Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dronedarone
Drug ID BADD_D00730
Description Dronedarone is a Class III antiarrhythmic drug that works to restore the normal sinus rhythm in patients with paroxysmal or persistent atrial fibrillation. Atrial fibrillation is a common sustained arrhythmia where the treatment primarily focuses on stroke prevention and symptom management. It is managed by rate control, rhythm control, prevention of thromboembolic events, and treatment of the underlying disease.[A34604] Similar to [amiodarone], dronedarone is a multichannel blocker that works to control rhythm and rate in atrial fibrillation.[A186071] It meets criteria of all four Vaughan Williams antiarrhythmic drug classes by blocking sodium, potassium, and calcium ion channels and inhibiting β-adrenergic receptors.[A34604,L8699] Dronedarone is a related benzofuran compound to amiodarone but its chemical structure lacks iodine moieties which are associated with amiodarone-induced thyroid problems.[A34604,T28] Additionally, the methyl sulfonyl group in its structure renders dronedarone to be more lipophilic with a shorter half-life than amiodarone.[A34604] This ultimately leads to reduced tissue accumulation of the drug and decreased risk for organ toxicities, such as thyroid and pulmonary toxicities.[T28] Commonly marketed as Multaq®, dronedarone was approved by the FDA in July 2009 and Health Canada in August 2009. A safety concern for the risk of drug-induced hepatocellular injury has been issued following marketing of dronedarone.[L8800]
Indications and Usage Management of paroxysmal or persistent atrial fibrillation via restoration of normal sinus rhythm.
Marketing Status Prescription
ATC Code C01BD07
DrugBank ID DB04855
KEGG ID D02537
MeSH ID D000077764
PubChem ID 208898
TTD Drug ID D05CPV
NDC Product Code 53360-4142; 55154-8104; 0024-4142
Synonyms Dronedarone | Multaq | SR 33589B | SR 33589
Chemical Information
Molecular Formula C31H44N2O5S
CAS Registry Number 141626-36-0
SMILES CCCCC1=C(C2=C(O1)C=CC(=C2)NS(=O)(=O)C)C(=O)C3=CC=C(C=C3)OCCCN(CCCC)CCCC
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Thyroid function test abnormal13.10.06.0010.002245%Not Available
Torsade de pointes02.03.04.0050.001171%Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.0010.004490%
Tremor17.01.06.0020.004490%
Upper respiratory tract infection22.07.03.011; 11.01.13.0090.002245%
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.05.02.001; 10.02.02.006--
Ventricular extrasystoles02.03.04.0070.003368%Not Available
Ventricular tachycardia02.03.04.0100.004490%
Vision blurred17.17.01.010; 06.02.06.0070.003368%
Visual impairment06.02.06.0080.006735%Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.0050.008980%
Weight increased13.15.01.006--
White blood cell count increased13.01.06.0130.002245%Not Available
Ejection fraction decreased13.14.02.0030.002245%
Pruritus generalised23.03.12.0030.002245%Not Available
Affect lability19.04.01.0010.002245%Not Available
Transaminases increased13.03.01.0150.003368%Not Available
Haemorrhage24.07.01.002--Not Available
Dermatitis psoriasiform23.03.14.0040.002245%Not Available
Angiopathy24.03.02.007--Not Available
Blood alkaline phosphatase increased13.04.02.0040.003368%
Hepatic enzyme increased13.03.01.0190.011225%Not Available
Cardiac disorder02.01.01.003--Not Available
Mediastinal disorder22.09.03.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Cardiac fibrillation02.03.02.0210.002245%Not Available
Drug intolerance08.06.01.013--Not Available
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