Prescription medicine
Dronedarone Brand names: Multaq
Dronedarone (Multaq) is a prescription medicine with an FDA approval on record since 2009. No generic is listed; pharmacies paid $13.19 per Multaq 400 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the dronedarone FDA label on DailyMed (effective May 29, 2025, Sanofi-Aventis U.S. LLC); the NDA 22425 record on Drugs@FDA; every dronedarone label on DailyMed.
Highlights of the record
FDA label of May 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION.
In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death [see Clinical Studies (14.3) ]. MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure [see Contraindications (4), Warnings and Precautions (5.1) ]. In patients with permanent atrial fibrillation, MULTAQ doubles the risk of death, stroke and hospitalization for heart failure [see Clinical Studies (14.4) ]. MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm [see Contraindications (4), Warnings and Precautions (5.2) ]. WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION See full prescribing information for complete boxed warning. MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. MULTAQ doubles the risk of death in these patients. […]
Used for
From the label: indications and usageMULTAQ ® 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) ].
Forms and strengths
- 400 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 1, 2009 Multaq, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first January 31, 2024; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 30, 2031 Multaq tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $13.19 per tablet Multaq 400 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 10,142 through July 30, 2026
What is dronedarone used for?
From the label: indications and usageMULTAQ ® 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 ).
FDA pharmacologic class: Antiarrhythmic.
Source: FDA drug label (Multaq), Sanofi-Aventis U.S. LLC, effective May 29, 2025 (SPL set 7fa41601-7fb5-4155-8e50-2ae903f0d2d6), via openFDA; the full label on DailyMed
What does the patient leaflet for dronedarone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about MULTAQ?MULTAQ may cause serious side effects, including: Increased risk of death, stroke, and heart failure in people with: A certain type of heart failure called decompensated heart failure. Heart failure is when your heart does not pump blood through your body as well as it should. MULTAQ can cause new or worsening heart failure. Do not take MULTAQ if you have symptoms of heart failure that recently worsened and you were hospitalized, or if you have severe heart failure. Call your healthcare provider right away if you develop any of the following signs or symptoms of heart failure during treatment with MULTAQ: shortness of breath or wheezing at rest wheezing, chest tightness or coughing up frothy sputum at rest, nighttime or after minor exercise trouble sleeping or waking up at night because of breathing problems using more pillows to prop yourself up at night so you can breathe more easily gaining more than 5 pounds quickly increasing swelling of feet or legs A certain type of irregular heartbeat (rhythm) called permanent atrial fibrillation (AF). Permanent AF is when you and your healthcare provider decide not to try to change your heart rhythm back to a normal heart rhythm or your heart rhythm cannot be changed back to a normal rhythm. Do not take MULTAQ if you have permanent AF. Your healthcare provider should check your heart rhythm regularly to make sure your heart keeps a normal rhythm. Call your healthcare provider right away if you develop any of the following signs or symptoms of AF during treatment with MULTAQ such as: fast or irregular heartbeat or pulse chest pain dizziness or lightheadedness tiredness or weakness reduced ability to exercise shortness of breath MULTAQ doubles your risk of dying if you have these conditions. […]
From the patient leaflet: What should I avoid while taking MULTAQ?Do not drink grapefruit juice during treatment with MULTAQ. Grapefruit juice can increase the amount of MULTAQ in your blood and can increase your chance of getting side effects.
From the patient leaflet: How should I store MULTAQ?Store MULTAQ at room temperature between 68°F to 77°F (20°C to 25°C). Keep MULTAQ and all medicines out of the reach of children.
Source: FDA drug label (Multaq), Sanofi-Aventis U.S. LLC, effective May 29, 2025 (SPL set 7fa41601-7fb5-4155-8e50-2ae903f0d2d6), via openFDA; the full label on DailyMed
Is there a generic for dronedarone (Multaq)?
The FDA approved the first generic dronedarone on January 31, 2024. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 3 patents for Multaq tablets, the last expiring on June 30, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2024 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dronedarone (Multaq)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $13.19 per Multaq 400 mg tablet, up 2% from $12.93 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Multaq 400 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Multaq 400 mg tablet | Brand | $13.19 per tablet | $395.60 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dronedarone label say about other medicines?
