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

Stem definitionDrug idCAS RN
antiarrhythmics 176 1951-25-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amiodarone
  • amidorone
  • sedacoron
  • amiodarone hydrochloride
  • amiodarone HCl
An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.
  • Molecular weight: 645.32
  • Formula: C25H29I2NO3
  • CLOGP: 8.95
  • LIPINSKI: 2
  • HAC: 4
  • HDO: 0
  • TPSA: 42.68
  • ALOGS: -5.13
  • ROTB: 11
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.70 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 41.37 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.90 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 820 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1985 FDA WYETH PHARMS INC

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
Drug interaction 1027.49 12.37 1122 49251 198499 50356252
Bradycardia 731.02 12.37 565 49808 63861 50490890
Torsade de pointes 693.55 12.37 303 50070 11532 50543219
Electrocardiogram QT prolonged 677.36 12.37 495 49878 51391 50503360
Atrial fibrillation 625.61 12.37 630 49743 101115 50453636
Hyperthyroidism 590.11 12.37 273 50100 11902 50542849
Acute kidney injury 385.74 12.37 758 49615 227300 50327451
Pulmonary toxicity 357.25 12.37 152 50221 5410 50549341
International normalised ratio increased 352.32 12.37 313 50060 42839 50511912
Myxoedema coma 318.52 12.37 75 50298 324 50554427
Cardiac failure 317.88 12.37 385 49988 75655 50479096
Interstitial lung disease 316.67 12.37 324 50049 52852 50501899
Ventricular tachycardia 311.74 12.37 195 50178 15626 50539125
Sinus bradycardia 236.10 12.37 153 50220 13030 50541721
Hypothyroidism 219.72 12.37 217 50156 33908 50520843
Cardiogenic shock 203.64 12.37 149 50224 15450 50539301
Ventricular fibrillation 190.19 12.37 123 50250 10436 50544315
Syncope 185.34 12.37 352 50021 102650 50452101
Gastrointestinal haemorrhage 184.93 12.37 291 50082 73030 50481721
Pain 184.89 12.37 183 50190 578720 49976031
Haematoma 183.52 12.37 187 50186 30323 50524428
Hyperkalaemia 182.37 12.37 232 50141 47857 50506894
Hypotension 181.09 12.37 580 49793 234889 50319862
Hyponatraemia 169.80 12.37 326 50047 95813 50458938
Tachyarrhythmia 153.23 12.37 77 50296 4028 50550723
Cardiac arrest 150.58 12.37 286 50087 83365 50471386
Shock haemorrhagic 144.89 12.37 95 50278 8249 50546502
Arthralgia 144.12 12.37 135 50238 438567 50116184
Joint swelling 143.57 12.37 34 50339 245252 50309499
Renal failure 139.73 12.37 320 50053 106313 50448438
Headache 130.75 12.37 189 50184 506346 50048405
Thyroiditis 127.71 12.37 53 50320 1769 50552982
Rheumatoid arthritis 126.86 12.37 24 50349 202526 50352225
Cardiac failure congestive 126.11 12.37 267 50106 84115 50470636
Drug ineffective 122.49 12.37 414 49959 818919 49735832
Rash 122.18 12.37 154 50219 437317 50117434
Sinus node dysfunction 118.44 12.37 64 50309 3891 50550860
Sinusitis 111.61 12.37 18 50355 170540 50384211
Synovitis 109.29 12.37 3 50370 123862 50430889
Hypokalaemia 105.36 12.37 255 50118 87737 50467014
Therapeutic product effect decreased 104.96 12.37 8 50365 136042 50418709
Drug intolerance 103.97 12.37 44 50329 219060 50335691
Atrial flutter 103.85 12.37 79 50294 8684 50546067
Arthropathy 102.57 12.37 17 50356 157889 50396862
Infusion related reaction 102.17 12.37 22 50351 169535 50385216
Alopecia 101.52 12.37 59 50314 244988 50309763
Glossodynia 101.22 12.37 3 50370 115566 50439185
Lactic acidosis 100.60 12.37 144 50229 33211 50521540
Systemic lupus erythematosus 93.90 12.37 14 50359 140608 50414143
Labelled drug-drug interaction medication error 93.47 12.37 80 50293 10397 50544354
Long QT syndrome 91.61 12.37 49 50324 2918 50551833
Multiple organ dysfunction syndrome 90.39 12.37 172 50201 50165 50504586
Cerebral haemorrhage 87.83 12.37 121 50252 26931 50527820
Swelling 86.59 12.37 46 50327 200826 50353925
Mitral valve incompetence 85.46 12.37 96 50277 17375 50537376
Hypersensitivity 81.97 12.37 57 50316 215104 50339647
Arrhythmia 81.39 12.37 130 50243 33002 50521749
Anaemia 81.15 12.37 478 49895 251978 50302773
Melaena 79.57 12.37 115 50258 26749 50528002
Fatigue 79.53 12.37 399 49974 707202 49847549
Nasopharyngitis 79.10 12.37 47 50326 192880 50361871
Ventricular arrhythmia 75.97 12.37 45 50328 3264 50551487
Cholestasis 74.16 12.37 108 50265 25293 50529458
Cardio-respiratory arrest 74.16 12.37 165 50208 53727 50501024
Fall 74.04 12.37 578 49795 334354 50220397
Ventricular extrasystoles 73.52 12.37 70 50303 10446 50544305
Alveolitis 73.08 12.37 40 50333 2494 50552257
Maternal exposure during pregnancy 71.21 12.37 35 50338 159743 50395008
Rhabdomyolysis 70.86 12.37 134 50239 38893 50515858
Hypoxia 69.75 12.37 156 50217 50967 50503784
Respiratory failure 69.30 12.37 224 50149 90957 50463794
Musculoskeletal stiffness 69.07 12.37 21 50352 128460 50426291
Injection site pain 67.68 12.37 14 50359 111010 50443741
Wound 67.33 12.37 12 50361 105782 50448969
Atrioventricular block 67.23 12.37 54 50319 6424 50548327
Renal injury 63.41 12.37 59 50314 8552 50546199
Rectal haemorrhage 62.24 12.37 126 50247 38432 50516319
Abdominal discomfort 61.97 12.37 84 50289 231557 50323194
Cerebral haematoma 61.77 12.37 39 50334 3172 50551579
Pulmonary fibrosis 61.55 12.37 97 50276 24340 50530411
Pain in extremity 60.65 12.37 112 50261 272753 50281998
Atrial tachycardia 59.69 12.37 33 50340 2099 50552652
Infection 59.26 12.37 51 50322 172903 50381848
Lung disorder 59.21 12.37 135 50238 44664 50510087
Brugada syndrome 58.43 12.37 19 50354 311 50554440
Infusion site phlebitis 57.93 12.37 13 50360 43 50554708
Cardioversion 56.46 12.37 26 50347 1119 50553632
Pericarditis 54.47 12.37 7 50366 78682 50476069
Atrioventricular block complete 53.99 12.37 50 50323 7205 50547546
Migraine 53.83 12.37 6 50367 75274 50479477
Haematoma muscle 53.82 12.37 22 50351 706 50554045
Haemorrhage 53.68 12.37 145 50228 53296 50501455
Hepatocellular injury 53.31 12.37 94 50279 25853 50528898
Therapeutic product effect incomplete 52.85 12.37 13 50360 91502 50463249
Arthritis 52.72 12.37 11 50362 86710 50468041
Pulmonary hypertension 52.51 12.37 108 50265 33309 50521442
Hypoaesthesia 52.13 12.37 31 50342 127226 50427525
Neuromyopathy 51.96 12.37 20 50353 546 50554205
Orthopnoea 51.89 12.37 44 50329 5645 50549106
Blood thyroid stimulating hormone increased 51.27 12.37 45 50328 6047 50548704
Ischaemic stroke 51.26 12.37 71 50302 15877 50538874
Lymphatic fistula 49.82 12.37 21 50352 729 50554022
Femoral hernia incarcerated 49.53 12.37 21 50352 740 50554011
Blood loss anaemia 49.12 12.37 50 50323 8089 50546662
Coronary artery disease 49.00 12.37 98 50275 29628 50525123
Arterial haemorrhage 48.87 12.37 26 50347 1531 50553220
Injection site erythema 48.78 12.37 8 50365 74928 50479823
Toxic skin eruption 48.61 12.37 58 50315 11193 50543558
Cardioactive drug level increased 48.23 12.37 28 50345 1956 50552795
Exposure during pregnancy 47.46 12.37 31 50342 120984 50433767
Hyperglobulinaemia 47.31 12.37 8 50365 0 50554751
Urticaria 47.12 12.37 36 50337 129525 50425226
Treatment failure 46.63 12.37 41 50332 137596 50417155
Toxicity to various agents 46.44 12.37 366 50007 212133 50342618
Weight increased 45.60 12.37 82 50291 201809 50352942
Pancreatic steatosis 45.51 12.37 21 50352 908 50553843
Corneal deposits 45.27 12.37 14 50359 193 50554558
Keratopathy 44.62 12.37 17 50356 451 50554300
Product use issue 44.36 12.37 50 50323 149425 50405326
Muscle spasms 44.25 12.37 36 50337 125517 50429234
Faecaloma 43.50 12.37 44 50329 7064 50547687
Thyrotoxic crisis 43.20 12.37 19 50354 733 50554018
Diarrhoea 43.07 12.37 377 49996 588099 49966652
Haemarthrosis 43.05 12.37 30 50343 2878 50551873
Product dose omission issue 43.03 12.37 73 50300 183765 50370986
Nodal rhythm 42.88 12.37 24 50349 1563 50553188
Haematuria 42.88 12.37 85 50288 25528 50529223
Urinary retention 42.75 12.37 86 50287 26104 50528647
Dyspnoea 42.29 12.37 772 49601 546836 50007915
Pruritus 42.22 12.37 143 50230 283425 50271326
Coagulopathy 42.14 12.37 69 50304 17875 50536876
Wound infection pseudomonas 42.07 12.37 22 50351 1251 50553500
Pyrexia 41.58 12.37 216 50157 379987 50174764
Respiratory distress 41.53 12.37 93 50280 30396 50524355
Stomatitis 41.06 12.37 25 50348 101319 50453432
Bundle branch block left 40.78 12.37 40 50333 6190 50548561
Depression 40.28 12.37 64 50309 165359 50389392
Hypomagnesaemia 40.17 12.37 78 50295 23078 50531673
Myocardial infarction 39.87 12.37 185 50188 88842 50465909
Drug level increased 39.83 12.37 70 50303 19198 50535553
Back pain 39.21 12.37 102 50271 219928 50334823
Bradyarrhythmia 38.99 12.37 24 50349 1866 50552885
Septic shock 38.58 12.37 135 50238 57040 50497711
Discomfort 38.28 12.37 31 50342 108349 50446402
Nausea 38.18 12.37 485 49888 704913 49849838
Acute respiratory distress syndrome 37.74 12.37 72 50301 21027 50533724
Extravasation 37.72 12.37 24 50349 1978 50552773
Cerebellar haematoma 37.49 12.37 14 50359 351 50554400
Hepatic cyst 37.43 12.37 33 50340 4460 50550291
Contraindicated product administered 36.87 12.37 57 50316 148901 50405850
Ecchymosis 36.85 12.37 48 50325 10121 50544630
Respiratory acidosis 36.32 12.37 37 50336 5991 50548760
Acute respiratory failure 36.12 12.37 85 50288 28697 50526054
Injection site reaction 35.74 12.37 4 50369 50028 50504723
Blood cholesterol increased 35.70 12.37 6 50367 55209 50499542
Cornea verticillata 35.62 12.37 9 50364 55 50554696
Alveolar proteinosis 35.54 12.37 13 50360 307 50554444
General physical health deterioration 35.42 12.37 253 50120 142181 50412570
Tricuspid valve incompetence 35.40 12.37 53 50320 12717 50542034
Device stimulation issue 35.08 12.37 9 50364 59 50554692
Subdural haematoma 34.85 12.37 53 50320 12894 50541857
Seroma 34.51 12.37 22 50351 1819 50552932
Myalgia 34.31 12.37 44 50329 124275 50430476
Mixed liver injury 34.19 12.37 28 50345 3423 50551328
Listless 33.86 12.37 24 50349 2366 50552385
Organising pneumonia 33.79 12.37 32 50341 4742 50550009
Fibromyalgia 33.68 12.37 3 50370 44975 50509776
Ventricular tachyarrhythmia 33.63 12.37 9 50364 71 50554680
Agranulocytosis 33.37 12.37 69 50304 21352 50533399
Anuria 33.09 12.37 48 50325 11196 50543555
Psoriatic arthropathy 33.00 12.37 4 50369 47028 50507723
Inflammatory marker increased 32.89 12.37 34 50339 5600 50549151
Medication error 32.35 12.37 94 50279 36010 50518741
Reduced facial expression 32.27 12.37 20 50353 1574 50553177
Off label use 31.60 12.37 311 50062 474115 50080636
Prothrombin time shortened 31.45 12.37 20 50353 1647 50553104
Muscle haemorrhage 31.42 12.37 25 50348 2933 50551818
Chills 31.32 12.37 30 50343 96657 50458094
Aortic valve stenosis 31.30 12.37 25 50348 2950 50551801
Left ventricular dysfunction 31.14 12.37 45 50328 10461 50544290
Ill-defined disorder 31.09 12.37 8 50365 54646 50500105
Cerebellar syndrome 31.00 12.37 26 50347 3285 50551466
Asthma 30.99 12.37 26 50347 89311 50465440
Hepatic failure 30.82 12.37 86 50287 32197 50522554
Herpes zoster 30.77 12.37 16 50357 70770 50483981
Abortion spontaneous 30.71 12.37 3 50370 41769 50512982
Hypoglycaemia 30.69 12.37 120 50253 53461 50501290
Extrasystoles 30.68 12.37 30 50343 4625 50550126
Pleural effusion 30.58 12.37 161 50212 81293 50473458
Anticoagulation drug level increased 30.35 12.37 10 50363 171 50554580
Spontaneous haematoma 30.09 12.37 15 50358 771 50553980
Haemorrhagic stroke 29.53 12.37 31 50342 5197 50549554
Psoriasis 29.40 12.37 16 50357 68984 50485767
Gastrooesophageal reflux disease 29.39 12.37 20 50353 76408 50478343
Right ventricular failure 29.37 12.37 55 50318 15838 50538913
