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
Drug interaction 1008.60 12.39 1188 54316 218141 53075421
Atrial fibrillation 1007.12 12.39 872 54632 110780 53182782
Torsade de pointes 735.31 12.39 329 55175 12676 53280886
Bradycardia 728.55 12.39 598 54906 70458 53223104
Electrocardiogram QT prolonged 666.35 12.39 516 54988 55887 53237675
Hyperthyroidism 587.21 12.39 282 55222 12791 53280771
International normalised ratio increased 425.48 12.39 371 55133 47390 53246172
Ventricular tachycardia 404.58 12.39 244 55260 17518 53276044
Pulmonary toxicity 385.32 12.39 161 55343 5230 53288332
Acute kidney injury 375.90 12.39 820 54684 253048 53040514
Cardiac failure 326.75 12.39 424 55080 85420 53208142
Myxoedema coma 298.08 12.39 73 55431 365 53293197
Interstitial lung disease 287.12 12.39 329 55175 58293 53235269
Rheumatoid arthritis 241.37 12.39 24 55480 314507 52979055
Ventricular fibrillation 221.59 12.39 144 55360 11781 53281781
Sinus bradycardia 218.07 12.39 154 55350 14447 53279115
Hypothyroidism 217.43 12.39 226 55278 35881 53257681
Cardiogenic shock 212.83 12.39 163 55341 17319 53276243
Gastrointestinal haemorrhage 203.21 12.39 327 55177 80003 53213559
Haematoma 198.71 12.39 209 55295 33635 53259927
Hypotension 195.11 12.39 644 54860 253432 53040130
Syncope 181.63 12.39 376 55128 111617 53181945
Hyperkalaemia 178.82 12.39 250 55254 54006 53239556
Pain 175.75 12.39 213 55291 588185 52705377
Renal failure 169.48 12.39 378 55126 118074 53175488
Tachyarrhythmia 162.39 12.39 85 55419 4631 53288931
Cardiac arrest 159.57 12.39 321 55183 93346 53200216
Headache 155.32 12.39 199 55305 536622 52756940
Hyponatraemia 153.57 12.39 345 55159 108262 53185300
Shock haemorrhagic 146.80 12.39 101 55403 9082 53284480
Cardiac failure congestive 144.03 12.39 306 55198 92451 53201111
Arthralgia 141.12 12.39 150 55354 439633 52853929
Joint swelling 139.60 12.39 36 55468 234602 53058960
Drug ineffective 133.60 12.39 423 55081 816822 52476740
Arrhythmia 126.45 12.39 173 55331 36606 53256956
Thyroiditis 124.34 12.39 53 55451 1809 53291753
Atrial flutter 117.98 12.39 90 55414 9501 53284061
Sinusitis 112.17 12.39 20 55484 168544 53125018
Rash 110.65 12.39 184 55320 446007 52847555
Sinus node dysfunction 109.95 12.39 64 55440 4297 53289265
Therapeutic product effect decreased 97.78 12.39 9 55495 125646 53167916
Hypokalaemia 93.80 12.39 266 55238 96251 53197311
Drug intolerance 92.85 12.39 49 55455 205444 53088118
Long QT syndrome 92.84 12.39 52 55452 3244 53290318
Synovitis 91.80 12.39 5 55499 107888 53185674
Labelled drug-drug interaction medication error 91.62 12.39 82 55422 10817 53282745
Multiple organ dysfunction syndrome 91.41 12.39 188 55316 55489 53238073
Cerebral haemorrhage 91.11 12.39 133 55371 29863 53263699
Mitral valve incompetence 91.05 12.39 107 55397 19444 53274118
Alopecia 89.44 12.39 68 55436 234515 53059047
Arthropathy 89.42 12.39 19 55485 141434 53152128
Ventricular arrhythmia 87.77 12.39 52 55452 3608 53289954
Infusion related reaction 87.00 12.39 27 55477 155930 53137632
Fatigue 86.10 12.39 430 55074 730076 52563486
Lactic acidosis 83.86 12.39 144 55360 37109 53256453
Systemic lupus erythematosus 83.15 12.39 15 55489 125399 53168163
Melaena 82.51 12.39 125 55379 29004 53264558
Nasopharyngitis 78.20 12.39 52 55452 192243 53101319
Infusion site phlebitis 76.77 12.39 17 55487 49 53293513
Anaemia 75.23 12.39 519 54985 276199 53017363
Rectal haemorrhage 75.19 12.39 146 55358 41335 53252227
Ventricular extrasystoles 73.45 12.39 75 55429 11649 53281913
Hypersensitivity 72.98 12.39 67 55437 210598 53082964
Cardio-respiratory arrest 72.43 12.39 177 55327 58581 53234981
Fall 71.24 12.39 625 54879 357815 52935747
Swelling 70.79 12.39 57 55447 191048 53102514
Renal injury 70.65 12.39 68 55436 9836 53283726
Injection site pain 70.10 12.39 16 55488 113375 53180187
Rhabdomyolysis 69.38 12.39 146 55358 43777 53249785
Respiratory failure 69.20 12.39 246 55258 100266 53193296
Maternal exposure during pregnancy 68.98 12.39 38 55466 155601 53137961
Cholestasis 68.66 12.39 114 55390 28581 53264981
Atrioventricular block 66.60 12.39 57 55447 7083 53286479
Pulmonary fibrosis 66.14 12.39 102 55402 24033 53269529
Brugada syndrome 65.48 12.39 21 55483 313 53293249
Atrial tachycardia 64.23 12.39 36 55468 2248 53291314
Musculoskeletal stiffness 64.21 12.39 24 55480 123344 53170218
Hypoxia 63.66 12.39 163 55341 55517 53238045
Infection 61.75 12.39 53 55451 172152 53121410
Alveolitis 60.91 12.39 37 55467 2687 53290875
Cerebral haematoma 59.37 12.39 40 55464 3474 53290088
Pain in extremity 58.78 12.39 131 55373 284919 53008643
Lung disorder 58.75 12.39 144 55360 47735 53245827
Therapeutic product effect incomplete 58.67 12.39 12 55492 91772 53201790
Abdominal discomfort 57.63 12.39 88 55416 220974 53072588
Cardioversion 56.97 12.39 27 55477 1186 53292376
Wound 56.43 12.39 13 55491 91544 53202018
Cardioactive drug level increased 55.68 12.39 32 55472 2097 53291465
Hypoaesthesia 55.35 12.39 35 55469 132960 53160602
Corneal deposits 55.29 12.39 17 55487 219 53293343
Blood thyroid stimulating hormone increased 55.13 12.39 49 55455 6403 53287159
Migraine 54.65 12.39 9 55495 80408 53213154
Neuromyopathy 54.47 12.39 21 55483 550 53293012
Muscle spasms 54.04 12.39 37 55467 134758 53158804
Diarrhoea 52.36 12.39 409 55095 625137 52668425
Product dose omission issue 52.17 12.39 74 55430 191546 53102016
Haemorrhage 51.67 12.39 155 55349 57832 53235730
Toxicity to various agents 51.64 12.39 398 55106 219200 53074362
Pyrexia 51.59 12.39 230 55274 402963 52890599
Orthopnoea 51.45 12.39 46 55458 6058 53287504
Blood loss anaemia 50.89 12.39 54 55450 8769 53284793
Arthritis 50.70 12.39 14 55490 87284 53206278
Ischaemic stroke 50.65 12.39 77 55427 17916 53275646
Haematoma muscle 50.62 12.39 21 55483 669 53292893
Nodal rhythm 50.20 12.39 28 55476 1732 53291830
Urticaria 49.71 12.39 41 55463 135844 53157718
