dronedarone
Brand names: Multaq
Multaq is a medicine that helps lower the risk of needing to stay in the hospital for atrial fibrillation (AFib). It is for people who have a history of AFib and are currently in normal heart rhythm.
Drug Pricing (NADAC)
Brand Price
$12.76/unit
Generic Available
No
SANOFI AVENTIS US
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Multaq is used to lower the risk of hospitalization if you have atrial fibrillation (AFib).
Common side effects
Diarrhea, Nausea, Abdominal pain
Key warnings
Multaq can increase the risk of death, stroke, and heart failure in patients with severe heart failure or permanent AFib.
How It Works
Multaq is an antiarrhythmic drug. It works by changing the electrical signals in the heart. This helps to keep your heart in a normal rhythm and prevent AFib from returning.
How to Take It
Take one 400 mg tablet twice a day. Take one tablet with your morning meal and one with your evening meal. Do not start Multaq if you are taking certain other heart medicines or strong CYP3A inhibitors. Make sure you are not pregnant before starting Multaq.
Pregnancy & Breastfeeding
Multaq can harm an unborn baby. If you are a woman who could become pregnant, use effective birth control while taking Multaq. Do not breastfeed while taking Multaq and for 5 days after your last dose.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store Multaq at room temperature, between 68°F and 77°F.
Side Effects (from patient reports)
Based on 5,959 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 9,899 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2009–2025.
Total Reports
9,899
Death-Related Reports
658
Hospitalization Reports
3,327
Top Indication
Atrial Fibrillation
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ATRIAL FIBRILLATION | 1,420 |
| 2 | DYSPNOEA | 838 |
| 3 | FATIGUE | 615 |
| 4 | DIARRHOEA | 477 |
| 5 | NAUSEA | 472 |
| 6 | DRUG INTERACTION | 467 |
| 7 | DIZZINESS | 449 |
| 8 | OFF LABEL USE | 431 |
| 9 | GASTROINTESTINAL HAEMORRHAGE | 420 |
| 10 | ASTHENIA | 381 |
| 11 | DRUG INEFFECTIVE | 328 |
| 12 | BLOOD CREATININE INCREASED | 312 |
| 13 | HEADACHE | 225 |
| 14 | CARDIAC FAILURE | 221 |
| 15 | OEDEMA PERIPHERAL | 219 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Multaq can increase the risk of death, stroke, and heart failure in patients with severe heart failure or permanent AFib. You should not take this medicine if you have severe heart failure that recently required hospitalization or if you have permanent AFib and will not be converted to a normal heart rhythm.
Known Drug Interactions
7.2 Effects of Other Drugs on Dronedarone Ketoconazole and Other Potent CYP3A Inhibitors Concomitant use of ketoconazole as well as other potent CYP3A inhibitors such as itraconazole, voriconazole, ritonavir, clarithromycin, and nefazodone is contraindicated because exposure to dronedarone is significantly increased [see Contraindications (4) , Clinical Pharmacology (12.3) ] .
Mechanism: Ketoconazole stops the liver enzyme that breaks down dronedarone from working. This causes dronedarone to build up to much higher levels in your body.
What to do: Do not use these medications at the same time. This combination is contraindicated by the manufacturer.
7.2 Effects of Other Drugs on Dronedarone Ketoconazole and Other Potent CYP3A Inhibitors Concomitant use of ketoconazole as well as other potent CYP3A inhibitors such as itraconazole, voriconazole, ritonavir, clarithromycin, and nefazodone is contraindicated because exposure to dronedarone is significantly increased [see Contraindications (4) , Clinical Pharmacology (12.3) ] .
Mechanism: Clarithromycin blocks the process your body uses to clear dronedarone. This leads to a significant increase in the amount of dronedarone in your blood.
What to do: You should not take these two drugs together. Consult your doctor for a safer alternative.
7.2 Effects of Other Drugs on Dronedarone Ketoconazole and Other Potent CYP3A Inhibitors Concomitant use of ketoconazole as well as other potent CYP3A inhibitors such as itraconazole, voriconazole, ritonavir, clarithromycin, and nefazodone is contraindicated because exposure to dronedarone is significantly increased [see Contraindications (4) , Clinical Pharmacology (12.3) ] .
Mechanism: Voriconazole interferes with the way your body breaks down dronedarone. This results in much higher levels of dronedarone, which can be unsafe.
What to do: This drug combination must be avoided. Your doctor will need to adjust your treatment plan.
dronedarone ↑ dronedarone Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Mechanism: Darunavir raises the level of dronedarone in your blood by slowing its breakdown. This can cause your heart to beat in a dangerous or irregular way.
What to do: This combination is unsafe and should be avoided to prevent serious heart rhythm issues.
Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ezetimibe and simvastatin. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ezetimibe and simvastatin 10 mg/10 mg daily.
Mechanism: Dronedarone makes it harder for your body to process the cholesterol medicine, which can lead to severe muscle breakdown.
What to do: If you take dronedarone, your daily dose of ezetimibe and simvastatin should not exceed 10 mg/10 mg.
Common Questions
Can I take Multaq if I have heart failure?
What should I do if I experience side effects?
Can I drink grapefruit juice while taking Multaq?
Will Multaq cure my atrial fibrillation?
How often will I need to see my doctor while taking Multaq?
What other medicines should I avoid while taking Multaq?
Can Multaq cause liver problems?
What if I gain weight or have shortness of breath while taking Multaq?
Can I take Multaq if I am pregnant?
Will Multaq interact with my other medications?
What are the common side effects of dronedarone?
Does dronedarone interact with other medications?
What drug class is dronedarone?
Is dronedarone safe during pregnancy?
Related Medications in Class III Antiarrhythmic
Other drugs grouped near dronedarone — same-class peers and common alternatives.
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amiodarone
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atropine
AtroPen
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bumetanide
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carvedilol
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for dronedarone
The FDA label for dronedarone (sold under brand names such as Multaq) classifies it as a prescription-only medication in the Class III Antiarrhythmic class. Multaq is used to lower the risk of hospitalization if you have atrial fibrillation (AFib). Official labeling lists 7 commonly reported side effects, including Diarrhea, Nausea, Abdominal pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,959 voluntary reports. The database also lists 22 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 27, 2026
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages