Dronedarone

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.

• 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) [see Clinical Studies (14) ] . 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 ( 1 , 14 ).ICD-10: I48.91

• MULTAQ is contraindicated in patients with: • Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning , Warnings and Precautions (5.2) ] • Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning , Warnings and Precautions (5.1) ] • 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 [see Drug Interactions (7.2) ] • Concomitant use of erythromycin [see Clinical Pharmacology (12.3) ] • Concomitant use of drugs or herbal products that prolong the QT interval and might increase the risk of torsade de pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, certain oral macrolide antibiotics, and Class I and III antiarrhythmics • Liver or lung toxicity related to the previous use of amiodarone • QTc interval >500 ms or PR interval >280 ms • Severe hepatic impairment • Hyp…contraindicated

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 [see Contraindications (4) ] . Verify that females of reproductive potential are not pregnant prior to initiating MULTAQ [see Warnings and Precautions (5.10) , Use in Specific Populations (8.1 , 8.3) ]. One tablet of 400 mg twice a day with morning and evening meals ( 2 )

• Determine cardiac rhythm at least once every 3 months. If AF is detected discontinue MULTAQ or cardiovert. ( 5.2 ) • Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use. ( 5.3 ) • Liver injury: If hepatic injury is suspected, discontinue MULTAQ. ( 5.5 ) • If pulmonary toxicity is confirmed, discontinue treatment. ( 5.6 ) • Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range. ( 5.7 ) • Renal impairment: Monitor renal function periodically. ( 5.9 ) • Embryofetal Toxicity: Based on animal data, MULTAQ may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception while using MULTAQ. ( 5.10 ) 5.1 Cardiovascular Death in NYHA Class IV or Decompensated Heart Failure MULTAQ is contraindicated in patients with NYHA Class IV heart failure or symptomatic heart failure with recent decompensation requiring hospitalization because it doubles the risk of death. 5.2 Cardiovascular Death and Heart Failure in Permanent AF MULTAQ doubles the risk of cardiovascular death (largely arrhythmic) and heart failure events in patients with permanent AF. Patients treated with dronedarone should undergo monitoring of cardiac rhythm no less often than every 3 months. Cardiovert patients who are in atrial fibrillation (if clinically indicated) or discontinue MULTAQ. MULTAQ offers no benefit in subjects in permanent AF.

The following safety concerns are described elsewhere in the label: • New or worsening heart failure [see Warnings and Precautions (5.4) ] • Liver Injury [see Warnings and Precautions (5.5) ] • Pulmonary toxicity [see Warnings and Precautions (5.6) ] • Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.7) ] • QT prolongation [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The safety evaluation of dronedarone 400 mg twice daily in patients with AF or AFL is based on 5 placebo-controlled studies, ATHENA, EURIDIS, ADONIS, ERATO and DAFNE. In these studies, a total of 6285 patients were randomized and treated, 3282 patients with MULTAQ 400 mg twice daily, and 2875 with placebo. The mean exposure across studies was 12 months. In ATHENA, the maximum follow-up was 30 months. In clinical trials, premature discontinuation because of adverse reactions occurred in 11.8% of the dronedarone-treated patients and in 7.7% of the placebo-treated group. The most common reasons for discontinuation of therapy with MULTAQ were gastrointestinal disorders (3.2% vs 1.8% in the placebo group) and QT prolongation (1.5% vs 0.5% in the placebo group).

• Lactation: Do not breastfeed ( 8.2) 8.1 Pregnancy Risk Summary MULTAQ may cause fetal harm when administered to a pregnant woman. In animal studies, dronedarone administered to pregnant rats and rabbits during the period of organogenesis caused multiple visceral (rats) and skeletal malformations (rats and rabbits) when administered at doses equivalent to or lower than the maximum recommended human dose (MRHD) (see Data ). There are no available data on dronedarone use in pregnant women to evaluate for a drug-associated risk of major birth defects or miscarriage or other adverse maternal or fetal outcomes. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Dronedarone is extensively metabolized and has low systemic bioavailability; its bioavailability is increased by meals. Its elimination half-life is 13 to 19 hours.

In the event of overdosage, monitor the patient's cardiac rhythm and blood pressure. Treatment should be supportive and based on symptoms. It is not known whether dronedarone or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis or hemofiltration). There is no specific antidote available.

• Jul 1, 2009NDANDA022425Sanofi Aventis Us

1. 1Atrial Fibrillation1,42314%
2. 2Dyspnoea8428.4%
3. 3Fatigue6196.2%
4. 4Off Label Use4834.8%
5. 5Diarrhoea4824.8%
6. 6Nausea4734.7%
7. 7Drug Interaction4694.7%
8. 8Dizziness4514.5%
9. 9Gastrointestinal Haemorrhage4214.2%
10. 10Asthenia3813.8%
11. 11Drug Ineffective3283.3%
12. 12Blood Creatinine Increased3113.1%
13. 13Headache2312.3%
14. 14Cardiac Failure2232.2%
15. 15Malaise2202.2%