Atrioventricular block complete 49.71 12.39 51 55453 7964 53285598
Injection site erythema 49.57 12.39 10 55494 77239 53216323
Keratopathy 49.41 12.39 18 55486 401 53293161
Haematuria 49.12 12.39 98 55406 28291 53265271
Weight increased 49.05 12.39 86 55418 204481 53089081
Hepatocellular injury 48.90 12.39 101 55403 29885 53263677
Coagulopathy 48.12 12.39 79 55425 19619 53273943
Coronary artery disease 48.06 12.39 107 55397 33330 53260232
Treatment failure 47.90 12.39 38 55466 128365 53165197
Exposure during pregnancy 47.79 12.39 36 55468 124824 53168738
Pulmonary hypertension 47.77 12.39 114 55390 37156 53256406
Hyperglobulinaemia 46.95 12.39 8 55496 0 53293562
Lymphatic fistula 45.30 12.39 21 55483 877 53292685
Off label use 45.15 12.39 297 55207 471915 52821647
Femoral hernia incarcerated 44.99 12.39 21 55483 891 53292671
Arterial haemorrhage 44.60 12.39 26 55478 1750 53291812
Depression 43.83 12.39 77 55427 182975 53110587
Dyspnoea 43.59 12.39 853 54651 585379 52708183
Asthma 43.55 12.39 30 55474 108942 53184620
Stomatitis 43.42 12.39 24 55480 98134 53195428
Nausea 42.54 12.39 544 54960 755547 52538015
Back pain 42.49 12.39 115 55389 234132 53059430
Pericarditis 42.04 12.39 8 55496 64398 53229164
Product use issue 41.99 12.39 50 55454 139534 53154028
Psoriasis 41.97 12.39 19 55485 87070 53206492
Thyrotoxic crisis 41.59 12.39 19 55485 767 53292795
Pancreatic steatosis 41.27 12.39 21 55483 1078 53292484
Haemarthrosis 40.91 12.39 31 55473 3239 53290323
Respiratory distress 40.71 12.39 101 55403 33726 53259836
Bundle branch block left 40.58 12.39 43 55461 6970 53286592
Heparin-induced thrombocytopenia 39.77 12.39 35 55469 4514 53289048
Acute respiratory distress syndrome 39.71 12.39 80 55424 23252 53270310
Toxic skin eruption 39.51 12.39 58 55446 13081 53280481
Injection site reaction 38.90 12.39 4 55500 51162 53242400
General physical health deterioration 38.89 12.39 274 55230 146668 53146894
Bradyarrhythmia 38.75 12.39 25 55479 2018 53291544
Subdural haematoma 38.72 12.39 59 55445 13754 53279808
Wound infection pseudomonas 38.23 12.39 22 55482 1445 53292117
Ecchymosis 37.81 12.39 52 55452 11047 53282515
Drug level increased 37.15 12.39 72 55432 20349 53273213
Hepatic cyst 36.96 12.39 35 55469 4961 53288601
Myocardial infarction 36.79 12.39 202 55302 99152 53194410
Pruritus 36.70 12.39 169 55335 293663 52999899
Faecaloma 36.55 12.39 44 55460 8197 53285365
Urinary retention 36.40 12.39 87 55417 28379 53265183
Contraindicated product administered 36.28 12.39 53 55451 135576 53157986
Psoriatic arthropathy 36.04 12.39 4 55500 48186 53245376
Herpes zoster 35.90 12.39 16 55488 74003 53219559
Chills 35.50 12.39 34 55470 104814 53188748
Cornea verticillata 35.23 12.39 9 55495 55 53293507
Hypomagnesaemia 35.21 12.39 79 55425 24732 53268830
Septic shock 35.12 12.39 143 55361 62086 53231476
White blood cell count decreased 34.93 12.39 47 55457 124428 53169134
Cerebellar haematoma 34.78 12.39 14 55490 412 53293150
Peripheral swelling 34.57 12.39 105 55399 206003 53087559
Haemorrhagic stroke 34.56 12.39 36 55468 5722 53287840
Insomnia 34.54 12.39 91 55413 186981 53106581
Suicide attempt 34.39 12.39 9 55495 58159 53235403
Tricuspid valve incompetence 34.17 12.39 57 55447 14339 53279223
Pericardial haemorrhage 34.11 12.39 21 55483 1562 53292000
Gastrooesophageal reflux disease 34.05 12.39 22 55482 82641 53210921
Myalgia 33.94 12.39 54 55450 133437 53160125
Extravasation 33.79 12.39 24 55480 2270 53291292
Alveolar proteinosis 33.66 12.39 13 55491 342 53293220
Muscle haemorrhage 33.31 12.39 28 55476 3395 53290167
Anuria 33.27 12.39 52 55452 12388 53281174
Drug hypersensitivity 32.85 12.39 153 55351 265089 53028473
Right ventricular failure 32.63 12.39 61 55443 16782 53276780
Device stimulation issue 32.59 12.39 9 55495 77 53293485
Aortic valve stenosis 32.21 12.39 27 55477 3261 53290301
Abortion spontaneous 32.17 12.39 5 55499 46630 53246932
Fibromyalgia 32.11 12.39 4 55500 44071 53249491
Organising pneumonia 32.11 12.39 33 55471 5163 53288399
Mixed liver injury 31.89 12.39 29 55475 3904 53289658
Blood cholesterol increased 31.71 12.39 8 55496 52981 53240581
Respiratory acidosis 31.48 12.39 36 55468 6352 53287210
Prothrombin time shortened 31.38 12.39 21 55483 1803 53291759
Listless 31.30 12.39 24 55480 2552 53291010
Lower gastrointestinal haemorrhage 31.29 12.39 39 55465 7527 53286035
Acute respiratory failure 31.16 12.39 87 55417 31171 53262391
Neck pain 30.67 12.39 12 55492 60004 53233558
Extrasystoles 30.47 12.39 32 55472 5134 53288428
Seroma 30.39 12.39 22 55482 2143 53291419
Cerebellar syndrome 30.04 12.39 27 55477 3580 53289982
Discomfort 30.01 12.39 33 55471 95439 53198123
Cardiac disorder 29.80 12.39 112 55392 46854 53246708
Reduced facial expression 29.71 12.39 20 55484 1734 53291828
Glomerular filtration rate decreased 29.57 12.39 50 55454 12717 53280845
Medication error 29.41 12.39 94 55410 36271 53257291
Renal impairment 29.25 12.39 167 55337 83151 53210411
Haemorrhage intracranial 29.23 12.39 51 55453 13301 53280261
Inflammatory marker increased 29.02 12.39 34 55470 6156 53287406
Spontaneous haematoma 28.74 12.39 15 55489 812 53292750
Craniocerebral injury 28.39 12.39 22 55482 2376 53291186
Ventricular tachyarrhythmia 28.22 12.39 8 55496 76 53293486
Intra-abdominal haematoma 28.03 12.39 19 55485 1666 53291896
Splenic haemorrhage 27.96 12.39 10 55494 211 53293351
Head injury 27.85 12.39 74 55430 25759 53267803
Agranulocytosis 27.62 12.39 70 55434 23679 53269883
Pleural effusion 27.54 12.39 172 55332 88407 53205155
Atrioventricular block first degree 27.53 12.39 34 55470 6501 53287061
Hypoglycaemia 27.48 12.39 128 55376 58885 53234677
Anticoagulation drug level increased 27.44 12.39 10 55494 223 53293339
Left ventricular dysfunction 27.35 12.39 45 55459 11192 53282370
Mediastinal haematoma 27.17 12.39 8 55496 88 53293474
Acute pulmonary oedema 27.11 12.39 38 55466 8217 53285345