Peripheral swelling 29.18 12.37 106 50267 205830 50348921
Glomerular filtration rate decreased 28.99 12.37 46 50327 11606 50543145
Haemorrhagic diathesis 28.97 12.37 27 50346 3921 50550830
Lower gastrointestinal haemorrhage 28.96 12.37 35 50338 6844 50547907
Pericardial haemorrhage 28.78 12.37 18 50355 1440 50553311
Suicide attempt 28.62 12.37 8 50365 51724 50503027
White blood cell count decreased 28.55 12.37 45 50328 116677 50438074
Rales 28.50 12.37 42 50331 9936 50544815
Insomnia 28.22 12.37 85 50288 174780 50379971
Cardiac ablation 28.15 12.37 17 50356 1277 50553474
Head injury 28.06 12.37 69 50304 23951 50530800
Renal impairment 28.03 12.37 149 50224 75512 50479239
Arrhythmia supraventricular 27.94 12.37 15 50358 900 50553851
Mediastinal haematoma 27.85 12.37 8 50365 84 50554667
Myxoedema 27.12 12.37 8 50365 93 50554658
Oliguria 27.04 12.37 37 50336 8179 50546572
Heparin-induced thrombocytopenia 26.97 12.37 26 50347 3939 50550812
Cardiac disorder 26.88 12.37 99 50274 42880 50511871
Goitre congenital 26.63 12.37 5 50368 4 50554747
Hepatitis acute 26.42 12.37 36 50337 7925 50546826
Hypervolaemia 26.41 12.37 70 50303 25429 50529322
Craniocerebral injury 26.26 12.37 20 50353 2201 50552550
Overdose 25.86 12.37 179 50194 99548 50455203
Subcutaneous haematoma 25.69 12.37 17 50356 1498 50553253
Asthenia 25.65 12.37 453 49920 318589 50236162
Oedema peripheral 25.63 12.37 255 50118 157706 50397045
Atrioventricular block first degree 25.21 12.37 31 50342 6170 50548581
Nodal arrhythmia 25.06 12.37 15 50358 1109 50553642
Drug-induced liver injury 25.03 12.37 73 50300 28022 50526729
Influenza like illness 24.96 12.37 13 50360 57446 50497305
Irritable bowel syndrome 24.89 12.37 10 50363 51431 50503320
Subarachnoid haemorrhage 24.71 12.37 41 50332 10735 50544016
Pneumonitis 24.70 12.37 75 50298 29435 50525316
Diverticulum intestinal 24.67 12.37 30 50343 5903 50548848
Sinoatrial block 24.49 12.37 13 50360 762 50553989
Central nervous system injury 24.32 12.37 8 50365 136 50554615
Device capturing issue 24.13 12.37 6 50367 34 50554717
Feeling abnormal 24.04 12.37 56 50317 125436 50429315
Myopathy 24.01 12.37 37 50336 9102 50545649
Drug hypersensitivity 23.94 12.37 149 50224 250861 50303890
Injection site bruising 23.76 12.37 4 50369 36764 50517987
Coronary artery bypass 23.55 12.37 19 50354 2274 50552477
Cardiac failure chronic 23.55 12.37 23 50350 3540 50551211
Neck pain 23.22 12.37 14 50359 57053 50497698
Pulmonary alveolar haemorrhage 22.96 12.37 24 50349 4003 50550748
Knee arthroplasty 22.94 12.37 4 50369 35842 50518909
Intra-abdominal haematoma 22.90 12.37 16 50357 1541 50553210
Cardiac arrest neonatal 22.80 12.37 7 50366 94 50554657
Abdominal wall haematoma 22.78 12.37 20 50353 2688 50552063
Shock 22.73 12.37 58 50315 20592 50534159
Eosinophilia 22.23 12.37 54 50319 18598 50536153
Electrocardiogram QRS complex prolonged 22.19 12.37 27 50346 5317 50549434
Hypoxic-ischaemic encephalopathy 22.09 12.37 23 50350 3819 50550932
Paraesthesia 21.97 12.37 55 50318 120188 50434563
Splenic injury 21.87 12.37 8 50365 189 50554562
Retroperitoneal haemorrhage 21.75 12.37 19 50354 2537 50552214
Splenic haemorrhage 21.71 12.37 8 50365 193 50554558
Presyncope 21.67 12.37 63 50310 24135 50530616
Hepatic cytolysis 21.57 12.37 33 50340 8070 50546681
Bone pain 21.55 12.37 10 50363 47219 50507532
Local anaesthetic systemic toxicity 21.44 12.37 11 50362 601 50554150
Pericardial effusion 21.38 12.37 65 50308 25524 50529227
Retroperitoneal haematoma 21.20 12.37 19 50354 2624 50552127
Prerenal failure 21.17 12.37 15 50358 1478 50553273
Hypochromasia 21.12 12.37 9 50364 321 50554430
Transaminases increased 20.79 12.37 68 50305 27756 50526995
Gastrointestinal disorder 20.73 12.37 39 50334 94417 50460334
Abdominal pain upper 20.63 12.37 85 50288 159224 50395527
Hepatic enzyme increased 20.60 12.37 69 50304 137311 50417440
Blood pressure increased 20.56 12.37 66 50307 133066 50421685
Constipation 20.53 12.37 105 50268 185603 50369148
Potentiating drug interaction 20.44 12.37 22 50351 3794 50550957
Injection site swelling 20.41 12.37 8 50365 41765 50512986
Cyanosis 20.32 12.37 46 50327 15138 50539613
Osteoarthritis 20.28 12.37 23 50350 68583 50486168
Neovascular age-related macular degeneration 20.18 12.37 7 50366 141 50554610
Thrombocytopenia 20.17 12.37 205 50168 127468 50427283
Cardioactive drug level above therapeutic 20.13 12.37 7 50366 142 50554609
Device pacing issue 20.09 12.37 6 50367 73 50554678
Oropharyngeal pain 19.98 12.37 29 50344 77772 50476979
Memory impairment 19.97 12.37 30 50343 79330 50475421
Acute pulmonary oedema 19.91 12.37 30 50343 7237 50547514
Propionibacterium infection 19.87 12.37 5 50368 30 50554721
Upper respiratory tract infection 19.58 12.37 22 50351 65876 50488875
Foreign body 19.54 12.37 16 50357 1955 50552796
Intentional overdose 19.54 12.37 20 50353 62484 50492267
Haemorrhage intracranial 19.44 12.37 40 50333 12334 50542417
Musculoskeletal pain 19.44 12.37 26 50347 72151 50482600
Acute hepatic failure 19.34 12.37 46 50327 15631 50539120
Pulmonary arterial hypertension 19.27 12.37 54 50319 20265 50534486
Pulmonary oedema 19.24 12.37 98 50275 48840 50505911
Anti-thyroid antibody positive 19.13 12.37 9 50364 407 50554344
Anisocytosis 19.08 12.37 10 50363 571 50554180
Aortic arteriosclerosis 18.87 12.37 25 50348 5357 50549394
Hepatitis fulminant 18.79 12.37 19 50354 3049 50551702
Thyroxine free increased 18.67 12.37 11 50362 790 50553961
Subdural haemorrhage 18.65 12.37 18 50355 2731 50552020
Cardiac tamponade 18.58 12.37 22 50351 4210 50550541
Thyroiditis acute 18.58 12.37 6 50367 96 50554655
Drug level above therapeutic 18.25 12.37 21 50352 3899 50550852
Conduction disorder 18.22 12.37 13 50360 1295 50553456
Altered visual depth perception 18.20 12.37 8 50365 308 50554443
Wound dehiscence 18.18 12.37 22 50351 4308 50550443
Blood creatinine increased 18.17 12.37 134 50239 76026 50478725
Hypoglycaemic seizure 18.17 12.37 9 50364 456 50554295
Prothrombin time prolonged 18.12 12.37 32 50341 8806 50545945
Palpitations 18.04 12.37 158 50215 94348 50460403
Throat irritation 18.03 12.37 4 50369 30235 50524516
Escherichia infection 17.94 12.37 36 50337 10905 50543846
Chorea 17.94 12.37 13 50360 1327 50553424
Thyroglobulin increased 17.81 12.37 5 50368 48 50554703
Type 2 diabetes mellitus 17.78 12.37 6 50367 34369 50520382
Ischaemic hepatitis 17.76 12.37 15 50358 1914 50552837
Iodine overload 17.74 12.37 3 50370 0 50554751
Anhedonia 17.65 12.37 33 50340 9491 50545260
Liver function test abnormal 17.58 12.37 89 50284 44250 50510501
Swelling face 17.40 12.37 16 50357 52579 50502172
Drug clearance decreased 17.35 12.37 12 50361 1137 50553614
Red blood cell sedimentation rate increased 17.33 12.37 4 50369 29412 50525339
Prescription drug used without a prescription 17.28 12.37 14 50359 1686 50553065
Anaphylactic reaction 17.23 12.37 17 50356 54038 50500713
Fear 17.21 12.37 42 50331 14507 50540244
Oesophageal squamous cell carcinoma 17.15 12.37 6 50367 124 50554627
Congenital hypothyroidism 17.14 12.37 7 50366 224 50554527
Tri-iodothyronine increased 17.10 12.37 6 50367 125 50554626
Cardiac failure acute 17.08 12.37 30 50343 8220 50546531
Tubulointerstitial nephritis 17.03 12.37 43 50330 15168 50539583
Circulatory collapse 16.89 12.37 51 50322 19949 50534802
Petechiae 16.85 12.37 38 50335 12474 50542277
Febrile neutropenia 16.82 12.37 46 50327 97621 50457130
Intentional product use issue 16.67 12.37 32 50341 76886 50477865
Encephalopathy 16.54 12.37 72 50301 33639 50521112
Compensatory sweating 16.51 12.37 4 50369 20 50554731
Ear infection 16.40 12.37 3 50370 25967 50528784
Ejection fraction decreased 16.38 12.37 48 50325 18472 50536279
Ear pain 16.35 12.37 4 50369 28279 50526472
Secondary hyperthyroidism 16.19 12.37 4 50369 22 50554729
Electrocardiogram T wave inversion 16.08 12.37 18 50355 3243 50551508
Therapeutic response decreased 16.07 12.37 14 50359 47217 50507534
Suicidal ideation 15.90 12.37 19 50354 55366 50499385
Eosinophilic pneumonia 15.89 12.37 14 50359 1890 50552861
Electrocardiogram QRS complex shortened 15.78 12.37 8 50365 426 50554325
Kidney malrotation 15.75 12.37 4 50369 25 50554726
Gastroenteritis aeromonas 15.75 12.37 4 50369 25 50554726
Endovenous ablation 15.66 12.37 3 50370 3 50554748
Blister 15.65 12.37 39 50334 85379 50469372
Pelvic fracture 15.53 12.37 35 50338 11485 50543266
Erythema 15.49 12.37 84 50289 146330 50408421
Ataxia 15.47 12.37 39 50334 13747 50541004
Head discomfort 15.44 12.37 34 50339 10985 50543766
Acute generalised exanthematous pustulosis 15.37 12.37 30 50343 8908 50545843
Neutrophil count decreased 15.23 12.37 14 50359 46012 50508739
Chronic kidney disease 15.19 12.37 79 50294 39692 50515059
Disease progression 15.16 12.37 47 50326 95819 50458932
Infective pericardial effusion 15.12 12.37 4 50369 30 50554721
Electrocardiogram U wave present 15.04 12.37 5 50368 88 50554663
Coagulation test abnormal 15.01 12.37 9 50364 667 50554084
Cutaneous lupus erythematosus 14.79 12.37 15 50358 2416 50552335
Hyperchloraemia 14.71 12.37 9 50364 692 50554059
Hypocoagulable state 14.67 12.37 10 50363 926 50553825
Atrioventricular block second degree 14.55 12.37 18 50355 3603 50551148
Hepatitis 14.54 12.37 66 50307 31387 50523364
Renal function test abnormal 14.52 12.37 16 50357 2833 50551918
Oesophageal adenocarcinoma recurrent 14.48 12.37 4 50369 36 50554715
Paroxysmal arrhythmia 14.29 12.37 4 50369 38 50554713
Myocardial ischaemia 14.25 12.37 34 50339 11579 50543172
Activated partial thromboplastin time prolonged 14.20 12.37 24 50349 6378 50548373
Lower respiratory tract infection 14.14 12.37 48 50325 95153 50459598
Sudden death 14.05 12.37 29 50344 8962 50545789
Apnoea 14.00 12.37 25 50348 6941 50547810
Night sweats 13.99 12.37 8 50365 33566 50521185
Photosensitivity reaction 13.94 12.37 36 50337 12875 50541876
Atrioventricular dissociation 13.93 12.37 6 50367 220 50554531
Electrocardiogram T wave alternans 13.93 12.37 4 50369 42 50554709
Extradural haematoma 13.91 12.37 12 50361 1575 50553176
Electrocardiogram T wave abnormal 13.88 12.37 14 50359 2239 50552512
Oral mucosa haematoma 13.85 12.37 3 50370 8 50554743
Apathy 13.79 12.37 26 50347 7522 50547229
Completed suicide 13.77 12.37 76 50297 131813 50422938
Thyroxine increased 13.71 12.37 8 50365 564 50554187
Cardiovascular insufficiency 13.69 12.37 11 50362 1309 50553442
Eosinophilic pleural effusion 13.60 12.37 4 50369 46 50554705
Mesenteric artery stenosis 13.52 12.37 4 50369 47 50554704
Sopor 13.45 12.37 47 50326 19832 50534919
Product quality issue 13.37 12.37 7 50366 30851 50523900
Left ventricular failure 13.29 12.37 20 50353 4821 50549930
Cardiovascular disorder 13.25 12.37 31 50342 10423 50544328
Osteonecrosis of jaw 13.20 12.37 8 50365 32518 50522233
Sedation 13.18 12.37 7 50366 30603 50524148
Bullous haemorrhagic dermatosis 13.15 12.37 4 50369 52 50554699
Eosinophilia myalgia syndrome 13.13 12.37 3 50370 11 50554740
Corynebacterium infection 13.11 12.37 7 50366 415 50554336
Hepatitis toxic 12.97 12.37 15 50358 2801 50551950
Thyroiditis chronic 12.92 12.37 3 50370 12 50554739
Lymphocyte count decreased 12.91 12.37 5 50368 26302 50528449
Pancreatitis 12.91 12.37 14 50359 42600 50512151
Abdominal wall haemorrhage 12.87 12.37 5 50368 140 50554611
Hot flush 12.84 12.37 15 50358 44154 50510597
Toxic epidermal necrolysis 12.82 12.37 48 50325 20944 50533807
Seizure 12.82 12.37 67 50306 117807 50436944
Aortic valve incompetence 12.78 12.37 21 50352 5455 50549296
Low cardiac output syndrome 12.72 12.37 6 50367 273 50554478
