Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amiodarone
Drug ID BADD_D00115
Description Amiodarone is a benzofuran derivative, anti-arrhythmic drug used commonly in a variety of settings.[A36817] Most known for its approved indication in life-threatening ventricular arrhythmias, it is also used off-label in the outpatient and inpatient setting for atrial fibrillation. Because of its ability to cause serious toxicity and possibly death, amiodarone use should be reserved for its approved indications, according to prescribing information.[L3561,L11265,L11286]
Indications and Usage Intravenously, for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Orally, for the treatment of life-threatening recurrent ventricular arrhythmias such as recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia.
Marketing Status Prescription; Discontinued
ATC Code C01BD01
DrugBank ID DB01118
KEGG ID D02910
MeSH ID D000638
PubChem ID 2157
NDC Product Code Not Available
Synonyms Amiodarone | Amiodarona | Amiodarone Hydrochloride | Hydrochloride, Amiodarone | Amiohexal | Aratac | Tachydaron | Corbionax | Cordarone | Amiodarex | Trangorex | Kordaron | Cordarex | L-3428 | L 3428 | L3428 | Ortacrone | Rytmarone | SKF 33134-A | SKF 33134 A | SKF 33134A | Amiobeta | Braxan
Chemical Information
Molecular Formula C25H29I2NO3
CAS Registry Number 1951-25-3
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HaemorrhageCytochrome P450 2C9P11712T19244806430; 5458032; 1109248
HypotensionCytochrome P450 3A4P08684T378488805725; 8805726; 7489857; 8614120
Liver injuryAlanine aminotransferase 1Q8QZR5Not Available25900201
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
RhabdomyolysisCytochrome P450 3A4P08684T378488805725; 8805726; 7489857; 8614120
Sudden cardiac deathPotassium voltage-gated channel subfamily H member 2Q12809T202519927398; 10810773; 10082151; 10408028
Sudden cardiac deathPotassium voltage-gated channel subfamily KQT member 1P51787T495269927398; 10810773; 10082151; 10408028
Sudden cardiac deathSodium channel protein type 5 subunit alphaQ14524T397169927398; 10810773; 10082151; 10408028
Sudden cardiac deathPotassium voltage-gated channel subfamily E member 1P15382Not Available9927398; 10810773; 10082151; 10408028
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams17.15.02.001; Available
Abortion spontaneous18.01.04.001--Not Available
Activated partial thromboplastin time prolonged13.01.02.0010.000893%
Acute febrile neutrophilic dermatosis23.03.03.033; Available
Acute hepatic failure09.01.03.0010.000543%Not Available
Acute pulmonary oedema22.01.03.005; Available
Acute respiratory distress syndrome22.01.03.0010.001553%
Acute respiratory failure22.02.06.001; Available
Ageusia17.02.07.001; Available
Agranulocytosis01.02.03.001--Not Available
Akinesia17.01.02.003--Not Available
Alanine aminotransferase increased13.03.01.0030.001488%
Altered state of consciousness19.07.01.003; Available
Alveolitis22.01.01.001--Not Available
Alveolitis allergic22.01.01.002; Available
Anaemia macrocytic01.03.02.002; Available
Anaphylactic reaction24.06.03.006;
Anaphylactic shock24.06.02.004; Available
Anaphylactoid reaction24.06.03.007; Available
Angina pectoris24.04.04.002;
Angioedema10.01.05.009; Available
Aplastic anaemia01.03.03.002--Not Available
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