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)
Abdominal pain07.01.05.002--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Acute febrile neutrophilic dermatosis01.02.01.006; 23.03.03.0330.000337%Not Available
Acute hepatic failure09.01.03.0010.000875%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000337%Not Available
Acute respiratory distress syndrome22.01.03.001; 24.03.02.034; 10.02.01.0670.002114%
Acute respiratory failure22.02.06.001; 14.01.04.0040.001077%Not Available
Ageusia17.02.07.001; 07.14.03.0030.000202%Not Available
Agitation17.02.05.012; 19.06.02.001--
Agranulocytosis01.02.03.001--Not Available
Akinesia17.01.02.003--Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Alveolitis22.01.01.001--Not Available
Amnesia17.03.02.001; 19.20.01.0010.000808%
Anaemia01.03.02.0010.001953%
Anaemia macrocytic01.03.02.002; 14.12.01.0020.000202%Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.0010.000404%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angina pectoris02.02.02.002; 24.04.04.0020.000202%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.0020.002289%
Aortic stenosis24.04.01.0010.000135%Not Available
Aplastic anaemia01.03.03.002--Not Available
Apnoea22.02.01.0010.000135%
Arrhythmia02.03.02.0010.001104%Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000404%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.018302%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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