amiodarone 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 ┬ÁM/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
Atrial fibrillation 909.98 12.08 823 51485 102767 46530987
Drug interaction 903.42 12.08 1122 51186 201972 46431782
Torsade de pointes 704.74 12.08 320 51988 11834 46621920
Bradycardia 684.61 12.08 578 51730 65720 46568034
Electrocardiogram QT prolonged 621.29 12.08 491 51817 50834 46582920
Hyperthyroidism 551.21 12.08 267 52041 11444 46622310
International normalised ratio increased 397.98 12.08 366 51942 46517 46587237
Ventricular tachycardia 388.04 12.08 240 52068 16727 46617027
Pulmonary toxicity 374.94 12.08 155 52153 4538 46629216
Acute kidney injury 335.45 12.08 784 51524 235071 46398683
Cardiac failure 293.57 12.08 403 51905 79545 46554209
Myxoedema coma 286.53 12.08 71 52237 344 46633410
Interstitial lung disease 264.42 12.08 314 51994 53635 46580119
Hypothyroidism 208.21 12.08 214 52094 31124 46602630
Cardiogenic shock 202.81 12.08 159 52149 16225 46617529
Ventricular fibrillation 202.30 12.08 138 52170 11358 46622396
Rheumatoid arthritis 197.75 12.08 20 52288 240195 46393559
Gastrointestinal haemorrhage 186.44 12.08 321 51987 77052 46556702
Sinus bradycardia 179.83 12.08 138 52170 13644 46620110
Haematoma 175.39 12.08 197 52111 31675 46602079
Syncope 160.18 12.08 359 51949 104444 46529310
Tachyarrhythmia 155.12 12.08 84 52224 4548 46629206
Hypotension 153.76 12.08 590 51718 231999 46401755
Renal failure 152.69 12.08 370 51938 113224 46520530
Hyperkalaemia 151.52 12.08 232 52076 50477 46583277
Headache 143.91 12.08 196 52112 478156 46155598
Cardiac arrest 141.86 12.08 313 51995 90086 46543668
Pain 136.93 12.08 202 52106 476746 46157008
Hyponatraemia 132.89 12.08 327 51981 101005 46532749
Drug ineffective 128.53 12.08 365 51943 677473 45956281
Shock haemorrhagic 127.31 12.08 93 52215 8531 46625223
Cardiac failure congestive 123.40 12.08 299 52009 91451 46542303
Thyroiditis 116.81 12.08 50 52258 1598 46632156
Arrhythmia 113.47 12.08 166 52142 34675 46599079
Arthralgia 112.95 12.08 146 52162 364457 46269297
Atrial flutter 107.24 12.08 86 52222 9062 46624692
Sinus node dysfunction 101.39 12.08 62 52246 4227 46629527
Joint swelling 97.97 12.08 32 52276 166041 46467713
Long QT syndrome 92.53 12.08 52 52256 3028 46630726
Cerebral haemorrhage 89.25 12.08 133 52175 28238 46605516
Mitral valve incompetence 86.18 12.08 106 52202 18746 46615008
Sinusitis 85.87 12.08 20 52288 129748 46504006
Ventricular arrhythmia 84.85 12.08 51 52257 3370 46630384
Labelled drug-drug interaction medication error 81.20 12.08 73 52235 8988 46624766
Multiple organ dysfunction syndrome 81.00 12.08 179 52129 51531 46582223
Infusion site phlebitis 79.23 12.08 17 52291 36 46633718
Rash 78.04 12.08 178 52130 356334 46277420
Fatigue 75.99 12.08 388 51920 608309 46025445
Hypokalaemia 74.95 12.08 243 52065 87781 46545973
Melaena 74.52 12.08 121 52187 27651 46606103
Injection site pain 71.91 12.08 16 52292 107136 46526618
Brugada syndrome 70.79 12.08 21 52287 219 46633535
Pulmonary fibrosis 70.20 12.08 99 52209 19993 46613761
Rectal haemorrhage 69.85 12.08 141 52167 38114 46595640
Lactic acidosis 67.99 12.08 130 52178 33779 46599975
Anaemia 63.64 12.08 497 51811 255282 46378472
Drug intolerance 62.80 12.08 44 52264 147005 46486749
Therapeutic product effect decreased 62.64 12.08 9 52299 82592 46551162
Cholestasis 62.63 12.08 110 52198 26783 46606971
Nasopharyngitis 62.01 12.08 49 52259 153949 46479805
Ventricular extrasystoles 61.89 12.08 69 52239 10994 46622760
Pain in extremity 59.13 12.08 126 52182 258554 46375200
Cardio-respiratory arrest 59.04 12.08 174 52134 59695 46574059
Diarrhoea 58.82 12.08 377 51931 559225 46074529
Respiratory failure 58.77 12.08 236 52072 94580 46539174
Cerebral haematoma 58.53 12.08 40 52268 3299 46630455
Cardioversion 56.39 12.08 27 52281 1125 46632629
Hypoxia 56.31 12.08 156 52152 51682 46582072
Synovitis 56.09 12.08 3 52305 61072 46572682
Therapeutic product effect incomplete 55.92 12.08 10 52298 78143 46555611
Hypoaesthesia 55.65 12.08 32 52276 118837 46514917
Corneal deposits 55.61 12.08 17 52291 198 46633556
Fall 55.12 12.08 587 51721 328510 46305244
Cardioactive drug level increased 54.47 12.08 32 52276 2027 46631727
Injection site erythema 54.41 12.08 9 52299 74418 46559336
Renal injury 54.22 12.08 60 52248 9481 46624273
Muscle spasms 53.68 12.08 36 52272 123077 46510677
Keratopathy 53.64 12.08 18 52290 288 46633466
Atrial tachycardia 53.60 12.08 32 52276 2088 46631666
Rhabdomyolysis 53.55 12.08 134 52174 41775 46591979
Migraine 52.24 12.08 8 52300 70018 46563736
Infusion related reaction 52.20 12.08 24 52284 101184 46532570
Haematoma muscle 51.02 12.08 21 52287 607 46633147
Musculoskeletal stiffness 50.91 12.08 23 52285 97970 46535784
Lung disorder 50.72 12.08 134 52174 43170 46590584
Nausea 50.63 12.08 510 51798 686944 45946810
Arthropathy 50.48 12.08 16 52292 84684 46549070
Product dose omission issue 49.49 12.08 70 52238 168450 46465304
Nodal rhythm 48.79 12.08 28 52280 1697 46632057
Atrioventricular block complete 48.67 12.08 51 52257 7576 46626178
Alopecia 48.16 12.08 67 52241 162347 46471407
Urticaria 48.09 12.08 37 52271 117855 46515899
Atrioventricular block 47.92 12.08 48 52260 6763 46626991
Blood loss anaemia 47.23 12.08 53 52255 8504 46625250
Arthritis 47.16 12.08 14 52294 77302 46556452
Depression 46.71 12.08 74 52234 170030 46463724
Exposure during pregnancy 46.69 12.08 32 52276 108180 46525574
Haematuria 46.67 12.08 97 52211 26761 46606993
Dyspnoea 46.57 12.08 823 51485 514725 46119029
Hyperglobulinaemia 46.36 12.08 8 52300 0 46633754
Alveolitis 46.19 12.08 31 52277 2482 46631272
Maternal exposure during pregnancy 46.04 12.08 29 52279 102520 46531234
Pyrexia 45.84 12.08 218 52090 348584 46285170
Ischaemic stroke 45.05 12.08 73 52235 16649 46617105
Hepatocellular injury 44.87 12.08 101 52207 29421 46604333
Blood thyroid stimulating hormone increased 44.33 12.08 43 52265 5826 46627928
