359 113190 117515 50374060
Movement disorder 15.20 9.97 79 113470 17553 50474022
Off label use 15.12 9.97 891 112658 473535 50018040
SLE arthritis 15.08 9.97 12 113537 618 50490957
Paranasal cyst 15.07 9.97 9 113540 289 50491286
Incontinence 15.04 9.97 53 113496 9932 50481643
Unevaluable event 14.97 9.97 53 113496 46013 50445562
Vascular malformation 14.93 9.97 9 113540 294 50491281
Sensitivity to weather change 14.89 9.97 38 113511 5963 50485612
Hot flush 14.81 9.97 158 113391 44011 50447564
Pancytopenia 14.80 9.97 119 113430 83911 50407664
Plasma cell myeloma 14.75 9.97 30 113519 31292 50460283
Impaired quality of life 14.67 9.97 38 113511 6018 50485557
Abnormal loss of weight 14.63 9.97 34 113515 5030 50486545
Hostility 14.61 9.97 19 113530 1763 50489812
Blister 14.58 9.97 122 113427 85296 50406279
Pyrexia 14.55 9.97 701 112848 379502 50112073
Oxalosis 14.51 9.97 5 113544 41 50491534
Laryngeal dyspnoea 14.41 9.97 7 113542 147 50491428
Renal impairment 14.34 9.97 105 113444 75556 50416019
Injection site bruising 14.29 9.97 39 113510 36729 50454846
Pulmonary hypertension 14.10 9.97 34 113515 33383 50458192
Feeling abnormal 14.06 9.97 375 113174 125117 50366458
Mental disorder 14.05 9.97 91 113458 21900 50469675
Sinusitis 14.03 9.97 284 113265 170274 50321301
Myoglobin urine 14.01 9.97 4 113545 16 50491559
Mania 13.99 9.97 55 113494 10861 50480714
Bacteriuria 13.96 9.97 12 113537 689 50490886
Genital infection female 13.88 9.97 6 113543 95 50491480
Norovirus infection 13.88 9.97 8 113541 240 50491335
Caesarean section 13.85 9.97 9 113540 15630 50475945
Live birth 13.79 9.97 10 113539 16398 50475177
Concussion 13.73 9.97 43 113506 7585 50483990
Limb injury 13.68 9.97 85 113464 20165 50471410
Hypoglycaemic seizure 13.65 9.97 10 113539 455 50491120
Amnesia 13.63 9.97 150 113399 42110 50449465
Complication associated with device 13.58 9.97 8 113541 14647 50476928
Enthesopathy 13.37 9.97 41 113508 7152 50484423
General physical health deterioration 13.32 9.97 232 113317 142202 50349373
Skin necrosis 13.16 9.97 4 113545 10863 50480712
Joint effusion 13.13 9.97 61 113488 12960 50478615
Adiposis dolorosa 13.01 9.97 8 113541 271 50491304
Axonal neuropathy 12.94 9.97 13 113536 911 50490664
Menstruation delayed 12.91 9.97 16 113533 1415 50490160
Lymphocytosis 12.91 9.97 20 113529 2182 50489393
Overlap syndrome 12.80 9.97 11 113538 631 50490944
Oral herpes 12.78 9.97 85 113464 20640 50470935
Irritability 12.67 9.97 108 113441 28318 50463257
Herpes zoster meningoencephalitis 12.62 9.97 8 113541 286 50491289
Aphasia 12.56 9.97 108 113441 28386 50463189
Procedural anxiety 12.54 9.97 11 113538 649 50490926
Flat affect 12.43 9.97 15 113534 1290 50490285
Acquired diaphragmatic eventration 12.43 9.97 9 113540 402 50491173
Death 12.42 9.97 600 112949 324779 50166796
HLA marker study positive 12.39 9.97 7 113542 202 50491373
Deep vein thrombosis 12.37 9.97 105 113444 73199 50418376
Dysphemia 12.22 9.97 20 113529 2286 50489289
Chondropathy 12.21 9.97 19 113530 2081 50489494
Therapeutic response changed 12.18 9.97 12 113537 821 50490754
Post-traumatic neck syndrome 12.12 9.97 18 113531 1892 50489683
Premature baby 12.06 9.97 14 113535 18323 50473252
Immune thrombocytopenia 12.02 9.97 46 113503 8971 50482604
Food refusal 11.96 9.97 8 113541 314 50491261
Autonomic neuropathy 11.94 9.97 13 113536 1000 50490575
Diaphragmatic paralysis 11.92 9.97 10 113539 555 50491020
Chemical burns of eye 11.88 9.97 5 113544 74 50491501
IIIrd nerve paresis 11.85 9.97 6 113543 138 50491437
Central obesity 11.85 9.97 13 113536 1009 50490566
Aorta hypoplasia 11.81 9.97 6 113543 139 50491436
Allergic sinusitis 11.71 9.97 10 113539 569 50491006
Hypoaesthesia 11.71 9.97 371 113178 126886 50364689
Blood bilirubin increased 11.70 9.97 35 113514 32003 50459572
Musculoskeletal stiffness 11.67 9.97 374 113175 128107 50363468
Vaccination site pain 11.64 9.97 5 113544 78 50491497
Pericardial effusion 11.64 9.97 25 113524 25564 50466011
Musculoskeletal pain 11.62 9.97 227 113322 71950 50419625
Gastrointestinal disorder 11.55 9.97 146 113403 94310 50397265
Wrong technique in product usage process 11.52 9.97 75 113474 55435 50436140
Vitreous detachment 11.52 9.97 17 113532 1777 50489798
Appetite disorder 11.50 9.97 35 113514 6079 50485496
Glomerulonephritis minimal lesion 11.44 9.97 7 113542 235 50491340
Ear haemorrhage 11.43 9.97 14 113535 1223 50490352
Open angle glaucoma 11.26 9.97 7 113542 242 50491333
Infrapatellar fat pad inflammation 11.02 9.97 6 113543 161 50491414
Delusion 11.01 9.97 50 113499 10519 50481056
Cholecystitis chronic 10.93 9.97 4 113545 9665 50481910
Lymphoedema 10.92 9.97 45 113504 9077 50482498
Staphylococcal infection 10.90 9.97 42 113507 35574 50456001
Respiratory acidosis 10.87 9.97 34 113515 5994 50485581
Product monitoring error 10.82 9.97 21 113528 2743 50488832
Haemophagocytic lymphohistiocytosis 10.78 9.97 3 113546 8630 50482945
Pneumonia 10.76 9.97 718 112831 377683 50113892
Adverse event 10.75 9.97 56 113493 43707 50447868
No adverse event 10.67 9.97 39 113510 33539 50458036
Foetal exposure during pregnancy 10.65 9.97 29 113520 27330 50464245
Pharyngeal mass 10.64 9.97 7 113542 267 50491308
Cystitis interstitial 10.63 9.97 14 113535 1315 50490260
Small fibre neuropathy 10.63 9.97 6 113543 173 50491402
Intestinal adenocarcinoma 10.59 9.97 6 113543 174 50491401
Asthma 10.59 9.97 269 113280 89068 50402507
Bruxism 10.58 9.97 22 113527 3018 50488557
Agranulocytosis 10.53 9.97 20 113529 21401 50470174
Intrusive thoughts 10.53 9.97 6 113543 176 50491399
Maternal condition affecting foetus 10.53 9.97 6 113543 176 50491399
Metabolic myopathy 10.50 9.97 3 113546 12 50491563
Ovarian adhesion 10.50 9.97 3 113546 12 50491563
Chronic sinusitis 10.48 9.97 34 113515 6111 50485464
Terminal insomnia 10.47 9.97 10 113539 659 50490916
Binge eating 10.45 9.97 8 113541 389 50491186
Ventricular tachycardia 10.43 9.97 66 113483 15755 50475820
Purpura 10.41 9.97 47 113502 9864 50481711
Dry eye 10.39 9.97 114 113435 31981 50459594
Naevus haemorrhage 10.38 9.97 5 113544 103 50491472
Psychotic disorder 10.32 9.97 84 113465 21728 50469847
Mastoiditis 10.31 9.97 11 113538 827 50490748
