Dronedarone
Antiarrhythmics, Class Iii
Sold as MULTAQ
- Drug class
- Antiarrhythmics, Class Iii
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 22
Overview
Dronedarone is an active pharmaceutical ingredient in the Antiarrhythmics, Class Iii group (C01BD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 19 | May 15, 2026 |
| CA Canada | Health Canada | 2 | April 22, 2025 |
| EU European Union | EMA | 1 | October 28, 2025 |
GBUnited Kingdom· MHRA
19 products
Uses
Dronedarone Aristo is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). 4), Dronedarone Aristo should only be prescribed after alternative treatment options have been considered.
Dronedarone Aristo must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
How to take
CACanada· Health Canada
2 products
Uses
MULTAQ (dronedarone hydrochloride) is indicated for: • the treatment of patients with paroxysmal or persistent atrial fibrillation (AF) who are in sinus rhythm or who are intended to be cardioverted, to reduce the risk of cardiovascular hospitalization due to atrial fibrillation (see 14 CLINICAL TRIALS).
MULTAQ should only be prescribed after alternative treatment options have been considered. 1 Pediatrics • Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics 2 EFFICACY AND SAFETY WERE COMPARABLE IN BOTH ELDERLY AND YOUNGER PATIENTS. CONTRAINDICATIONS MULTAQ is contraindicated in patients with: • Permanent atrial fibrillation of any duration in which sinus rhythm cannot be restored and attempts to restore it are no longer considered by the attending physician.
1 WARNINGS AND PRECAUTIONS, Special Populations) • History of hypersensitivity reactions to dronedarone or any of its excipients or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
EUEuropean Union· EMA
1 product
Uses
MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). 4), MULTAQ should only be prescribed after alternative treatment options have been considered.
MULTAQ must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
How to take
Drug interactions
Known interactions involving Dronedarone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 554. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL405460149 · revised May 15, 2026
- [2]Health Canada (DPD) · 02330989 · revised April 22, 2025
- [3]European Medicines Agency · EMEA/H/C/001043 · revised October 28, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.