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)
Abdominal pain07.01.05.002--
Accommodation disorder06.02.04.001--Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.001--
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Akinesia17.01.02.003--Not Available
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001--Not Available
Anxiety19.06.02.002--
Aplastic anaemia01.03.03.002--Not Available
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Atrioventricular block02.03.01.002--Not Available
Bradycardia02.03.02.002--Not Available
Bradykinesia17.01.02.004--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Cardiac failure congestive02.05.01.002--Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Cirrhosis alcoholic09.01.04.005--Not Available
Coagulopathy01.01.02.001--Not Available
Coma17.02.09.001--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Coordination abnormal17.02.02.004--Not Available
Cough22.02.03.001--
Death08.04.01.001--
Delirium19.13.02.001--
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