Orthopnoea 44.27 12.08 43 52265 5837 46627917
Neuromyopathy 44.20 12.08 18 52290 506 46633248
Lymphatic fistula 43.82 12.08 21 52287 877 46632877
Pulmonary hypertension 43.81 12.08 113 52195 35880 46597874
Arterial haemorrhage 43.61 12.08 26 52282 1692 46632062
Hypersensitivity 43.58 12.08 63 52245 150258 46483496
Femoral hernia incarcerated 43.57 12.08 21 52287 888 46632866
Infection 42.79 12.08 52 52256 133540 46500214
Haemorrhage 42.70 12.08 147 52161 54722 46579032
General physical health deterioration 42.58 12.08 248 52060 115521 46518233
Coronary artery disease 42.15 12.08 107 52201 33645 46600109
Pancreatic steatosis 41.57 12.08 21 52287 984 46632770
Haemarthrosis 41.31 12.08 31 52277 2962 46630792
Thyrotoxic crisis 41.22 12.08 19 52289 726 46633028
Off label use 40.77 12.08 254 52054 379587 46254167
Herpes zoster 40.12 12.08 13 52295 67859 46565895
Psoriasis 39.98 12.08 19 52289 78585 46555169
Bradyarrhythmia 39.91 12.08 26 52282 1980 46631774
Coagulopathy 39.66 12.08 73 52235 18426 46615328
Injection site reaction 39.25 12.08 4 52304 47845 46585909
Back pain 38.85 12.08 114 52194 209925 46423829
Toxic skin eruption 38.84 12.08 58 52250 12329 46621425
Respiratory distress 38.64 12.08 100 52208 31816 46601938
Acute respiratory distress syndrome 37.88 12.08 79 52229 21843 46611911
Weight increased 37.63 12.08 80 52228 164393 46469361
Wound infection pseudomonas 36.89 12.08 22 52286 1433 46632321
Cornea verticillata 36.25 12.08 9 52299 44 46633710
Hepatic cyst 36.15 12.08 35 52273 4731 46629023
Bundle branch block left 35.94 12.08 40 52268 6359 46627395
Asthma 35.74 12.08 30 52278 91512 46542242
Chills 35.65 12.08 33 52275 95999 46537755
Cerebellar haematoma 35.55 12.08 14 52294 360 46633394
Suicide attempt 35.37 12.08 9 52299 55027 46578727
Subdural haematoma 35.36 12.08 57 52251 12940 46620814
Heparin-induced thrombocytopenia 35.27 12.08 33 52275 4276 46629478
Insomnia 34.66 12.08 84 52224 164840 46468914
White blood cell count decreased 34.57 12.08 45 52263 112186 46521568
Systemic lupus erythematosus 34.32 12.08 15 52293 65165 46568589
Alveolar proteinosis 33.96 12.08 13 52295 309 46633445
Extravasation 33.94 12.08 24 52284 2091 46631663
Treatment failure 33.37 12.08 33 52275 93054 46540700
Haemorrhagic stroke 33.36 12.08 36 52272 5530 46628224
Myalgia 33.35 12.08 54 52254 123034 46510720
Tricuspid valve incompetence 33.10 12.08 57 52251 13660 46620094
Pericardial haemorrhage 33.07 12.08 21 52287 1530 46632224
Abortion spontaneous 32.52 12.08 5 52303 43641 46590113
Swelling 32.46 12.08 56 52252 124455 46509299
Muscle haemorrhage 32.36 12.08 28 52280 3276 46630478
Gastrooesophageal reflux disease 32.04 12.08 22 52286 74322 46559432
Device stimulation issue 31.93 12.08 9 52299 77 46633677
Completed suicide 31.71 12.08 73 52235 145847 46487907
Aortic valve stenosis 31.67 12.08 27 52281 3097 46630657
Drug hypersensitivity 31.63 12.08 153 52155 243672 46390082
Drug level increased 31.33 12.08 66 52242 18375 46615379
Cerebellar syndrome 31.21 12.08 28 52280 3437 46630317
Anuria 30.92 12.08 50 52258 11381 46622373
Prothrombin time shortened 30.66 12.08 21 52287 1738 46632016
Toxicity to various agents 30.51 12.08 367 51941 211399 46422355
Neck pain 30.29 12.08 12 52296 55294 46578460
Right ventricular failure 30.18 12.08 60 52248 16033 46617721
Extrasystoles 30.08 12.08 32 52276 4837 46628917
Lower gastrointestinal haemorrhage 30.02 12.08 39 52269 7281 46626473
Acute respiratory failure 29.97 12.08 86 52222 29052 46604702
Organising pneumonia 29.90 12.08 32 52276 4870 46628884
Faecaloma 29.78 12.08 40 52268 7712 46626042
Ecchymosis 29.62 12.08 47 52261 10529 46623225
Seroma 29.47 12.08 22 52286 2085 46631669
Anticoagulation drug level increased 28.92 12.08 10 52298 176 46633578
Septic shock 28.86 12.08 135 52173 57758 46575996
Craniocerebral injury 28.62 12.08 22 52286 2178 46631576
Myocardial infarction 28.45 12.08 197 52111 97331 46536423
Hypomagnesaemia 28.34 12.08 71 52237 22139 46611615
Left ventricular dysfunction 27.93 12.08 45 52263 10210 46623544
Paraesthesia 27.80 12.08 56 52252 117381 46516373
Ventricular tachyarrhythmia 27.64 12.08 8 52300 76 46633678
Fibromyalgia 27.57 12.08 4 52304 36459 46597295
Intra-abdominal haematoma 27.32 12.08 19 52289 1612 46632142
Splenic haemorrhage 27.06 12.08 10 52298 215 46633539
Haemorrhage intracranial 27.01 12.08 50 52258 12674 46621080
Inflammatory marker increased 27 12.08 32 52276 5443 46628311
Medication error 26.88 12.08 86 52222 30825 46602929
Mediastinal haematoma 26.83 12.08 8 52300 85 46633669
Spontaneous haematoma 26.73 12.08 14 52294 708 46633046
Goitre congenital 26.63 12.08 5 52303 3 46633751
Febrile neutropenia 26.11 12.08 41 52267 94586 46539168
Diverticulum intestinal 26.06 12.08 33 52275 6008 46627746
Urinary retention 25.92 12.08 76 52232 25985 46607769
Stomatitis 25.90 12.08 23 52285 68274 46565480
Hypoxic-ischaemic encephalopathy 25.57 12.08 27 52281 4046 46629708
Abdominal wall haematoma 25.40 12.08 23 52285 2858 46630896
Local anaesthetic systemic toxicity 25.25 12.08 11 52297 367 46633387
Renal impairment 25.20 12.08 156 52152 74216 46559538
Injection site swelling 25.14 12.08 7 52301 40320 46593434
Pruritus 24.95 12.08 164 52144 242188 46391566
Influenza like illness 24.86 12.08 17 52291 57553 46576201
Acute pulmonary oedema 24.81 12.08 37 52271 7854 46625900
Arrhythmia supraventricular 24.68 12.08 15 52293 1011 46632743
Head injury 24.65 12.08 72 52236 24564 46609190
Coronary artery bypass 24.52 12.08 21 52287 2424 46631330
Abdominal discomfort 24.48 12.08 87 52221 151078 46482676
Device pacing issue 24.40 12.08 6 52302 28 46633726
Bone pain 24.35 12.08 11 52297 46879 46586875
Abdominal pain upper 23.95 12.08 83 52225 145222 46488532
Cardiac disorder 23.90 12.08 105 52203 43753 46590001
Electrocardiogram QRS complex prolonged 23.87 12.08 30 52278 5419 46628335
Drug-induced liver injury 23.36 12.08 72 52236 25296 46608458
