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 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 D02910
MeSH ID D000638
PubChem ID 2157
TTD Drug ID D0L5WM
NDC Product Code Not Available
UNII N3RQ532IUT
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
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)
Hypercalcaemia14.04.01.003; 05.04.01.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkeratosis23.01.01.001--
Hypersensitivity10.01.03.003--
Hypertensive crisis24.08.01.0010.000202%Not Available
Hyperthyroidism14.11.01.011; 05.02.02.0010.014316%
Hypervolaemia02.05.04.019; 14.05.06.003--Not Available
Hypokalaemia14.05.03.0020.000673%
Hypokinesia17.01.02.009--Not Available
Hyponatraemia14.05.04.0020.000970%
Hypotension24.06.03.0020.002761%
Hypothermia12.05.03.001; 08.05.01.0030.000269%
Hypothyroidism14.11.01.012; 05.02.03.0010.006855%
Hypoxia22.02.02.0030.001145%
Idiopathic pulmonary fibrosis22.01.02.014; 10.02.01.034--Not Available
Impaired healing08.03.02.0010.000202%Not Available
Increased tendency to bruise24.07.06.012; 23.06.01.009; 01.01.03.005--Not Available
Infection11.01.08.002--Not Available
Injection site erythema08.02.03.001; 23.03.06.015; 12.07.03.0010.000296%Not Available
Injection site extravasation12.07.03.002; 08.02.03.0020.001212%Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Injection site warmth12.07.03.036; 08.02.03.036--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.009279%Not Available
Irritability08.01.03.011; 19.04.02.0130.001481%
Ischaemic hepatitis24.04.07.004; 09.01.07.0180.000202%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Keratopathy06.06.03.0070.001468%Not Available
Left ventricular failure02.05.02.0010.000202%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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