Pleural effusion 10.30 9.97 125 113424 81329 50410246
Pyelonephritis acute 10.28 9.97 26 113523 4057 50487518
Haemodialysis 10.26 9.97 3 113546 8359 50483216
Onychophagia 10.26 9.97 4 113545 48 50491527
Lagophthalmos 10.19 9.97 7 113542 287 50491288
Vaccination site erythema 10.18 9.97 4 113545 49 50491526
Duodenogastric reflux 10.18 9.97 4 113545 49 50491526
Pleural disorder 10.15 9.97 9 113540 539 50491036
Acquired cystic kidney disease 10.11 9.97 4 113545 50 50491525
Drug tolerance decreased 10.01 9.97 4 113545 9156 50482419
Neurogenic shock 9.98 9.97 7 113542 297 50491278

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
Toxicity to various agents 306.06 11.33 665 35759 172996 29365107
Serotonin syndrome 232.38 11.33 184 36240 17328 29520775
Completed suicide 155.41 11.33 343 36081 89903 29448200
Overdose 146.11 11.33 311 36113 79508 29458595
Migraine 130.33 11.33 114 36310 12316 29525787
Drug abuse 116.99 11.33 285 36139 79598 29458505
Coma 116.60 11.33 189 36235 39261 29498842
Electrocardiogram QRS complex prolonged 90.99 11.33 59 36365 4051 29534052
Intentional overdose 87.03 11.33 164 36260 38364 29499739
Poisoning deliberate 77.66 11.33 61 36363 5670 29532433
Coombs positive haemolytic anaemia 68.39 11.33 28 36396 724 29537379
Sedation 59.20 11.33 89 36335 17316 29520787
Allodynia 56.34 11.33 23 36401 590 29537513
Lymphadenitis 53.55 11.33 30 36394 1577 29536526
Suicide attempt 44.93 11.33 117 36307 33993 29504110
Somnolence 43.21 11.33 229 36195 93726 29444377
Foetal disorder 41.61 11.33 20 36404 763 29537340
Nightmare 41.15 11.33 60 36364 11357 29526746
Platelet count decreased 41.05 11.33 41 36383 104631 29433472
Confusional state 37.09 11.33 277 36147 127600 29410503
Delusion of replacement 35.77 11.33 11 36413 118 29537985
Neutropenia neonatal 35.58 11.33 17 36407 640 29537463
Nephrolithiasis 34.49 11.33 88 36336 25246 29512857
Patient dissatisfaction with treatment 31.62 11.33 9 36415 72 29538031
Colour blindness acquired 31.40 11.33 9 36415 74 29538029
Disturbance in attention 30.82 11.33 76 36348 21348 29516755
Delirium 28.61 11.33 110 36314 39287 29498816
Hyperaesthesia 27.06 11.33 27 36397 3442 29534661
Disease progression 26.83 11.33 37 36387 81879 29456224
Suicidal ideation 26.09 11.33 98 36326 34618 29503485
Sopor 25.23 11.33 47 36377 10887 29527216
Head discomfort 24.86 11.33 25 36399 3217 29534886
White blood cell count decreased 24.09 11.33 41 36383 83321 29454782
Sitting disability 23.70 11.33 8 36416 118 29537985
Febrile neutropenia 23.51 11.33 66 36358 112174 29425929
HIV peripheral neuropathy 23.49 11.33 6 36418 30 29538073
Drug ineffective for unapproved indication 23.23 11.33 53 36371 14161 29523942
Femoral nerve palsy 23.17 11.33 6 36418 32 29538071
Chemical submission 23.17 11.33 6 36418 32 29538071
Anxiety 23.09 11.33 182 36242 85183 29452920
Quality of life decreased 22.92 11.33 24 36400 3238 29534865
Foetal exposure during pregnancy 22.52 11.33 92 36332 33775 29504328
Anaemia 22.51 11.33 150 36274 200801 29337302
Drug withdrawal syndrome neonatal 22.13 11.33 24 36400 3371 29534732
Astigmatism 21.58 11.33 14 36410 962 29537141
Thoracic vertebral fracture 21.39 11.33 16 36408 1382 29536721
Alcoholic ketoacidosis 21.35 11.33 5 36419 16 29538087
Depressed level of consciousness 20.47 11.33 95 36329 36847 29501256
Muscle twitching 20.43 11.33 36 36388 7990 29530113
Hallucination, visual 20.27 11.33 52 36372 14963 29523140
Constipation 20.09 11.33 222 36202 113938 29424165
Anophthalmos 20.04 11.33 4 36420 4 29538099
Myoclonus 19.98 11.33 48 36376 13261 29524842
Hallucination 19.85 11.33 108 36316 44604 29493499
Acute lung injury 19.83 11.33 15 36409 1318 29536785
Bradyphrenia 19.50 11.33 25 36399 4189 29533914
Substance abuse 19.32 11.33 32 36392 6755 29531348
Sepsis 18.87 11.33 101 36323 142581 29395522
Acute psychosis 18.74 11.33 16 36408 1671 29536432
Agoraphobia 18.62 11.33 8 36416 234 29537869
Multiple drug therapy 18.38 11.33 9 36415 358 29537745
Haemoglobin decreased 18.35 11.33 70 36354 108305 29429798
Renal failure 17.96 11.33 80 36344 118519 29419584
Pain 17.71 11.33 303 36121 171129 29366974
Insomnia 17.68 11.33 177 36247 88584 29449519
Burning sensation 17.34 11.33 51 36373 15887 29522216
Depressed mood 17.29 11.33 52 36372 16396 29521707
Hyperhidrosis 16.57 11.33 136 36288 64404 29473699
Agitation 16.50 11.33 114 36310 51190 29486913
Hyperthermia 16.35 11.33 36 36388 9394 29528709
Skull fracture 16.21 11.33 11 36413 815 29537288
Electric shock 16.13 11.33 6 36418 119 29537984
Sedation complication 15.99 11.33 13 36411 1269 29536834
Velopharyngeal incompetence 15.83 11.33 4 36420 19 29538084
Depression 15.63 11.33 167 36257 84980 29453123
Multiple sclerosis 15.56 11.33 26 36398 5528 29532575
Mast cell degranulation present 15.53 11.33 5 36419 63 29538040
Bursitis 15.42 11.33 24 36400 4808 29533295
Brugada syndrome 15.36 11.33 10 36414 691 29537412
Headache 15.32 11.33 300 36124 173707 29364396
Victim of crime 15.32 11.33 8 36416 365 29537738
Tension headache 15.31 11.33 13 36411 1348 29536755
Hypomania 15.28 11.33 16 36408 2159 29535944
Insulin resistance 15.21 11.33 9 36415 525 29537578
Diarrhoea 15.16 11.33 304 36120 332394 29205709
Mydriasis 15.11 11.33 27 36397 6058 29532045
Device effect decreased 15.03 11.33 3 36421 3 29538100
Hypotension 15.00 11.33 160 36264 194194 29343909
Ventricular hypoplasia 14.92 11.33 5 36419 72 29538031
Thrombocytopenia 14.89 11.33 101 36323 134722 29403381
Altered state of consciousness 14.81 11.33 56 36368 19833 29518270
Post herpetic neuralgia 14.76 11.33 11 36413 945 29537158
Sensorimotor disorder 14.63 11.33 8 36416 401 29537702
Cyclic vomiting syndrome 14.52 11.33 4 36420 28 29538075
Neutropenia 14.38 11.33 99 36325 131612 29406491
Death 14.29 11.33 317 36107 341767 29196336
Sleep deficit 14.01 11.33 8 36416 436 29537667
Facial pain 13.99 11.33 14 36410 1791 29536312
Dysarthria 13.94 11.33 75 36349 30836 29507267
Lower respiratory tract infection 13.84 11.33 67 36357 26435 29511668
Agitation neonatal 13.79 11.33 11 36413 1045 29537058
Haemolysis 13.73 11.33 28 36396 6928 29531175
Panic attack 13.56 11.33 31 36393 8295 29529808
