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)
Gamma-glutamyltransferase increased13.03.01.0110.004490%
Gastrointestinal disorder07.11.01.0010.004490%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.012348%Not Available
Gastrointestinal pain07.01.05.005--
Glomerular filtration rate decreased13.13.01.0090.011225%Not Available
Headache17.14.01.001--
Heart rate decreased13.14.04.0010.003368%Not Available
Heart rate increased13.14.04.0020.002245%Not Available
Hepatic failure09.01.03.0020.001757%
Hepatitis09.01.07.0040.002245%Not Available
Hepatitis acute09.01.07.0050.002245%Not Available
Hepatocellular injury09.01.07.0080.003368%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.003368%Not Available
Hyperbilirubinaemia01.06.04.003; 14.11.01.010; 09.01.01.0030.002245%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.0280.004490%
Hypersensitivity10.01.03.0030.004490%
Hypersensitivity vasculitis24.05.02.012; 23.06.02.005; 01.01.04.008; 10.02.02.017--Not Available
Hypertension24.08.02.001--
Hyperthyroidism14.11.01.011; 05.02.02.0010.010103%
Hypoaesthesia17.02.06.0230.004490%Not Available
Hypokalaemia14.05.03.002--
Hypomagnesaemia14.04.02.001--
Hyponatraemia14.05.04.0020.002245%
Hypotension24.06.03.002--
Hypothyroidism14.11.01.012; 05.02.03.0010.002245%
Hypoxia22.02.02.0030.005613%
Immune system disorder10.02.01.001--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.010103%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.002245%Not Available
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