Ill-defined disorder 26.77 12.39 9 55495 49435 53244127
Hepatic failure 26.67 12.39 90 55414 35716 53257846
Hypoxic-ischaemic encephalopathy 26.50 12.39 27 55477 4181 53289381
Asthenia 26.46 12.39 503 55001 343087 52950475
Goitre congenital 26.41 12.39 5 55499 4 53293558
Abdominal wall haematoma 26.08 12.39 23 55481 2975 53290587
Diverticulum intestinal 25.85 12.39 33 55471 6524 53287038
Coronary artery bypass 25.63 12.39 21 55483 2457 53291105
Sinoatrial block 25.60 12.39 14 55490 833 53292729
Subarachnoid haemorrhage 25.48 12.39 45 55459 11848 53281714
Arrhythmia supraventricular 25.43 12.39 15 55489 1032 53292530
Overdose 25.13 12.39 195 55309 107541 53186021
Oedema peripheral 25.12 12.39 280 55224 170507 53123055
Blood creatinine increased 24.76 12.39 159 55345 82503 53211059
Nodal arrhythmia 24.73 12.39 16 55488 1298 53292264
Cardiac ablation 24.62 12.39 16 55488 1308 53292254
Bone pain 24.54 12.39 11 55493 50711 53242851
Injection site swelling 24.44 12.39 7 55497 42621 53250941
Electrocardiogram QRS complex prolonged 24.39 12.39 30 55474 5712 53287850
Paraesthesia 24.32 12.39 61 55443 127454 53166108
Abdominal pain upper 24.25 12.39 90 55414 166201 53127361
Influenza like illness 23.98 12.39 17 55487 60842 53232720
Myopathy 23.85 12.39 39 55465 9653 53283909
Cardiac failure chronic 23.83 12.39 25 55479 4005 53289557
Cyanosis 23.63 12.39 53 55451 16586 53276976
Subcutaneous haematoma 23.62 12.39 17 55487 1641 53291921
Cardioactive drug level above therapeutic 23.55 12.39 8 55496 144 53293418
Fluid overload 23.48 12.39 73 55431 27758 53265804
Central nervous system injury 23.25 12.39 8 55496 150 53293412
Drug-induced liver injury 23.13 12.39 75 55429 29158 53264404
Constipation 23.07 12.39 117 55387 198295 53095267
Retroperitoneal haematoma 22.95 12.39 21 55483 2849 53290713
Retroperitoneal haemorrhage 22.80 12.39 21 55483 2873 53290689
Device capturing issue 22.66 12.39 6 55498 43 53293519
Febrile neutropenia 22.60 12.39 47 55457 104889 53188673
Pregnancy 22.55 12.39 3 55501 31438 53262124
Fear 22.51 12.39 52 55452 16589 53276973
Oliguria 22.49 12.39 37 55467 9201 53284361
Petechiae 22.38 12.39 46 55458 13559 53280003
Cardiac arrest neonatal 22.36 12.39 7 55497 96 53293466
Knee arthroplasty 22.27 12.39 4 55500 33565 53259997
Thyroiditis acute 22.04 12.39 7 55497 101 53293461
Blood pressure increased 21.84 12.39 74 55430 140405 53153157
Pulmonary oedema 21.77 12.39 112 55392 53611 53239951
Shock 21.69 12.39 63 55441 23076 53270486
Haemorrhagic diathesis 21.67 12.39 25 55479 4453 53289109
Ejection fraction decreased 21.54 12.39 57 55447 19791 53273771
Osteoarthritis 21.45 12.39 25 55479 70461 53223101
Left ventricular failure 21.28 12.39 27 55477 5306 53288256
Local anaesthetic systemic toxicity 21.26 12.39 11 55493 585 53292977
Feeling abnormal 21.22 12.39 71 55433 135230 53158332
Suicidal ideation 21.21 12.39 19 55485 60492 53233070
Cardiac tamponade 21.12 12.39 25 55479 4575 53288987
Hypochromasia 21.12 12.39 9 55495 307 53293255
Wound dehiscence 20.92 12.39 25 55479 4621 53288941
Ear pain 20.89 12.39 3 55501 29670 53263892
Prothrombin time prolonged 20.83 12.39 37 55467 9785 53283777
Oesophageal squamous cell carcinoma 20.55 12.39 7 55497 127 53293435
Presyncope 20.54 12.39 67 55437 26127 53267435
Throat irritation 20.53 12.39 4 55500 31677 53261885
Electrocardiogram T wave inversion 20.50 12.39 22 55482 3617 53289945
Musculoskeletal pain 20.48 12.39 29 55475 75171 53218391
Conduction disorder 20.40 12.39 15 55489 1497 53292065
Neutrophil count decreased 20.30 12.39 13 55491 49085 53244477
Irritable bowel syndrome 20.28 12.39 10 55494 43622 53249940
Pulmonary alveolar haemorrhage 20.13 12.39 24 55480 4426 53289136
Injection site bruising 20.12 12.39 7 55497 37639 53255923
Splenic injury 20.12 12.39 8 55496 228 53293334
Myxoedema 20.06 12.39 7 55497 137 53293425
Memory impairment 19.95 12.39 36 55468 84721 53208841
Pneumonitis 19.88 12.39 74 55430 30814 53262748
Anhedonia 19.83 12.39 38 55466 10649 53282913
Thrombocytopenia 19.74 12.39 226 55278 138501 53155061
Propionibacterium infection 19.65 12.39 5 55499 30 53293532
Anaphylactic reaction 19.64 12.39 19 55485 58307 53235255
Device pacing issue 19.61 12.39 6 55498 76 53293486
Rales 19.46 12.39 38 55466 10794 53282768
Prerenal failure 19.36 12.39 15 55489 1619 53291943
Potentiating drug interaction 19.34 12.39 23 55481 4230 53289332
Eosinophilic pneumonia 19.23 12.39 17 55487 2205 53291357
Pericardial effusion 18.95 12.39 67 55437 27211 53266351
Gastrointestinal disorder 18.80 12.39 41 55463 89963 53203599
Liver function test abnormal 18.64 12.39 99 55405 47972 53245590
Lip swelling 18.57 12.39 3 55501 27198 53266364
Palpitations 18.47 12.39 175 55329 102173 53191389
Upper respiratory tract infection 18.47 12.39 27 55477 69070 53224492
Pelvic fracture 18.25 12.39 40 55464 12324 53281238
Intentional overdose 18.22 12.39 26 55478 67179 53226383
Activated partial thromboplastin time prolonged 18.18 12.39 29 55475 7030 53286532
Hepatitis acute 18.16 12.39 33 55471 8883 53284679
Completed suicide 18.12 12.39 78 55426 138123 53155439
Anisocytosis 18.09 12.39 10 55494 608 53292954
Eosinophilia myalgia syndrome 17.94 12.39 4 55500 12 53293550
Ischaemic hepatitis 17.91 12.39 16 55488 2104 53291458
Foreign body 17.84 12.39 16 55488 2115 53291447
Oropharyngeal pain 17.83 12.39 36 55468 81232 53212330
Ataxia 17.73 12.39 44 55460 14693 53278869
Hypocoagulable state 17.66 12.39 12 55492 1057 53292505
Iodine overload 17.61 12.39 3 55501 0 53293562
Electrocardiogram QRS complex shortened 17.60 12.39 9 55495 467 53293095
Thyroglobulin increased 17.59 12.39 5 55499 48 53293514
Liver scan abnormal 17.59 12.39 5 55499 48 53293514
Neovascular age-related macular degeneration 17.46 12.39 7 55497 204 53293358
Thyroxine free increased 17.45 12.39 11 55493 853 53292709
Ear infection 17.37 12.39 3 55501 25897 53267665