Constipation 23.29 12.08 108 52200 173989 46459765
Blood pressure increased 23.21 12.08 69 52239 126597 46507157
Retroperitoneal haematoma 23.12 12.08 21 52287 2619 46631135
Blood cholesterol increased 23.06 12.08 8 52300 40005 46593749
Hypoglycaemia 23.01 12.08 121 52187 54228 46579526
Peripheral swelling 23.00 12.08 95 52213 157976 46475778
Pleural effusion 22.70 12.08 165 52143 82787 46550967
Central nervous system injury 22.67 12.08 8 52300 150 46633604
Cardiac arrest neonatal 22.63 12.08 7 52301 85 46633669
Retroperitoneal haemorrhage 22.52 12.08 21 52287 2709 46631045
Cyanosis 22.45 12.08 53 52255 15918 46617836
Glomerular filtration rate decreased 22.41 12.08 44 52264 11650 46622104
Sinoatrial block 22.40 12.08 13 52295 805 46632949
Agranulocytosis 22.35 12.08 65 52243 22120 46611634
Feeling abnormal 22.29 12.08 69 52239 124991 46508763
Petechiae 22.29 12.08 46 52262 12624 46621130
Device capturing issue 22.22 12.08 6 52302 43 46633711
Osteoarthritis 22.21 12.08 22 52286 62003 46571751
Intentional overdose 22.17 12.08 24 52284 64920 46568834
Oliguria 21.93 12.08 37 52271 8722 46625032
Thyroiditis acute 21.92 12.08 7 52301 95 46633659
Cardiac ablation 21.87 12.08 15 52293 1244 46632510
Mixed liver injury 21.83 12.08 22 52286 3121 46630633
Memory impairment 21.82 12.08 33 52275 77304 46556450
Asthenia 21.68 12.08 478 51830 310597 46323157
Nodal arrhythmia 21.62 12.08 15 52293 1268 46632486
Blood creatinine increased 21.50 12.08 153 52155 76250 46557504
Cardiac failure chronic 21.48 12.08 23 52285 3501 46630253
Suicidal ideation 21.36 12.08 19 52289 56363 46577391
Hepatic failure 21.34 12.08 84 52224 33332 46600422
Oesophageal squamous cell carcinoma 21.22 12.08 7 52301 106 46633648
Hypochromasia 21.16 12.08 9 52299 283 46633471
Therapeutic response decreased 21.07 12.08 11 52297 43134 46590620
Respiratory acidosis 21.03 12.08 30 52278 6118 46627636
Fear 20.95 12.08 52 52256 16120 46617634
Product use issue 20.83 12.08 47 52261 94597 46539157
Subcutaneous haematoma 20.81 12.08 16 52292 1585 46632169
Injection site bruising 20.75 12.08 7 52301 35629 46598125
Musculoskeletal pain 20.69 12.08 29 52279 70099 46563655
Pregnancy 20.46 12.08 3 52305 27134 46606620
Conduction disorder 20.46 12.08 15 52293 1383 46632371
Splenic injury 20.26 12.08 8 52300 207 46633547
Eosinophilic pneumonia 20.11 12.08 17 52291 1927 46631827
Oedema peripheral 20.09 12.08 270 52038 159436 46474318
Upper respiratory tract infection 20.06 12.08 25 52283 63531 46570223
Throat irritation 20.02 12.08 4 52304 28897 46604857
Anaphylactic reaction 20.00 12.08 18 52290 53094 46580660
Contraindicated product administered 19.89 12.08 37 52271 79910 46553844
Wound dehiscence 19.84 12.08 25 52283 4529 46629225
Left ventricular failure 19.56 12.08 26 52282 4964 46628790
Myxoedema 19.55 12.08 7 52301 137 46633617
Prothrombin time prolonged 19.49 12.08 37 52271 9559 46624195
Listless 19.44 12.08 17 52291 2018 46631736
Propionibacterium infection 19.42 12.08 5 52303 29 46633725
Cardioactive drug level above therapeutic 19.41 12.08 7 52301 140 46633614
Overdose 18.94 12.08 186 52122 101793 46531961
Haemorrhagic diathesis 18.83 12.08 22 52286 3686 46630068
Anhedonia 18.74 12.08 38 52270 10297 46623457
Fluid overload 18.72 12.08 70 52238 27115 46606639
Lip swelling 18.71 12.08 3 52305 25392 46608362
Cardiac tamponade 18.69 12.08 24 52284 4430 46629324
Pneumonitis 18.60 12.08 72 52236 28348 46605406
Neutrophil count decreased 18.51 12.08 13 52295 43413 46590341
Pulmonary alveolar haemorrhage 18.37 12.08 23 52285 4139 46629615
Drug level above therapeutic 18.12 12.08 21 52287 3488 46630266
Electrocardiogram T wave inversion 18.09 12.08 21 52287 3495 46630259
Thyroxine free increased 17.97 12.08 11 52297 751 46633003
Drug abuse 17.94 12.08 27 52281 63381 46570373
Anisocytosis 17.89 12.08 10 52298 576 46633178
Prerenal failure 17.89 12.08 14 52294 1423 46632331
Oropharyngeal pain 17.86 12.08 35 52273 74133 46559621
Neovascular age-related macular degeneration 17.85 12.08 7 52301 178 46633576
Potentiating drug interaction 17.83 12.08 22 52286 3901 46629853
Myopathy 17.73 12.08 34 52274 8847 46624907
Eosinophilia myalgia syndrome 17.65 12.08 4 52304 12 46633742
Thyroglobulin increased 17.61 12.08 5 52303 44 46633710
Ejection fraction decreased 17.54 12.08 52 52256 17885 46615869
Product quality issue 17.54 12.08 9 52299 35639 46598115
Liver scan abnormal 17.51 12.08 5 52303 45 46633709
Iodine overload 17.39 12.08 3 52305 0 46633754
Pulmonary oedema 17.18 12.08 107 52201 50998 46582756
Activated partial thromboplastin time prolonged 17.11 12.08 29 52279 6860 46626894
Hypocoagulable state 17.08 12.08 12 52296 1035 46632719
Electrocardiogram U-wave abnormality 17.04 12.08 5 52303 50 46633704
Tri-iodothyronine increased 17.02 12.08 6 52302 112 46633642
Rales 16.98 12.08 35 52273 9596 46624158
Pericardial effusion 16.95 12.08 65 52243 25478 46608276
Influenza 16.81 12.08 48 52260 89222 46544532
Subarachnoid haemorrhage 16.77 12.08 38 52270 11115 46622639
Wound 16.73 12.08 14 52294 42788 46590966
Toxic epidermal necrolysis 16.73 12.08 59 52249 22219 46611535
Drug clearance decreased 16.70 12.08 12 52296 1072 46632682
Swelling face 16.61 12.08 21 52287 53038 46580716
Cardiovascular insufficiency 16.56 12.08 13 52295 1328 46632426
Disease progression 16.53 12.08 50 52258 91250 46542504
Shock 16.53 12.08 58 52250 21787 46611967
Weight decreased 16.41 12.08 154 52154 210695 46423059
Ear infection 16.34 12.08 3 52305 23010 46610744
Hypoglycaemic seizure 16.25 12.08 9 52299 509 46633245
Ataxia 16.19 12.08 43 52265 13887 46619867
Oral pain 16.04 12.08 4 52304 24793 46608961
Compensatory sweating 16.04 12.08 4 52304 20 46633734
Altered visual depth perception 15.97 12.08 8 52300 368 46633386
Haemodynamic instability 15.95 12.08 30 52278 7695 46626059
Abdominal wall haemorrhage 15.94 12.08 6 52302 136 46633618
