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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Delirium19.13.02.001--
Delusion19.10.01.001--
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Disorientation17.02.05.015; 19.13.01.002--Not Available
Disturbance in attention17.03.03.001; 19.21.02.002--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Dysarthria17.02.08.001; 19.19.03.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyskinesia17.01.02.006--
Dyspnoea02.01.03.002; 22.02.01.004--
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002--Not Available
Electroencephalogram abnormal13.07.03.001--Not Available
Eosinophilia01.02.04.001--
Epididymitis11.01.19.005; 21.09.02.001--Not Available
Erythema multiforme10.01.03.015; 23.03.01.003--
Extrapyramidal disorder17.01.02.007--
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fatigue08.01.01.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gait disturbance08.01.02.002; 17.02.05.016--
Granuloma08.01.05.001; 23.03.15.001--Not Available
Haemolytic anaemia01.06.03.002--Not Available
Haemoptysis02.01.02.006; 22.02.03.004; 24.07.01.006--Not Available
Hallucination19.10.02.002--
Headache17.14.01.001--
Heart disease congenital02.01.01.009; 03.07.07.001--Not Available
Hepatic function abnormal09.01.02.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatitis cholestatic09.01.01.002--Not Available
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