The dronedarone label names 24 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name dronedarone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | contraindications | … 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 Hypersensitivity to the active substance or to any of the excipients Permanent AF (patients in whom normal sinus rhythm will … |
| Carbamazepine | drug interactions | Rifampin and Other CYP3A Inducers Avoid rifampin or other CYP3A inducers such as phenobarbital, carbamazepine, phenytoin, and St. John's wort because they decrease exposure to dronedarone significantly [see Clinical Pharmacology (12.3) ]. |
| Clarithromycin | contraindications | … 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 … |
| Cyclosporine | contraindications | … 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 … |
| Dabigatran | drug interactions | Dabigatran Dronedarone increases dabigatran plasma exposures by inhibiting the P-gp transporter [see Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | Contraindicated. ( 4 , 7.1 ) Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor digoxin levels. ( 7.1 , 7.3 ) Calcium channel blockers (CCB): |
| Diltiazem | drug interactions | Calcium Channel Blockers Verapamil and diltiazem are moderate CYP3A inhibitors and increase dronedarone exposure. |
| Erythromycin | contraindications | … 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 … |
| Itraconazole | contraindications | … 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 … |
| Ketoconazole | contraindications | … 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 … |
| Metoprolol | drug interactions | Beta-Blockers and Other CYP2D6 Substrates Dronedarone increased the exposure of propranolol and metoprolol. |
| Nefazodone | contraindications | … 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 … |
| Nifedipine | drug interactions | Calcium Channel Blockers Dronedarone increased the exposure of calcium channel blockers (verapamil, diltiazem or nifedipine). |
| Phenobarbital | drug interactions | Rifampin and Other CYP3A Inducers Avoid rifampin or other CYP3A inducers such as phenobarbital, carbamazepine, phenytoin, and St. John's wort because they decrease exposure to dronedarone significantly [see Clinical Pharmacology (12.3) ]. |
Every other medicine the dronedarone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenytoin | drug interactions | Rifampin and Other CYP3A Inducers Avoid rifampin or other CYP3A inducers such as phenobarbital, carbamazepine, phenytoin, and St. … |
| Propranolol | drug interactions | Beta-Blockers and Other CYP2D6 Substrates Dronedarone increased the exposure of propranolol and metoprolol. |
| Rifampin | drug interactions | Rifampin and Other CYP3A Inducers Avoid rifampin or other CYP3A inducers such as phenobarbital, carbamazepine, phenytoin, and St. … |
| Ritonavir | contraindications | … voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir [see Drug Interactions (7.2) ] Concomitant use of erythromycin [see Clinical Pharmacology (12.3) ] Concomitant use … |
| Simvastatin | drug interactions | Avoid concomitant use. ( 7.2 ) Grapefruit juice: Avoid concomitant use. ( 7.2 ) Statins: Avoid simvastatin doses greater than 10 mg daily. |
| Sirolimus | drug interactions | … dronedarone. ( 7.3 ) CYP3A substrates with a narrow therapeutic index (e.g., sirolimus and tacrolimus): |
| Tacrolimus | drug interactions | … CYP3A substrates with a narrow therapeutic index (e.g., sirolimus and tacrolimus): |
| Verapamil | drug interactions | Calcium Channel Blockers Verapamil and diltiazem are moderate CYP3A inhibitors and increase dronedarone exposure. |
| Voriconazole | contraindications | … use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir [see Drug Interactions (7.2) ] Concomitant use … |
| Warfarin | drug interactions | Monitor INR after initiating dronedarone in patients taking warfarin. |
Other labels that name dronedarone
Source: FDA drug label (Multaq), Sanofi-Aventis U.S. LLC, effective May 29, 2025 (SPL set 7fa41601-7fb5-4155-8e50-2ae903f0d2d6), via openFDA; the full label on DailyMed
What do FAERS reports show for dronedarone?
The FDA Adverse Event Reporting System holds 10,142 reports that list dronedarone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 668 are coded as a death and 3,359 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antiarrhythmics
- the pharmacologic class, with prices and generics
- Dronedarone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other