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 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 D02910
MeSH ID D000638
PubChem ID 2157
TTD Drug ID D0L5WM
NDC Product Code Not Available
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HaemorrhageCytochrome P450 2C9P11712T19244806430; 5458032; 1109248
HypotensionCytochrome P450 3A4P08684T378488805725; 8805726; 7489857; 8614120
Liver injuryAlanine aminotransferase 1Q8QZR5Not Available25900201
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
RhabdomyolysisCytochrome P450 3A4P08684T378488805725; 8805726; 7489857; 8614120
Sudden cardiac deathPotassium voltage-gated channel subfamily KQT member 1P51787T495269927398; 10810773; 10082151; 10408028
Sudden cardiac deathSodium channel protein type 5 subunit alphaQ14524T397169927398; 10810773; 10082151; 10408028
Sudden cardiac deathPotassium voltage-gated channel subfamily E member 1P15382Not Available9927398; 10810773; 10082151; 10408028
Sudden cardiac deathPotassium voltage-gated channel subfamily H member 2Q12809T202519927398; 10810773; 10082151; 10408028
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Rales22.02.04.0040.001786%Not Available
Rash23.03.13.001--Not Available
Rash generalised23.03.13.002--Not Available
Rash macular23.03.13.0030.000595%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal disorder20.01.02.0020.004464%Not Available
Renal failure20.01.03.0050.001553%Not Available
Renal tubular necrosis20.01.07.0030.000595%Not Available
Respiratory acidosis22.02.02.004; 14.01.04.0020.000595%Not Available
Respiratory arrest22.02.01.0090.000543%Not Available
Respiratory disorder22.02.07.0020.000388%Not Available
Respiratory distress22.02.01.0120.001488%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.007531%
Respiratory paralysis22.02.06.003; 17.01.04.0100.000155%Not Available
Restlessness19.11.02.002; 17.02.05.0210.007143%
Rhabdomyolysis15.05.05.002--
Right ventricular failure02.05.03.0020.000893%Not Available
Salivary hypersecretion07.06.01.009--Not Available
Sarcoidosis10.02.06.0010.000595%Not Available
Seizure17.12.03.001--
Sensory disturbance17.02.07.0060.000595%Not Available
Sepsis11.01.11.003--
Septic shock11.01.11.004; 24.06.02.0110.000233%Not Available
Shock24.06.02.0020.001786%Not Available
Sinoatrial block02.03.01.010--Not Available
Sinus arrest02.03.03.007--Not Available
Sinus bradycardia02.03.03.0090.002976%
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Skin discolouration23.03.03.0050.001488%Not Available
Skin disorder23.03.03.007--Not Available
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