Congestive hepatopathy 12.70 12.37 14 50359 2480 50552271
Fungal infection 12.69 12.37 7 50366 29958 50524793
Mouth ulceration 12.68 12.37 6 50367 28018 50526733
Arterial insufficiency 12.67 12.37 5 50368 146 50554605
Anticoagulation drug level below therapeutic 12.64 12.37 8 50365 653 50554098
Respiratory alkalosis 12.59 12.37 14 50359 2505 50552246
Adverse event 12.58 12.37 15 50358 43748 50511003
Splenic rupture 12.46 12.37 10 50363 1188 50553563
Electrocardiogram repolarisation abnormality 12.44 12.37 10 50363 1190 50553561
Lung consolidation 12.40 12.37 17 50356 3763 50550988
Proctitis haemorrhagic 12.38 12.37 3 50370 15 50554736

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
Hyperthyroidism 1760.16 11.38 691 70085 7917 29495834
Pulmonary toxicity 672.52 11.38 296 70480 4594 29499157
Drug interaction 539.14 11.38 1344 69432 196041 29307710
Ventricular tachycardia 467.78 11.38 406 70370 22168 29481583
Bradycardia 456.50 11.38 667 70109 64962 29438789
Interstitial lung disease 417.95 11.38 598 70178 57120 29446631
Cardiac failure 414.60 11.38 707 70069 78580 29425171
Thyroiditis 359.66 11.38 145 70631 1783 29501968
Hypothyroidism 353.77 11.38 298 70478 15608 29488143
Atrial fibrillation 321.21 11.38 751 70025 104895 29398856
Electrocardiogram QT prolonged 313.72 11.38 409 70367 35728 29468023
Torsade de pointes 311.98 11.38 196 70580 6465 29497286
Pulmonary fibrosis 276.73 11.38 257 70519 15325 29488426
Cardiogenic shock 214.76 11.38 247 70529 18943 29484808
Thyrotoxic crisis 195.65 11.38 60 70716 299 29503452
International normalised ratio increased 182.50 11.38 357 70419 44015 29459736
Acute kidney injury 175.47 11.38 1159 69617 264108 29239643
Ventricular fibrillation 167.48 11.38 198 70578 15635 29488116
Cardiac failure congestive 158.38 11.38 472 70304 76109 29427642
Pulmonary alveolar haemorrhage 157.40 11.38 127 70649 6253 29497498
Hypotension 136.07 11.38 862 69914 193492 29310259
Ventricular arrhythmia 125.06 11.38 97 70679 4507 29499244
Completed suicide 125.04 11.38 31 70745 90215 29413536
Multiple organ dysfunction syndrome 122.93 11.38 381 70395 62735 29441016
Pyrexia 117.37 11.38 329 70447 287293 29216458
Ejection fraction decreased 110.24 11.38 162 70614 15816 29487935
Appendicolith 109.36 11.38 80 70696 3400 29500351
Acute respiratory distress syndrome 103.45 11.38 192 70584 22743 29481008
Lung disorder 101.01 11.38 224 70552 30138 29473613
Atrial flutter 100.41 11.38 144 70632 13750 29490001
Blood thyroid stimulating hormone increased 96.71 11.38 71 70705 3034 29500717
Thyroid disorder 93.37 11.38 66 70710 2656 29501095
Febrile neutropenia 93.18 11.38 79 70697 112161 29391590
Organising pneumonia 92.96 11.38 85 70691 4963 29498788
Arthralgia 87.52 11.38 124 70652 139493 29364258
Cardiac failure chronic 87.51 11.38 92 70684 6375 29497376
Syncope 85.88 11.38 404 70372 80967 29422784
Cardiac arrest 85.31 11.38 418 70358 85173 29418578
Renal failure 83.38 11.38 527 70249 118072 29385679
Atrioventricular block 78.30 11.38 90 70686 6892 29496859
Atrial tachycardia 78.26 11.38 52 70724 1889 29501862
Sinus bradycardia 74.83 11.38 114 70662 11489 29492262
Drug abuse 72.92 11.38 51 70725 79832 29423919
Headache 71.56 11.38 198 70578 173809 29329942
Corneal deposits 70.92 11.38 24 70752 172 29503579
Myxoedema coma 70.72 11.38 26 70750 244 29503507
Cornea verticillata 69.93 11.38 17 70759 26 29503725
N-terminal prohormone brain natriuretic peptide increased 68.96 11.38 48 70728 1884 29501867
BRASH syndrome 67.92 11.38 22 70754 135 29503616
Appendicitis 67.89 11.38 94 70682 8685 29495066
Infusion site phlebitis 67.72 11.38 17 70759 32 29503719
Diarrhoea 66.10 11.38 496 70280 332202 29171549
Hyperglobulinaemia 65.49 11.38 13 70763 0 29503751
Seizure 65.25 11.38 76 70700 93047 29410704
Dyspnoea 64.46 11.38 1118 69658 325614 29178137
Pericardial haemorrhage 63.25 11.38 54 70722 2877 29500874
Venous pressure jugular increased 62.85 11.38 32 70744 697 29503054
Palpitations 60.82 11.38 194 70582 32410 29471341
Hyperkalaemia 60.54 11.38 299 70477 61093 29442658
Cardiac failure acute 60.24 11.38 91 70685 9101 29494650
Labelled drug-drug interaction medication error 58.88 11.38 105 70671 12054 29491697
Suicidal ideation 58.80 11.38 7 70769 34709 29469042
Haematuria 58.66 11.38 235 70541 43904 29459847
Shock haemorrhagic 57.62 11.38 91 70685 9460 29494291
Cerebral haematoma 56.14 11.38 60 70716 4236 29499515
Nasopharyngitis 53.25 11.38 39 70737 59626 29444125
Anticoagulation drug level increased 52.47 11.38 25 70751 469 29503282
Arrhythmia 51.88 11.38 179 70597 31134 29472617
Pain in extremity 51.29 11.38 118 70658 110315 29393436
Anhedonia 51.10 11.38 74 70702 7126 29496625
Product dose omission issue 50.63 11.38 96 70680 96287 29407464
Thyroxine increased 50.03 11.38 14 70762 47 29503704
Off label use 49.93 11.38 470 70306 300330 29203421
Neutrophil count decreased 49.66 11.38 21 70755 43546 29460205
Atrioventricular block complete 49.26 11.38 77 70699 7934 29495817
Malignant neoplasm progression 48.85 11.38 63 70713 73796 29429955
Stress 48.71 11.38 137 70639 21353 29482398
Sinus node dysfunction 48.53 11.38 52 70724 3682 29500069
Dyspnoea exertional 48.26 11.38 194 70582 36296 29467455
Drug-induced liver injury 48.06 11.38 137 70639 21518 29482233
Neutropenia 47.57 11.38 159 70617 131552 29372199
Cardioactive drug level increased 47.46 11.38 36 70740 1617 29502134
Gastrointestinal haemorrhage 47.17 11.38 339 70437 79194 29424557
Keratopathy 45.95 11.38 21 70755 357 29503394
Pericardial effusion 45.93 11.38 133 70643 21075 29482676
Tachycardia induced cardiomyopathy 45.25 11.38 15 70761 100 29503651
Jugular vein distension 44.11 11.38 24 70752 601 29503150
Death 43.85 11.38 567 70209 341517 29162234
Rash 43.52 11.38 271 70505 189548 29314203
Phlebitis 43.34 11.38 48 70728 3528 29500223
Goitre 42.23 11.38 32 70744 1435 29502316
Ventricular extrasystoles 42.07 11.38 84 70692 10498 29493253
Rectal haemorrhage 42.01 11.38 179 70597 34370 29469381
Haematoma 41.37 11.38 136 70640 23076 29480675
Coronary artery bypass 40.55 11.38 53 70723 4632 29499119
Muscle spasms 39.54 11.38 59 70717 65023 29438728
Rhabdomyolysis 39.47 11.38 265 70511 60543 29443208
Cardiac tamponade 39.44 11.38 52 70724 4583 29499168
Subdural haematoma 39.31 11.38 114 70662 18079 29485672
Thyroxine free increased 38.14 11.38 16 70760 219 29503532
Melaena 37.49 11.38 161 70615 31015 29472736
Pneumonitis 37.00 11.38 149 70627 27895 29475856
Musculoskeletal stiffness 36.77 11.38 22 70754 37436 29466315
Fatigue 35.62 11.38 539 70237 316282 29187469
Orthopnoea 35.52 11.38 49 70727 4511 29499240
Injection site pain 34.85 11.38 17 70759 32429 29471322
Left ventricular failure 34.75 11.38 49 70727 4604 29499147
Renal injury 34.74 11.38 76 70700 10126 29493625
Nausea 34.63 11.38 486 70290 288769 29214982
Deep vein thrombosis 33.94 11.38 53 70723 57346 29446405
Drug dependence 33.69 11.38 5 70771 20976 29482775
Crepitations 33.60 11.38 37 70739 2702 29501049
Potentiating drug interaction 33.54 11.38 47 70729 4391 29499360
Hepatocellular injury 33.08 11.38 119 70657 21124 29482627
Asthma 33.06 11.38 20 70756 33829 29469922
Renal impairment 32.85 11.38 318 70458 81015 29422736
White blood cell count decreased 32.63 11.38 97 70679 83265 29420486
Fear 32.58 11.38 71 70705 9433 29494318
Disease progression 32.29 11.38 95 70681 81821 29421930
Therapeutic product effect incomplete 32.16 11.38 28 70748 39277 29464474
Insomnia 32.12 11.38 107 70669 88654 29415097
Cytomegalovirus infection 32.07 11.38 8 70768 23207 29480544
Aggression 32.00 11.38 23 70753 35518 29468233
Coagulopathy 31.98 11.38 105 70671 17802 29485949
Pleural effusion 31.98 11.38 287 70489 71621 29432130
Asthenia 31.92 11.38 706 70070 214544 29289207
Nodal arrhythmia 31.80 11.38 21 70755 755 29502996
Acute respiratory failure 31.48 11.38 136 70640 26266 29477485
Pulmonary embolism 31.46 11.38 87 70689 76447 29427304
Rheumatoid arthritis 31.39 11.38 19 70757 32133 29471618
Myalgia 31.28 11.38 83 70693 73936 29429815
Tachyarrhythmia 31.17 11.38 37 70739 2932 29500819
Hyponatraemia 31.14 11.38 272 70504 67361 29436390
Pacemaker generated rhythm 31.06 11.38 10 70766 60 29503691
Stomatitis 30.90 11.38 26 70750 37087 29466664
Mitochondrial aspartate aminotransferase increased 30.43 11.38 7 70769 7 29503744
Long QT syndrome 30.33 11.38 32 70744 2226 29501525
Cardioversion 30.31 11.38 21 70755 818 29502933
Anticoagulation drug level above therapeutic 30.19 11.38 29 70747 1802 29501949
Bundle branch block left 30.08 11.38 49 70727 5228 29498523
Sinusitis 29.93 11.38 23 70753 34327 29469424
Platelet count decreased 29.72 11.38 139 70637 104533 29399218
Optic neuropathy 29.60 11.38 28 70748 1707 29502044
Cerebral haemorrhage 29.50 11.38 151 70625 31275 29472476
Infusion related reaction 29.46 11.38 37 70739 43849 29459902
Spontaneous haematoma 29.41 11.38 17 70759 480 29503271
Low cardiac output syndrome 29.28 11.38 17 70759 484 29503267
Blood loss anaemia 29.27 11.38 58 70718 7208 29496543
Foetal exposure during pregnancy 29.10 11.38 23 70753 33844 29469907
Blood glucose increased 29.02 11.38 61 70715 58923 29444828
Back pain 28.94 11.38 136 70640 102148 29401603
Gastrooesophageal reflux disease 28.86 11.38 20 70756 31476 29472275
Angiodysplasia 28.85 11.38 17 70759 498 29503253
Pain 28.72 11.38 267 70509 171165 29332586
Chills 28.60 11.38 82 70694 71218 29432533
Hypertransaminasaemia 28.46 11.38 39 70737 3567 29500184
Atrioventricular block first degree 28.45 11.38 48 70728 5271 29498480
Respiratory failure 28.31 11.38 356 70420 96775 29406976
Traumatic lung injury 28.07 11.38 23 70753 1157 29502594
Intraocular haematoma 27.61 11.38 7 70769 14 29503737
Gravitational oedema 27.50 11.38 17 70759 544 29503207
Injury 27.40 11.38 104 70672 18942 29484809
Optic ischaemic neuropathy 27.13 11.38 28 70748 1898 29501853
Dissociation 26.84 11.38 22 70754 1107 29502644
Intentional product use issue 26.32 11.38 38 70738 42460 29461291
Influenza like illness 26.01 11.38 13 70763 24457 29479294
Cardiac output decreased 25.93 11.38 19 70757 809 29502942
Hypoaesthesia 25.72 11.38 56 70720 53411 29450340
Myoclonus 25.55 11.38 80 70696 13229 29490522
Xyphoid retraction 25.49 11.38 11 70765 162 29503589
Halo vision 25.43 11.38 11 70765 163 29503588
Herpes zoster 25.09 11.38 21 70755 30031 29473720
Diaphragmatic paralysis 25.01 11.38 15 70761 454 29503297
Device inappropriate shock delivery 24.90 11.38 7 70769 24 29503727
International normalised ratio abnormal 24.84 11.38 33 70743 2930 29500821
Pancreatitis 24.33 11.38 28 70748 34486 29469265
Fall 24.32 11.38 575 70201 176603 29327148
Antiacetylcholine receptor antibody positive 24.05 11.38 8 70768 54 29503697
Glomerular filtration rate decreased 23.76 11.38 70 70706 11196 29492555
Urinary tract infection 23.66 11.38 91 70685 72263 29431488
Depression 23.62 11.38 114 70662 85033 29418718
Blood pressure increased 23.38 11.38 94 70682 73709 29430042
Hypersensitivity 23.36 11.38 58 70718 52845 29450906
Cardiac murmur 23.35 11.38 50 70726 6563 29497188
Urticaria 23.31 11.38 61 70715 54599 29449152
Puncture site haematoma 23.25 11.38 10 70766 146 29503605
Mucosal inflammation 22.96 11.38 25 70751 31570 29472181
Left atrial enlargement 22.96 11.38 17 70759 736 29503015
Periorbital haemorrhage 22.89 11.38 9 70767 103 29503648
Atrial thrombosis 22.87 11.38 26 70750 1967 29501784
Toxic goitre 22.85 11.38 5 70771 3 29503748
Ischaemic stroke 22.78 11.38 87 70689 15890 29487861
Gastrointestinal angiodysplasia 22.50 11.38 15 70761 548 29503203
Hypertension 22.48 11.38 175 70601 116439 29387312
