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MULTAQ is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II – III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic [see Contraindications].

In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.


Initial U.S. Approval: 2009
Dronedarone HCl is a benzofuran derivative with the following chemical name:
N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride.

Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol.

MULTAQ is provided as tablets for oral administration.
Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base).

The inactive ingredients are:
Core of the tablets- hypromellose, starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal silicon dioxide, magnesium stearate.
Coating / polishing of the tablets- hypromellose, polyethylene glycol 6000, titanium dioxide, carnauba wax.

Clinical pharmacology

Mechanism of Action
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.

Indications and usage 

MULTAQ® is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted


  • Class IV heart failure or symptomatic heart failure with a recent decompensation
  • Second- or third- degree atrioventicular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
  • Bradycardia <50 bpm
  • Concomitant use of a strong CYP3A inhibitor
  • Concomitant use of drugs or herbal products that prolong the QT interval and may induce Torsade de Pointes
  • Severe hepatic impairment
  • QTc Bazett interval ≥500 ms
  • Pregnancy
  • Nursing mothers



  • Heart failure: If heart failure develops or worsens, consider the suspension or discontinuation of MULTAQ
  • Liver injury: if hepatic injury is suspected, discontinue MULTAQ
  • Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range
  • QT prolongation: Stop MULTAQ if QTc Bazett ≥500ms
  • Increase in creatinine: Monitor serum creatinine periodically
  • Teratogen: Women of childbearing potential should use effective contraception while using MULTAQ

Dronedarone is metabolized by CYP 3A and is a moderate inhibitor of
CYP 3A and CYP 2D6 and has potentially important pharmacodynamic interactions.

  • Antiarrhythmics: Avoid concomitant use
  • Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor
  • 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
  • CYP 3A inducers: Avoid concomitant use
  • Grapefruit juice: Avoid concomitant use
  • Statins: Follow label recommendations for concomitant use of certain statins with a CYP 3A and P-gP inhibitor like dronedarone
  • CYP 3A substrates with a narrow therapeutic index (e.g., sirolimus and tacrolimus): Monitor and adjust dosage of concomitant drug as needed when used with MULTAQ
  • Warfarin: Monitor INR after initiating dronedarone in patients taking warfarin.

Adverse reactions

Most common adverse reactions (=2%) are diarrhea, nausea, abdominal pain, vomiting, and asthenia

Dosage and administration 

The only 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

How supplied

MULTAQ 400-mg tablets are provided as white film-coated tablets for oral administration, oblong-shaped, engraved with a double wave marking on one side and "4142" code on the other side in:

Bottles of 60 tablets, NDC 0024-4142-60
Bottles of 180 tablets, NDC 0024-4142-18
Bottles of 500 tablets NDC 0024-4142-50
Box of 10 blisters (10 tablets per blister) NDC 0024-4142-10

Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F), [see USP controlled room temperature].


Package Insert data: 
Issued February 2011
Manufactured by Sanofi Winthrop Industrie
1, rue de la Vierge
33440 Ambares, France

©sanofi-aventis, 2011
All rights reserved.

MULTAQ is a trademark of sanofi-aventis.

The brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC.

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807


National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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MULTAQ® (dronedarone) tablet