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)
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Wheezing22.03.01.0090.009225%
Yellow skin09.01.01.009; 08.01.03.046; 23.03.03.0420.000135%Not Available
Mental status changes19.07.01.0010.000700%Not Available
Weight fluctuation14.03.02.0020.001010%Not Available
Emotional distress19.04.02.008--Not Available
Food aversion19.09.03.002; 14.03.02.029--Not Available
Sudden cardiac death02.03.04.016; 08.04.01.0080.000135%Not Available
General physical health deterioration08.01.03.0180.001145%Not Available
Tachyarrhythmia02.03.02.0080.000269%Not Available
Left ventricular hypertrophy02.04.02.0140.000202%Not Available
Pneumomediastinum22.09.03.0040.000135%Not Available
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.000135%Not Available
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.0030.000135%Not Available
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.000135%Not Available
Foreign body sensation in eyes06.01.01.006--Not Available
Exercise tolerance decreased08.01.03.0360.000202%Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000135%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000471%Not Available
Lymphoid tissue hyperplasia01.09.01.0090.000875%Not Available
Haemodynamic instability24.03.02.0060.000633%Not Available
Ocular discomfort06.08.03.008--Not Available
Foetor hepaticus09.01.05.006; 07.01.06.026--Not Available
Eosinophilic pneumonia acute22.01.01.008; 01.02.04.0040.000135%Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000269%Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.000296%Not Available
Infusion site phlebitis24.12.03.002; 08.02.05.003; 12.07.05.0040.001818%Not Available
Haemorrhage24.07.01.0020.001481%Not Available
Pulmonary mass22.02.07.0040.000471%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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