Presyncope 22.44 11.38 87 70689 16002 29487749
Femoral artery aneurysm 22.43 11.38 10 70766 160 29503591
Urine iodine increased 22.26 11.38 5 70771 4 29503747
Joint swelling 22.24 11.38 54 70722 49576 29454175
Sedation 22.18 11.38 7 70769 17398 29486353
Arteriosclerotic gangrene 22.15 11.38 8 70768 71 29503680
Cardiorenal syndrome 22.07 11.38 16 70760 670 29503081
Blood pressure fluctuation 22.02 11.38 10 70766 19884 29483867
Nodal rhythm 21.94 11.38 21 70755 1299 29502452
Blood creatinine increased 21.91 11.38 305 70471 84797 29418954
Iodine uptake abnormal 21.73 11.38 5 70771 5 29503746
Cardiac ventricular disorder 21.67 11.38 11 70765 238 29503513
Anaemia macrocytic 21.62 11.38 29 70747 2599 29501152
Acute pulmonary oedema 21.40 11.38 49 70727 6730 29497021
Dyspnoea at rest 21.32 11.38 32 70744 3182 29500569
Neonatal pneumonia 21.27 11.38 9 70767 126 29503625
Papilloedema 21.26 11.38 27 70749 2293 29501458
Device pacing issue 21.25 11.38 6 70770 21 29503730
Activated partial thromboplastin time prolonged 21.24 11.38 53 70723 7689 29496062
Subarachnoid haemorrhage 21.19 11.38 61 70715 9631 29494120
Exercise tolerance decreased 21.08 11.38 37 70739 4194 29499557
Lymphocyte count decreased 20.84 11.38 10 70766 19261 29484490
Nephrolithiasis 20.78 11.38 18 70758 25316 29478435
Sinoatrial block 20.73 11.38 13 70763 427 29503324
Prothrombin time prolonged 20.69 11.38 57 70719 8775 29494976
Drug resistance 20.65 11.38 13 70763 21527 29482224
Therapeutic product effect decreased 20.64 11.38 24 70752 29427 29474324
Thyroid function test abnormal 20.31 11.38 15 70761 647 29503104
Cholestasis 20.14 11.38 110 70666 23352 29480399
Neonatal hypotension 20.02 11.38 9 70767 147 29503604
Drug withdrawal syndrome 19.96 11.38 9 70767 17975 29485776
Conjunctival haemorrhage 19.94 11.38 28 70748 2620 29501131
Migraine 19.87 11.38 3 70773 12427 29491324
Anuria 19.85 11.38 59 70717 9482 29494269
Haemodynamic instability 19.81 11.38 53 70723 8020 29495731
Lupus pneumonitis 19.80 11.38 7 70769 58 29503693
Haemothorax 19.71 11.38 32 70744 3404 29500347
Normocytic anaemia 19.56 11.38 24 70752 1968 29501783
Bundle branch block 19.54 11.38 16 70760 804 29502947
Pruritus 19.54 11.38 182 70594 116667 29387084
Myelosuppression 19.43 11.38 3 70773 12224 29491527
Supine hypertension 19.34 11.38 11 70765 301 29503450
Lymphoid tissue hyperplasia 19.20 11.38 7 70769 64 29503687
Haemoptysis 19.13 11.38 132 70644 30418 29473333
Respiratory distress 19.09 11.38 137 70639 31969 29471782
Irritability 19.09 11.38 15 70761 22137 29481614
Hyperglycaemia 19.01 11.38 33 70743 34254 29469497
Aerophagia 18.92 11.38 6 70770 34 29503717
Pseudolymphoma 18.59 11.38 13 70763 514 29503237
Left ventricular dysfunction 18.48 11.38 55 70721 8847 29494904
Colitis ulcerative 18.43 11.38 4 70772 12765 29490986
Pulmonary oedema 18.19 11.38 169 70607 42566 29461185
Diabetes mellitus 18.11 11.38 43 70733 39788 29463963
Neuropathy peripheral 18.05 11.38 98 70678 70929 29432822
Rhinorrhoea 18.01 11.38 15 70761 21504 29482247
Heparin-induced thrombocytopenia 17.99 11.38 38 70738 4941 29498810
Coma uraemic 17.97 11.38 6 70770 41 29503710
Iodine overload 17.92 11.38 4 70772 3 29503748
Ejection fraction abnormal 17.83 11.38 15 70761 783 29502968
Musculoskeletal pain 17.82 11.38 26 70750 28927 29474824
Oesophageal infection 17.77 11.38 10 70766 268 29503483
Swelling 17.76 11.38 36 70740 35247 29468504
Cardio-respiratory arrest 17.63 11.38 192 70584 50409 29453342
Systemic inflammatory response syndrome 17.53 11.38 42 70734 5939 29497812
Muscle haemorrhage 17.53 11.38 30 70746 3332 29500419
Secondary hyperthyroidism 17.39 11.38 4 70772 4 29503747
Vascular purpura 17.29 11.38 19 70757 1384 29502367
Osteonecrosis of jaw 17.20 11.38 9 70767 16501 29487250
Abnormal behaviour 17.14 11.38 18 70758 23109 29480642
Rales 17.13 11.38 48 70728 7462 29496289
Depressed mood 17.09 11.38 9 70767 16439 29487312
Orthostatic hypertension 17.08 11.38 9 70767 211 29503540
Ischaemic cardiomyopathy 16.97 11.38 40 70736 5598 29498153
Vomiting 16.93 11.38 383 70393 211877 29291874
Heart rate abnormal 16.80 11.38 20 70756 1589 29502162
Withdrawal syndrome 16.80 11.38 3 70773 10989 29492762
Ilium fracture 16.74 11.38 7 70769 95 29503656
Haemorrhage intracranial 16.64 11.38 74 70702 14468 29489283
Cognitive disorder 16.63 11.38 19 70757 23480 29480271
Blood thyroid stimulating hormone decreased 16.60 11.38 21 70755 1777 29501974
Neuroleptic malignant syndrome 16.54 11.38 9 70767 16139 29487612
Scrotal haematocoele 16.46 11.38 5 70771 24 29503727
Upper respiratory tract infection 16.40 11.38 25 70751 27324 29476427
Alopecia 16.34 11.38 13 70763 19071 29484680
Accidental exposure to product 16.29 11.38 3 70773 10750 29493001
Hospitalisation 16.24 11.38 56 70720 45932 29457819
Thyroiditis acute 16.23 11.38 7 70769 103 29503648
Suicide attempt 16.17 11.38 36 70740 34074 29469677
Epistaxis 16.12 11.38 192 70584 51512 29452239
Oesophageal achalasia 16.12 11.38 10 70766 322 29503429
Lower respiratory tract infection 16.11 11.38 24 70752 26478 29477273
Product quality issue 16.07 11.38 9 70767 15886 29487865
Cardiac arrest neonatal 15.97 11.38 5 70771 27 29503724
Pemphigoid 15.89 11.38 47 70729 7534 29496217
Eosinophilia 15.84 11.38 99 70677 22062 29481689
Abdominal discomfort 15.81 11.38 60 70716 47843 29455908
Dyspepsia 15.80 11.38 30 70746 30095 29473656
Ischaemic hepatitis 15.77 11.38 19 70757 1529 29502222
Ascites 15.67 11.38 145 70631 36474 29467277
Decreased appetite 15.67 11.38 249 70527 145093 29358658
Hirsutism 15.52 11.38 8 70768 179 29503572
Influenza 15.47 11.38 50 70726 41831 29461920
Injection site erythema 15.47 11.38 7 70769 13949 29489802
Oedema peripheral 15.40 11.38 340 70436 103217 29400534
Product use issue 15.37 11.38 67 70709 51377 29452374
Emotional distress 15.37 11.38 70 70706 13825 29489926
Tumour lysis syndrome 15.33 11.38 7 70769 13877 29489874
Ecchymosis 15.18 11.38 41 70735 6239 29497512
Fasting 15.16 11.38 4 70772 10 29503741
Systemic-pulmonary artery shunt 15.11 11.38 3 70773 0 29503751
Bone marrow granuloma 15.11 11.38 3 70773 0 29503751
Thyrotoxic periodic paralysis 15.01 11.38 6 70770 72 29503679
Serotonin syndrome 14.91 11.38 12 70764 17500 29486251
Angioedema 14.87 11.38 34 70742 31881 29471870
Pseudarthrosis 14.86 11.38 6 70770 74 29503677
Diffuse vasculitis 14.86 11.38 6 70770 74 29503677
Electrocardiogram PR prolongation 14.82 11.38 13 70763 718 29503033
Mitral valve incompetence 14.73 11.38 67 70709 13226 29490525
Oropharyngeal pain 14.64 11.38 30 70746 29255 29474496
Tri-iodothyronine decreased 14.64 11.38 5 70771 37 29503714
Cardiothoracic ratio increased 14.63 11.38 4 70772 12 29503739
Hypophonesis 14.63 11.38 4 70772 12 29503739
Amaurosis 14.57 11.38 12 70764 608 29503143
Cell death 14.49 11.38 21 70755 2023 29501728
Non-compaction cardiomyopathy 14.41 11.38 5 70771 39 29503712
Tri-iodothyronine increased 14.41 11.38 5 70771 39 29503712
Mediastinal haemorrhage 14.41 11.38 5 70771 39 29503712
Myxoedema 14.39 11.38 4 70772 13 29503738
Dry skin 14.27 11.38 21 70755 23286 29480465
Cellulitis 14.13 11.38 59 70717 45781 29457970
Bone pain 14.08 11.38 14 70762 18438 29485313
Colitis 13.99 11.38 34 70742 31214 29472537
Anaphylactic reaction 13.99 11.38 28 70748 27545 29476206
Graft versus host disease 13.93 11.38 3 70773 9625 29494126
Myopathy 13.92 11.38 56 70720 10477 29493274
Basal cell carcinoma 13.89 11.38 12 70764 16898 29486853
Dysphagia 13.83 11.38 76 70700 54850 29448901
Bone marrow failure 13.82 11.38 28 70748 27421 29476330
Supraventricular extrasystoles 13.73 11.38 25 70751 2916 29500835
Pericarditis fungal 13.72 11.38 7 70769 153 29503598
Depressed level of consciousness 13.72 11.38 44 70732 36898 29466853
Orthostatic hypotension 13.71 11.38 97 70679 22532 29481219
Loss of personal independence in daily activities 13.64 11.38 25 70751 25415 29478336
Arthropathy 13.61 11.38 19 70757 21535 29482216
Chronotropic incompetence 13.56 11.38 4 70772 17 29503734
Bradyarrhythmia 13.50 11.38 20 70756 1965 29501786
Therapeutic response decreased 13.50 11.38 24 70752 24687 29479064
Cardiac dysfunction 13.45 11.38 19 70757 1788 29501963
Injection site reaction 13.39 11.38 5 70771 11183 29492568
Erectile dysfunction 13.36 11.38 14 70762 17995 29485756
Linear IgA disease 13.31 11.38 17 70759 1452 29502299
Hepatic cirrhosis 13.27 11.38 69 70707 14375 29489376
Proteinuria 13.24 11.38 11 70765 15793 29487958
General physical health deterioration 13.24 11.38 331 70445 102526 29401225
Tri-iodothyronine free decreased 13.23 11.38 5 70771 51 29503700
Fascial rupture 13.20 11.38 4 70772 19 29503732
Osteonecrosis 13.18 11.38 8 70768 13511 29490240
Adrenal haematoma 13.14 11.38 5 70771 52 29503699
Sinus arrhythmia 13.14 11.38 12 70764 699 29503052
Hypersensitivity pneumonitis 13.13 11.38 16 70760 1303 29502448
Lymphadenopathy 13.09 11.38 25 70751 25024 29478727
Subdural haematoma evacuation 13.03 11.38 4 70772 20 29503731
Toxic nodular goitre 13.03 11.38 4 70772 20 29503731
Alveolitis necrotising 13.03 11.38 4 70772 20 29503731
Acute lung injury 12.99 11.38 16 70760 1317 29502434
Nephroangiosclerosis 12.98 11.38 7 70769 172 29503579
Traumatic haemothorax 12.97 11.38 8 70768 255 29503496
Psoriasis 12.96 11.38 37 70739 32190 29471561
Hypervolaemia 12.93 11.38 79 70697 17466 29486285
Septic shock 12.92 11.38 216 70560 62344 29441407
Prostate cancer 12.89 11.38 26 70750 25501 29478250
Lung infiltration 12.77 11.38 59 70717 11720 29492031
Oedema genital 12.76 11.38 9 70767 361 29503390
Pulseless electrical activity 12.65 11.38 39 70737 6395 29497356
Infection 12.62 11.38 120 70656 76631 29427120
Therapeutic drug monitoring analysis not performed 12.61 11.38 10 70766 480 29503271
Osteoporosis 12.58 11.38 5 70771 10764 29492987
Neuromyopathy 12.54 11.38 13 70763 886 29502865
Paranoia 12.53 11.38 4 70772 9873 29493878
Leukopenia 12.51 11.38 79 70697 55124 29448627
Hepatitis C 12.44 11.38 3 70773 8907 29494844
Pulmonary vascular resistance abnormality 12.43 11.38 5 70771 61 29503690
Cardiovascular insufficiency 12.43 11.38 16 70760 1377 29502374
Hyponatraemic syndrome 12.42 11.38 7 70769 188 29503563
Prothrombin time shortened 12.39 11.38 16 70760 1382 29502369
Acute hepatic failure 12.33 11.38 59 70717 11893 29491858
Failure to suspend medication 12.29 11.38 9 70767 383 29503368
Hepatotoxicity 12.27 11.38 79 70697 17788 29485963
Intentional overdose 12.24 11.38 49 70727 38479 29465272
Iron deficiency anaemia 12.18 11.38 48 70728 8894 29494857
Progressive multifocal leukoencephalopathy 12.05 11.38 3 70773 8716 29495035
Electrocardiogram low voltage 12.02 11.38 4 70772 27 29503724
Deposit eye 12.02 11.38 4 70772 27 29503724
Optic nerve infarction 12.02 11.38 4 70772 27 29503724
Haemorrhagic stroke 11.98 11.38 36 70740 5820 29497931
Generalised tonic-clonic seizure 11.96 11.38 17 70759 19122 29484629
Type 2 diabetes mellitus 11.95 11.38 9 70767 13572 29490179
Cardiac disorder 11.89 11.38 139 70637 37124 29466627
Flushing 11.87 11.38 33 70743 28959 29474792
Tooth disorder 11.84 11.38 4 70772 9525 29494226
Heart transplant 11.82 11.38 12 70764 798 29502953
Eosinophilic pneumonia 11.80 11.38 23 70753 2823 29500928
Ventricular dyskinesia 11.79 11.38 7 70769 208 29503543
Mesenteric artery thrombosis 11.75 11.38 9 70767 410 29503341
Ulcer haemorrhage 11.71 11.38 21 70755 2420 29501331
Bundle branch block right 11.65 11.38 39 70737 6678 29497073
Postrenal failure 11.64 11.38 9 70767 416 29503335
Drug intolerance 11.61 11.38 68 70708 48311 29455440