Congenital hypothyroidism 15.89 12.08 7 52301 240 46633514
Electrocardiogram QRS complex shortened 15.85 12.08 8 52300 374 46633380
Ischaemic cardiomyopathy 15.85 12.08 17 52291 2593 46631161
Progressive supranuclear palsy 15.65 12.08 5 52303 68 46633686
Arterial insufficiency 15.58 12.08 6 52302 145 46633609
Erythema 15.53 12.08 95 52213 142725 46491029
Seizure 15.48 12.08 78 52230 122976 46510778
Electrocardiogram abnormal 15.45 12.08 28 52280 6984 46626770
Palpitations 15.44 12.08 169 52139 95090 46538664
Ear pain 15.43 12.08 3 52305 22089 46611665
Subgaleal haematoma 15.39 12.08 5 52303 72 46633682
Endovenous ablation 15.31 12.08 3 52305 3 46633751
International normalised ratio abnormal 15.28 12.08 18 52290 3041 46630713
Fungal infection 15.21 12.08 7 52301 29513 46604241
Device dislocation 15.14 12.08 3 52305 21799 46611955
Osteonecrosis of jaw 15.06 12.08 10 52298 34392 46599362
Knee arthroplasty 14.95 12.08 4 52304 23661 46610093
Hot flush 14.94 12.08 16 52292 43501 46590253
Infective pericardial effusion 14.65 12.08 4 52304 30 46633724
Secondary hyperthyroidism 14.65 12.08 4 52304 30 46633724
Chronic kidney disease 14.64 12.08 87 52221 40784 46592970
Tooth disorder 14.61 12.08 4 52304 23299 46610455
Cutaneous lupus erythematosus 14.53 12.08 16 52292 2513 46631241
Dyspnoea at rest 14.53 12.08 19 52289 3569 46630185
Myocardial ischaemia 14.46 12.08 39 52269 12710 46621044
Creatinine renal clearance decreased 14.45 12.08 27 52281 6893 46626861
International normalised ratio 14.41 12.08 5 52303 89 46633665
Subdural haemorrhage 14.33 12.08 17 52291 2895 46630859
Thrombocytopenia 14.30 12.08 210 52098 126371 46507383
Optic atrophy 14.29 12.08 11 52297 1091 46632663
Escherichia infection 14.24 12.08 35 52273 10782 46622972
Respiratory alkalosis 14.21 12.08 16 52292 2575 46631179
Vision blurred 14.18 12.08 44 52264 79664 46554090
Aortic arteriosclerosis 14.10 12.08 24 52284 5697 46628057
Coagulation test abnormal 14.02 12.08 9 52299 668 46633086
Nephrolithiasis 13.95 12.08 10 52298 33041 46600713
Pancreatitis 13.94 12.08 17 52291 43610 46590144
Hyperchloraemia 13.83 12.08 9 52299 684 46633070
Extradural haematoma 13.82 12.08 12 52296 1411 46632343
Pulseless electrical activity 13.78 12.08 27 52281 7140 46626614
Electrocardiogram T wave abnormal 13.75 12.08 15 52293 2331 46631423
Haemothorax 13.75 12.08 14 52294 2010 46631744
Presyncope 13.66 12.08 59 52249 24395 46609359
Cardiac rehabilitation therapy 13.50 12.08 3 52305 8 46633746
Eosinophilic pleural effusion 13.46 12.08 4 52304 42 46633712
Electrocardiogram T wave alternans 13.46 12.08 4 52304 42 46633712
Liver injury 13.44 12.08 44 52264 15957 46617797
Haemoglobin decreased 13.43 12.08 211 52097 128738 46505016
Bone disorder 13.41 12.08 3 52305 20030 46613724
Splenic rupture 13.41 12.08 11 52297 1196 46632558
Aortic valve incompetence 13.35 12.08 24 52284 5946 46627808
Transaminases increased 13.29 12.08 64 52244 27697 46606057
Mesenteric artery stenosis 13.29 12.08 4 52304 44 46633710
Atrioventricular dissociation 13.27 12.08 6 52302 219 46633535
Thyroxine increased 13.26 12.08 8 52300 532 46633222
Blood pressure fluctuation 13.13 12.08 9 52299 30439 46603315
Paroxysmal arrhythmia 12.98 12.08 4 52304 48 46633706
Malignant neoplasm progression 12.90 12.08 34 52274 64892 46568862
Wrong technique in product usage process 12.83 12.08 26 52282 54396 46579358
Neoplasm progression 12.74 12.08 7 52301 26676 46607078
Cardiac failure acute 12.68 12.08 28 52280 8050 46625704
Thyroiditis chronic 12.57 12.08 3 52305 12 46633742
Corynebacterium infection 12.50 12.08 7 52301 405 46633349
Neuropathy peripheral 12.37 12.08 56 52252 90837 46542917
Cellulitis 12.36 12.08 39 52269 70249 46563505
Oral mucosa haematoma 12.20 12.08 3 52305 14 46633740
Monoclonal gammopathy 12.16 12.08 8 52300 619 46633135
Apnoea 12.16 12.08 26 52282 7313 46626441

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 1661.65 11.06 652 71124 7446 29873256
Ventricular tachycardia 651.46 11.06 504 71272 23358 29857344
Pulmonary toxicity 648.75 11.06 282 71494 4234 29876468
Atrial fibrillation 617.58 11.06 1003 70773 107121 29773581
Drug interaction 517.86 11.06 1334 70442 198234 29682468
Bradycardia 483.00 11.06 685 71091 64841 29815861
Cardiac failure 394.17 11.06 712 71064 82706 29797996
Torsade de pointes 368.09 11.06 224 71552 6966 29873736
Hypothyroidism 344.16 11.06 286 71490 14677 29866025
Thyroiditis 343.84 11.06 134 71642 1495 29879207
Pulmonary fibrosis 329.19 11.06 286 71490 15604 29865098
Interstitial lung disease 326.14 11.06 546 71230 59651 29821051
Electrocardiogram QT prolonged 303.55 11.06 401 71375 35434 29845268
International normalised ratio increased 276.01 11.06 446 71330 47293 29833409
Thyrotoxic crisis 181.53 11.06 57 71719 311 29880391
Acute kidney injury 172.93 11.06 1184 70592 272658 29608044
Pulmonary alveolar haemorrhage 172.89 11.06 136 71640 6445 29874257
Ventricular fibrillation 159.40 11.06 189 71587 14949 29865753
Cardiac failure congestive 157.22 11.06 502 71274 83905 29796797
Cardiogenic shock 149.37 11.06 193 71583 16668 29864034
Myxoedema coma 138.05 11.06 44 71732 254 29880448
Pyrexia 118.35 11.06 340 71436 294149 29586553
Completed suicide 113.73 11.06 48 71728 99444 29781258
Atrial flutter 111.95 11.06 154 71622 14127 29866575
Ventricular arrhythmia 107.03 11.06 86 71690 4202 29876500
Multiple organ dysfunction syndrome 99.08 11.06 356 71420 63131 29817571
Hypotension 98.42 11.06 818 70958 199747 29680955
Syncope 95.60 11.06 430 71346 84473 29796229
Arthralgia 93.20 11.06 113 71663 135678 29745024
Drug abuse 86.95 11.06 44 71732 82028 29798674
Atrioventricular block 85.17 11.06 96 71680 7186 29873516
Atrial tachycardia 84.96 11.06 57 71719 2102 29878600
Thyroid disorder 84.32 11.06 62 71714 2652 29878050
Renal failure 84.18 11.06 563 71213 128403 29752299
Febrile neutropenia 84.11 11.06 79 71697 106614 29774088
Blood thyroid stimulating hormone increased 83.71 11.06 63 71713 2793 29877909