Chylothorax 13.54 11.33 9 36415 644 29537459
Tongue spasm 13.26 11.33 4 36420 40 29538063
Behaviour disorder 13.02 11.33 19 36405 3597 29534506
Cardiotoxicity 13.02 11.33 22 36402 4722 29533381
Neuralgia 13.00 11.33 36 36388 10838 29527265
Lid lag 12.95 11.33 3 36421 9 29538094
Tremor 12.92 11.33 143 36281 73395 29464708
Hepatocellular injury 12.79 11.33 56 36368 21187 29516916
Interstitial lung disease 12.78 11.33 33 36391 57685 29480418
Benzodiazepine drug level therapeutic 12.60 11.33 4 36420 48 29538055
Respiratory depression 12.60 11.33 41 36383 13482 29524621
Neck pain 12.51 11.33 56 36368 21391 29516712
Mucocutaneous disorder 12.48 11.33 5 36419 122 29537981
Victim of homicide 12.48 11.33 5 36419 122 29537981
Asphyxia 12.45 11.33 23 36401 5292 29532811
Sports injury 12.29 11.33 5 36419 127 29537976
Colour blindness 12.27 11.33 6 36418 238 29537865
Clumsiness 12.26 11.33 12 36412 1494 29536609
Faecaloma 12.22 11.33 20 36404 4182 29533921
Anaemia of malignant disease 12.14 11.33 7 36417 389 29537714
Clonic convulsion 11.98 11.33 8 36416 577 29537526
Temperature regulation disorder 11.97 11.33 8 36416 578 29537525
Pneumocystis jirovecii pneumonia 11.88 11.33 3 36421 16776 29521327
Hyponatraemic seizure 11.85 11.33 4 36420 59 29538044
Neurosis 11.74 11.33 5 36419 143 29537960
Atrial fibrillation 11.73 11.33 79 36345 105567 29432536
Oedema peripheral 11.72 11.33 77 36347 103480 29434623
Loss of consciousness 11.66 11.33 141 36283 73915 29464188
Drug dependence 11.65 11.33 54 36370 20927 29517176
Disseminated intravascular coagulation 11.65 11.33 5 36419 19975 29518128
Fall 11.64 11.33 293 36131 176885 29361218
Blood bilirubin increased 11.40 11.33 15 36409 33878 29504225
Cardiac failure congestive 11.38 11.33 52 36372 76529 29461574

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
Toxicity to various agents 696.45 9.97 1989 132184 361524 64003035
Completed suicide 445.34 9.97 1245 132928 223169 64141390
Sedation complication 345.91 9.97 234 133939 10120 64354439
Sedation 333.11 9.97 421 133752 41041 64323518
Serotonin syndrome 326.97 9.97 406 133767 38876 64325683
Cognitive disorder 284.67 9.97 453 133720 54634 64309925
Creatinine renal clearance decreased 258.50 9.97 225 133948 14196 64350363
Coma 236.92 9.97 547 133626 87068 64277491
Migraine 233.26 9.97 446 133727 62231 64302328
Electrocardiogram QRS complex prolonged 230.78 9.97 175 133998 9069 64355490
Balance disorder 219.29 9.97 517 133656 83409 64281150
Orthostatic hypotension 212.69 9.97 363 133810 46375 64318184
Drug abuse 207.97 9.97 677 133496 131697 64232862
Depressed level of consciousness 207.72 9.97 497 133676 80939 64283620
Overdose 204.69 9.97 763 133410 158803 64205756
Blood calcium decreased 191.90 9.97 251 133922 25303 64339256
Poisoning deliberate 148.71 9.97 161 134012 13297 64351262
Platelet count decreased 122.91 9.97 101 134072 167610 64196949
Intentional overdose 120.18 9.97 436 133737 89508 64275051
Febrile neutropenia 113.34 9.97 134 134039 187523 64177036
Constipation 112.78 9.97 840 133333 228497 64136062
Fibromyalgia 111.08 9.97 236 133937 35495 64329064
Neutropenia 109.00 9.97 208 133965 239416 64125143
Mydriasis 99.17 9.97 140 134033 15172 64349387
Anticholinergic syndrome 98.03 9.97 64 134109 2605 64361954
Anaemia 92.53 9.97 439 133734 378241 63986318
Disturbance in attention 91.34 9.97 238 133935 40836 64323723
Somnolence 89.60 9.97 727 133446 202918 64161641
Impaired work ability 88.16 9.97 132 134041 15087 64349472
Systemic lupus erythematosus 84.46 9.97 28 134145 77584 64286975
Suicidal ideation 83.38 9.97 316 133857 66226 64298333
Fall 82.75 9.97 1271 132902 415555 63949004
Glossodynia 82.46 9.97 17 134156 64679 64299880
Nightmare 80.05 9.97 151 134022 20842 64343717
Gastric pH decreased 79.26 9.97 36 134137 699 64363860
Derealisation 73.06 9.97 43 134130 1452 64363107
Suicide attempt 71.37 9.97 315 133858 70692 64293867
Anxiety 70.83 9.97 688 133485 201961 64162598
Arthropathy 70.24 9.97 89 134084 120878 64243681
Synovial fluid analysis 68.57 9.97 42 134131 1527 64363032
Feeling jittery 68.52 9.97 97 134076 10538 64354021
Hand deformity 67.68 9.97 23 134150 62748 64301811
Tenosynovitis stenosans 67.14 9.97 45 134128 1915 64362644
Rubber sensitivity 66.91 9.97 39 134134 1293 64363266
Drug ineffective for unapproved indication 66.78 9.97 178 133995 30955 64333604
Mobility decreased 66.25 9.97 353 133820 85487 64279072
Withdrawal syndrome 64.90 9.97 148 134025 23344 64341215
Cytomegalovirus infection 64.65 9.97 3 134170 37196 64327363
Bursitis 64.58 9.97 140 134033 21345 64343214
Depressed mood 63.63 9.97 209 133964 40803 64323756
Scleritis 62.90 9.97 51 134122 2915 64361644
Thrombocytopenia 62.82 9.97 246 133927 223555 64141004
Confusional state 62.41 9.97 823 133350 260321 64104238
Pericarditis 62.23 9.97 26 134147 62490 64302069
Aspartate aminotransferase increased 60.76 9.97 97 134076 119691 64244868
Duodenal ulcer perforation 59.51 9.97 3 134170 34622 64329937
Restless legs syndrome 59.02 9.97 118 134055 16998 64347561
Hallucination, visual 58.55 9.97 158 134015 27676 64336883
Feeling of despair 58.39 9.97 46 134127 2522 64362037
Hallucinations, mixed 57.61 9.97 67 134106 5985 64358574
Hyperhidrosis 56.54 9.97 449 133724 124471 64240088
Atrial fibrillation 56.09 9.97 176 133997 170913 64193646
Lip pruritus 53.12 9.97 27 134146 678 64363881
Tinnitus 53.00 9.97 174 133999 33959 64330600
Agitation 52.39 9.97 339 133834 88028 64276531
Dissociation 51.99 9.97 46 134127 2965 64361594
Poor quality sleep 51.92 9.97 119 134054 18832 64345727
Alanine aminotransferase increased 51.45 9.97 135 134038 138896 64225663
Coombs positive haemolytic anaemia 50.26 9.97 28 134145 850 64363709
H1N1 influenza 50.25 9.97 40 134133 2226 64362333
Medication overuse headache 50.05 9.97 26 134147 684 64363875
Sacroiliitis 49.99 9.97 45 134128 2967 64361592
Disease progression 49.86 9.97 141 134032 141539 64223020
Rheumatoid factor positive 49.32 9.97 7 134166 34931 64329628
Sepsis 48.88 9.97 280 133893 230061 64134498
Paraesthesia 48.59 9.97 460 133713 134062 64230497
Emotional disorder 48.46 9.97 91 134082 12516 64352043
