Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amiodarone hydrochloride
Drug ID BADD_D00116
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 D00636
MeSH ID D000638
PubChem ID 441325
TTD Drug ID D0L5WM
NDC Product Code 71335-0881; 70518-1939; 72888-061; 51672-4056; 51662-1358; 68382-227; 0143-9875; 43066-360; 49632-080; 68083-112; 51672-4057; 71335-1297; 55150-181; 29300-359; 63629-7300; 55154-3365; 43066-150; 42494-309; 25021-302; 0904-6993; 65085-0022; 63629-2001; 0904-6556; 0245-1645; 70518-3246; 72888-039; 63739-051; 50090-3015; 72888-060; 17337-0403; 70518-2792; 66039-111; 70518-1231; 52584-153; 67457-153; 71335-1942; 50090-5766; 51862-240; 71872-7149; 71872-7000; 63629-2076; 50268-097; 16714-843; 14335-270; 0404-9815; 42494-308; 50090-5062; 55150-182; 16714-844; 0615-8258; 42494-307; 51862-241; 71872-7034; 55150-180; 51862-242; 50090-3496; 60687-437; 16714-845; 71872-7163; 71335-1985; 51672-4055; 63323-616; 0245-0145; 55154-8185; 0245-0144; 65841-631; 52584-063; 51672-4025; 42419-017; 0185-0144; 0245-0147; 70934-280; 51662-1205; 67544-570; 65862-732
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 C25H30ClI2NO3
CAS Registry Number 19774-82-4
SMILES CCCCC1=C(C2=CC=CC=C2O1)C(=O)C3=CC(=C(C(=C3)I)OCCN(CC)CC)I.Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HaemorrhageCytochrome P450 2C9P11712T19244Not Available
HypotensionCytochrome P450 3A4P08684T37848Not Available
Liver injuryAlanine aminotransferase 1Q8QZR5Not AvailableNot Available
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
RhabdomyolysisCytochrome P450 3A4P08684T37848Not Available
Sudden cardiac deathPotassium voltage-gated channel subfamily H member 2Q12809T20251Not Available
Sudden cardiac deathPotassium voltage-gated channel subfamily KQT member 1P51787T49526Not Available
Sudden cardiac deathSodium channel protein type 5 subunit alphaQ14524T39716Not Available
Sudden cardiac deathPotassium voltage-gated channel subfamily E member 1P15382Not AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Accommodation disorder06.02.04.001--Not Available
Acute respiratory distress syndrome22.01.03.001--
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Akinesia17.01.02.003--Not Available
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Aplastic anaemia01.03.03.002--Not Available
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Atrioventricular block02.03.01.002--Not Available
Benign intracranial hypertension17.07.02.001--Not Available
Bradycardia02.03.02.002--Not Available
Bradykinesia17.01.02.004--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Cardiac failure congestive02.05.01.002--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cirrhosis alcoholic09.01.04.005--Not Available
Coagulopathy01.01.02.001--Not Available
Coma17.02.09.001--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Coordination abnormal17.02.02.004--Not Available
Cough22.02.03.001--
Death08.04.01.001--
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