Recent PubMed references pinned to Dronedarone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Retrospective Analysis of Dronedarone Versus Amiodarone on Outcomes Following Radiofrequency Ablation for Atrial Fibrillation.
  British journal of hospital medicine (London, England : 2005) · 2026 · Shi Y, Shi X, Li H, et al.
  PMID 42053007DOI 10.31083/BJHM53024
• Comparison of the effectiveness and safety of dronedarone and amiodarone for preventing recurrence after catheter ablation of atrial fibrillation: an open-label randomized controlled trial.
  Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026 · Zhang X, Jiang R, Chen Y, et al.
  PMID 42048541DOI 10.1093/europace/euag095
• Repurposing dronedarone for colorectal cancer therapeutic via suppression of the AKT/ERK signaling pathways.
  Biochemical pharmacology · 2026 · Gong T, Jin Y, Zhu H, et al.
  PMID 41548816DOI 10.1016/j.bcp.2026.117715
• Dronedarone synergizes with colistin against planktonic and biofilm forms of multidrug-resistant Gram-negative pathogens.
  Microbiology spectrum · 2026 · Mohamed MF, Abdelmegeed SM, Abdelsattar AS, et al.
  PMID 41432158DOI 10.1128/spectrum.03006-25
• Clinical and Economic Outcomes of Dronedarone Versus Amiodarone Among Patients With Atrial Fibrillation.
  Journal of the American Heart Association · 2026 · Steinberg BA, Dabbous F, Preblick R, et al.
  PMID 41413395DOI 10.1161/JAHA.125.042178
• Impact of Dronedarone on Early Recurrence After Catheter Ablation in Patients With Nonparoxysmal Atrial Fibrillation.
  Cardiovascular therapeutics · 2025 · Long X, Lv H, Zhang J, et al.
  PMID 41278585DOI 10.1155/cdr/2585953
• The antiarrhythmic drugs dronedarone and amiodarone exhibit potent in vitro and in vivo activity against Clostridioides difficile.
  International journal of antimicrobial agents · 2026 · Abouelkhair AA, Abutaleb NS, Seleem MN, et al.
  PMID 41161584DOI 10.1016/j.ijantimicag.2025.107649
• Dronedarone hydrochloride targets cardiolipin and phosphatidylglycerol to increase colistin susceptibility in gram-negative pathogens.
  Microbiology spectrum · 2025 · Liu Z, Liu M, Wang Z, et al.
  PMID 41025656DOI 10.1128/spectrum.01196-25

The 10 most recently updated of 50 ClinicalTrials.gov registrations naming Dronedarone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy of Early Rhythm Control in AF With TR Patients
  Recruiting · Observational · 5,800 enrolled · Samsung Medical Center
  NCT07607093updated 2026-05-29
• Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
  Recruiting · Phase 3 · Interventional · 1,746 enrolled · Universitätsklinikum Hamburg-Eppendorf
  NCT05293080updated 2026-05-18
• Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
  Active not recruiting · Interventional · 484 enrolled · Boston Scientific Corporation
  NCT06096337updated 2026-03-31
• Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
  Recruiting · Interventional · 520 enrolled · Samsung Medical Center
  NCT07447297updated 2026-03-03
• Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions
  Completed · Interventional · 51 enrolled · Shandong New Time Pharmaceutical Co., LTD
  NCT07396506updated 2026-02-09
• Bioequivalence Study of Dronedarone Hydrochloride Tablets
  Completed · Interventional · 48 enrolled · Shandong New Time Pharmaceutical Co., LTD
  NCT07396519updated 2026-02-09
• Dronedarone Rhythm Intervention for Early Atrial Fibrillation
  Not yet recruiting · Phase 4 · Interventional · 1,898 enrolled · Inha University Hospital
  NCT07270848updated 2025-12-22
• Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
  Terminated · Phase 4 · Interventional · 22 enrolled · Tulane University School of Medicine
  NCT04704050updated 2025-10-30
• Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
  Recruiting · Interventional · 50 enrolled · Seoul National University Hospital
  NCT06699342updated 2025-05-18
• Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes
  Terminated · Phase 3 · Interventional · 2,608 enrolled · Atrial Fibrillation Network
  NCT02618577updated 2025-02-06

Frequently asked questions

How does Dronedarone work?

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.

What is Dronedarone used for?

According to FDA labeling, Dronedarone carries indications including: 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) [see Clinical Studies (14) ] . 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 ( 1 , 14 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dronedarone?

Dronedarone is classified as Antiarrhythmics, class III, Antiarrhythmic, Cytochrome P450 3A Inhibitors, Unknown Cellular or Molecular Interaction.

What are the brand names for Dronedarone?

Dronedarone is marketed under brand names including Multaq.

What are the contraindications for Dronedarone?

Dronedarone labeling lists contraindications including: MULTAQ is contraindicated in patients with: • Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning , Warnings and Precautions (5.2) ] • Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning , Warnings and Precautions (5.1) ] • 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 [see Drug Interactions (7.2) ] • Concomitant use of erythromycin [see Clinical Pharmacology (12.3) ] • Concomitant use of drugs or herbal products that prolong the QT interval and might increase the risk of torsade de pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, certain oral macrolide antibiotics, and Class I and III antiarrhythmics • Liver or lung toxicity related to the previous use of amiodarone • QTc interval >500 ms or PR interval >280 ms • Severe hepatic impairment • Hyp…. Always consult the full prescribing information and a clinician.