Demyelinating polyneuropathy 11.59 11.38 14 70762 1130 29502621
Spinal cord haemorrhage 11.58 11.38 8 70768 310 29503441
Viral infection 11.58 11.38 11 70765 14799 29488952
Ventricular dysfunction 11.55 11.38 25 70751 3306 29500445
Palmar-plantar erythrodysaesthesia syndrome 11.49 11.38 11 70765 14748 29489003
Amnesia 11.49 11.38 23 70753 22620 29481131
Cardiac pacemaker insertion 11.48 11.38 21 70755 2458 29501293
Hepatitis fulminant 11.48 11.38 26 70750 3545 29500206

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
Hyperthyroidism 2191.82 11.26 906 108391 17273 64372162
Drug interaction 1449.61 11.26 2362 106935 359721 64029714
Bradycardia 1110.12 11.26 1176 108121 117043 64272392
Pulmonary toxicity 1005.45 11.26 419 108878 8142 64381293
Torsade de pointes 904.53 11.26 485 108812 16878 64372557
Electrocardiogram QT prolonged 883.02 11.26 866 108431 78582 64310853
Atrial fibrillation 771.30 11.26 1181 108116 169908 64219527
Ventricular tachycardia 766.13 11.26 559 108738 33706 64355729
Interstitial lung disease 731.11 11.26 864 108433 96868 64292567
Cardiac failure 665.46 11.26 962 108335 131411 64258024
Acute kidney injury 521.37 11.26 1807 107490 447433 63942002
Hypothyroidism 500.23 11.26 468 108829 39989 64349446
Thyroiditis 478.71 11.26 193 109104 3431 64386004
International normalised ratio increased 459.69 11.26 617 108680 78550 64310885
Cardiogenic shock 396.77 11.26 373 108924 32054 64357381
Ventricular fibrillation 354.09 11.26 306 108991 23554 64365881
Myxoedema coma 346.53 11.26 100 109197 587 64388848
Pulmonary fibrosis 302.67 11.26 310 108987 29568 64359867
Sinus bradycardia 267.95 11.26 257 109040 22636 64366799
Arthralgia 262.31 11.26 219 109078 442041 63947394
Hypotension 260.34 11.26 1304 107993 379670 64009765
Headache 242.68 11.26 326 108971 529141 63860294
Syncope 242.35 11.26 700 108597 156935 64232500
Cardiac failure congestive 238.73 11.26 618 108679 129962 64259473
Multiple organ dysfunction syndrome 222.63 11.26 515 108782 100898 64288537
Thyrotoxic crisis 217.77 11.26 79 109218 1037 64388398
Renal failure 217.67 11.26 740 108557 180948 64208487
Cardiac arrest 206.52 11.26 652 108645 153412 64236023
Pain 206.21 11.26 391 108906 553120 63836315
Hyperkalaemia 204.05 11.26 497 108800 100632 64288803
Ventricular arrhythmia 191.08 11.26 132 109165 7283 64382152
Atrial flutter 187.11 11.26 196 109101 19184 64370251
Joint swelling 178.14 11.26 71 109226 215311 64174124
Pulmonary alveolar haemorrhage 178.06 11.26 141 109156 9597 64379838
Gastrointestinal haemorrhage 177.32 11.26 560 108737 131752 64257683
Haematoma 175.94 11.26 296 109001 45954 64343481
Shock haemorrhagic 169.63 11.26 174 109123 16617 64372818
Rheumatoid arthritis 164.99 11.26 38 109259 164256 64225179
Nasopharyngitis 163.18 11.26 64 109233 196009 64193426
Hyponatraemia 157.65 11.26 581 108716 147758 64241677
Alopecia 157.35 11.26 43 109254 165647 64223788
Tachyarrhythmia 154.63 11.26 107 109190 5919 64383516
Labelled drug-drug interaction medication error 153.14 11.26 188 109109 21874 64367561
Lung disorder 151.99 11.26 325 108972 60375 64329060
Sinus node dysfunction 149.34 11.26 110 109187 6718 64382717
Rash 143.19 11.26 357 108940 458192 63931243
Acute respiratory distress syndrome 141.24 11.26 244 109053 38691 64350744
Atrioventricular block 140.80 11.26 135 109162 11880 64377555
Completed suicide 140.50 11.26 105 109192 224309 64165126
Sinusitis 140.20 11.26 37 109260 145891 64243544
Pain in extremity 139.17 11.26 186 109111 302899 64086536
Synovitis 138.79 11.26 7 109290 99083 64290352
Appendicolith 134.76 11.26 80 109217 3389 64386046
Infusion related reaction 133.06 11.26 56 109241 164411 64225024
Pyrexia 132.30 11.26 494 108803 558150 63831285
Drug intolerance 131.07 11.26 78 109219 187914 64201521
Organising pneumonia 128.01 11.26 113 109184 8942 64380493
Arthropathy 127.53 11.26 25 109272 120942 64268493
Fatigue 124.66 11.26 752 108545 747978 63641457
Rhabdomyolysis 124.46 11.26 390 108907 91336 64298099
Therapeutic product effect decreased 123.39 11.26 23 109274 115328 64274107
Haematuria 121.70 11.26 297 109000 60174 64329261
Blood thyroid stimulating hormone increased 121.36 11.26 102 109195 7552 64381883
Hypersensitivity 117.78 11.26 96 109201 196356 64193079
Cerebral haematoma 116.51 11.26 97 109200 7088 64382347
Melaena 115.30 11.26 270 109027 53278 64336157
Ventricular extrasystoles 114.66 11.26 145 109152 17384 64372051
Swelling 113.77 11.26 65 109232 160153 64229282
Hyperglobulinaemia 113.03 11.26 21 109276 0 64389435
Musculoskeletal stiffness 107.89 11.26 37 109260 123169 64266266
Arrhythmia 107.56 11.26 261 109036 52683 64336752
Infusion site phlebitis 107.25 11.26 28 109269 105 64389330
Cerebral haemorrhage 106.09 11.26 254 109043 50836 64338599
Rectal haemorrhage 105.15 11.26 285 109012 61532 64327903
Long QT syndrome 103.94 11.26 79 109218 5060 64384375
Injection site pain 103.72 11.26 30 109267 111378 64278057
Atrial tachycardia 102.79 11.26 68 109229 3491 64385944
Pericardial haemorrhage 100.43 11.26 71 109226 4065 64385370
Nausea 99.75 11.26 853 108444 784947 63604488
Cardiac failure chronic 99.22 11.26 98 109199 8943 64380492
Orthopnoea 98.37 11.26 98 109199 9036 64380399
Corneal deposits 97.82 11.26 33 109264 344 64389091
Febrile neutropenia 95.75 11.26 106 109191 187551 64201884
Diarrhoea 94.61 11.26 778 108519 721926 63667509
Cornea verticillata 94.12 11.26 24 109273 80 64389355
Maternal exposure during pregnancy 90.78 11.26 25 109272 95859 64293576
Stomatitis 90.77 11.26 36 109261 109569 64279866
Cardioactive drug level increased 90.02 11.26 62 109235 3403 64386032
Atrioventricular block complete 89.16 11.26 116 109181 14302 64375133
Dyspnoea 88.33 11.26 1707 107590 716967 63672468
Systemic lupus erythematosus 86.22 11.26 14 109283 77598 64311837
Hand deformity 86.13 11.26 5 109292 62766 64326669
Migraine 85.98 11.26 5 109292 62672 64326763
Hypoaesthesia 84.57 11.26 67 109230 139041 64250394
Renal injury 83.01 11.26 116 109181 15313 64374122
Pemphigus 82.79 11.26 5 109292 60696 64328739
Respiratory failure 82.49 11.26 511 108786 160672 64228763
Cholestasis 81.50 11.26 212 109085 44660 64344775
Subdural haematoma 80.57 11.26 159 109138 27895 64361540
Anaemia 79.34 11.26 985 108312 377695 64011740
Therapeutic product effect incomplete 79.33 11.26 38 109259 103444 64285991
Ejection fraction decreased 79.20 11.26 160 109137 28547 64360888
Back pain 78.52 11.26 194 109103 249977 64139458
Glossodynia 78.18 11.26 9 109288 64687 64324748
Product dose omission issue 78.16 11.26 131 109166 194616 64194819
Keratopathy 77.74 11.26 34 109263 746 64388689
Hepatocellular injury 77.37 11.26 209 109088 45026 64344409
Urticaria 76.48 11.26 82 109215 147235 64242200
Cardiac failure acute 76.45 11.26 115 109182 16229 64373206
Abdominal discomfort 74.69 11.26 121 109176 182201 64207234
Coronary artery bypass 73.22 11.26 68 109229 5747 64383688
Off label use 72.71 11.26 704 108593 632102 63757333
Anticoagulation drug level increased 72.26 11.26 31 109266 648 64388787
Injection site erythema 71.79 11.26 16 109281 70784 64318651
Drug-induced liver injury 71.56 11.26 210 109087 47433 64342002
Muscle spasms 71.54 11.26 80 109217 140943 64248492
Lactic acidosis 70.66 11.26 247 109050 61163 64328272
Cardio-respiratory arrest 70.57 11.26 342 108955 98051 64291384
Asthma 68.48 11.26 38 109259 95187 64294248
Hypokalaemia 68.44 11.26 396 108901 121507 64267928
Pleural effusion 68.39 11.26 407 108890 126152 64263283
Ischaemic stroke 67.57 11.26 151 109146 28884 64360551
Respiratory distress 66.84 11.26 218 109079 52113 64337322
Cardioversion 66.84 11.26 41 109256 1844 64387591
Blood loss anaemia 66.77 11.26 99 109198 13793 64375642
Coagulopathy 66.58 11.26 159 109138 31761 64357674
Mitral valve incompetence 66.51 11.26 139 109158 25399 64364036
Alveolitis 66.51 11.26 53 109244 3639 64385796
Myalgia 66.16 11.26 104 109193 158513 64230922
Pruritus 65.72 11.26 289 109008 312111 64077324
Pericardial effusion 63.78 11.26 178 109119 39076 64350359
Fall 63.10 11.26 1024 108273 415802 63973633
Pneumonitis 62.71 11.26 208 109089 50157 64339278
Arthritis 62.39 11.26 32 109265 83782 64305653
Venous pressure jugular increased 62.17 11.26 34 109263 1229 64388206
Anhedonia 62.07 11.26 95 109202 13611 64375824
Drug abuse 61.93 11.26 80 109217 132294 64257141
Renal impairment 61.67 11.26 416 108881 134601 64254834
Insomnia 61.60 11.26 154 109143 197682 64191753
Acute respiratory failure 61.08 11.26 205 109092 49729 64339706
Hypoxia 60.79 11.26 303 108994 87846 64301589
Coronary artery disease 60.21 11.26 232 109065 60201 64329234
Appendicitis 59.97 11.26 93 109204 13476 64375959
Lower respiratory tract infection 59.50 11.26 44 109253 94570 64294865
Cardiac tamponade 58.97 11.26 71 109226 8093 64381342
Product use issue 58.17 11.26 105 109192 151610 64237825
Bundle branch block left 57.84 11.26 78 109219 9956 64379479
Injection site reaction 57.63 11.26 6 109291 46658 64342777
Nodal arrhythmia 57.60 11.26 37 109260 1806 64387629
Depression 57.59 11.26 142 109155 183149 64206286
Exposure during pregnancy 57.31 11.26 30 109267 77645 64311790
Atrioventricular block first degree 56.70 11.26 80 109217 10654 64378781
Seizure 56.69 11.26 124 109173 166768 64222667
Neutrophil count decreased 56.68 11.26 30 109267 77166 64312269
BRASH syndrome 56.50 11.26 22 109275 355 64389080
Herpes zoster 56.36 11.26 32 109265 79155 64310280
Tachycardia induced cardiomyopathy 55.98 11.26 17 109280 122 64389313
Gastrooesophageal reflux disease 55.82 11.26 36 109261 83107 64306328
Wound 55.74 11.26 30 109267 76447 64312988
Influenza like illness 54.92 11.26 18 109279 61684 64327751
White blood cell count decreased 54.66 11.26 116 109181 157721 64231714
Potentiating drug interaction 54.62 11.26 67 109230 7785 64381650
Neuromyopathy 54.32 11.26 32 109265 1336 64388099
Spontaneous haematoma 53.83 11.26 31 109266 1240 64388195
Infection 53.68 11.26 149 109148 184731 64204704
Chills 53.52 11.26 94 109203 137170 64252265
Suicidal ideation 53.23 11.26 23 109274 66519 64322916
Anuria 52.67 11.26 106 109191 18858 64370577
Palpitations 52.63 11.26 330 108967 104158 64285277
Thyroid disorder 51.49 11.26 80 109217 11612 64377823
Blood pressure increased 50.14 11.26 139 109158 172413 64217022
Peripheral swelling 49.93 11.26 184 109113 208969 64180466
N-terminal prohormone brain natriuretic peptide increased 49.48 11.26 44 109253 3515 64385920
Anticoagulation drug level above therapeutic 49.14 11.26 41 109256 3004 64386431
Fibromyalgia 48.55 11.26 3 109294 35728 64353707
Oropharyngeal pain 47.76 11.26 48 109249 88819 64300616
Subarachnoid haemorrhage 47.60 11.26 100 109197 18338 64371097
Thyroxine free increased 46.88 11.26 27 109270 1080 64388355
Arterial haemorrhage 46.68 11.26 35 109262 2196 64387239
Intentional product use issue 46.30 11.26 56 109241 95308 64294127
Dyspnoea exertional 45.67 11.26 246 109051 73484 64315951
General physical health deterioration 45.43 11.26 538 108759 203887 64185548
Septic shock 45.25 11.26 320 108977 105117 64284318
Left ventricular dysfunction 44.99 11.26 93 109204 16861 64372574
Nodal rhythm 44.95 11.26 38 109259 2836 64386599
Left ventricular failure 44.86 11.26 63 109234 8354 64381081
Abdominal pain upper 44.44 11.26 150 109147 174880 64214555
Thyroxine increased 44.41 11.26 22 109275 646 64388789
Haemarthrosis 43.67 11.26 49 109248 5180 64384255
Eosinophilia 43.66 11.26 153 109144 37923 64351512
Musculoskeletal pain 43.58 11.26 44 109253 81250 64308185
Toxic skin eruption 43.43 11.26 99 109198 19185 64370250