Cogwheel rigidity 48.10 9.97 43 134130 2810 64361749
Dystonia 47.91 9.97 115 134058 18750 64345809
Wound 47.88 9.97 53 134120 76424 64288135
Body tinea 47.47 9.97 31 134142 1262 64363297
Persistent genital arousal disorder 46.67 9.97 18 134155 227 64364332
Cardiac failure congestive 46.65 9.97 129 134044 130451 64234108
Pain 46.46 9.97 1492 132681 552019 63812540
Somatic symptom disorder 45.82 9.97 35 134138 1833 64362726
Electrocardiogram QT prolonged 45.40 9.97 302 133871 79146 64285413
Allodynia 45.26 9.97 30 134143 1253 64363306
Parosmia 45.23 9.97 52 134121 4588 64359971
Pleuritic pain 45.16 9.97 69 134104 8027 64356532
Abdominal discomfort 44.65 9.97 211 133962 182111 64182448
Multiple organ dysfunction syndrome 44.35 9.97 90 134083 101323 64263236
White blood cell count decreased 43.94 9.97 174 133999 157663 64206896
Swollen tongue 43.77 9.97 166 134007 34788 64329771
Feeling of body temperature change 43.68 9.97 52 134121 4762 64359797
Muscle injury 43.28 9.97 3 134170 26434 64338125
Muscle twitching 43.17 9.97 111 134062 18887 64345672
Depersonalisation/derealisation disorder 43.05 9.97 32 134141 1608 64362951
Eye pain 42.80 9.97 154 134019 31471 64333088
Vision blurred 42.16 9.97 327 133846 89989 64274570
Hypersensitivity 42.11 9.97 238 133935 196214 64168345
Insomnia 41.75 9.97 610 133563 197226 64167333
Dizziness 41.56 9.97 1180 132993 428983 63935576
Tremor 41.33 9.97 481 133692 147749 64216810
Renal failure 41.20 9.97 216 133957 181472 64183087
Haemoglobin decreased 40.90 9.97 238 133935 194825 64169734
Bradypnoea 40.80 9.97 52 134121 5107 64359452
Malignant neoplasm progression 39.95 9.97 112 134061 112759 64251800
Dry mouth 39.69 9.97 238 133935 60180 64304379
Delirium 39.52 9.97 263 133910 68931 64295628
Neovascularisation 39.41 9.97 26 134147 1077 64363482
Flank pain 38.26 9.97 96 134077 16093 64348466
Blood creatinine increased 38.23 9.97 149 134024 135633 64228926
Myoclonus 38.06 9.97 127 134046 24991 64339568
Neuralgia 37.58 9.97 130 134043 26054 64338505
Photophobia 37.21 9.97 99 134074 17194 64347365
Swelling face 36.93 9.97 230 133943 58936 64305623
Hyperaesthesia 36.90 9.97 71 134102 9943 64354616
Neutrophil count decreased 36.83 9.97 65 134108 77131 64287428
Menstrual disorder 36.72 9.97 40 134133 3325 64361234
Malaise 36.62 9.97 1081 133092 395166 63969393
Sopor 36.43 9.97 140 134033 29521 64335038
Crystal nephropathy 36.19 9.97 26 134147 1239 64363320
Pituitary tumour benign 35.60 9.97 33 134140 2260 64362299
Loss of consciousness 35.56 9.97 468 133705 147897 64216662
Myelosuppression 35.51 9.97 4 134169 23826 64340733
Sensory loss 34.93 9.97 70 134103 10099 64354460
Cestode infection 34.42 9.97 15 134158 263 64364296
Psychotic disorder due to a general medical condition 34.26 9.97 15 134158 266 64364293
Drug withdrawal syndrome 33.88 9.97 142 134031 31149 64333410
Synovitis 33.84 9.97 100 134073 98990 64265569
Palpitations 33.68 9.97 349 133824 104139 64260420
Dysarthria 33.44 9.97 225 133948 59181 64305378
Pyrexia 33.37 9.97 896 133277 557748 63806811
Maternal exposure during pregnancy 33.30 9.97 96 134077 95788 64268771
Cervix neoplasm 32.81 9.97 13 134160 177 64364382
Hallucination 32.57 9.97 261 133912 72527 64292032
Infection susceptibility increased 32.57 9.97 34 134139 2692 64361867
Alopecia 31.69 9.97 208 133965 165482 64199077
Muscle disorder 31.66 9.97 45 134128 4906 64359653
Autonomic dysreflexia 31.65 9.97 16 134157 397 64364162
Multiple sclerosis relapse 31.61 9.97 169 134004 40966 64323593
Crepitations 31.51 9.97 58 134115 7857 64356702
Renal impairment 31.46 9.97 159 134014 134858 64229701
Akathisia 31.22 9.97 72 134101 11438 64353121
Haemorrhage 30.93 9.97 75 134098 79276 64285283
Oedema peripheral 30.88 9.97 284 133889 210033 64154526
Septic shock 30.77 9.97 114 134059 105323 64259236
Bone marrow failure 30.27 9.97 33 134140 47919 64316640
Synovial cyst 30.08 9.97 56 134117 7651 64356908
Dehydration 29.58 9.97 298 133875 216465 64148094
Inhibitory drug interaction 29.38 9.97 37 134136 3590 64360969
Therapy non-responder 29.22 9.97 58 134115 65841 64298718
Cardiac failure 29.10 9.97 159 134014 132214 64232345
Hepatic function abnormal 29.04 9.97 56 134117 64257 64300302
C-reactive protein abnormal 29.04 9.97 12 134161 29035 64335524
Respiratory failure 29.01 9.97 206 133967 160977 64203582
Pancytopenia 28.90 9.97 177 133996 143132 64221427
Musculoskeletal stiffness 28.84 9.97 387 133786 122819 64241740
Neck pain 28.83 9.97 223 133950 61310 64303249
Blood glucose increased 28.65 9.97 106 134067 97967 64266592
Impaired reasoning 28.65 9.97 10 134163 93 64364466
Leukopenia 28.55 9.97 111 134062 101131 64263428
Tachycardia 28.38 9.97 453 133720 149126 64215433
Pneumonia 28.29 9.97 918 133255 558658 63805901
Tension headache 28.18 9.97 35 134138 3348 64361211
Delusion of replacement 28.15 9.97 11 134162 144 64364415
Premenstrual syndrome 28.07 9.97 16 134157 508 64364051
Hyperlactacidaemia 28.03 9.97 42 134131 4802 64359757
Therapeutic product ineffective 27.90 9.97 24 134149 1489 64363070
Pleural effusion 27.82 9.97 152 134021 126407 64238152
Drooling 27.81 9.97 44 134129 5275 64359284
Folliculitis 27.62 9.97 14 134159 30063 64334496
Speech disorder 27.58 9.97 184 133989 48257 64316302
Visual impairment 27.57 9.97 255 133918 73822 64290737
Respiratory depression 27.45 9.97 109 134064 23334 64341225
Blood bilirubin increased 26.97 9.97 49 134124 57504 64307055
Eyelid exfoliation 26.91 9.97 10 134163 113 64364446
Sleep disorder 26.66 9.97 214 133959 59495 64305064
Feeling abnormal 26.63 9.97 408 133765 133194 64231365
Haematuria 26.15 9.97 54 134119 60417 64304142
Tenderness 26.14 9.97 95 134078 19507 64345052
Clear cell renal cell carcinoma 25.72 9.97 27 134146 2152 64362407
Brain injury 25.57 9.97 61 134112 9904 64354655
Disseminated intravascular coagulation 25.57 9.97 18 134155 32330 64332229
Cardio-respiratory arrest 25.53 9.97 315 133858 98078 64266481
Pneumocystis jirovecii pneumonia 25.17 9.97 13 134160 27621 64336938
Deep vein thrombosis 24.99 9.97 123 134050 105059 64259500
General physical health deterioration 24.69 9.97 289 133884 204136 64160423
Cushingoid 24.53 9.97 51 134122 7552 64357007