Drug level above therapeutic 17.22 12.39 21 55483 3963 53289599
Electrocardiogram U-wave abnormality 17.06 12.39 5 55499 54 53293508
Disease progression 17.01 12.39 52 55452 101868 53191694
Cardiovascular insufficiency 16.86 12.39 13 55491 1393 53292169
Transaminases increased 16.80 12.39 69 55435 30063 53263499
Drug clearance decreased 16.72 12.39 12 55492 1154 53292408
Hypoglycaemic seizure 16.69 12.39 9 55495 521 53293041
Subdural haemorrhage 16.60 12.39 18 55486 2994 53290568
Altered visual depth perception 16.60 12.39 8 55496 365 53293197
Therapeutic response decreased 16.60 12.39 15 55489 47554 53246008
Chronic kidney disease 16.59 12.39 89 55415 43281 53250281
Chorea 16.53 12.39 13 55491 1434 53292128
Toxic epidermal necrolysis 16.49 12.39 58 55446 23492 53270070
Haemodynamic instability 16.49 12.39 31 55473 8563 53284999
Product quality issue 16.44 12.39 9 55495 37014 53256548
Congenital hypothyroidism 16.36 12.39 7 55497 241 53293321
Compensatory sweating 16.33 12.39 4 55500 20 53293542
Respiratory alkalosis 16.27 12.39 17 55487 2711 53290851
Tri-iodothyronine increased 16.21 12.39 6 55498 140 53293422
Aortic arteriosclerosis 16.21 12.39 25 55479 5889 53287673
International normalised ratio abnormal 16.19 12.39 18 55486 3079 53290483
Oral pain 16.15 12.39 4 55500 26833 53266729
Myocardial ischaemia 16.14 12.39 39 55465 12805 53280757
Prescription drug used without a prescription 16.08 12.39 14 55490 1780 53291782
Abdominal wall haemorrhage 16.01 12.39 6 55498 145 53293417
Intentional product use issue 16.00 12.39 32 55472 72462 53221100
Arterial insufficiency 15.86 12.39 6 55498 149 53293413
Electrocardiogram T wave abnormal 15.80 12.39 16 55488 2460 53291102
Progressive supranuclear palsy 15.75 12.39 5 55499 72 53293490
Pulseless electrical activity 15.71 12.39 28 55476 7426 53286136
Swelling face 15.61 12.39 22 55482 57146 53236416
Fungal infection 15.59 12.39 7 55497 32239 53261323
Kidney malrotation 15.58 12.39 4 55500 25 53293537
Subgaleal haematoma 15.56 12.39 5 55499 75 53293487
Endovenous ablation 15.53 12.39 3 55501 3 53293559
Weight decreased 15.45 12.39 163 55341 234785 53058777
Aortic valve incompetence 15.31 12.39 25 55479 6180 53287382
Photosensitivity reaction 15.30 12.39 40 55464 13788 53279774
Cardiac failure acute 15.26 12.39 31 55473 9061 53284501
Acute hepatic failure 15.17 12.39 45 55459 16675 53276887
Electrocardiogram abnormal 15.14 12.39 29 55475 8124 53285438
Type 2 diabetes mellitus 15.11 12.39 7 55497 31663 53261899
Ischaemic cardiomyopathy 15.11 12.39 16 55488 2592 53290970
Anti-thyroid antibody positive 14.99 12.39 8 55496 453 53293109
Haemoglobin decreased 14.99 12.39 213 55291 137094 53156468
Infective pericardial effusion 14.95 12.39 4 55500 30 53293532
Secondary hyperthyroidism 14.95 12.39 4 55500 30 53293532
Congestive hepatopathy 14.86 12.39 16 55488 2640 53290922
Nephrolithiasis 14.83 12.39 10 55494 36737 53256825
Night sweats 14.80 12.39 9 55495 34938 53258624
Dialysis 14.75 12.39 33 55471 10309 53283253
International normalised ratio 14.72 12.39 5 55499 90 53293472
Cutaneous lupus erythematosus 14.54 12.39 16 55488 2707 53290855
Extradural haematoma 14.52 12.39 13 55491 1715 53291847
Escherichia infection 14.52 12.39 36 55468 12014 53281548
Osteonecrosis of jaw 14.37 12.39 10 55494 36136 53257426
Dyspnoea at rest 14.37 12.39 19 55485 3888 53289674
Hepatic enzyme increased 14.33 12.39 75 55429 126120 53167442
Oesophageal adenocarcinoma recurrent 14.30 12.39 4 55500 36 53293526
Erythema 14.30 12.39 100 55404 156869 53136693
Head discomfort 14.17 12.39 35 55469 11649 53281913
Haemothorax 14.11 12.39 14 55490 2100 53291462
Hot flush 14.06 12.39 17 55487 47143 53246419
Hepatitis 13.96 12.39 71 55433 33823 53259739
Electrocardiogram U wave present 13.91 12.39 5 55499 107 53293455
Hyperchloraemia 13.79 12.39 9 55495 741 53292821
Electrocardiogram T wave alternans 13.75 12.39 4 55500 42 53293520
Thyroxine increased 13.73 12.39 8 55496 538 53293024
Cardiac rehabilitation therapy 13.72 12.39 3 55501 8 53293554
Coagulation test abnormal 13.70 12.39 9 55495 749 53292813
Atrioventricular dissociation 13.70 12.39 6 55498 219 53293343
Neoplasm progression 13.69 12.39 7 55497 29912 53263650
Seizure 13.59 12.39 79 55425 129430 53164132
Hemiplegia 13.58 12.39 27 55477 7773 53285789
Cardiomegaly 13.48 12.39 45 55459 17755 53275807
Acute coronary syndrome 13.47 12.39 32 55472 10392 53283170
Eosinophilic pleural effusion 13.42 12.39 4 55500 46 53293516
Pancreatitis 13.37 12.39 17 55487 46125 53247437
Splenic rupture 13.36 12.39 11 55493 1296 53292266
Mesenteric artery stenosis 13.34 12.39 4 55500 47 53293515
Device dislocation 13.30 12.39 4 55500 23593 53269969
Paroxysmal arrhythmia 13.27 12.39 4 55500 48 53293514
Electrocardiogram repolarisation abnormality 13.16 12.39 11 55493 1323 53292239
Encephalopathy 13.05 12.39 74 55430 36734 53256828
Lung infiltration 12.80 12.39 39 55465 14668 53278894
Thyroiditis chronic 12.79 12.39 3 55501 12 53293550
Lower respiratory tract infection 12.76 12.39 50 55454 90931 53202631
Atrioventricular block second degree 12.74 12.39 18 55486 3921 53289641
Dehydration 12.73 12.39 246 55258 168164 53125398
Goitre 12.68 12.39 22 55482 5712 53287850
Circulatory collapse 12.65 12.39 52 55452 22662 53270900
Bone disorder 12.61 12.39 3 55501 20680 53272882
Corynebacterium infection 12.53 12.39 7 55497 434 53293128
Neuropathy peripheral 12.47 12.39 60 55444 103127 53190435
Monoclonal gammopathy 12.42 12.39 8 55496 644 53292918
Oral mucosa haematoma 12.42 12.39 3 55501 14 53293548

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 1800.74 11.57 719 77059 8643 32427105
Pulmonary toxicity 711.11 11.57 309 77469 4644 32431104
Ventricular tachycardia 707.75 11.57 544 77234 25012 32410736
Atrial fibrillation 680.86 11.57 1092 76686 115612 32320136
Drug interaction 539.59 11.57 1431 76347 216754 32218994
Bradycardia 484.52 11.57 718 77060 70844 32364904