Haemorrhage 43.36 11.26 256 109041 79095 64310340
Ecchymosis 43.35 11.26 82 109215 13940 64375495
Asthenia 43.30 11.26 989 108308 427055 63962380
Presyncope 42.86 11.26 144 109153 34945 64354490
Malignant neoplasm progression 42.47 11.26 79 109218 112792 64276643
Jugular vein distension 42.45 11.26 27 109270 1295 64388140
Goitre 42.21 11.26 47 109250 4926 64384509
Rales 42.15 11.26 85 109212 15144 64374291
Bradyarrhythmia 41.73 11.26 41 109256 3717 64385718
Muscle haemorrhage 41.50 11.26 50 109247 5703 64383732
Psoriatic arthropathy 41.49 11.26 11 109286 43270 64346165
Prothrombin time shortened 41.16 11.26 36 109261 2813 64386622
Oedema peripheral 40.94 11.26 540 108757 209777 64179658
Discomfort 40.87 11.26 46 109251 80832 64308603
Drug level increased 40.59 11.26 139 109158 34057 64355378
Fear 40.48 11.26 99 109198 20072 64369363
Haemorrhage intracranial 40.48 11.26 110 109187 23774 64365661
Glomerular filtration rate decreased 40.28 11.26 97 109200 19475 64369960
Device pacing issue 40.28 11.26 12 109285 80 64389355
Heparin-induced thrombocytopenia 40.14 11.26 60 109237 8419 64381016
Neutropenia 39.98 11.26 240 109057 239384 64150051
Blood pressure fluctuation 39.82 11.26 19 109278 51852 64337583
Haemorrhagic stroke 39.58 11.26 65 109232 9886 64379549
Lymphatic fistula 38.96 11.26 21 109276 737 64388698
Ill-defined disorder 38.94 11.26 13 109284 44039 64345396
Femoral hernia incarcerated 38.89 11.26 21 109276 740 64388695
Sedation 38.88 11.26 11 109286 41451 64347984
Cardiac murmur 38.73 11.26 70 109227 11493 64377942
Psoriasis 38.22 11.26 39 109258 71664 64317771
Low cardiac output syndrome 38.03 11.26 21 109276 774 64388661
Rhinorrhoea 37.55 11.26 28 109269 59941 64329494
Optic neuropathy 37.50 11.26 35 109262 2976 64386459
Brugada syndrome 37.09 11.26 23 109274 1055 64388380
Drug dependence 37.01 11.26 6 109291 33306 64356129
Blood creatinine increased 36.42 11.26 371 108926 135411 64254024
Pulmonary hypertension 36.14 11.26 157 109140 42982 64346453
Upper respiratory tract infection 36.12 11.26 42 109255 72743 64316692
Optic ischaemic neuropathy 36.02 11.26 32 109265 2553 64386882
Activated partial thromboplastin time prolonged 35.97 11.26 72 109225 12759 64376676
Bone pain 35.64 11.26 18 109279 47554 64341881
Sinoatrial block 35.43 11.26 23 109274 1143 64388292
Weight increased 35.42 11.26 214 109083 213134 64176301
Iodine overload 35.18 11.26 7 109290 3 64389432
Irritable bowel syndrome 34.88 11.26 10 109287 37359 64352076
Acute pulmonary oedema 34.86 11.26 71 109226 12738 64376697
Myopathy 34.66 11.26 86 109211 17594 64371841
Craniocerebral injury 34.65 11.26 39 109258 4137 64385298
Pericarditis 34.47 11.26 33 109264 62483 64326952
Gravitational oedema 34.47 11.26 26 109271 1646 64387789
Folliculitis 34.37 11.26 5 109292 30072 64359363
Suicide attempt 34.15 11.26 42 109255 70965 64318470
Vomiting 34.12 11.26 694 108603 550423 63839012
Pacemaker generated rhythm 34.05 11.26 10 109287 63 64389372
Myocardial infarction 34.04 11.26 430 108867 165391 64224044
Extravasation 34.02 11.26 34 109263 3146 64386289
Cerebellar syndrome 33.61 11.26 42 109255 4974 64384461
Injection site swelling 33.54 11.26 14 109283 41339 64348096
Ischaemic hepatitis 33.44 11.26 34 109263 3212 64386223
Atrial thrombosis 33.43 11.26 33 109264 3009 64386426
Pancreatic steatosis 33.40 11.26 21 109276 987 64388448
Haemoptysis 33.38 11.26 168 109129 48880 64340555
Anaemia macrocytic 33.00 11.26 39 109258 4359 64385076
Haematoma muscle 32.86 11.26 26 109271 1767 64387668
Mitochondrial aspartate aminotransferase increased 32.83 11.26 7 109290 7 64389428
Phlebitis 32.62 11.26 52 109245 7714 64381721
Disease progression 32.27 11.26 127 109170 141553 64247882
Myxoedema 32.24 11.26 11 109286 119 64389316
International normalised ratio abnormal 32.20 11.26 41 109256 4947 64384488
Pulmonary oedema 32.15 11.26 236 109061 78438 64310997
Wound infection pseudomonas 31.96 11.26 24 109273 1509 64387926
Angiodysplasia 31.89 11.26 19 109278 810 64388625
Cardiac output decreased 31.85 11.26 25 109272 1679 64387756
Swelling face 31.74 11.26 32 109265 59134 64330301
Osteonecrosis of jaw 31.48 11.26 14 109283 39811 64349624
Prothrombin time prolonged 31.31 11.26 77 109220 15664 64373771
Cytomegalovirus infection 31.14 11.26 12 109285 37187 64352248
Lymphocyte count decreased 31.10 11.26 15 109282 40684 64348751
Osteoarthritis 30.95 11.26 37 109260 63299 64326136
Respiratory acidosis 30.92 11.26 58 109239 9797 64379638
Mixed liver injury 30.67 11.26 42 109255 5439 64383996
Shock 30.39 11.26 137 109160 38103 64351332
Intentional overdose 30.38 11.26 67 109230 89877 64299558
Lung infiltration 30.34 11.26 91 109206 20798 64368637
Hypervolaemia 30.31 11.26 137 109160 38148 64351287
Dyspnoea at rest 30.27 11.26 45 109252 6284 64383151
Head injury 30.22 11.26 123 109174 32719 64356716
Injection site bruising 30.01 11.26 12 109285 36361 64353074
Pancreatitis 30.01 11.26 34 109263 59573 64329862
Toxic goitre 30.01 11.26 7 109290 14 64389421
Haemothorax 30.00 11.26 39 109258 4803 64384632
Deep vein thrombosis 29.60 11.26 86 109211 105096 64284339
Anaphylactic reaction 29.59 11.26 44 109253 68620 64320815
Drug hypersensitivity 29.59 11.26 259 109038 237556 64151879
Tricuspid valve incompetence 29.51 11.26 79 109218 16924 64372511
Xyphoid retraction 29.17 11.26 11 109286 162 64389273
Neck pain 28.96 11.26 37 109260 61496 64327939
Cardiac ablation 28.89 11.26 24 109273 1748 64387687
Exercise tolerance decreased 28.84 11.26 49 109248 7661 64381774
Fungal infection 28.76 11.26 11 109286 34240 64355195
Type 2 diabetes mellitus 28.44 11.26 11 109286 34009 64355426
Hot flush 28.42 11.26 22 109275 46213 64343222
Throat irritation 28.32 11.26 10 109287 32701 64356734
Hepatitis acute 28.25 11.26 67 109230 13322 64376113
Palmar-plantar erythrodysaesthesia syndrome 28.25 11.26 7 109290 28812 64360623
Ventricular tachyarrhythmia 28.19 11.26 12 109285 246 64389189
Blood cholesterol increased 28.11 11.26 26 109271 50040 64339395
Cardiovascular insufficiency 27.97 11.26 28 109269 2596 64386839
Femoral artery aneurysm 27.94 11.26 11 109286 183 64389252
Toxicity to various agents 27.94 11.26 810 108487 362703 64026732
Hepatic failure 27.91 11.26 175 109122 55219 64334216
Feeling hot 27.72 11.26 22 109275 45641 64343794
Hepatitis fulminant 27.72 11.26 43 109254 6231 64383204
Ischaemic cardiomyopathy 27.65 11.26 45 109252 6793 64382642
Knee arthroplasty 27.57 11.26 6 109291 26993 64362442
Intraocular haematoma 27.53 11.26 7 109290 23 64389412
Gastrointestinal angiodysplasia 27.36 11.26 18 109279 915 64388520
Erythema 27.32 11.26 195 109102 186875 64202560
Cardiac disorder 27.29 11.26 175 109122 55641 64333794
Feeling abnormal 27.20 11.26 125 109172 133477 64255958
Abdominal wall haematoma 27.18 11.26 35 109262 4270 64385165
Mediastinal haematoma 27.10 11.26 11 109286 199 64389236
Oral herpes 26.96 11.26 3 109294 22149 64367286
Periorbital haemorrhage 26.95 11.26 11 109286 202 64389233
Cellulitis 26.78 11.26 76 109221 93581 64295854
Ilium fracture 26.60 11.26 11 109286 209 64389226
Cerebellar haematoma 26.51 11.26 15 109282 580 64388855
Drug withdrawal syndrome 26.35 11.26 10 109287 31281 64358154
Orthostatic hypotension 26.31 11.26 152 109145 46586 64342849
Mouth ulceration 26.29 11.26 11 109286 32433 64357002
Papilloedema 26.12 11.26 39 109258 5466 64383969
Drug ineffective 26.02 11.26 1162 108135 839085 63550350
Antiacetylcholine receptor antibody positive 25.92 11.26 8 109289 61 64389374
Puncture site haematoma 25.70 11.26 10 109287 161 64389274
Intra-abdominal haematoma 25.60 11.26 26 109271 2453 64386982
Haemodynamic instability 25.59 11.26 69 109228 14843 64374592
Traumatic lung injury 25.59 11.26 25 109272 2251 64387184
Eosinophilic pneumonia 25.50 11.26 35 109262 4542 64384893
Lower gastrointestinal haemorrhage 25.45 11.26 66 109231 13873 64375562
Flushing 25.42 11.26 60 109237 78588 64310847
Cardioactive drug level above therapeutic 25.25 11.26 11 109286 239 64389196
Influenza 25.22 11.26 94 109203 106437 64282998
Electrocardiogram PR prolongation 25.18 11.26 20 109277 1367 64388068
Mobility decreased 25.03 11.26 69 109228 85771 64303664
Cataract 24.99 11.26 30 109267 51232 64338203
Dry mouth 24.81 11.26 40 109257 60378 64329057
Ascites 24.76 11.26 185 109112 61816 64327619
Tri-iodothyronine increased 24.73 11.26 10 109287 179 64389256
Urinary tract infection 24.66 11.26 262 109035 231334 64158101
Arteriosclerotic gangrene 24.66 11.26 8 109289 73 64389362
Red blood cell sedimentation rate increased 24.66 11.26 11 109286 31224 64358211
Medication error 24.64 11.26 157 109140 49809 64339626
Thyroiditis acute 24.38 11.26 10 109287 186 64389249
Right ventricular failure 24.37 11.26 86 109211 21385 64368050
Acute hepatic failure 24.19 11.26 98 109199 26014 64363421
Alveolar proteinosis 24.17 11.26 14 109283 566 64388869
Nephrolithiasis 24.15 11.26 23 109274 43660 64345775
Memory impairment 24.15 11.26 70 109227 85612 64303823
Basal cell carcinoma 24.12 11.26 11 109286 30827 64358608
Seroma 23.91 11.26 23 109274 2031 64387404
Myoclonus 23.85 11.26 95 109202 25023 64364412
Colitis ulcerative 23.75 11.26 5 109292 23023 64366412
Bursitis 23.58 11.26 4 109293 21481 64367954
Secondary hyperthyroidism 23.53 11.26 6 109291 20 64389415
Hypertension 23.48 11.26 304 108993 258957 64130478
Urine iodine increased 23.45 11.26 5 109292 5 64389430
Iodine uptake abnormal 23.45 11.26 5 109292 5 64389430
Osteoporosis 23.45 11.26 22 109275 42058 64347377
Platelet count decreased 23.44 11.26 177 109120 167534 64221901
Left atrial enlargement 23.41 11.26 17 109280 1015 64388420
Hypertransaminasaemia 23.41 11.26 43 109254 7148 64382287
Hip arthroplasty 23.38 11.26 4 109293 21347 64368088
Depressed mood 23.38 11.26 21 109276 40991 64348444
Blood thyroid stimulating hormone decreased 23.33 11.26 36 109261 5194 64384241
Neoplasm progression 23.32 11.26 21 109276 40943 64348492
Haemorrhagic diathesis 23.27 11.26 37 109260 5477 64383958
Irritability 23.21 11.26 17 109280 36729 64352706
Extrasystoles 23.19 11.26 41 109256 6617 64382818
Vascular purpura 23.16 11.26 25 109272 2531 64386904
Pulmonary embolism 23.14 11.26 149 109148 146207 64243228
Epistaxis 22.99 11.26 261 109036 97870 64291565
Ear pain 22.96 11.26 7 109290 25129 64364306
Blister 22.93 11.26 66 109231 80901 64308534
Therapeutic response decreased 22.92 11.26 33 109264 52155 64337280
Blood glucose increased 22.91 11.26 87 109210 97986 64291449
Adverse event 22.77 11.26 20 109277 39469 64349966
Aortic valve incompetence 22.57 11.26 46 109251 8255 64381180
Retroperitoneal haemorrhage 22.41 11.26 34 109263 4834 64384601
Night sweats 22.35 11.26 17 109280 36029 64353406
Loss of personal independence in daily activities 22.06 11.26 57 109240 72397 64317038
Supine hypertension 21.40 11.26 11 109286 350 64389085
Nasal congestion 21.35 11.26 43 109254 59615 64329820
Neonatal hypotension 21.27 11.26 6 109291 32 64389403
Neonatal pneumonia 21.27 11.26 6 109291 32 64389403
Accidental exposure to product 21.26 11.26 9 109288 26355 64363080
Product quality issue 21.26 11.26 12 109285 29787 64359648
Jaundice 21.25 11.26 148 109149 48364 64341071
Halo vision 21.25 11.26 13 109284 582 64388853
Hepatotoxicity 21.23 11.26 128 109169 39834 64349601
Cell death 21.09 11.26 30 109267 4024 64385411
Feeling cold 20.91 11.26 7 109290 23671 64365764
Tooth disorder 20.90 11.26 6 109291 22396 64367039
Acute coronary syndrome 20.78 11.26 76 109221 19234 64370201
Cystitis 20.77 11.26 25 109272 42650 64346785
Paraesthesia 20.73 11.26 138 109159 134384 64255051
