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
TTD Drug ID D0L5WM
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
SMILES CCCCC1=C(C2=CC=CC=C2O1)C(=O)C3=CC(=C(C(=C3)I)OCCN(CC)CC)I
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 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
Sudden cardiac deathPotassium voltage-gated channel subfamily H member 2Q12809T202519927398; 10810773; 10082151; 10408028
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Apnoea22.02.01.0010.000595%
Arrhythmia02.03.02.0010.002976%Not Available
Arthralgia15.01.02.001--
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.001191%
Aspartate aminotransferase increased13.03.01.0060.001191%
Asthenia08.01.01.0010.058930%Not Available
Asthma22.03.01.002; 10.01.03.0100.000893%Not Available
Ataxia17.02.02.001; 08.01.02.0040.002083%
Atrial fibrillation02.03.03.0020.009226%
Atrial flutter02.03.03.0030.002679%
Atrial tachycardia02.03.03.0040.001488%
Atrioventricular block02.03.01.0020.001191%Not Available
Atrioventricular block complete02.03.01.0030.001786%
Atrioventricular block first degree02.03.01.0040.000595%
Atrioventricular block second degree02.03.01.0050.000595%
Atypical pneumonia22.07.01.010; 11.01.09.0120.000595%Not Available
Azotaemia20.01.01.0010.000595%Not Available
Back pain15.03.04.005--
Basedow's disease10.04.08.004; 06.09.04.003; 05.02.02.0030.001488%Not Available
Benign intracranial hypertension17.07.02.001--Not Available
Blindness17.17.01.003; 06.02.02.0010.012578%Not Available
Blindness unilateral17.17.01.016; 06.02.02.0090.001488%Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.0040.001786%
Blood glucose increased13.02.02.002--Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Blood thyroid stimulating hormone decreased13.10.03.0110.000893%Not Available
Blood thyroid stimulating hormone increased13.10.03.0060.001786%
Body temperature increased13.15.01.001--Not Available
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