Cardiac failure 422.14 11.57 773 77005 90900 32344848
Interstitial lung disease 377.87 11.57 608 77170 64393 32371355
Thyroiditis 373.17 11.57 150 77628 1830 32433918
Hypothyroidism 371.41 11.57 315 77463 16660 32419088
Torsade de pointes 369.70 11.57 227 77551 7188 32428560
Pulmonary fibrosis 335.01 11.57 297 77481 16677 32419071
Electrocardiogram QT prolonged 312.56 11.57 428 77350 39213 32396535
International normalised ratio increased 277.10 11.57 453 77325 48582 32387166
Cardiogenic shock 208.18 11.57 252 77526 20410 32415338
Ventricular fibrillation 205.99 11.57 230 77548 17080 32418668
Thyrotoxic crisis 197.75 11.57 62 77716 337 32435411
Cardiac failure congestive 182.35 11.57 530 77248 84322 32351426
Pulmonary alveolar haemorrhage 165.60 11.57 137 77641 6992 32428756
Acute kidney injury 164.76 11.57 1232 76546 292236 32143512
Myxoedema coma 136.41 11.57 44 77734 266 32435482
Ventricular arrhythmia 133.65 11.57 105 77673 4974 32430774
Hypotension 133.58 11.57 929 76849 215181 32220567
Multiple organ dysfunction syndrome 129.10 11.57 414 77364 69440 32366308
Pyrexia 126.01 11.57 372 77406 319596 32116152
Atrial flutter 124.21 11.57 167 77611 15016 32420732
Acute respiratory distress syndrome 112.21 11.57 210 77568 25043 32410705
Arthralgia 100.99 11.57 124 77654 148324 32287424
Completed suicide 100.15 11.57 48 77730 92469 32343279
Febrile neutropenia 99.36 11.57 84 77694 119482 32316266
Syncope 97.82 11.57 451 77327 89673 32346075
Renal failure 95.57 11.57 599 77179 133879 32301869
Ejection fraction decreased 95.42 11.57 160 77618 17498 32418250
Blood thyroid stimulating hormone increased 94.39 11.57 71 77707 3151 32432597
Thyroid disorder 93.61 11.57 68 77710 2859 32432889
Headache 93.33 11.57 207 77571 195990 32239758
Appendicolith 93.29 11.57 70 77708 3095 32432653
Lung disorder 92.70 11.57 231 77547 33523 32402225
Atrial tachycardia 89.44 11.57 59 77719 2118 32433630
Cardiac arrest 89.07 11.57 462 77316 96314 32339434
Cardiac failure chronic 87.48 11.57 97 77681 7143 32428605
Arrhythmia 87.04 11.57 232 77546 35071 32400677
Organising pneumonia 86.30 11.57 86 77692 5595 32430153
Atrioventricular block 83.07 11.57 97 77681 7558 32428190
Venous pressure jugular increased 77.31 11.57 38 77740 766 32434982
Diarrhoea 77.13 11.57 534 77244 364268 32071480
Sinus bradycardia 76.35 11.57 122 77656 12816 32422932
Infusion site phlebitis 70.33 11.57 17 77761 25 32435723
BRASH syndrome 69.99 11.57 20 77758 74 32435674
Cornea verticillata 69.93 11.57 17 77761 26 32435722
Corneal deposits 68.97 11.57 24 77754 189 32435559
Seizure 68.24 11.57 89 77689 103765 32331983
Drug abuse 67.09 11.57 56 77722 80187 32355561
Dyspnoea 67.00 11.57 1226 76552 360819 32074929
Hyperglobulinaemia 65.49 11.57 13 77765 0 32435748
Haematuria 63.15 11.57 256 77522 48105 32387643
Anhedonia 63.05 11.57 89 77689 8375 32427373
Off label use 62.90 11.57 452 77326 305868 32129880
Rheumatoid arthritis 62.20 11.57 15 77763 44529 32391219
Suicidal ideation 61.31 11.57 9 77769 38074 32397674
Palpitations 59.98 11.57 206 77572 35763 32399985
Death 58.29 11.57 610 77168 381907 32053841
Product dose omission issue 57.57 11.57 98 77680 102477 32333271
Keratopathy 56.51 11.57 22 77756 245 32435503
Nasopharyngitis 56.49 11.57 42 77736 63745 32372003
N-terminal prohormone brain natriuretic peptide increased 55.61 11.57 43 77735 1989 32433759
Shock haemorrhagic 55.57 11.57 95 77683 10550 32425198
Neutrophil count decreased 54.86 11.57 22 77756 47117 32388631
Cardiac failure acute 54.64 11.57 92 77686 10092 32425656
Pain in extremity 54.39 11.57 128 77650 118773 32316975
Cardioactive drug level increased 54.35 11.57 40 77738 1716 32434032
Fear 53.88 11.57 97 77681 11222 32424526
Gastrointestinal haemorrhage 53.74 11.57 374 77404 86508 32349240
Neutropenia 53.10 11.57 169 77609 142006 32293742
Thyroxine increased 53.03 11.57 15 77763 53 32435695
Malignant neoplasm progression 52.86 11.57 66 77712 78430 32357318
Injury 52.62 11.57 144 77634 22101 32413647
Appendicitis 52.35 11.57 84 77694 8853 32426895
Cerebral haematoma 52.26 11.57 61 77717 4750 32430998
Labelled drug-drug interaction medication error 51.15 11.57 100 77678 12313 32423435
Anticoagulation drug level increased 50.86 11.57 25 77753 504 32435244
Phlebitis 50.78 11.57 54 77724 3792 32431956
Renal injury 50.75 11.57 98 77680 11957 32423791
Asthma 50.58 11.57 21 77757 44044 32391704
Pericardial effusion 50.58 11.57 145 77633 22857 32412891
Stress 50.44 11.57 148 77630 23634 32412114
Hyperkalaemia 50.27 11.57 312 77466 69438 32366310
Rash 49.40 11.57 296 77482 209037 32226711
Pericardial haemorrhage 49.26 11.57 48 77730 3038 32432710
Atrioventricular block complete 46.93 11.57 80 77698 8864 32426884
Sinus node dysfunction 46.83 11.57 53 77725 3991 32431757
Rhabdomyolysis 46.06 11.57 297 77481 66968 32368780
Muscle spasms 45.56 11.57 61 77717 70357 32365391
Dyspnoea exertional 45.22 11.57 199 77579 38762 32396986
Cardiac tamponade 44.86 11.57 58 77720 5017 32430731
Fatigue 44.55 11.57 582 77196 350119 32085629
Goitre 44.02 11.57 34 77744 1570 32434178
Haematoma 43.60 11.57 148 77630 25536 32410212
Melaena 43.27 11.57 181 77597 34484 32401264
Ventricular extrasystoles 42.59 11.57 91 77687 11935 32423813
Rectal haemorrhage 41.82 11.57 189 77589 37234 32398514
Thyroxine free increased 41.52 11.57 17 77761 218 32435530
Pneumonitis 41.32 11.57 162 77616 29972 32405776
Insomnia 41.26 11.57 114 77664 100234 32335514
Drug-induced liver injury 41.15 11.57 139 77639 23924 32411824
White blood cell count decreased 41.03 11.57 99 77679 91099 32344649
Renal impairment 40.94 11.57 367 77411 91605 32344143
Coronary artery bypass 40.24 11.57 55 77723 5021 32430727
Orthopnoea 38.65 11.57 54 77724 5033 32430715
Activated partial thromboplastin time prolonged 38.40 11.57 71 77707 8384 32427364
Nausea 37.64 11.57 541 77237 320308 32115440
Subdural haematoma 37.48 11.57 119 77659 19834 32415914