Device capturing issue 20.54 11.26 6 109291 37 64389398
Ear infection 20.52 11.26 7 109290 23397 64366038
Bundle branch block 20.41 11.26 18 109279 1422 64388013
Localised infection 20.32 11.26 13 109284 30148 64359287
Electrocardiogram QRS complex prolonged 20.31 11.26 47 109250 9197 64380238
Subcutaneous haematoma 20.28 11.26 23 109274 2460 64386975
Conjunctival haemorrhage 20.24 11.26 33 109264 4988 64384447
Pemphigoid 20.22 11.26 58 109239 12928 64376507
Acne 20.07 11.26 7 109290 23074 64366361
Supraventricular extrasystoles 20.06 11.26 36 109261 5879 64383556
Lupus pneumonitis 20.01 11.26 7 109290 82 64389353
Aerophagia 20.01 11.26 6 109291 41 64389394
Treatment failure 19.99 11.26 116 109181 116700 64272735
Pharyngitis 19.92 11.26 4 109293 19035 64370400
Coma uraemic 19.89 11.26 6 109291 42 64389393
Diabetes mellitus 19.70 11.26 53 109244 66421 64323014
Local anaesthetic systemic toxicity 19.57 11.26 13 109284 672 64388763
Normocytic anaemia 19.56 11.26 26 109271 3273 64386162
Central nervous system injury 19.54 11.26 8 109289 148 64389287
Hypophonesis 19.53 11.26 5 109292 17 64389418
Myelosuppression 19.44 11.26 8 109289 23822 64365613
Osteonecrosis 19.25 11.26 12 109285 28217 64361218
Hypoglycaemia 19.24 11.26 235 109062 89657 64299778
Device inappropriate shock delivery 19.19 11.26 6 109291 48 64389387
Atrioventricular block second degree 19.04 11.26 37 109260 6417 64383018
Contraindicated product administered 19.03 11.26 106 109191 107723 64281712
Pseudolymphoma 19.03 11.26 15 109282 1014 64388421
Diaphragmatic paralysis 18.96 11.26 15 109282 1019 64388416
Oliguria 18.85 11.26 61 109236 14515 64374920
Cyanosis 18.84 11.26 81 109216 22074 64367361
Gastrointestinal disorder 18.81 11.26 83 109214 89626 64299809
Acute interstitial pneumonitis 18.80 11.26 15 109282 1032 64388403
Hypoxic-ischaemic encephalopathy 18.70 11.26 39 109258 7113 64382322
Bone disorder 18.66 11.26 3 109294 16756 64372679
Skin disorder 18.55 11.26 12 109285 27668 64361767
Arrhythmia supraventricular 18.52 11.26 19 109278 1814 64387621
Wheezing 18.49 11.26 72 109225 80507 64308928
Cardiorenal syndrome 18.47 11.26 16 109281 1234 64388201
Mucosal inflammation 18.47 11.26 50 109247 62534 64326901
Injection site haemorrhage 18.47 11.26 9 109288 24269 64365166
Heart transplant 18.46 11.26 16 109281 1235 64388200
Body temperature increased 18.36 11.26 21 109276 36645 64352790
Aortic valve stenosis 18.33 11.26 30 109267 4550 64384885
Musculoskeletal disorder 18.24 11.26 4 109293 17902 64371533
Crepitations 18.23 11.26 41 109256 7874 64381561
Bundle branch block right 18.11 11.26 48 109249 10221 64379214
Joint stiffness 18.02 11.26 15 109282 30389 64359046
Amnesia 17.96 11.26 34 109263 48235 64341200
Respiratory disorder neonatal 17.92 11.26 6 109291 61 64389374
Device issue 17.84 11.26 8 109289 22640 64366795
Orchitis 17.82 11.26 15 109282 1113 64388322
Viral infection 17.77 11.26 21 109276 36119 64353316
Wrong technique in product usage process 17.65 11.26 54 109243 64920 64324515
Dysgeusia 17.63 11.26 33 109264 47014 64342421
Traumatic haemothorax 17.59 11.26 10 109287 390 64389045
Cardiomegaly 17.45 11.26 83 109214 23601 64365834
Acute generalised exanthematous pustulosis 17.44 11.26 58 109239 14000 64375435
Withdrawal syndrome 17.43 11.26 9 109288 23483 64365952
Eye pain 17.08 11.26 17 109280 31608 64357827
Unevaluable event 17.07 11.26 145 109152 50344 64339091
Hyperglycaemia 17.04 11.26 50 109247 60918 64328517
Oral pain 17 11.26 13 109284 27480 64361955
Therapeutic drug monitoring analysis not performed 16.88 11.26 15 109282 1197 64388238
Myocardial ischaemia 16.78 11.26 81 109216 23170 64366265
Amaurosis 16.73 11.26 14 109283 1030 64388405
Pain in jaw 16.71 11.26 27 109270 40728 64348707
Atrioventricular dissociation 16.70 11.26 9 109288 316 64389119
Neuralgia 16.68 11.26 12 109285 26172 64363263
Limb discomfort 16.61 11.26 13 109284 27162 64362273
Impaired healing 16.61 11.26 50 109247 60423 64329012
Thrombotic microangiopathy 16.41 11.26 4 109293 16651 64372784
Intentional self-injury 16.40 11.26 15 109282 29029 64360406
Toxic nodular goitre 16.33 11.26 5 109292 37 64389398
Conjunctivitis 16.33 11.26 7 109290 20347 64369088
Cardiac pacemaker insertion 16.31 11.26 30 109267 4993 64384442
Electrocardiogram RR interval prolonged 16.26 11.26 4 109293 11 64389424
Ocular hyperaemia 16.22 11.26 9 109288 22555 64366880
Systemic inflammatory response syndrome 16.22 11.26 46 109251 10189 64379246
Pulseless electrical activity 16.20 11.26 53 109244 12686 64376749
Endovenous ablation 16.15 11.26 3 109294 0 64389435
Intervertebral disc protrusion 16.11 11.26 7 109290 20184 64369251
Non-compaction cardiomyopathy 16.10 11.26 5 109292 39 64389396
Splenic injury 16.02 11.26 8 109289 239 64389196
Thyroid function test abnormal 16.02 11.26 22 109275 2857 64386578
Crying 15.98 11.26 7 109290 20083 64369352
Paranoia 15.97 11.26 4 109293 16348 64373087
Bone marrow failure 15.96 11.26 36 109261 47916 64341519
Neuropathy peripheral 15.96 11.26 125 109172 117400 64272035
Burning sensation 15.95 11.26 38 109259 49626 64339809
Coagulation test abnormal 15.89 11.26 14 109283 1105 64388330
Anti-thyroid antibody positive 15.87 11.26 10 109287 472 64388963
Anticoagulation drug level below therapeutic 15.86 11.26 15 109282 1297 64388138
Treatment noncompliance 15.85 11.26 31 109266 43451 64345984
Agranulocytosis 15.79 11.26 115 109182 38114 64351321
Sopor 15.75 11.26 95 109202 29566 64359869
Transplant rejection 15.62 11.26 5 109292 17396 64372039
Concomitant disease aggravated 15.56 11.26 49 109248 11493 64377942
Stress 15.55 11.26 164 109133 60370 64329065
Thyrotoxic periodic paralysis 15.51 11.26 6 109291 95 64389340
Conduction disorder 15.50 11.26 22 109275 2946 64386489
Gastroenteritis viral 15.49 11.26 7 109290 19722 64369713
Chorea 15.45 11.26 18 109279 1982 64387453
Neutrophil count increased 15.44 11.26 12 109285 25162 64364273
Hepatic cyst 15.41 11.26 30 109267 5210 64384225
Ulcer 15.36 11.26 10 109287 22980 64366455
Pericarditis fungal 15.35 11.26 7 109290 170 64389265
Pulmonary arterial hypertension 15.27 11.26 84 109213 25283 64364152
Dissociation 15.25 11.26 22 109275 2989 64386446
Dry eye 15.22 11.26 16 109281 29003 64360432
Paroxysmal arrhythmia 15.19 11.26 5 109292 48 64389387
Listless 15.17 11.26 23 109274 3267 64386168
Subdural haemorrhage 15.15 11.26 30 109267 5273 64384162
Retroperitoneal haematoma 15.12 11.26 28 109269 4683 64384752
Photosensitivity reaction 15.11 11.26 66 109231 18107 64371328
COVID-19 15.07 11.26 58 109239 65082 64324353
Inappropriate schedule of product administration 15.07 11.26 93 109204 92193 64297242
Colitis 15.07 11.26 50 109247 58624 64330811
Hepatojugular reflux 15.05 11.26 10 109287 517 64388918
Diabetic ketoacidosis 15.05 11.26 17 109280 29828 64359607
Intraventricular haemorrhage 15.02 11.26 26 109271 4127 64385308
Thyroxine free decreased 14.97 11.26 12 109285 831 64388604
Chronic kidney disease 14.92 11.26 157 109140 57762 64331673
Diffuse vasculitis 14.86 11.26 6 109291 107 64389328
Failure to suspend medication 14.85 11.26 9 109288 396 64389039
Mesenteric artery thrombosis 14.75 11.26 10 109287 535 64388900
Sciatica 14.69 11.26 8 109289 20256 64369179
Reduced facial expression 14.65 11.26 18 109279 2095 64387340
Vascular pseudoaneurysm 14.63 11.26 22 109275 3102 64386333
Oesophageal infection 14.61 11.26 10 109287 543 64388892
Ventricular remodelling 14.61 11.26 6 109291 112 64389323
Cholestatic liver injury 14.59 11.26 24 109273 3655 64385780
Fascial rupture 14.56 11.26 4 109293 19 64389416
Drug clearance decreased 14.55 11.26 20 109277 2599 64386836
Mental disorder 14.53 11.26 14 109283 26431 64363004
Renal function test abnormal 14.53 11.26 25 109272 3949 64385486
Thyroglobulin increased 14.42 11.26 5 109292 57 64389378
Hepatitis 14.42 11.26 129 109168 45453 64343982
Alveolitis necrotising 14.40 11.26 4 109293 20 64389415
Sneezing 14.38 11.26 4 109293 15247 64374188
Throat tightness 14.26 11.26 11 109286 23149 64366286
Hypothermia 14.21 11.26 69 109228 19787 64369648
Blood pressure decreased 14.20 11.26 215 109082 85984 64303451
Blood creatine increased 14.15 11.26 38 109259 8154 64381281
Thrombin time prolonged 14.14 11.26 8 109289 309 64389126
Liver injury 14.11 11.26 93 109204 29839 64359596
Leukopenia 14.06 11.26 107 109190 101135 64288300
Illness 14.05 11.26 10 109287 21928 64367507
Generalised tonic-clonic seizure 14.03 11.26 29 109268 39828 64349607
Neuroleptic malignant syndrome 14.01 11.26 13 109284 24983 64364452
Brain natriuretic peptide increased 13.79 11.26 36 109261 7597 64381838
Amyloidosis 13.79 11.26 19 109278 2475 64386960
Hypoglycaemic seizure 13.78 11.26 11 109286 757 64388678
Injection site warmth 13.73 11.26 3 109294 13459 64375976
Oedema genital 13.73 11.26 9 109288 455 64388980
Gastroenteritis aeromonas 13.65 11.26 4 109293 25 64389410
Adrenal haematoma 13.62 11.26 6 109291 134 64389301
Swollen tongue 13.56 11.26 24 109273 34930 64354505
Serotonin syndrome 13.48 11.26 29 109268 39253 64350182
Electrocardiogram T wave abnormal 13.45 11.26 22 109275 3334 64386101
Carpal tunnel syndrome 13.43 11.26 5 109292 15823 64373612
Weight decreased 13.42 11.26 375 108922 285364 64104071
Diverticulum intestinal 13.41 11.26 35 109262 7385 64382050
Hyperthermia 13.33 11.26 57 109240 15493 64373942
Splenic haemorrhage 13.33 11.26 10 109287 628 64388807
Rash maculo-papular 13.32 11.26 130 109167 46896 64342539
Orthostatic hypertension 13.31 11.26 10 109287 629 64388806
Hypovolaemic shock 13.31 11.26 43 109254 10223 64379212
Electrocardiogram QRS complex shortened 13.29 11.26 10 109287 631 64388804
Lymphadenopathy 13.26 11.26 38 109259 46648 64342787
Congestive hepatopathy 13.24 11.26 24 109273 3949 64385486
Neovascular age-related macular degeneration 13.22 11.26 7 109290 237 64389198
Hepatitis cholestatic 13.21 11.26 48 109249 12107 64377328
Hypocoagulable state 13.20 11.26 16 109281 1837 64387598
Eye swelling 13.19 11.26 11 109286 22270 64367165
Abdominal pain 13.17 11.26 416 108881 311959 64077476
Vascular graft 13.15 11.26 16 109281 1843 64387592
Device dislocation 13.11 11.26 10 109287 21168 64368267
Sinus arrhythmia 13.08 11.26 16 109281 1854 64387581
Obstructive airways disorder 13.06 11.26 12 109285 23173 64366262
Hypochromasia 13.03 11.26 10 109287 650 64388785
Infective pericardial effusion 13.02 11.26 4 109293 30 64389405
Procedural pain 12.99 11.26 5 109292 15503 64373932
Altered visual depth perception 12.92 11.26 8 109289 366 64389069
Constipation 12.91 11.26 293 109004 229044 64160391
Blood triglycerides increased 12.89 11.26 8 109289 18858 64370577
Full blood count abnormal 12.89 11.26 19 109278 29738 64359697
Dry skin 12.86 11.26 44 109253 51117 64338318
Faecaloma 12.84 11.26 41 109256 9687 64379748
Vision blurred 12.76 11.26 95 109202 90221 64299214
Prerenal failure 12.75 11.26 21 109276 3201 64386234
Ventricular enlargement 12.75 11.26 9 109288 514 64388921
Lymphoid tissue hyperplasia 12.72 11.26 7 109290 256 64389179
Rash pruritic 12.72 11.26 52 109245 57352 64332083
Electrocardiogram low voltage 12.69 11.26 4 109293 33 64389402
Colonic haematoma 12.66 11.26 5 109292 84 64389351
Oesophageal achalasia 12.63 11.26 10 109287 680 64388755
Demyelinating polyneuropathy 12.61 11.26 14 109283 1462 64387973
Chest X-ray abnormal 12.57 11.26 32 109265 6649 64382786
Mood swings 12.51 11.26 7 109290 17461 64371974
Toothache 12.50 11.26 7 109290 17452 64371983
Fasting 12.48 11.26 4 109293 35 64389400
Bronchitis 12.40 11.26 121 109176 108622 64280813
Oesophageal adenocarcinoma recurrent 12.38 11.26 4 109293 36 64389399