Dyskinesia 24.50 9.97 153 134020 39235 64325324
Diarrhoea 24.43 9.97 1242 132931 721462 63643097
Drug dependence 24.34 9.97 135 134038 33177 64331382
Urinary retention 23.99 9.97 180 133993 49021 64315538
Pulmonary eosinophilia 23.96 9.97 15 134158 567 64363992
Diaphragmatic rupture 23.92 9.97 11 134162 220 64364339
Red blood cell sedimentation rate increased 23.88 9.97 18 134155 31217 64333342
Muscle spasms 23.78 9.97 419 133754 140604 64223955
Hypoaesthesia oral 23.62 9.97 65 134108 11515 64353044
Condition aggravated 23.60 9.97 592 133581 371834 63992725
Heart sounds 23.48 9.97 15 134158 588 64363971
Diet failure 23.45 9.97 7 134166 37 64364522
Hepatic enzyme increased 23.41 9.97 166 134007 129777 64234782
Gastrointestinal haemorrhage 23.37 9.97 170 134003 132142 64232417
Biliary sepsis 23.04 9.97 21 134152 1407 64363152
Haematoma 22.92 9.97 38 134135 46212 64318347
Paralysis 22.58 9.97 64 134109 11531 64353028
Infusion related reaction 22.47 9.97 226 133947 164241 64200318
Peritonitis 22.45 9.97 12 134161 25011 64339548
Circulatory collapse 22.23 9.97 133 134040 33599 64330960
Blood urea increased 22.14 9.97 36 134137 44117 64320442
Oedema 22.14 9.97 107 134066 91828 64272731
Patient dissatisfaction with treatment 21.99 9.97 9 134164 134 64364425
Tension 21.80 9.97 33 134140 3807 64360752
Pulmonary hypertension 21.80 9.97 35 134138 43104 64321455
Haemophagocytic lymphohistiocytosis 21.68 9.97 5 134168 17604 64346955
Memory impairment 21.67 9.97 273 133900 85409 64279150
Aspergillus infection 21.51 9.97 4 134169 16375 64348184
Exposure during pregnancy 21.37 9.97 86 134087 77589 64286970
Pulmonary embolism 21.31 9.97 198 133975 146158 64218401
Contraindicated product administered 21.31 9.97 134 134039 107695 64256864
Myocardial infarction 20.97 9.97 232 133941 165589 64198970
Thymus disorder 20.92 9.97 10 134163 219 64364340
Death 20.91 9.97 807 133366 481898 63882661
Oesophageal spasm 20.84 9.97 26 134147 2499 64362060
Haemodialysis 20.72 9.97 5 134168 17072 64347487
Device expulsion 20.70 9.97 9 134164 21127 64343432
Sinus tachycardia 20.63 9.97 126 134047 32062 64332497
Bone density decreased 20.43 9.97 56 134117 9896 64354663
Hyperthermia 20.43 9.97 75 134098 15475 64349084
Vulvovaginal swelling 20.36 9.97 11 134162 314 64364245
Mood swings 20.27 9.97 81 134092 17387 64347172
Lichen sclerosus 20.25 9.97 16 134157 881 64363678
Shock haemorrhagic 20.21 9.97 5 134168 16786 64347773
Polymenorrhoea 20.04 9.97 16 134157 894 64363665
Premature labour 19.94 9.97 47 134126 7573 64356986
Mental disorder 19.88 9.97 108 134065 26337 64338222
CYP3A4 polymorphism 19.60 9.97 7 134166 70 64364489
Respiratory arrest 19.52 9.97 182 133991 52803 64311756
Cerebellar stroke 19.47 9.97 12 134161 441 64364118
Anaemia of malignant disease 19.47 9.97 14 134159 668 64363891
HIV peripheral neuropathy 19.46 9.97 6 134167 36 64364523
Magnesium deficiency 19.46 9.97 13 134160 550 64364009
Bradyphrenia 19.38 9.97 53 134120 9353 64355206
Lymphadenitis 19.36 9.97 31 134142 3754 64360805
Prolonged expiration 19.27 9.97 15 134158 808 64363751
Impaired healing 19.25 9.97 63 134110 60410 64304149
Hypoaesthesia 19.24 9.97 401 133772 138707 64225852
Drug interaction 19.20 9.97 929 133244 361154 64003405
Cerebral infarction 19.18 9.97 35 134138 41009 64323550
Cyanosis 19.10 9.97 94 134079 22061 64342498
Antinuclear antibody positive 19.09 9.97 41 134132 6209 64358350
CFTR gene mutation 19.09 9.97 7 134166 76 64364483
Enterococcal infection 19.06 9.97 3 134170 13863 64350696
Subclavian artery embolism 18.99 9.97 5 134168 15 64364544
Tenosynovitis 18.98 9.97 61 134112 11772 64352787
Wrist deformity 18.96 9.97 21 134152 1779 64362780
Headache 18.95 9.97 1311 132862 528156 63836403
Bronchopulmonary aspergillosis 18.89 9.97 8 134165 19077 64345482
Tubulointerstitial nephritis and uveitis syndrome 18.88 9.97 10 134163 274 64364285
Depression 18.82 9.97 507 133666 182784 64181775
Pericardial effusion 18.77 9.97 33 134140 39221 64325338
Alcoholic ketoacidosis 18.75 9.97 5 134168 16 64364543
Unevaluable event 18.68 9.97 49 134124 50440 64314119
Myelodysplastic syndrome 18.51 9.97 18 134155 27561 64336998
Off label use 18.49 9.97 1103 133070 631703 63732856
Hospitalisation 18.41 9.97 87 134086 75120 64289439
Limb injury 18.35 9.97 97 134076 23408 64341151
Glucose tolerance impaired 18.25 9.97 41 134132 6402 64358157
Incontinence 18.23 9.97 61 134112 12020 64352539
Sensitivity to weather change 18.21 9.97 42 134131 6672 64357887
Drug resistance 18.19 9.97 28 134145 35074 64329485
Poliomyelitis 18.09 9.97 6 134167 47 64364512
Anterograde amnesia 17.96 9.97 13 134160 627 64363932
Mood altered 17.68 9.97 73 134100 15906 64348653
Soft tissue injury 17.63 9.97 19 134154 1560 64362999
Postural orthostatic tachycardia syndrome 17.63 9.97 12 134161 524 64364035
Plasma cell myeloma 17.60 9.97 44 134129 46031 64318528
Multiple sclerosis 17.51 9.97 82 134091 18859 64345700
International normalised ratio increased 17.44 9.97 95 134078 79072 64285487
Agoraphobia 17.41 9.97 12 134161 535 64364024
Staphylococcal infection 17.40 9.97 51 134122 50627 64313932
Conjunctivitis 17.29 9.97 86 134087 20268 64344291
Injection site erythema 17.28 9.97 82 134091 70718 64293841
Oesophageal pain 17.07 9.97 27 134146 3236 64361323
Hostility 17.07 9.97 22 134151 2185 64362374
Interstitial lung disease 17.05 9.97 126 134047 97606 64266953
Dry eye 16.99 9.97 111 134062 28908 64335651
Femoral nerve palsy 16.89 9.97 6 134167 59 64364500
Sternal fracture 16.75 9.97 22 134151 2225 64362334
Depressive symptom 16.72 9.97 32 134141 4464 64360095
Vaccination site bruising 16.68 9.97 4 134169 7 64364552
Blood lactate dehydrogenase increased 16.56 9.97 27 134146 33051 64331508
Accidental overdose 16.49 9.97 123 134050 33434 64331125
Infection 16.41 9.97 278 133895 184602 64179957
Vaccination site oedema 16.33 9.97 4 134169 8 64364551
Vaccination site pruritus 16.33 9.97 4 134169 8 64364551
Genital infection female 16.21 9.97 6 134167 67 64364492
Hot flush 16.13 9.97 157 134016 46078 64318481
Burning sensation 16.05 9.97 166 134007 49498 64315061
Panic attack 16.04 9.97 86 134087 20867 64343692
