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 The FDA approved indications for amiodarone are recurrent ventricular fibrillation (VF) and recurrent hemodynamically unstable ventricular tachycardia (VT). The FDA emphasizes that this drug should only be given in these conditions when they are clinically documented and have not responded to normal therapeutic doses of other antiarrhythmic agents, or when other drugs are not tolerated by the patient.[L3561] Off-label indications include atrial fibrillation and supraventricular tachycardia.[A189666,A189720,A189723,L11286]
Marketing Status approved; investigational
ATC Code C01BD01
DrugBank ID DB01118
KEGG ID D00636
MeSH ID D000638
PubChem ID 441325
TTD Drug ID D0L5WM
NDC Product Code 66039-111; 42494-308; 43066-150; 0245-0145; 55154-8185; 63629-2001; 63739-051; 65841-841; 0404-9815; 70934-280; 14593-947; 25021-302; 0245-0147; 52584-153; 65862-732; 72888-039; 42494-307; 42494-309; 50268-097; 51662-1358; 51862-240; 63629-2076; 70518-3439; 72078-046; 70518-1939; 72888-061; 65085-0022; 51672-4025; 51672-4055; 51672-4056; 55150-180; 60687-437; 63323-616; 67457-153; 70518-2792; 71335-0881; 71335-1985; 71872-7163; 43066-360; 0245-1645; 68382-298; 71872-7034; 0904-6993; 49632-080; 51672-4057; 51862-242; 55150-181; 68083-112; 71872-7149; 0615-8258; 72888-060; 14335-270; 42419-017; 16714-845; 50090-5766; 55150-182; 65841-631; 65841-840; 71872-7000; 17337-0403; 50090-5062; 0245-0144; 55154-3365; 68382-227; 70518-3246; 29300-359; 51862-241; 68382-297; 0143-9875; 51662-1205
UNII 976728SY6Z
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
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Delusion19.10.01.001--
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Disorientation17.02.05.015; 19.13.01.002---
Disturbance in attention17.03.03.001; 19.21.02.002--
Dizziness02.11.04.006; 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--
Dyspnoea02.11.05.003; 22.02.01.004--
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002---
Electroencephalogram abnormal13.07.03.001---
Eosinophilia01.02.04.001--
Epididymitis11.01.19.005; 21.09.02.001---
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; 15.03.05.013; 17.02.05.016--
Granuloma08.01.05.001; 23.03.15.001---
Haemolytic anaemia01.06.03.002---
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.006---
Hallucination19.10.04.003--
Headache17.14.01.001--
Heart disease congenital02.11.01.014; 03.07.07.001---
Hepatic function abnormal09.01.02.001---
Hepatitis09.01.07.004---
Hepatitis cholestatic09.01.01.002---
Hyperpyrexia08.05.02.002---
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