Tooth abscess 12.36 11.26 4 109293 13822 64375613
Graft versus host disease 12.34 11.26 4 109293 13809 64375626
Hypernatraemia 12.30 11.26 47 109250 12142 64377293
Lip swelling 12.29 11.26 22 109275 31885 64357550
Linear IgA disease 12.24 11.26 19 109278 2755 64386680
Haemoperitoneum 12.23 11.26 23 109274 3892 64385543
Arteriovenous fistula 12.20 11.26 11 109286 895 64388540
Blood pressure systolic increased 12.12 11.26 43 109254 49410 64340025
Transaminases increased 12.02 11.26 122 109175 44472 64344963
Electrocardiogram T wave inversion 12.00 11.26 26 109271 4868 64384567
Postrenal failure 12.00 11.26 9 109288 565 64388870
Foot fracture 11.99 11.26 8 109289 18149 64371286
Pulmonary haemorrhage 11.98 11.26 49 109248 13060 64376375
Cardiac dysfunction 11.96 11.26 20 109277 3086 64386349
Anxiety 11.95 11.26 257 109040 202392 64187043
C-reactive protein increased 11.95 11.26 103 109194 94806 64294629
Ventricular flutter 11.90 11.26 5 109292 99 64389336
Blood phosphorus increased 11.82 11.26 26 109271 4920 64384515
Ventricular dysfunction 11.80 11.26 27 109270 5243 64384192
Microcytic anaemia 11.79 11.26 25 109272 4613 64384822
Sinus disorder 11.79 11.26 7 109290 16901 64372534
Tooth infection 11.75 11.26 5 109292 14596 64374839
Nodule 11.73 11.26 8 109289 17939 64371496
Tri-iodothyronine decreased 11.73 11.26 6 109291 189 64389246
Blood cyanide increased 11.66 11.26 4 109293 44 64389391
Cyst 11.63 11.26 3 109294 12024 64377411
Panic attack 11.62 11.26 11 109286 20942 64368493
Kidney infection 11.60 11.26 8 109289 17830 64371605
Iron deficiency anaemia 11.55 11.26 70 109227 21819 64367616
Nephroangiosclerosis 11.55 11.26 7 109290 308 64389127
Eosinophilia myalgia syndrome 11.54 11.26 3 109294 11 64389424
Secretion discharge 11.54 11.26 3 109294 11961 64377474
Lung opacity 11.53 11.26 20 109277 3179 64386256
Petechiae 11.43 11.26 62 109235 18564 64370871
Ejection fraction abnormal 11.39 11.26 13 109284 1400 64388035
Hypersensitivity pneumonitis 11.38 11.26 20 109277 3212 64386223
Liver function test abnormal 11.32 11.26 152 109145 59249 64330186
Arterial insufficiency 11.31 11.26 7 109290 320 64389115
Liver scan abnormal 11.28 11.26 4 109293 49 64389386
Foot deformity 11.27 11.26 7 109290 16497 64372938

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01BD01 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
ANTIARRHYTHMICS, CLASS I AND III
Antiarrhythmics, class III
FDA EPC N0000175426 Antiarrhythmic
CHEBI has role CHEBI:35554 cardiovascular agent
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D065609 Cytochrome P-450 CYP1A2 Inhibitors
MeSH PA D065688 Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA D065690 Cytochrome P-450 CYP2D6 Inhibitors
MeSH PA D065692 Cytochrome P-450 CYP3A Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D026902 Potassium Channel Blockers
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D014665 Vasodilator Agents
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000182138 Cytochrome P450 1A2 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Ventricular fibrillation indication 71908006
Prevention of Ventricular Fibrillation indication
Life-Threatening Ventricular Tachycardia indication
Atrial fibrillation off-label use 49436004 DOID:0060224
Cardioversion of Atrial Fibrillation off-label use
Prevention of Post Cardio-Thoracic Surgery Atrial Fibrillation off-label use
Complete atrioventricular block contraindication 27885002
Torsades de pointes contraindication 31722008
Hyperthyroidism contraindication 34486009 DOID:7998
Extrinsic allergic alveolitis contraindication 37471005 DOID:841
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Refractive keratoplasty by laser surgery contraindication 58076004
Sinus node dysfunction contraindication 60423000
Interstitial pneumonia contraindication 64667001
Optic neuritis contraindication 66760008 DOID:1210
Corneal deposit contraindication 74460005 DOID:11547
Disorder of optic nerve contraindication 77157004 DOID:1891
Pulmonary hemorrhage contraindication 78144005
Cardiogenic shock contraindication 89138009
Thyrotoxicosis contraindication 90739004 DOID:7997
Prolonged QT interval contraindication 111975006
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Second degree atrioventricular block contraindication 195042002
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Pregnancy, function contraindication 289908002
Peripheral nerve disease contraindication 302226006
Eosinophilic asthma contraindication 367542003 DOID:9498
Surgical procedure contraindication 387713003
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Congenital long QT syndrome contraindication 442917000
Syncope due to Bradycardia contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.72 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
Potassium voltage-gated channel subfamily H member 2 Ion channel BLOCKER IC50 5 WOMBAT-PK CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 7.10 WOMBAT-PK
Mu-type opioid receptor GPCR Ki 5.11 DRUG MATRIX
D(1A) dopamine receptor GPCR Ki 5.34 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 5.18 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR IC50 6.30 WOMBAT-PK
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7 WOMBAT-PK
Thyroid hormone receptor alpha Nuclear hormone receptor IC50 5.64 WOMBAT-PK
Thyroid hormone receptor beta Nuclear hormone receptor IC50 6.22 WOMBAT-PK
Cytochrome P450 3A4 Enzyme Ki 6.22 WOMBAT-PK
3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase Enzyme Ki 7.60 WOMBAT-PK
Multidrug resistance protein 1 Transporter Ki 5.30 WOMBAT-PK
B2 bradykinin receptor GPCR Ki 5.12 DRUG MATRIX
Sodium-dependent serotonin transporter Transporter Ki 5.91 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.65 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 5.99 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.23 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.67 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.05 DRUG MATRIX
Alpha-2B adrenergic receptor GPCR Ki 5.23 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.39 DRUG MATRIX
Histamine H2 receptor GPCR Ki 4.98 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 6.20 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 5.74 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 6.17 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 6.30 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 5.97 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 4.50 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.70 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 5.00 DRUG MATRIX
D(4) dopamine receptor GPCR Ki 5.21 DRUG MATRIX
Kappa-type opioid receptor GPCR Ki 5.18 DRUG MATRIX
Delta-type opioid receptor GPCR Ki 5.55 DRUG MATRIX
Cytochrome P450 2C9 Enzyme EC50 7.40 WOMBAT-PK
Voltage-dependent T-type calcium channel subunit alpha-1H Ion channel Ki 5.28 WOMBAT-PK
Endothelin-1 receptor GPCR Ki 4.79 DRUG MATRIX
Squalene monooxygenase Enzyme IC50 4.92 CHEMBL
Tyrosine-protein kinase Fyn Kinase IC50 6.09 DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 5.04 DRUG MATRIX
Squalene synthase Enzyme IC50 5.10 CHEMBL
C-C chemokine receptor type 2 GPCR Ki 5.37 DRUG MATRIX
Substance-K receptor GPCR Ki 5.19 DRUG MATRIX
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 Ion channel IC50 5.35 WOMBAT-PK
Potassium voltage-gated channel subfamily A member 7 Ion channel IC50 6 WOMBAT-PK
Melanocortin receptor 4 GPCR Ki 4.88 DRUG MATRIX
Melanocortin receptor 5 GPCR Ki 5.05 DRUG MATRIX
Melanocortin receptor 3 GPCR Ki 4.97 DRUG MATRIX
C-C chemokine receptor type 4 GPCR Ki 4.94 DRUG MATRIX
THAP domain-containing protein 1 Unclassified IC50 6.19 WOMBAT-PK
Lysine-specific demethylase PHF2 Enzyme IC50 4.08 CHEMBL
Lysine-specific demethylase 5A Enzyme IC50 4 CHEMBL
Beta-1 adrenergic receptor GPCR IC50 4.70 WOMBAT-PK
Lysine-specific demethylase 7A Enzyme IC50 4.10 CHEMBL
Androgen receptor Transcription factor Ki 4.55 DRUG MATRIX
Lethal factor Enzyme IC50 5.46 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 4.41 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor IC50 6.93 DRUG MATRIX
C-8 sterol isomerase Enzyme Ki 7.21 CHEMBL
Cruzipain Enzyme IC50 5.40 CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 5.70 IUPHAR

External reference:

IDSource
4019606 VUID
N0000147701 NUI
D00636 KEGG_DRUG
19774-82-4 SECONDARY_CAS_RN
203114 RXNORM
C0002598 UMLSCUI
CHEBI:2663 CHEBI
BBI PDB_CHEM_ID
CHEMBL633 ChEMBL_ID
CHEMBL1083993 ChEMBL_ID
D000638 MESH_DESCRIPTOR_UI
DB01118 DRUGBANK_ID
2566 IUPHAR_LIGAND_ID
2012 INN_ID
N3RQ532IUT UNII
2157 PUBCHEM_CID
13960 MMSL
4177 MMSL
d00002 MMSL
000629 NDDF
004484 NDDF
4018065 VANDF
4019606 VANDF
372821002 SNOMEDCT_US
52574003 SNOMEDCT_US
69236009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9875 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9875 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-0144 TABLET 200 mg ORAL ANDA 27 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-0144 TABLET 100 mg ORAL ANDA 30 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-0145 TABLET 400 mg ORAL ANDA 27 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-0145 TABLET 400 mg ORAL ANDA 27 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-0147 TABLET 200 mg ORAL ANDA 30 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-1645 TABLET 400 mg ORAL ANDA 30 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9815 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 16 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9815 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 16 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8258 TABLET 200 mg ORAL ANDA 27 sections
Amiodarone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6556 TABLET 200 mg ORAL ANDA 19 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6993 TABLET 200 mg ORAL ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-843 TABLET 100 mg ORAL ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-844 TABLET 200 mg ORAL ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-845 TABLET 400 mg ORAL ANDA 28 sections
Amiodarone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-796 TABLET 200 mg ORAL ANDA 25 sections
amiodarone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 25021-302 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 28 sections
amiodarone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 25021-302 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-359 TABLET 200 mg ORAL ANDA 19 sections
Amiodarone HCl HUMAN PRESCRIPTION DRUG LABEL 1 42494-307 TABLET 100 mg ORAL ANDA 29 sections
Amiodarone HCl HUMAN PRESCRIPTION DRUG LABEL 1 42494-308 TABLET 200 mg ORAL ANDA 29 sections
Amiodarone HCl HUMAN PRESCRIPTION DRUG LABEL 1 42494-309 TABLET 400 mg ORAL ANDA 29 sections
Nexterone HUMAN PRESCRIPTION DRUG LABEL 1 43066-150 INJECTION, SOLUTION 1.50 mg INTRAVENOUS NDA 25 sections
Nexterone HUMAN PRESCRIPTION DRUG LABEL 1 43066-360 INJECTION, SOLUTION 1.80 mg INTRAVENOUS NDA 25 sections
Amiodarone Hydrochloride Human Prescription Drug Label 1 50090-3015 TABLET 200 mg ORAL ANDA 30 sections
Amiodarone Hydrochloride Human Prescription Drug Label 1 50090-3015 TABLET 200 mg ORAL ANDA 30 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-3496 TABLET 200 mg ORAL ANDA 27 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-5062 TABLET 200 mg ORAL ANDA 27 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-5766 TABLET 200 mg ORAL ANDA 19 sections