Aggression 37.43 11.57 24 77754 39365 32396383
Asthenia 37.38 11.57 781 76997 235163 32200585
Coagulopathy 36.99 11.57 117 77661 19460 32416288
Drug dependence 36.77 11.57 6 77772 23478 32412270
Tachyarrhythmia 36.76 11.57 43 77735 3356 32432392
Injection site pain 35.97 11.57 17 77761 33041 32402707
Musculoskeletal stiffness 35.87 11.57 25 77753 39239 32396509
Cardioversion 35.66 11.57 24 77754 891 32434857
Therapeutic product effect incomplete 35.60 11.57 28 77750 41313 32394435
Respiratory failure 33.98 11.57 399 77379 106783 32328965
Stomatitis 33.70 11.57 28 77750 40201 32395547
Left ventricular failure 33.61 11.57 51 77727 5122 32430626
Pleural effusion 33.51 11.57 312 77466 78680 32357068
Bundle branch block left 33.41 11.57 54 77724 5725 32430023
Gastrooesophageal reflux disease 33.24 11.57 21 77757 34717 32401031
International normalised ratio abnormal 32.92 11.57 40 77738 3249 32432499
Traumatic lung injury 32.57 11.57 26 77752 1260 32434488
Blood glucose increased 32.46 11.57 67 77711 65174 32370574
Supraventricular tachycardia 32.40 11.57 77 77701 10839 32424909
Nodal arrhythmia 32.33 11.57 22 77756 832 32434916
Deep vein thrombosis 32.07 11.57 65 77713 63648 32372100
Potentiating drug interaction 32.01 11.57 49 77729 4959 32430789
Psoriasis 31.86 11.57 38 77740 46085 32389663
Jugular vein distension 31.81 11.57 19 77759 571 32435177
Pulmonary embolism 31.51 11.57 99 77679 83560 32352188
Blood loss anaemia 31.42 11.57 63 77715 7899 32427849
Optic neuropathy 31.36 11.57 29 77749 1718 32434030
Low cardiac output syndrome 31.31 11.57 17 77761 424 32435324
Crepitations 31.30 11.57 38 77740 3084 32432664
Halo vision 31.25 11.57 13 77765 174 32435574
Cytomegalovirus infection 31.10 11.57 11 77767 25453 32410295
Pacemaker generated rhythm 30.65 11.57 10 77768 63 32435685
Atrioventricular block first degree 30.57 11.57 52 77726 5751 32429997
Disease progression 30.51 11.57 106 77672 86756 32348992
Mitochondrial aspartate aminotransferase increased 30.43 11.57 7 77771 7 32435741
Angiodysplasia 30.29 11.57 18 77760 536 32435212
Hypertension 30.14 11.57 188 77590 131562 32304186
Myalgia 29.98 11.57 97 77681 81133 32354615
Drug withdrawal syndrome 29.88 11.57 6 77772 20225 32415523
Acute respiratory failure 29.81 11.57 142 77636 28586 32407162
Haemoptysis 29.38 11.57 158 77620 33367 32402381
Suicide attempt 29.19 11.57 29 77749 38215 32397533
Myoclonus 29.09 11.57 89 77689 14540 32421208
Anticoagulation drug level above therapeutic 29.04 11.57 29 77749 1891 32433857
Urticaria 29.01 11.57 62 77716 59552 32376196
Chills 28.99 11.57 93 77685 77991 32357757
Hypoaesthesia 28.97 11.57 60 77718 58293 32377455
Tachycardia induced cardiomyopathy 28.96 11.57 11 77767 114 32435634
Cardiac output decreased 28.78 11.57 21 77757 889 32434859
Atrial thrombosis 28.20 11.57 29 77749 1958 32433790
Depression 28.03 11.57 128 77650 96932 32338816
Long QT syndrome 27.98 11.57 33 77745 2598 32433150
Influenza like illness 27.96 11.57 15 77763 27125 32408623
Spontaneous haematoma 27.90 11.57 17 77761 530 32435218
Herpes zoster 27.72 11.57 22 77756 32319 32403429
Emotional distress 27.71 11.57 94 77684 16212 32419536
Intraocular haematoma 27.61 11.57 7 77771 14 32435734
Sinusitis 27.59 11.57 28 77750 36532 32399216
Dissociation 27.57 11.57 23 77755 1187 32434561
Colitis ulcerative 27.51 11.57 4 77774 17047 32418701
Hypersensitivity 27.33 11.57 61 77717 57697 32378051
Cerebral haemorrhage 27.29 11.57 159 77619 34588 32401160
Pain 27.26 11.57 302 77476 187254 32248494
Urine iodine increased 27.17 11.57 6 77772 4 32435744
Hyponatraemia 27.08 11.57 285 77493 74228 32361520
Nodal rhythm 26.91 11.57 25 77753 1490 32434258
Intentional product use issue 26.86 11.57 37 77741 42174 32393574
Blood creatinine increased 26.22 11.57 348 77430 95784 32339964
Pruritus 25.78 11.57 191 77587 128511 32307237
Back pain 25.63 11.57 158 77620 110895 32324853
Haemorrhage intracranial 25.61 11.57 90 77688 15797 32419951
Lymphoid tissue hyperplasia 25.52 11.57 9 77769 74 32435674
Foetal exposure during pregnancy 25.48 11.57 37 77741 41264 32394484
Gravitational oedema 25.46 11.57 17 77761 623 32435125
Hepatocellular injury 25.45 11.57 124 77654 25194 32410554
Platelet count decreased 25.44 11.57 165 77613 114426 32321322
Device pacing issue 25.37 11.57 7 77771 22 32435726
Ischaemic stroke 25.32 11.57 96 77682 17480 32418268
Urinary tract infection 25.32 11.57 102 77676 79969 32355779
Infusion related reaction 25.16 11.57 44 77734 45555 32390193
Cardiac murmur 24.98 11.57 54 77724 7137 32428611
Optic ischaemic neuropathy 24.95 11.57 28 77750 2089 32433659
Prothrombin time prolonged 24.93 11.57 65 77713 9690 32426058
Haemodynamic instability 24.91 11.57 61 77717 8750 32426998
Epistaxis 24.89 11.57 223 77555 55632 32380116
Neonatal pneumonia 24.72 11.57 10 77768 124 32435624
Heparin-induced thrombocytopenia 24.72 11.57 47 77731 5667 32430081
Pancreatitis 24.72 11.57 33 77745 38118 32397630
Lymphocyte count decreased 24.33 11.57 10 77768 21109 32414639
Xyphoid retraction 24.29 11.57 11 77767 183 32435565
Nephrolithiasis 24.22 11.57 18 77760 27336 32408412
Joint swelling 24.18 11.57 55 77723 51680 32384068
Left ventricular dysfunction 24.17 11.57 64 77714 9631 32426117
Hypertransaminasaemia 24.13 11.57 39 77739 4135 32431613
Antiacetylcholine receptor antibody positive 24.05 11.57 8 77770 54 32435694
Intentional overdose 24.01 11.57 39 77739 41562 32394186
Mucosal inflammation 23.68 11.57 27 77751 33407 32402341
Acute pulmonary oedema 23.40 11.57 55 77723 7686 32428062
Blood pressure increased 23.30 11.57 104 77674 79250 32356498
Migraine 23.23 11.57 3 77775 13982 32421766
Drug resistance 23.21 11.57 13 77765 22952 32412796
Diaphragmatic paralysis 23.02 11.57 15 77763 527 32435221
Cardiac ventricular disorder 23.02 11.57 12 77766 275 32435473
Toxic goitre 22.85 11.57 5 77773 3 32435745
