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)
Parosmia22.04.03.007; 17.04.04.002--Not Available
Photosensitivity reaction23.03.09.003--
Pleurisy22.05.01.001--Not Available
Pruritus23.03.12.001--
Pulmonary alveolar haemorrhage24.07.01.015; 22.01.02.005--Not Available
Pulmonary fibrosis22.01.02.006--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Respiratory arrest22.02.01.009--Not Available
Respiratory disorder22.02.07.002--Not Available
Respiratory distress22.02.01.012--Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Restlessness19.11.02.002; 17.02.05.021--
Rhabdomyolysis15.05.05.002--
Salivary hypersecretion07.06.01.009--Not Available
Seizure17.12.03.001--
Shock24.06.02.002--Not Available
Sinus arrest02.03.03.007--Not Available
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Skin discolouration23.03.03.005--Not Available
Solar dermatitis23.03.09.009--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tardive dyskinesia17.01.02.012--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thyroid neoplasm16.24.01.002; 05.02.05.002--Not Available
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