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 Dronedarone is indicated for the management of atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF to reduce the risk of hospitalization.[L8699]
Marketing Status approved
ATC Code C01BD07
DrugBank ID DB04855
KEGG ID D02537
MeSH ID D000077764
PubChem ID 208898
TTD Drug ID D05CPV
NDC Product Code 53360-4142; 0024-4142; 55154-8104
UNII JQZ1L091Y2
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
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)
Proteinuria20.02.01.0110.001078%
Pruritus23.03.12.001--
Pulmonary congestion02.05.02.002; 22.01.03.002; 24.03.08.0010.000735%-
Pulmonary fibrosis22.01.02.0060.004409%
Pulmonary hypertension22.06.01.001; 24.08.03.0020.000490%
Pulmonary oedema02.05.02.003; 22.01.03.0030.001470%
Rash23.03.13.001---
Rash erythematous23.03.13.0290.000490%-
Rash macular23.03.13.003---
Rash maculo-papular23.03.13.004--
Rash pruritic23.03.13.0300.001078%-
Rash vesicular23.03.13.0090.001078%-
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000735%
Renal disorder20.01.02.0020.001910%-
Renal failure20.01.03.0050.003919%-
Respiratory disorder22.02.07.0020.000735%-
Respiratory distress22.02.01.0120.000980%-
Respiratory failure14.01.04.003; 22.02.06.0020.001225%
Retinal vein thrombosis06.10.01.003; 24.01.07.0020.000490%-
Sarcoma15.09.03.002; 16.33.01.0020.000490%-
Sinoatrial block02.03.01.0100.000490%-
Sinus arrest02.03.03.0070.000490%-
Sinus arrhythmia02.03.03.0080.001078%-
Sinus bradycardia02.03.03.0090.000490%
Skin disorder23.03.03.0070.000490%-
Skin exfoliation23.03.07.0030.000490%-
Sleep disorder19.02.04.0010.000980%-
Supraventricular tachycardia02.03.03.0120.000490%
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.000735%
Tachycardia02.03.02.0070.002400%-
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