Substance abuse 15.91 9.97 49 134124 9243 64355316
Palmar-plantar erythrodysaesthesia syndrome 15.90 9.97 22 134151 28797 64335762
Sleep deficit 15.89 9.97 14 134159 897 64363662
Discomfort 15.72 9.97 101 134072 80777 64283782
Personality disorder 15.67 9.97 32 134141 4679 64359880
Ascites 15.61 9.97 71 134102 61930 64302629
Vascular malformation 15.59 9.97 9 134164 293 64364266
Abnormal loss of weight 15.55 9.97 42 134131 7358 64357201
Respiration abnormal 15.50 9.97 38 134135 6277 64358282
Decreased appetite 15.50 9.97 456 133717 280833 64083726
Post procedural complication 15.45 9.97 13 134160 21340 64343219
Illness 15.43 9.97 88 134085 21850 64342709
Restlessness 15.33 9.97 138 134035 39647 64324912
Vestibular migraine 15.27 9.97 7 134166 139 64364420
Hyperprolactinaemia 15.20 9.97 29 134144 4036 64360523
Product use issue 15.18 9.97 223 133950 151492 64213067
Acute myeloid leukaemia 15.12 9.97 21 134152 27442 64337117
Femoral artery dissection 15.09 9.97 5 134168 39 64364520
Respiratory distress 14.99 9.97 57 134116 52274 64312285
Musculoskeletal pain 14.96 9.97 245 133928 81049 64283510
Peripheral circulatory failure 14.90 9.97 12 134161 679 64363880
Impaired quality of life 14.90 9.97 38 134135 6433 64358126
Dyspnoea exertional 14.89 9.97 91 134082 73639 64290920
Menstruation delayed 14.83 9.97 15 134158 1144 64363415
Sitting disability 14.82 9.97 7 134166 149 64364410
Norovirus infection 14.82 9.97 8 134165 228 64364331
Cytokine release syndrome 14.68 9.97 13 134160 20816 64343743
White blood cell count increased 14.66 9.97 79 134094 65935 64298624
Rectal cancer metastatic 14.64 9.97 10 134163 439 64364120
Oliguria 14.60 9.97 6 134167 14570 64349989
Faecaloma 14.57 9.97 49 134124 9679 64354880
Cytopenia 14.51 9.97 7 134166 15464 64349095
Paranasal cyst 14.50 9.97 9 134164 335 64364224
Accidental death 14.45 9.97 27 134146 3698 64360861
Pulmonary arterial hypertension 14.37 9.97 19 134154 25348 64339211
Wrong patient received product 14.26 9.97 27 134146 3735 64360824
Coma scale abnormal 14.26 9.97 42 134131 7732 64356827
Agranulocytosis 14.22 9.97 37 134136 38192 64326367
Drug eruption 14.20 9.97 34 134139 36102 64328457
Eye irritation 14.19 9.97 68 134105 15788 64348771
Disorientation 14.16 9.97 178 133995 55650 64308909
Asthenia 14.14 9.97 737 133436 427307 63937252
Viral diarrhoea 14.12 9.97 8 134165 251 64364308
Libido increased 14.09 9.97 18 134155 1772 64362787
Lymphoedema 14.06 9.97 49 134124 9856 64354703
Myofascial pain syndrome 14.02 9.97 18 134155 1780 64362779
Schizophrenia 13.95 9.97 53 134120 11115 64353444
Dialysis 13.93 9.97 9 134164 16911 64347648
Tumour lysis syndrome 13.86 9.97 12 134161 19428 64345131
Heart rate increased 13.82 9.97 285 133888 98390 64266169
Pulmonary haemorrhage 13.79 9.97 5 134168 13104 64351455
Wrong technique in product usage process 13.75 9.97 79 134094 64895 64299664
Concussion 13.72 9.97 42 134131 7896 64356663
Multiple drug therapy 13.70 9.97 20 134153 2234 64362325
Joint effusion 13.70 9.97 60 134113 13413 64351146
Anti-neutrophil cytoplasmic antibody positive vasculitis 13.61 9.97 23 134150 2913 64361646
Adiposis dolorosa 13.57 9.97 8 134165 271 64364288
Pregnancy 13.57 9.97 14 134159 20851 64343708
Knee arthroplasty 13.55 9.97 22 134151 26977 64337582
Acute lung injury 13.47 9.97 22 134151 2709 64361850
Procedural anxiety 13.43 9.97 11 134162 638 64363921
Renal mass 13.37 9.97 22 134151 2725 64361834
Dyspepsia 13.31 9.97 238 133935 80074 64284485
Nodule 13.29 9.97 73 134100 17874 64346685
Ventricular tachycardia 13.28 9.97 119 134054 34146 64330413
Post-traumatic neck syndrome 13.23 9.97 18 134155 1884 64362675
Anaphylactic shock 13.18 9.97 27 134146 30301 64334258
Hypovolaemia 13.07 9.97 8 134165 15478 64349081
Labelled drug-drug interaction issue 13.02 9.97 9 134164 403 64364156
Lip swelling 12.98 9.97 112 134061 31795 64332764
Mast cell degranulation present 12.97 9.97 5 134168 63 64364496
SLE arthritis 12.95 9.97 10 134163 532 64364027
Hyperbilirubinaemia 12.94 9.97 15 134158 21190 64343369
Swelling 12.92 9.97 245 133928 159973 64204586
Liver disorder 12.89 9.97 62 134111 53289 64311270
Pharyngeal oedema 12.75 9.97 65 134108 15466 64349093
Product dose omission issue 12.74 9.97 308 133865 194439 64170120
Dysphemia 12.60 9.97 23 134150 3096 64361463
Myoglobin urine 12.58 9.97 4 134169 27 64364532
Injection site swelling 12.53 9.97 44 134129 41309 64323250
Allergy to chemicals 12.51 9.97 13 134160 1024 64363535
Hypovolaemic shock 12.47 9.97 3 134170 10263 64354296
Acquired diaphragmatic eventration 12.46 9.97 10 134163 563 64363996
Hepatic failure 12.46 9.97 66 134107 55328 64309231
Therapeutic product effect decreased 12.45 9.97 167 134006 115184 64249375
Vertigo 12.44 9.97 182 133991 58829 64305730
Lenticular opacities 12.41 9.97 9 134164 435 64364124
Blood pressure decreased 12.37 9.97 117 134056 86082 64278477
COVID-19 12.33 9.97 82 134091 65058 64299501
Abdominal pain 12.31 9.97 780 133393 311595 64052964
Binge eating 12.31 9.97 9 134164 441 64364118
Amnesia 12.28 9.97 154 134019 48115 64316444
Maternal condition affecting foetus 12.28 9.97 6 134167 138 64364421
Head discomfort 12.26 9.97 53 134120 11781 64352778
Neurotoxicity 12.25 9.97 24 134149 27380 64337179
Right ventricular failure 12.24 9.97 16 134157 21455 64343104
Food refusal 12.22 9.97 9 134164 446 64364113
Injection site bruising 12.20 9.97 37 134136 36336 64328223
Dental restoration failure 12.19 9.97 10 134163 581 64363978
Gout 12.17 9.97 16 134157 21397 64343162
Ejection fraction decreased 12.10 9.97 26 134147 28681 64335878
Hip arthroplasty 12.08 9.97 16 134157 21335 64343224
Vaccination site pain 12.06 9.97 5 134168 77 64364482
Autonomic neuropathy 12.05 9.97 16 134157 1636 64362923
Lymphadenopathy 12.03 9.97 53 134120 46633 64317926
Thoracic vertebral fracture 11.82 9.97 28 134145 4525 64360034
Allergic sinusitis 11.82 9.97 9 134164 469 64364090
Phonophobia 11.79 9.97 9 134164 471 64364088
Small fibre neuropathy 11.74 9.97 7 134166 242 64364317
Bacteriuria 11.71 9.97 12 134161 930 64363629
Psychotic symptom 11.61 9.97 18 134155 2120 64362439
Muscle rigidity 11.58 9.97 69 134104 17404 64347155