Neonatal hypotension 22.72 11.57 10 77768 155 32435593
Hepatotoxicity 22.60 11.57 99 77679 19238 32416510
Arteriosclerotic gangrene 22.15 11.57 8 77770 71 32435677
Periorbital haemorrhage 22.15 11.57 9 77769 113 32435635
Irritability 22.12 11.57 16 77762 24638 32411110
Puncture site haematoma 22.10 11.57 10 77768 166 32435582
Therapeutic product effect decreased 22.02 11.57 25 77753 30992 32404756
Cardiorenal syndrome 22.01 11.57 17 77761 785 32434963
Diabetes mellitus 21.96 11.57 47 77731 45126 32390622
Respiratory distress 21.92 11.57 152 77626 35094 32400654
Glomerular filtration rate decreased 21.89 11.57 74 77704 12737 32423011
Iodine uptake abnormal 21.74 11.57 5 77773 5 32435743
Intentional product misuse 21.56 11.57 33 77745 36018 32399730
Femoral artery aneurysm 21.42 11.57 10 77768 179 32435569
Hospitalisation 21.35 11.57 54 77724 48917 32386831
Rales 20.99 11.57 53 77725 7748 32428000
Blood pressure fluctuation 20.93 11.57 11 77767 20124 32415624
Neuropathy peripheral 20.77 11.57 104 77674 76878 32358870
Device inappropriate shock delivery 20.71 11.57 7 77771 50 32435698
Depressed mood 20.55 11.57 9 77769 18291 32417457
Presyncope 20.55 11.57 89 77689 17212 32418536
Acute hepatic failure 20.50 11.57 73 77705 12896 32422852
Gastrointestinal angiodysplasia 20.49 11.57 15 77763 638 32435110
Vomiting 20.19 11.57 420 77358 235137 32200611
Fall 20.17 11.57 613 77165 195588 32240160
Thyroid function test abnormal 20.15 11.57 15 77763 655 32435093
Hepatitis C 19.98 11.57 4 77774 13514 32422234
Lupus pneumonitis 19.81 11.57 7 77771 58 32435690
Cardio-respiratory arrest 19.79 11.57 213 77565 55776 32379972
Conjunctival haemorrhage 19.77 11.57 29 77749 2826 32432922
Plasma cell myeloma 19.76 11.57 71 77707 57543 32378205
Sinoatrial block 19.67 11.57 13 77765 468 32435280
Ilium fracture 19.58 11.57 8 77770 102 32435646
Subarachnoid haemorrhage 19.46 11.57 62 77716 10349 32425399
Sedation 19.44 11.57 10 77768 18516 32417232
Bundle branch block 19.39 11.57 17 77761 939 32434809
Papilloedema 19.37 11.57 27 77751 2511 32433237
Thyrotoxic periodic paralysis 19.30 11.57 7 77771 63 32435685
Withdrawal syndrome 19.20 11.57 3 77775 12119 32423629
Thyroiditis acute 18.97 11.57 8 77770 111 32435637
Dyspnoea at rest 18.89 11.57 31 77747 3328 32432420
Ischaemic cardiomyopathy 18.68 11.57 45 77733 6389 32429359
Hyperglycaemia 18.61 11.57 40 77738 38351 32397397
Haemothorax 18.57 11.57 33 77745 3779 32431969
Oesophageal infection 18.36 11.57 10 77768 251 32435497
Influenza 18.36 11.57 53 77725 45961 32389787
Systemic inflammatory response syndrome 18.35 11.57 46 77732 6694 32429054
Musculoskeletal pain 18.31 11.57 30 77748 31867 32403881
Pulmonary oedema 18.25 11.57 180 77598 46087 32389661
Normocytic anaemia 18.14 11.57 24 77754 2123 32433625
Product use issue 18.12 11.57 65 77713 52712 32383036
Mediastinal haemorrhage 18.10 11.57 6 77772 40 32435708
Rhinorrhoea 18.04 11.57 17 77761 22969 32412779
Orthostatic hypotension 18.00 11.57 114 77664 25536 32410212
Iodine overload 17.92 11.57 4 77774 3 32435745
Pseudolymphoma 17.88 11.57 13 77765 547 32435201
Anaemia macrocytic 17.86 11.57 27 77751 2703 32433045
Electrocardiogram QRS complex prolonged 17.82 11.57 36 77742 4538 32431210
Osteonecrosis of jaw 17.77 11.57 12 77766 19154 32416594
Aerophagia 17.73 11.57 6 77772 43 32435705
Toxicity to various agents 17.69 11.57 554 77224 177487 32258261
Supine hypertension 17.58 11.57 11 77767 360 32435388
Ejection fraction abnormal 17.54 11.57 16 77762 931 32434817
Neuroleptic malignant syndrome 17.54 11.57 10 77768 17485 32418263
Heart transplant 17.48 11.57 15 77763 805 32434943
Decreased appetite 17.46 11.57 275 77503 160538 32275210
Osteonecrosis 17.40 11.57 9 77769 16613 32419135
Secondary hyperthyroidism 17.39 11.57 4 77774 4 32435744
Tri-iodothyronine increased 17.38 11.57 6 77772 46 32435702
Bone pain 17.23 11.57 14 77764 20330 32415418
Heart rate abnormal 17.18 11.57 21 77757 1716 32434032
Anuria 17.13 11.57 61 77717 10776 32424972
Unevaluable event 17.02 11.57 138 77640 33448 32402300
Psoriatic arthropathy 16.81 11.57 11 77767 17849 32417899
Coma uraemic 16.74 11.57 6 77772 52 32435696
Alopecia 16.66 11.57 15 77763 20715 32415033
Upper respiratory tract infection 16.66 11.57 28 77750 29445 32406303
Exercise tolerance decreased 16.57 11.57 35 77743 4553 32431195
Scrotal haematocoele 16.46 11.57 5 77773 24 32435724
Graft versus host disease 16.39 11.57 3 77775 10803 32424945
Erectile dysfunction 16.37 11.57 14 77764 19825 32415923
Lung infiltration 16.17 11.57 68 77710 12980 32422768
Myelosuppression 16.16 11.57 4 77774 11672 32424076
Haemorrhage 16.06 11.57 185 77593 49263 32386485
Abnormal behaviour 16.04 11.57 24 77754 26442 32409306
Abdominal discomfort 16.03 11.57 68 77710 52556 32383192
Cardiac arrest neonatal 15.97 11.57 5 77773 27 32435721
Optic nerve infarction 15.97 11.57 5 77773 27 32435721
Ecchymosis 15.94 11.57 44 77734 6784 32428964
Colitis 15.94 11.57 36 77742 33915 32401833
Cholestasis 15.89 11.57 115 77663 26918 32408830
Angioedema 15.83 11.57 40 77738 36249 32399499
Oropharyngeal pain 15.76 11.57 32 77746 31320 32404428
Ischaemic hepatitis 15.75 11.57 20 77758 1699 32434049
Muscle haemorrhage 15.68 11.57 31 77747 3848 32431900
Ventricular flutter 15.56 11.57 6 77772 65 32435683
Amaurosis 15.50 11.57 13 77765 676 32435072
Infection 15.42 11.57 129 77649 84586 32351162
Deposit eye 15.39 11.57 5 77773 31 32435717
Product quality issue 15.36 11.57 14 77764 19219 32416529
Blood thyroid stimulating hormone decreased 15.35 11.57 21 77757 1919 32433829
Hirsutism 15.32 11.57 8 77770 184 32435564
Thyroxine decreased 15.32 11.57 7 77771 119 32435629
Bone marrow failure 15.31 11.57 31 77747 30373 32405375
Oedema peripheral 15.28 11.57 369 77409 113722 32322026
Hepatic cirrhosis 15.25 11.57 80 77698 16729 32419019
Cognitive disorder 15.20 11.57 24 77754 25870 32409878
