Prescription medication · Class III Antiarrhythmic
dronedarone
Also sold as Multaq. Multaq is used to lower the risk of hospitalization if you have atrial fibrillation (AFib).
Data updated 2026-05-15
- 9,899
- FDA reportsLightly reported
- 22
- InteractionsSeveral interactions
- $12.76
- Brand price (NADAC)
What the data shows
dronedarone (Multaq) is a prescription Class III Antiarrhythmic, reported less often than most tracked drugs (9,899 FDA reports), with 22 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
dronedarone (Multaq) is a prescription Class III Antiarrhythmic. Multaq is used to lower the risk of hospitalization if you have atrial fibrillation (AFib).
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from dronedarone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 9,899 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for dronedarone, by number of reports
- Atrial Fibrillation
Atrial Fibrillation
1,420 reports
- Dyspnoea
Dyspnoea
838 reports
- Fatigue
Fatigue
615 reports
- Diarrhoea 477
Diarrhoea
477 reports
- Nausea 472
Nausea
472 reports
- Drug Interaction 467
Drug Interaction
467 reports
- Dizziness 449
Dizziness
449 reports
- Gastrointestinal Haemorrhage 420
Gastrointestinal Haemorrhage
420 reports
- Asthenia 381
Asthenia
381 reports
- Blood Creatinine Increased 312
Blood Creatinine Increased
312 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for dronedarone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where dronedarone sits
dronedarone has more FDA adverse-event reports than 39% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dronedarone; the line is the median (50th percentile).
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
Reports Mentioning Death
658
6.6% of reports — not proof of cause
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 |
| 9 | GASTROINTESTINAL HAEMORRHAGE | 420 |
| 10 | ASTHENIA | 381 |
| 12 | BLOOD CREATININE INCREASED | 312 |
| 13 | HEADACHE | 225 |
| 14 | CARDIAC FAILURE | 221 |
| 15 | OEDEMA PERIPHERAL | 219 |
| 16 | MALAISE | 218 |
| 17 | COUGH | 215 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for dronedarone?
Related Medications in Class III Antiarrhythmic
Other drugs grouped near dronedarone - same-class peers and common alternatives.
adenosine
Adenocard
Adenosine (Adenocard) is a medicine used to treat certain types of irregular heartbeats.
Compare with dronedarone →
amiodarone
Cordarone, Pacerone
Amiodarone (Pacerone) is a medicine used to treat life-threatening, irregular heartbeats.
Compare with dronedarone →
atropine
AtroPen
Atropine is a medicine that can temporarily block severe effects on your body.
Compare with dronedarone →
bumetanide
Bumex
Bumetanide is a water pill (diuretic).
Compare with dronedarone →
carvedilol
Coreg
Carvedilol is a medicine that lowers blood pressure and helps your heart work better.
Compare with dronedarone →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for dronedarone: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 9,899.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.65%.
- polyethylene glycol 3350 Δ 0.00 pts · 91,655 reports · Osmotic Laxative 6.65%death share
- ketoconazole Δ 0.00 pts · 16,231 reports · Azole Antifungal 6.65%death share
- cefixime Δ 0.01 pts · 2,824 reports · Third-Generation Cephalosporin 6.66%death share
- eszopiclone Δ 0.02 pts · 24,883 reports · Non-Benzodiazepine Hypnotic (Z-Drug) 6.63%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 9,899 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 27, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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