Cystitis interstitial 11.57 9.97 13 134160 1119 64363440
Pulmonary alveolar haemorrhage 11.53 9.97 3 134170 9735 64354824
Sports injury 11.44 9.97 6 134167 161 64364398
Infrapatellar fat pad inflammation 11.44 9.97 6 134167 161 64364398
Hypervolaemia 11.43 9.97 41 134132 38244 64326315
Enlarged uvula 11.42 9.97 8 134165 366 64364193
Laryngeal dyspnoea 11.39 9.97 7 134166 256 64364303
Breath sounds abnormal 11.38 9.97 5 134168 11664 64352895
Large intestine perforation 11.37 9.97 6 134167 12598 64351961
Rash 11.36 9.97 811 133362 457738 63906821
Sinoatrial block 11.25 9.97 13 134160 1153 64363406
Parkinsonian rest tremor 11.17 9.97 7 134166 265 64364294
Complication associated with device 11.13 9.97 9 134164 15071 64349488
Behaviour disorder 11.11 9.97 27 134146 4435 64360124
Post-traumatic stress disorder 11.07 9.97 26 134147 4179 64360380
Pharyngeal mass 11.01 9.97 7 134166 272 64364287
Second primary malignancy 10.95 9.97 6 134167 12331 64352228
Acute generalised exanthematous pustulosis 10.88 9.97 8 134165 14050 64350509
Oxalosis 10.78 9.97 5 134168 102 64364457
Plicated tongue 10.78 9.97 5 134168 102 64364457
Oral herpes 10.77 9.97 81 134092 22071 64342488
Haematocrit decreased 10.75 9.97 68 134105 54587 64309972
Naevus haemorrhage 10.74 9.97 5 134168 103 64364456
On and off phenomenon 10.72 9.97 19 134154 2500 64362059
Chemical burns of eye 10.69 9.97 5 134168 104 64364455
Basal cell carcinoma 10.61 9.97 31 134142 30807 64333752
Benzodiazepine drug level therapeutic 10.55 9.97 4 134169 48 64364511
Hyperuricaemia 10.53 9.97 4 134169 10187 64354372
Irritable bowel syndrome 10.51 9.97 41 134132 37328 64327231
Graft versus host disease 10.51 9.97 8 134165 13805 64350754
Victim of crime 10.47 9.97 8 134165 419 64364140
Judgement impaired 10.42 9.97 12 134161 1061 64363498
Secondary adrenocortical insufficiency 10.38 9.97 18 134155 2327 64362232
Dry age-related macular degeneration 10.35 9.97 6 134167 197 64364362
Duodenogastric reflux 10.33 9.97 4 134169 51 64364508
Organising pneumonia 10.33 9.97 3 134170 9052 64355507
Breast disorder 10.32 9.97 15 134158 1669 64362890
Peritonitis bacterial 10.31 9.97 3 134170 9040 64355519
Hypotension 10.26 9.97 923 133250 380051 63984508
Hypoalbuminaemia 10.25 9.97 13 134160 17661 64346898
Pulseless electrical activity 10.24 9.97 53 134120 12686 64351873
Hepatomegaly 10.24 9.97 12 134161 16870 64347689
Metastases to lung 10.20 9.97 10 134163 15254 64349305
Vaccination site erythema 10.13 9.97 4 134169 54 64364505
Antinuclear antibody 10.10 9.97 8 134165 442 64364117
Vitreous detachment 10.05 9.97 16 134157 1928 64362631
Hyperammonaemia 10.05 9.97 4 134169 9900 64354659
Bacteraemia 10.05 9.97 26 134147 26885 64337674
Skin necrosis 10.03 9.97 9 134164 14320 64350239
Hypotonia 9.97 9.97 48 134125 11164 64353395

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Telangiectasia congenital 31.08 31.00 9 328 18 84323

Pharmacologic Action:

SourceCodeDescription
ATC N06AA09 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Non-selective monoamine reuptake inhibitors
ATC N06CA01 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOLEPTICS AND PSYCHOANALEPTICS IN COMBINATION
Antidepressants in combination with psycholeptics
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35640 adrenergic uptake inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:140489 TrkB receptor agonist
MeSH PA D018663 Adrenergic Agents
MeSH PA D018759 Adrenergic Uptake Inhibitors
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000928 Antidepressive Agents
MeSH PA D000929 Antidepressive Agents, Tricyclic
MeSH PA D002491 Central Nervous System Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
FDA EPC N0000175752 Tricyclic Antidepressant

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

DiseaseRelationSNOMED_IDDOID
Depressive disorder indication 35489007
Mixed anxiety and depressive disorder indication 231504006
Posttraumatic stress disorder off-label use 47505003 DOID:2055
Bulimia nervosa off-label use 78004001
Fibromyalgia off-label use 203082005 DOID:631
Neuropathic pain off-label use 247398009
Migraine Prevention off-label use
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Organophosphate poisoning contraindication 8260003
Weight gain finding contraindication 8943002
Sinus tachycardia contraindication 11092001
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Chronic disease of respiratory system contraindication 17097001
Disorder of lung contraindication 19829001 DOID:850
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Parkinsonism contraindication 32798002
Hyperthyroidism contraindication 34486009 DOID:7998
Hyperactive behavior contraindication 44548000
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Paralytic ileus contraindication 55525008 DOID:8442
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Extrapyramidal disease contraindication 76349003
Hyperglycemia contraindication 80394007 DOID:4195
Chronic idiopathic constipation contraindication 82934008
Open-angle glaucoma contraindication 84494001 DOID:1067
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Stupor contraindication 89458003
Kidney disease contraindication 90708001 DOID:557
Tardive dyskinesia contraindication 102449007
Prolonged QT interval contraindication 111975006
Hypoalbuminemia contraindication 119247004
Acute disease of cardiovascular system contraindication 128487001
Bipolar affective disorder, current episode manic contraindication 191618007
Angina pectoris contraindication 194828000
Disease of liver contraindication 235856003 DOID:409
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Syncope contraindication 271594007
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Severe chronic obstructive pulmonary disease contraindication 313299006
Coma contraindication 371632003
At risk for aspiration contraindication 371736008
Angle-closure glaucoma contraindication 392291006 DOID:13550
Visual impairment contraindication 397540003
Breastfeeding (mother) contraindication 413712001
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Myocardial infarction in recovery phase contraindication 418044006