Accidental exposure to product 15.19 11.57 4 77774 11198 32424550
Bone marrow granuloma 15.11 11.57 3 77775 0 32435748
Tumour lysis syndrome 15.04 11.57 8 77770 14539 32421209
Anaphylactic reaction 14.99 11.57 31 77747 30141 32405607
Abdominal pain upper 14.91 11.57 97 77681 67241 32368507
Oesophageal achalasia 14.84 11.57 10 77768 372 32435376
Coronary artery disease 14.83 11.57 183 77595 49523 32386225
Dyspepsia 14.76 11.57 36 77742 33019 32402729
Vascular purpura 14.70 11.57 19 77759 1643 32434105
Cardiac disorder 14.67 11.57 159 77619 41707 32394041
Pemphigoid 14.65 11.57 49 77729 8387 32427361
Cardiothoracic ratio increased 14.64 11.57 4 77774 12 32435736
Proteinuria 14.63 11.57 12 77766 17343 32418405
Swelling 14.55 11.57 45 77733 38177 32397571
Fasting 14.40 11.57 4 77774 13 32435735
Paranoia 14.38 11.57 4 77774 10795 32424953
Electrocardiogram PR prolongation 14.33 11.57 13 77765 751 32434997
Tri-iodothyronine decreased 14.30 11.57 5 77773 40 32435708
Acute lung injury 14.18 11.57 17 77761 1361 32434387
Lymphadenopathy 14.16 11.57 27 77751 27055 32408693
Injection site reaction 14.12 11.57 5 77773 11564 32424184
Acute interstitial pneumonitis 14.09 11.57 10 77768 405 32435343
Arthropathy 14.02 11.57 20 77758 22469 32413279
Supraventricular extrasystoles 13.96 11.57 27 77751 3298 32432450
Pulseless electrical activity 13.92 11.57 42 77736 6808 32428940
Injection site erythema 13.85 11.57 9 77769 14659 32421089
Loss of personal independence in daily activities 13.82 11.57 27 77751 26806 32408942
Neoplasm progression 13.78 11.57 16 77762 19642 32416106
Hypophonesis 13.75 11.57 4 77774 16 32435732
Myxoedema 13.75 11.57 4 77774 16 32435732
Orthostatic hypertension 13.74 11.57 8 77770 229 32435519
Prothrombin time shortened 13.73 11.57 18 77760 1578 32434170
Failure to suspend medication 13.72 11.57 9 77769 320 32435428
Progressive multifocal leukoencephalopathy 13.72 11.57 3 77775 9528 32426220
Osteoporosis 13.66 11.57 6 77772 12176 32423572
Chronotropic incompetence 13.56 11.57 4 77774 17 32435731
Dry mouth 13.55 11.57 23 77755 24096 32411652
Spinal cord haemorrhage 13.55 11.57 9 77769 327 32435421
C-reactive protein increased 13.54 11.57 64 77714 48038 32387710
Cellulitis 13.46 11.57 68 77710 50162 32385586
Eosinophilia 13.44 11.57 104 77674 24854 32410894
Haemorrhagic stroke 13.43 11.57 40 77738 6438 32429310
Tri-iodothyronine free decreased 13.41 11.57 5 77773 49 32435699
Type 2 diabetes mellitus 13.41 11.57 10 77768 15162 32420586
Non-alcoholic steatohepatitis 13.36 11.57 13 77765 821 32434927
Diabetic ketoacidosis 13.23 11.57 14 77764 17918 32417830
Myopathy 13.21 11.57 58 77720 11283 32424465
Fascial rupture 13.20 11.57 4 77774 19 32435729
Cardiomegaly 13.18 11.57 71 77707 15000 32420748
Thyroxine free decreased 13.17 11.57 8 77770 248 32435500
Amnesia 13.06 11.57 25 77753 25011 32410737
Subdural haematoma evacuation 13.03 11.57 4 77774 20 32435728
Tooth disorder 12.98 11.57 4 77774 10103 32425645
Pulmonary vascular resistance abnormality 12.98 11.57 5 77773 54 32435694
Toxic nodular goitre 12.87 11.57 4 77774 21 32435727
Linear IgA disease 12.78 11.57 18 77760 1690 32434058
Viral infection 12.77 11.57 12 77766 16238 32419510
Acidosis 12.72 11.57 5 77773 10841 32424907
Extravasation 12.70 11.57 19 77759 1884 32433864
Psychomotor hyperactivity 12.70 11.57 3 77775 9036 32426712
Traumatic haemothorax 12.70 11.57 8 77770 265 32435483
Basal cell carcinoma 12.64 11.57 14 77764 17554 32418194
Cardiac dysfunction 12.64 11.57 19 77759 1892 32433856
Erythema multiforme 12.60 11.57 3 77775 8989 32426759
Systemic-pulmonary artery shunt 12.58 11.57 3 77775 4 32435744
Pericarditis fungal 12.56 11.57 7 77771 184 32435564
Epilepsy 12.50 11.57 21 77757 22088 32413660
Ascites 12.44 11.57 149 77629 40042 32395706
Bundle branch block right 12.44 11.57 43 77735 7485 32428263
Myoglobin urine present 12.39 11.57 7 77771 189 32435559
Iron deficiency anaemia 12.37 11.57 51 77727 9650 32426098
Drug intolerance 12.36 11.57 70 77708 50165 32385583
Therapeutic drug monitoring analysis not performed 12.31 11.57 10 77768 497 32435251
Cardioactive drug level above therapeutic 12.29 11.57 5 77773 63 32435685
Bradyarrhythmia 12.28 11.57 20 77758 2134 32433614
Vascular pseudoaneurysm 12.28 11.57 20 77758 2134 32433614
Hypersensitivity pneumonitis 12.27 11.57 16 77762 1395 32434353
Dry skin 12.12 11.57 26 77752 24952 32410796
Prostate cancer 12.12 11.57 30 77748 27376 32408372
Somnolence 12.11 11.57 175 77603 103622 32332126
Abdominal pain 12.09 11.57 269 77509 149260 32286488
Nephroangiosclerosis 12.07 11.57 7 77771 199 32435549
Electrocardiogram low voltage 12.03 11.57 4 77774 27 32435721
Sinus arrhythmia 12.00 11.57 12 77766 784 32434964
Posterior reversible encephalopathy syndrome 11.93 11.57 4 77774 9572 32426176
Serotonin syndrome 11.91 11.57 17 77761 19100 32416648
Alveolitis necrotising 11.90 11.57 4 77774 28 32435720
Adrenal haematoma 11.82 11.57 5 77773 70 32435678
Pathogen resistance 11.80 11.57 4 77774 9506 32426242
Cardiomyopathy 11.75 11.57 72 77706 15941 32419807
Oedema 11.70 11.57 162 77616 44985 32390763
Oedema genital 11.66 11.57 9 77769 415 32435333
Mitral valve incompetence 11.64 11.57 68 77710 14803 32420945
Hepatocellular carcinoma 11.61 11.57 5 77773 10265 32425483
Eosinophilic pneumonia 11.57 11.57 24 77754 3082 32432666
Heparin-induced thrombocytopenia test 11.57 11.57 6 77772 136 32435612

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
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
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
B2 bradykinin receptor GPCR Ki 5.12 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
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
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 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 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
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