Acute respiratory distress syndrome 83.41 11.06 178 71598 23294 29857408
Headache 83.37 11.06 197 71579 182109 29698593
Lung disorder 80.61 11.06 210 71566 31259 29849443
Venous pressure jugular increased 78.60 11.06 37 71739 674 29880028
Sinus bradycardia 76.86 11.06 116 71660 11579 29869123
Cardiac arrest 75.45 11.06 429 71347 92421 29788281
Organising pneumonia 71.83 11.06 74 71702 5000 29875702
Arrhythmia 71.69 11.06 208 71568 32961 29847741
Dyspnoea 70.65 11.06 1155 70621 332140 29548562
Infusion site phlebitis 70.30 11.06 17 71759 25 29880677
Cornea verticillata 69.90 11.06 17 71759 26 29880676
Haematuria 68.72 11.06 250 71526 44584 29836118
Diarrhoea 68.27 11.06 495 71281 333608 29547094
Off label use 67.36 11.06 338 71438 248952 29631750
Hyperglobulinaemia 65.47 11.06 13 71763 0 29880702
Anhedonia 63.71 11.06 89 71687 8280 29872422
Rheumatoid arthritis 63.64 11.06 11 71765 41186 29839516
Seizure 63.33 11.06 86 71690 98389 29782313
Corneal deposits 63.10 11.06 22 71754 174 29880528
Keratopathy 62.24 11.06 22 71754 182 29880520
Cardiac failure chronic 59.73 11.06 72 71704 5791 29874911
Product dose omission issue 56.94 11.06 82 71694 91549 29789153
Ejection fraction decreased 56.13 11.06 117 71659 15058 29865644
Death 55.68 11.06 568 71208 356715 29523987
Fear 55.60 11.06 96 71680 10729 29869973
Gastrointestinal haemorrhage 55.40 11.06 366 71410 83080 29797622
Pericardial effusion 55.06 11.06 142 71634 21002 29859700
Suicidal ideation 55.00 11.06 10 71766 36104 29844598
Cardioactive drug level increased 54.46 11.06 39 71737 1600 29879102
Cerebral haematoma 53.63 11.06 60 71716 4454 29876248
Labelled drug-drug interaction medication error 53.53 11.06 93 71683 10445 29870257
Cardiac failure acute 53.08 11.06 86 71690 9123 29871579
Thyroxine increased 53 11.06 15 71761 53 29880649
Injury 52.58 11.06 142 71634 21589 29859113
Renal injury 52.54 11.06 98 71678 11631 29869071
Palpitations 51.26 11.06 187 71589 33386 29847316
Phlebitis 49.76 11.06 53 71723 3722 29876980
Malignant neoplasm progression 49.70 11.06 60 71716 72227 29808475
Nasopharyngitis 49.44 11.06 41 71735 58808 29821894
Neutrophil count decreased 49.25 11.06 20 71756 42434 29838268
Sinus node dysfunction 48.98 11.06 53 71723 3790 29876912
Haematoma 47.76 11.06 146 71630 23807 29856895
Shock haemorrhagic 47.44 11.06 85 71691 9780 29870922
Nausea 46.65 11.06 471 71305 296486 29584216
Pain in extremity 46.50 11.06 124 71652 110097 29770605
Anticoagulation drug level increased 45.26 11.06 23 71753 498 29880204
Hyperkalaemia 44.69 11.06 291 71485 65719 29814983
N-terminal prohormone brain natriuretic peptide increased 44.66 11.06 32 71744 1314 29879388
Neutropenia 44.04 11.06 159 71617 128381 29752321
Pneumonitis 43.68 11.06 155 71621 27299 29853403
Goitre 43.07 11.06 33 71743 1503 29879199
Rash 42.16 11.06 278 71498 191611 29689091
Renal impairment 42.00 11.06 345 71431 83839 29796863
Atrioventricular block complete 42.00 11.06 74 71702 8403 29872299
Dyspnoea exertional 41.74 11.06 182 71594 35248 29845454
Melaena 41.61 11.06 171 71605 32266 29848436
Coronary artery bypass 39.45 11.06 55 71721 5107 29875595
Muscle spasms 39.31 11.06 59 71717 64779 29815923
Rectal haemorrhage 39.29 11.06 177 71599 34762 29845940
Thyroxine free increased 39.06 11.06 16 71760 205 29880497
Drug-induced liver injury 39.03 11.06 126 71650 21148 29859554
Rhabdomyolysis 38.68 11.06 273 71503 63307 29817395
Ventricular extrasystoles 38.45 11.06 85 71691 11389 29869313
White blood cell count decreased 38.06 11.06 91 71685 83856 29796846
Cardiac tamponade 37.78 11.06 51 71725 4593 29876109
Asthma 37.39 11.06 20 71756 36154 29844548
Subdural haematoma 37.22 11.06 115 71661 18857 29861845
Activated partial thromboplastin time prolonged 37.07 11.06 67 71709 7761 29872941
Fatigue 36.89 11.06 544 71232 320129 29560573
Bundle branch block left 36.17 11.06 53 71723 5151 29875551
Asthenia 35.86 11.06 736 71040 220554 29660148
Insomnia 35.69 11.06 110 71666 93226 29787476
Low cardiac output syndrome 35.66 11.06 17 71759 319 29880383
Coagulopathy 35.29 11.06 111 71665 18376 29862326
Pericardial haemorrhage 35.03 11.06 39 71737 2879 29877823
Respiratory failure 35.00 11.06 382 71394 100260 29780442
Myoclonus 34.24 11.06 89 71687 13223 29867479
Orthopnoea 34.14 11.06 48 71728 4492 29876210
Musculoskeletal stiffness 34.02 11.06 22 71754 35859 29844843
Injection site pain 34.00 11.06 15 71761 30295 29850407
Left ventricular failure 33.49 11.06 50 71726 4941 29875761
Aggression 33.17 11.06 24 71752 36883 29843819
Appendicolith 33.16 11.06 23 71753 896 29879806
Tachycardia induced cardiomyopathy 33.08 11.06 11 71765 74 29880628
Optic neuropathy 32.76 11.06 29 71747 1620 29879082
Blood glucose increased 32.66 11.06 61 71715 61469 29819233
Traumatic lung injury 32.30 11.06 25 71751 1156 29879546
Nodal arrhythmia 32.23 11.06 22 71754 835 29879867
Drug dependence 32.20 11.06 6 71770 21289 29859413
Halo vision 32.06 11.06 13 71763 162 29880540
Blood loss anaemia 32.02 11.06 62 71714 7565 29873137
Cardioversion 32.02 11.06 22 71754 844 29879858
Chills 31.55 11.06 80 71696 72258 29808444
Drug withdrawal syndrome 31.23 11.06 5 71771 19804 29860898
Deep vein thrombosis 31.22 11.06 61 71715 60440 29820262
Long QT syndrome 31.19 11.06 33 71743 2300 29878402
Supraventricular tachycardia 30.99 11.06 73 71703 10199 29870503
Haemoptysis 30.96 11.06 152 71624 30926 29849776
Crepitations 30.58 11.06 37 71739 2987 29877715
Potentiating drug interaction 30.52 11.06 46 71730 4585 29876117
Mitochondrial aspartate aminotransferase increased 30.42 11.06 7 71769 7 29880695
Angiodysplasia 30.14 11.06 17 71759 457 29880245
Stomatitis 30.05 11.06 27 71749 37252 29843450
Vomiting 29.92 11.06 360 71416 219458 29661244
Psoriasis 29.50 11.06 35 71741 42471 29838231
Atrial thrombosis 29.50 11.06 29 71747 1852 29878850
Emotional distress 29.49 11.06 94 71682 15671 29865031
