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)
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.008278%
Drug interaction08.06.03.0010.006956%Not Available
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.015185%
Dyspnoea02.11.05.003; 22.02.01.0040.018173%
Dyspnoea exertional22.02.01.005; 02.11.05.0050.000490%Not Available
Eczema23.03.04.006--
Electrocardiogram QT prolonged13.14.05.004--
Epistaxis24.07.01.005; 22.04.03.0010.000735%
Erythema23.03.06.001--Not Available
Fatigue08.01.01.0020.008915%
Gastrointestinal disorder07.11.01.0010.002988%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.002939%Not Available
Gastrointestinal pain07.01.05.005--
Hepatic failure09.01.03.0020.001225%
Hepatitis09.01.07.0040.000490%Not Available
Hepatitis acute09.01.07.0050.000490%Not Available
Hepatocellular injury09.01.07.0080.001323%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.001323%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.000490%Not Available
Hyperhidrosis08.01.03.028; 23.02.03.0040.000980%
Hyperkalaemia14.05.03.0010.000490%
Hypersensitivity10.01.03.0030.002988%
Hypersensitivity vasculitis24.12.04.013; 23.06.02.005; 10.02.02.017; 01.01.04.008--Not Available
Hypertension24.08.02.0010.001225%
Hyperthyroidism14.11.01.011; 05.02.02.0010.002449%
Hypoaesthesia23.03.03.081; 17.02.06.0230.000980%Not Available
Hypokalaemia14.05.03.002--
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