Porphyria contraindication 418470004
Congenital long QT syndrome contraindication 442917000
Carcinoma of female breast contraindication 447782002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.66 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Kd 7.46 WOMBAT-PK CHEMBL
Sodium-dependent serotonin transporter Transporter INHIBITOR Kd 8.37 WOMBAT-PK CHEMBL
D(1A) dopamine receptor GPCR Ki 7.05 WOMBAT-PK
D(2) dopamine receptor GPCR Ki 6.71 WOMBAT-PK
Alpha-2A adrenergic receptor GPCR Ki 6.88 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor IC50 6.25 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5 WOMBAT-PK
5-hydroxytryptamine receptor 1A GPCR Ki 6.72 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 7.96 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.40 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR Ki 8.10 WOMBAT-PK
5-hydroxytryptamine receptor 6 GPCR Ki 7.05 WOMBAT-PK
5-hydroxytryptamine receptor 7 GPCR Ki 6.40 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR IC50 8 WOMBAT-PK
D(3) dopamine receptor GPCR Ki 6.69 WOMBAT-PK
D(1B) dopamine receptor GPCR Ki 6.77 WOMBAT-PK
Histamine H1 receptor GPCR ANTAGONIST Ki 9.30 WOMBAT-PK
Histamine H2 receptor GPCR IC50 6.80 WOMBAT-PK
Histamine H4 receptor GPCR Ki 8.14 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 7.83 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 8.10 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 7.89 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 8.14 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 7.80 WOMBAT-PK
Aldehyde oxidase Enzyme IC50 6.59 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 8.07 DRUG MATRIX
Sodium channel protein type 2 subunit alpha Ion channel IC50 5.51 CHEMBL
Sodium channel protein type 9 subunit alpha Ion channel IC50 6 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.21 CHEMBL
Alpha-1D adrenergic receptor GPCR Ki 8.25 DRUG MATRIX
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase IC50 6 CHEMBL
High affinity nerve growth factor receptor Kinase IC50 4.22 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.77 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 4.85 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR IC50 7.90 WOMBAT-PK
Sodium channel protein type 5 subunit alpha Ion channel IC50 5.80 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 7.38 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 5.77 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 10.70 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 5.70 CHEMBL
Sodium-dependent serotonin transporter Transporter IC50 5.07 CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.40 IUPHAR
Transporter Transporter IC50 5.60 CHEMBL
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 7 IUPHAR
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 6.40 IUPHAR
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 8.10 IUPHAR
Histamine H1 receptor GPCR IC50 10.70 CHEMBL
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 7.20 IUPHAR
Muscarinic acetylcholine receptor GPCR IC50 6.52 CHEMBL
G protein-activated inward rectifier potassium channel 2 Ion channel BLOCKER IC50 4 IUPHAR

External reference:

IDSource
4019607 VUID
N0000147702 NUI
D00809 KEGG_DRUG
549-18-8 SECONDARY_CAS_RN
203168 RXNORM
C0002600 UMLSCUI
CHEBI:2666 CHEBI
TP0 PDB_CHEM_ID
CHEMBL629 ChEMBL_ID
DB00321 DRUGBANK_ID
CHEMBL1200964 ChEMBL_ID
D000639 MESH_DESCRIPTOR_UI
2160 PUBCHEM_CID
200 IUPHAR_LIGAND_ID
976 INN_ID
1806D8D52K UNII
4178 MMSL
4240 MMSL
d00146 MMSL
001501 NDDF
004600 NDDF
4017743 VANDF
4019607 VANDF
372726002 SNOMEDCT_US
40589005 SNOMEDCT_US
48384000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0042 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0042 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0073 TABLET, FILM COATED 50 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0073 TABLET, FILM COATED 50 mg ORAL ANDA 20 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0211 TABLET, FILM COATED 14 mg ORAL ANDA 24 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0277 TABLET, FILM COATED 27.98 mg ORAL ANDA 24 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0330 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0330 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0442 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0442 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0574 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0574 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0463-6351 TABLET, FILM COATED 25 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0463-6352 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0463-6354 TABLET, FILM COATED 100 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2212 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2213 TABLET, FILM COATED 25 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2214 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2215 TABLET, FILM COATED 75 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2216 TABLET, FILM COATED 100 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2217 TABLET, FILM COATED 150 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-1486 TABLET, FILM COATED 10 mg ORAL ANDA 21 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-1487 TABLET, FILM COATED 25 mg ORAL ANDA 21 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-1488 TABLET, FILM COATED 50 mg ORAL ANDA 21 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-1489 TABLET, FILM COATED 75 mg ORAL ANDA 21 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-1490 TABLET, FILM COATED 100 mg ORAL ANDA 21 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-1491 TABLET, FILM COATED 150 mg ORAL ANDA 21 sections
Amitriptyline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-1220 TABLET, FILM COATED 10 mg ORAL ANDA 21 sections
Amitriptyline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-1221 TABLET, COATED 25 mg ORAL ANDA 22 sections
Amitriptyline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-1222 TABLET, FILM COATED 50 mg ORAL ANDA 21 sections