International normalised ratio abnormal 29.41 11.06 37 71739 3109 29877593
Epistaxis 29.08 11.06 222 71554 52759 29827943
Gastrooesophageal reflux disease 28.95 11.06 21 71755 32234 29848468
Dissociation 28.79 11.06 23 71753 1114 29879588
Left ventricular dysfunction 28.69 11.06 64 71712 8627 29872075
Spontaneous haematoma 28.37 11.06 17 71759 513 29880189
Nodal rhythm 28.22 11.06 25 71751 1398 29879304
Jugular vein distension 28.08 11.06 17 71759 523 29880179
Cerebral haemorrhage 28.02 11.06 154 71622 32733 29847969
Suicide attempt 27.92 11.06 28 71748 36669 29844033
Disease progression 27.86 11.06 98 71678 79776 29800926
Cytomegalovirus infection 27.70 11.06 11 71765 23663 29857039
Intraocular haematoma 27.60 11.06 7 71769 14 29880688
Haemorrhage intracranial 27.54 11.06 89 71687 14943 29865759
Pleural effusion 27.54 11.06 285 71491 73781 29806921
Myalgia 27.46 11.06 93 71683 76574 29804128
Hypersensitivity 27.42 11.06 55 71721 53973 29826729
Urticaria 27.36 11.06 56 71720 54550 29826152
Atrioventricular block first degree 27.34 11.06 49 71727 5639 29875063
Cardiac output decreased 27.27 11.06 20 71756 852 29879850
Urine iodine increased 27.16 11.06 6 71770 4 29880698
Hepatocellular injury 27.12 11.06 127 71649 25344 29855358
Foetal exposure during pregnancy 27.07 11.06 29 71747 36842 29843860
Tachyarrhythmia 27.03 11.06 35 71741 3026 29877676
Hypertension 27.02 11.06 175 71601 121179 29759523
Prothrombin time prolonged 26.86 11.06 65 71711 9238 29871464
Anticoagulation drug level above therapeutic 26.85 11.06 27 71749 1772 29878930
Ischaemic stroke 26.84 11.06 93 71683 16182 29864520
Influenza like illness 26.69 11.06 14 71762 25591 29855111
Heparin-induced thrombocytopenia 26.68 11.06 47 71729 5336 29875366
Pulmonary embolism 26.50 11.06 97 71679 78038 29802664
Hypertransaminasaemia 26.18 11.06 39 71737 3846 29876856
Gravitational oedema 26.17 11.06 17 71759 593 29880109
Drug resistance 25.88 11.06 8 71768 20125 29860577
Lymphoid tissue hyperplasia 25.83 11.06 9 71767 71 29880631
Acute respiratory failure 25.44 11.06 126 71650 25724 29854978
Device pacing issue 25.36 11.06 7 71769 22 29880680
Depression 25.26 11.06 121 71655 90316 29790386
Constipation 25.04 11.06 163 71613 112743 29767959
Herpes zoster 24.97 11.06 21 71755 29922 29850780
Intentional overdose 24.89 11.06 38 71738 41443 29839259
Failure to suspend medication 24.80 11.06 9 71767 81 29880621
Intentional product misuse 24.64 11.06 28 71748 34639 29846063
Cardiac murmur 24.47 11.06 52 71724 6782 29873920
Blood creatinine increased 24.41 11.06 330 71446 91045 29789657
Therapeutic product effect incomplete 24.41 11.06 27 71749 33807 29846895
Hypoaesthesia 24.40 11.06 59 71717 54171 29826531
Intentional product use issue 24.24 11.06 31 71745 36409 29844293
Haemodynamic instability 24.22 11.06 57 71719 7958 29872744
Gastrointestinal angiodysplasia 23.94 11.06 15 71761 491 29880211
Respiratory distress 23.93 11.06 148 71628 32824 29847878
Heart transplant 23.73 11.06 15 71761 499 29880203
Acute pulmonary oedema 23.32 11.06 54 71722 7461 29873241
Pancreatitis 23.30 11.06 32 71744 36458 29844244
Pain 22.99 11.06 284 71492 172357 29708345
Toxic goitre 22.84 11.06 5 71771 3 29880699
Joint swelling 22.80 11.06 49 71727 46897 29833805
Rales 22.74 11.06 49 71727 6451 29874251
Cardiorenal syndrome 22.64 11.06 17 71759 751 29879951
Hospitalisation 22.59 11.06 45 71731 44274 29836428
Periorbital haemorrhage 22.58 11.06 9 71767 107 29880595
Sinusitis 22.56 11.06 28 71748 33317 29847385
Puncture site haematoma 22.25 11.06 10 71766 163 29880539
Arteriosclerotic gangrene 22.14 11.06 8 71768 71 29880631
Xyphoid retraction 22.08 11.06 10 71766 166 29880536
Lymphocyte count decreased 22.06 11.06 9 71767 19046 29861656
Hepatotoxicity 21.97 11.06 94 71682 18051 29862651
Colitis ulcerative 21.97 11.06 4 71772 14430 29866272
Fall 21.73 11.06 580 71196 181292 29699410
Iodine uptake abnormal 21.73 11.06 5 71771 5 29880697
Platelet count decreased 21.66 11.06 157 71619 105972 29774730
Femoral artery aneurysm 21.60 11.06 10 71766 175 29880527
Urinary tract infection 21.48 11.06 97 71679 73562 29807140
Supine hypertension 21.33 11.06 11 71765 246 29880456
Device inappropriate shock delivery 21.32 11.06 7 71769 45 29880657
Back pain 21.31 11.06 151 71625 102445 29778257
Mucosal inflammation 21.28 11.06 25 71751 30469 29850233
Abdominal pain 21.27 11.06 215 71561 135439 29745263
Nephrolithiasis 21.18 11.06 17 71759 24793 29855909
Conjunctival haemorrhage 20.98 11.06 29 71747 2671 29878031
Diabetes mellitus 20.92 11.06 43 71733 41822 29838880
Stress 20.89 11.06 100 71676 20135 29860567
Migraine 20.86 11.06 3 71773 12871 29867831
Irritability 20.69 11.06 15 71761 23035 29857667
Thyroid function test abnormal 20.66 11.06 15 71761 629 29880073
Bundle branch block 20.44 11.06 17 71759 872 29879830
Diaphragmatic paralysis 20.35 11.06 14 71762 538 29880164
Sinoatrial block 20.31 11.06 13 71763 442 29880260
Blood pressure increased 20.22 11.06 96 71680 71832 29808870
Unevaluable event 20.21 11.06 138 71638 31647 29849055
Pruritus 19.94 11.06 184 71592 118020 29762682
Musculoskeletal pain 19.88 11.06 27 71749 30913 29849789
Ilium fracture 19.85 11.06 8 71768 98 29880604
Exercise tolerance decreased 19.82 11.06 34 71742 3778 29876924
Osteonecrosis of jaw 19.67 11.06 10 71766 18608 29862094
Thyroiditis acute 19.57 11.06 8 71768 102 29880600
Optic ischaemic neuropathy 19.48 11.06 24 71752 1974 29878728
Subarachnoid haemorrhage 19.46 11.06 60 71716 9826 29870876
Hepatitis C 19.38 11.06 4 71772 13201 29867501
Papilloedema 19.36 11.06 26 71750 2330 29878372
Systemic inflammatory response syndrome 19.18 11.06 46 71730 6500 29874202
Infusion related reaction 19.15 11.06 43 71733 40521 29840181
Anaemia macrocytic 19.15 11.06 27 71749 2533 29878169
Blood pressure fluctuation 19.10 11.06 9 71767 17494 29863208
Therapeutic product effect decreased 19.07 11.06 25 71751 29051 29851651
