Dronedarone is an antiarrhythmic indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF). It is available as tablets for oral use. MedsAcross supplies Dronedarone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
MULTAQ ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF). MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.
Source: US FDA prescribing information
The mechanism of action of dronedarone is unknown. Dronedarone has antiarrhythmic properties belonging to all four Vaughan-Williams classes, but the contribution of each of these activities to the clinical effect is unknown.
Source: US FDA prescribing information
The recommended dosage of MULTAQ is 400 mg twice daily in adults. MULTAQ should be taken as one tablet with the morning meal and one tablet with the evening meal. Treatment with Class I or III antiarrhythmics (e.g., amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol) or drugs that are strong inhibitors of CYP3A (e.g., ketoconazole) must be stopped before starting MULTAQ. Verify that females of reproductive potential are not pregnant prior to initiating MULTAQ. One tablet of 400 mg twice a day with morning and evening meals
Source: US FDA prescribing information
MULTAQ is contraindicated in patients with: Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms Second or third-degree atrioventricular (AV) block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) Bradycardia <50 bpm Concomitant use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir Concomitant use of erythromycin Concomitant use of drugs or herbal products that prolong the QT interval and might increase the…
Source: US FDA prescribing information
Boxed warning: In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death. MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. Determine cardiac rhythm at least once every 3 months. If AF is detected discontinue MULTAQ or cardiovert. Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use. Liver injury: If hepatic injury is suspected, discontinue MULTAQ. If pulmonary toxicity is confirmed, discontinue treatment. Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range. Renal impairment: Monitor renal function periodically.
Source: US FDA prescribing information
The following safety concerns are described elsewhere in the label: New or worsening heart failure Liver Injury Pulmonary toxicity Hypokalemia and hypomagnesemia with potassium-depleting diuretics QT prolongation Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia
Source: US FDA prescribing information
Dronedarone is metabolized by CYP3A and is a moderate inhibitor of CYP3A and CYP2D6 and has potentially important pharmacodynamic interactions. Class I or III antiarrhythmics: Contraindicated. Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor digoxin levels. Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability. Beta-blockers: May provoke excessive bradycardia. Initiate with low dose and increase after ECG verification of tolerability. CYP3A inducers: Avoid concomitant use. Grapefruit juice: Avoid concomitant use. Statins: Avoid simvastatin doses greater than 10 mg daily. Follow label recommendations for concomitant use of other statins with a CYP3A and P-gp inhibitor like dronedarone.
Source: US FDA prescribing information
Store at room temperature between 68°F to 77°F (20°C to 25°C): excursions permitted to 59°F–86°F (15°C–30°C),.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Dronedarone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Multaq 400 mg tabletOral | Sanofi-Aventis | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Dronedarone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Dronedarone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Dronedarone, including Multaq.
Yes. The US FDA first approved Dronedarone on 1 July 2009, according to Drugs@FDA.
Yes. Dronedarone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Dronedarone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Dronedarone is classified under ATC code C01BD07 (Dronedarone).
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