Pacemaker generated rhythm 18.22 11.06 6 71770 39 29880663
Depressed mood 18.21 11.06 9 71767 17020 29863682
Ischaemic cardiomyopathy 18.18 11.06 44 71732 6253 29874449
Acute hepatic failure 18.14 11.06 66 71710 11761 29868941
BRASH syndrome 18.09 11.06 6 71770 40 29880662
Mediastinal haemorrhage 18.09 11.06 6 71770 40 29880662
Pemphigoid 18.01 11.06 49 71727 7479 29873223
Iodine overload 17.91 11.06 4 71772 3 29880699
Tri-iodothyronine increased 17.84 11.06 6 71770 42 29880660
Aerophagia 17.72 11.06 6 71770 43 29880659
Haemothorax 17.60 11.06 31 71745 3518 29877184
Lung infiltration 17.53 11.06 68 71708 12491 29868211
Secondary hyperthyroidism 17.38 11.06 4 71772 4 29880698
Withdrawal syndrome 17.38 11.06 3 71773 11247 29869455
Psoriatic arthropathy 17.36 11.06 8 71768 15753 29864949
Dyspnoea at rest 17.33 11.06 26 71750 2580 29878122
Presyncope 17.05 11.06 80 71696 15976 29864726
Oesophageal achalasia 17.05 11.06 10 71766 290 29880412
Neuropathy peripheral 17.04 11.06 99 71677 70376 29810326
Electrocardiogram QRS complex prolonged 17.03 11.06 34 71742 4243 29876459
Sedation 16.99 11.06 9 71767 16364 29864338
Abdominal discomfort 16.91 11.06 60 71716 48731 29831971
Cholestasis 16.87 11.06 110 71666 24840 29855862
Rhinorrhoea 16.76 11.06 15 71761 20739 29859963
Coma uraemic 16.73 11.06 6 71770 52 29880650
Alopecia 16.72 11.06 13 71763 19262 29861440
Pulmonary oedema 16.71 11.06 170 71606 43805 29836897
Lupus pneumonitis 16.63 11.06 6 71770 53 29880649
Oesophageal infection 16.62 11.06 9 71767 223 29880479
Pulseless electrical activity 16.57 11.06 42 71734 6145 29874557
Osteonecrosis 16.55 11.06 9 71767 16126 29864576
Haemorrhage 16.50 11.06 176 71600 45903 29834799
Scrotal haematocoele 16.45 11.06 5 71771 24 29880678
Oedema peripheral 16.42 11.06 350 71426 105482 29775220
Orthostatic hypotension 16.38 11.06 106 71670 23873 29856829
Blood thyroid stimulating hormone decreased 16.31 11.06 21 71755 1806 29878896
Bone pain 16.29 11.06 13 71763 19013 29861689
Deposit eye 16.28 11.06 5 71771 25 29880677
Ventricular flutter 16.25 11.06 6 71770 57 29880645
Anuria 16.19 11.06 58 71718 10258 29870444
Influenza 15.97 11.06 52 71724 43346 29837356
Cardiac arrest neonatal 15.96 11.06 5 71771 27 29880675
Optic nerve infarction 15.96 11.06 5 71771 27 29880675
Hirsutism 15.96 11.06 8 71768 168 29880534
Decreased appetite 15.90 11.06 258 71518 149652 29731050
Product quality issue 15.86 11.06 13 71763 18761 29861941
Plasma cell myeloma 15.83 11.06 70 71706 53392 29827310
Eosinophilia 15.78 11.06 99 71677 22061 29858641
Amaurosis 15.68 11.06 13 71763 664 29880038
Arthropathy 15.55 11.06 16 71760 20711 29859991
Neuroleptic malignant syndrome 15.43 11.06 10 71766 16285 29864417
Cardio-respiratory arrest 15.31 11.06 207 71569 57099 29823603
Hyperglycaemia 15.28 11.06 39 71737 35161 29845541
Ecchymosis 15.15 11.06 42 71734 6480 29874222
Bone marrow granuloma 15.11 11.06 3 71773 0 29880702
Thyroxine decreased 15.10 11.06 7 71769 123 29880579
Product use issue 15.02 11.06 58 71718 45958 29834744
Angioedema 15.00 11.06 38 71738 34346 29846356
Abnormal behaviour 14.87 11.06 24 71752 25599 29855103
Tri-iodothyronine decreased 14.75 11.06 5 71771 36 29880666
Erectile dysfunction 14.72 11.06 13 71763 18089 29862613
Haemorrhagic stroke 14.69 11.06 40 71736 6107 29874595
Glomerular filtration rate decreased 14.64 11.06 60 71716 11302 29869400
Cardiothoracic ratio increased 14.63 11.06 4 71772 12 29880690
Bone marrow failure 14.53 11.06 31 71745 29754 29850948
Myopathy 14.52 11.06 57 71719 10529 29870173
Electrocardiogram PR prolongation 14.51 11.06 13 71763 738 29879964
Non-alcoholic steatohepatitis 14.42 11.06 13 71763 744 29879958
Fasting 14.39 11.06 4 71772 13 29880689
Therapeutic drug monitoring analysis not performed 14.30 11.06 10 71766 395 29880307
Synovitis 14.28 11.06 3 71773 9780 29870922
Muscle haemorrhage 14.22 11.06 29 71747 3674 29877028
Prothrombin time shortened 14.08 11.06 18 71758 1537 29879165
C-reactive protein increased 14.06 11.06 55 71721 43418 29837284
Ischaemic hepatitis 14.04 11.06 18 71758 1541 29879161
Tri-iodothyronine free decreased 13.98 11.06 5 71771 43 29880659
Upper respiratory tract infection 13.91 11.06 28 71748 27448 29853254
Traumatic haemothorax 13.89 11.06 8 71768 224 29880478
Proteinuria 13.86 11.06 11 71765 16134 29864568
Heart rate decreased 13.85 11.06 92 71684 20902 29859800
Anaphylactic reaction 13.76 11.06 29 71747 27953 29852749
Myxoedema 13.75 11.06 4 71772 16 29880686
Hypophonesis 13.75 11.06 4 71772 16 29880686
Bradyarrhythmia 13.74 11.06 20 71756 1932 29878770
Linear IgA disease 13.65 11.06 18 71758 1584 29879118
Acute lung injury 13.64 11.06 15 71761 1092 29879610
Dyspepsia 13.64 11.06 33 71743 30296 29850406
Hypersensitivity pneumonitis 13.55 11.06 16 71760 1259 29879443
Spinal cord haemorrhage 13.53 11.06 9 71767 327 29880375
Neurotoxicity 13.50 11.06 65 71711 13117 29867585
Tumour lysis syndrome 13.49 11.06 7 71769 12878 29867824
Colitis 13.49 11.06 34 71742 30786 29849916
Neoplasm progression 13.42 11.06 14 71762 18009 29862693
Toxic nodular goitre 13.37 11.06 4 71772 18 29880684
Thyroxine free decreased 13.36 11.06 8 71768 241 29880461
Swelling 13.31 11.06 43 71733 35932 29844770
Somnolence 13.30 11.06 158 71618 96605 29784097
Extravasation 13.26 11.06 19 71757 1809 29878893
Fascial rupture 13.19 11.06 4 71772 19 29880683
Cardiac disorder 13.19 11.06 150 71626 39743 29840959
Paranoia 13.18 11.06 4 71772 10184 29870518
Cardiomegaly 13.07 11.06 69 71707 14440 29866262
Accidental exposure to product 13.04 11.06 4 71772 10111 29870591
Subdural haematoma evacuation 13.03 11.06 4 71772 20 29880682
Ejection fraction abnormal 13.01 11.06 12 71764 707 29879995
Hepatic cirrhosis 13.01 11.06 74 71702 15925 29864777
Drug intolerance 12.99 11.06 60 71716 45231 29835471
Tooth disorder 12.98 11.06 3 71773 9158 29871544
Pulmonary vascular resistance abnormality 12.97 11.06 5 71771 54 29880648
Infection 12.96 11.06 122 71654 77952 29802750
Electrocardiogram low voltage 12.87 11.06 4 71772 21 29880681
Cellulitis 12.82 11.06 63 71713 46721 29833981
Pericarditis fungal 12.80 11.06 7 71769 177 29880525
Adrenal haematoma 12.73 11.06 5 71771 57 29880645
Iron deficiency anaemia 12.71 11.06 49 71727 8975 29871727
Progressive multifocal leukoencephalopathy 12.68 11.06 3 71773 9010 29871692
Injection site reaction 12.59 11.06 5 71771 10755 29869947
Systemic-pulmonary artery shunt 12.58 11.06 3 71773 4 29880698
Injection site erythema 12.42 11.06 9 71767 13825 29866877
Osteoporosis 12.40 11.06 5 71771 10658 29870044
Arteriovenous fistula 12.34 11.06 11 71765 620 29880082
Urogenital haemorrhage 12.32 11.06 7 71769 191 29880511
Cardiomyopathy 12.29 11.06 70 71706 15073 29865629
Cardioactive drug level above therapeutic 12.28 11.06 5 71771 63 29880639
Coronary artery disease 12.24 11.06 177 71599 49535 29831167
Oedema 12.19 11.06 157 71619 42836 29837866
Vascular purpura 12.18 11.06 17 71759 1580 29879122
Pseudolymphoma 12.16 11.06 10 71766 505 29880197
Hepatitis acute 12.14 11.06 41 71735 7042 29873660
Amnesia 12.13 11.06 25 71751 24296 29856406
Cognitive disorder 12.11 11.06 24 71752 23666 29857036
Septic shock 12.11 11.06 217 71559 63390 29817312
Nephroangiosclerosis 12.06 11.06 7 71769 199 29880503
Abdominal pain upper 12.05 11.06 94 71682 62457 29818245
Oropharyngeal pain 12.04 11.06 32 71744 28464 29852238
Orthostatic hypertension 11.99 11.06 7 71769 201 29880501
Alveolitis necrotising 11.89 11.06 4 71772 28 29880674
Dry mouth 11.81 11.06 23 71753 22827 29857875
Aortic valve incompetence 11.73 11.06 32 71744 4891 29875811
Heparin-induced thrombocytopenia test 11.72 11.06 6 71770 132 29880570
Acidosis 11.70 11.06 5 71771 10296 29870406
Neuromyopathy 11.68 11.06 13 71763 959 29879743
Antiacetylcholine receptor antibody positive 11.66 11.06 4 71772 30 29880672
Epilepsy 11.60 11.06 19 71757 20150 29860552
Ulcer haemorrhage 11.59 11.06 21 71755 2437 29878265
Thrombosis 11.49 11.06 57 71719 42174 29838528
Postrenal failure 11.44 11.06 9 71767 426 29880276
Pathogen resistance 11.44 11.06 3 71773 8407 29872295
Basal cell carcinoma 11.39 11.06 13 71763 16055 29864647
Intervertebral disc protrusion 11.36 11.06 4 71772 9267 29871435
Dry skin 11.27 11.06 23 71753 22431 29858271
Diabetic ketoacidosis 11.26 11.06 13 71763 15973 29864729
Alveolitis 11.23 11.06 17 71759 1700 29879002
Cell death 11.22 11.06 20 71756 2291 29878411
Haemarthrosis 11.16 11.06 23 71753 2936 29877766
Hypothermia 11.15 11.06 49 71727 9518 29871184
Gastrointestinal candidiasis 11.10 11.06 6 71770 148 29880554
Viral infection 11.08 11.06 12 71764 15173 29865529
Demyelinating polyneuropathy 11.07 11.06 14 71762 1182 29879520
Psychomotor hyperactivity 11.06 11.06 3 71773 8221 29872481

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 drugs
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 (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

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
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
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 5.04 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
Endothelin-1 receptor GPCR Ki 4.79 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 6.09 DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 5.04 DRUG MATRIX
C-C chemokine receptor type 2 GPCR Ki 5.37 DRUG MATRIX
Substance-K receptor GPCR Ki 5.19 DRUG MATRIX
B2 bradykinin receptor GPCR Ki 5.11 DRUG MATRIX
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
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 7.10 WOMBAT-PK
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 beta Nuclear hormone receptor IC50 6.22 WOMBAT-PK
Thyroid hormone receptor alpha Nuclear hormone receptor IC50 5.64 WOMBAT-PK
3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase Enzyme Ki 7.60 WOMBAT-PK
Cytochrome P450 3A4 Enzyme Ki 6.22 WOMBAT-PK
Potassium voltage-gated channel subfamily A member 7 Ion channel IC50 6 WOMBAT-PK
Multidrug resistance protein 1 Transporter Ki 5.30 WOMBAT-PK
Beta-1 adrenergic receptor GPCR IC50 4.70 WOMBAT-PK
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 Ion channel IC50 5.35 WOMBAT-PK
Voltage-dependent T-type calcium channel subunit alpha-1H Ion channel Ki 5.28 WOMBAT-PK
Cytochrome P450 2C9 Enzyme EC50 7.40 WOMBAT-PK
THAP domain-containing protein 1 Unclassified IC50 6.19 WOMBAT-PK
Squalene monooxygenase Enzyme IC50 4.92 CHEMBL
Squalene synthase Enzyme IC50 5.10 CHEMBL
Androgen receptor Transcription factor Ki 4.55 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 4.41 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor IC50 6.93 DRUG MATRIX
Cruzipain Enzyme IC50 5.40 CHEMBL
Lethal factor Enzyme IC50 5.46 CHEMBL
C-8 sterol isomerase Enzyme Ki 7.21 CHEMBL
Sodium channel protein type 5 subunit alpha Unclassified BLOCKER IC50 5.70 IUPHAR

External reference:

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

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 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 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 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 26 sections
Nexterone HUMAN PRESCRIPTION DRUG LABEL 1 43066-360 INJECTION, SOLUTION 1.80 mg INTRAVENOUS NDA 26 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 50268-097 TABLET 100 mg ORAL ANDA 28 sections
AMIODARONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1205 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 18 sections
AMIODARONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1358 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 18 sections
AMIODARONE HCI HUMAN PRESCRIPTION DRUG LABEL 1 51662-1363 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 12 sections
NEXTERONE (AMIODARONE HCI) HUMAN PRESCRIPTION DRUG LABEL 1 51662-1480 INJECTION, SOLUTION 1.50 mg INTRAVENOUS NDA 18 sections