Dronedarone
Dronedarone is an antiarrhythmic (heart rhythm) medicine used to lower the risk of hospitalization for atrial fibrillation in people who are in normal rhythm but have a history of the condition.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Dronedarone (Multaq) is a heart rhythm drug that lowers the chance of hospital stays for atrial fibrillation in people back in normal rhythm, a less powerful relative of amiodarone on the market since about 2009 and available generically. Most people tolerate it reasonably well, though diarrhea, nausea and tiredness are common. Its boxed warning says it doubles the risk of death in severe or recently worsened heart failure and in permanent atrial fibrillation, so report weight gain, ankle swelling or worsening shortness of breath right away. Liver injury and lung problems are the other serious risks, so yellow skin, dark urine or a new dry cough needs a prompt call.
Clinical pearls
- Take each dose with breakfast and dinner, because food greatly increases how much dronedarone your body absorbs.
- Skip grapefruit juice entirely, and check before any new antibiotic or antifungal, since clarithromycin, ketoconazole and others raise dronedarone levels.
- If you take digoxin, simvastatin or another statin, or warfarin, expect dose changes or extra blood tests once dronedarone starts.
- Keep rhythm checks at least every 3 months, since slipping into permanent atrial fibrillation means dronedarone should stop.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Dronedarone doubles the risk of death in people with severe or recently worsened heart failure, and in people with permanent atrial fibrillation.
- It should not be used if you have heart failure that recently worsened enough to need hospitalization, or very severe (NYHA Class IV) heart failure.
- In permanent AF, it doubles the risk of death, stroke and hospitalization for heart failure.
- It should not be used if your AF cannot or will not be converted back to normal rhythm.
Watch for weight gain, swelling or worsening shortness of breath, and tell your doctor right away.
Patient information guide A plain-language walkthrough of Dronedarone, written from its FDA label.
What Dronedarone is used for
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Dronedarone is used for one main purpose.
- Multaq tablets reduce the risk of hospitalization for atrial fibrillation in people in sinus rhythm with a history of paroxysmal or persistent AF.
How Dronedarone works
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Dronedarone is an antiarrhythmic that helps keep the heart's rhythm steady. It has properties from all four Vaughan-Williams classes of antiarrhythmic drugs. How each property contributes to its benefit is not known.
Dronedarone dosage
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Multaq is a tablet taken by mouth twice daily, with the morning and evening meals. Taking it with food helps your body absorb it.
- Other heart rhythm medicines and strong CYP3A inhibitors must be stopped before you start.
- Follow your prescriber and the label for exact directions.
Dosing details from the FDA-approved label
From the Dronedarone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (recommended dosage of MULTAQ)
- 400 mg twice daily
- One tablet with the morning meal and one tablet with the evening meal
- Take with morning and evening meals; Class I or III antiarrhythmics or strong CYP3A inhibitors (e.g., ketoconazole) must be stopped before starting; verify females of reproductive potential are not pregnant prior to initiating
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 )
Read the full Dosage and Administration section on DailyMed →
Dronedarone side effects
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Most side effects involve the stomach, skin or heart rate.
Common side effects
- Diarrhea
- Nausea
- Stomach pain
- Vomiting
- Indigestion
- Slow heart rate (bradycardia)
- Rash, itching or eczema
- Weakness or tiredness
When to get medical help
- Weight gain, swelling in the legs or ankles, or increasing shortness of breath, which can be signs of heart failure
- Loss of appetite, nausea, vomiting, fever, unusual tiredness, right upper belly pain, yellow skin or eyes, dark urine or itching, which can be signs of liver injury
- New shortness of breath or a dry cough, which may signal lung problems
- Signs of a serious allergic reaction such as swelling of the face, lips or throat
- Signs of stroke or a very slow or irregular heartbeat: get emergency help
Call your doctor promptly about signs of heart failure, liver injury, new cough or breathing trouble, or allergic reactions. Photosensitivity (sun sensitivity) and a changed sense of taste were reported less often.
Dronedarone warnings and precautions
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- Death risk: doubled in severe or recently worsened heart failure and in permanent AF.
- Stroke: the risk was higher in permanent AF, especially in the first two weeks. Appropriate antithrombotic (clot-preventing) therapy is needed.
- Heart rhythm checks: at least every 3 months. If AF returns, the drug is stopped or the rhythm is corrected.
- Liver injury: including acute liver failure needing transplant. Report symptoms right away.
- Lung toxicity: new cough or breathlessness needs evaluation.
- QT prolongation: the drug is stopped if the QTc exceeds 500 ms.
- Kidneys: kidney function should be monitored periodically.
- Low potassium or magnesium: can occur with water pills and should be kept normal.
Dronedarone interactions
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Dronedarone is processed by CYP3A and affects several other drugs.
- Class I or III antiarrhythmics and QT-prolonging drugs: risk of dangerous rhythm problems.
- Strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, nefazodone): raise dronedarone levels.
- Grapefruit juice: raises dronedarone levels.
- Rifampin, phenobarbital, carbamazepine, phenytoin, St. John's wort: lower dronedarone levels.
- Digoxin: levels rise, with a higher risk of sudden death in some patients.
- Beta-blockers and calcium channel blockers: can cause excessive slowing of the heart.
- Simvastatin and other statins: levels rise.
- Warfarin: INR should be monitored.
- Dabigatran: levels rise, so the dose may be reduced or the combination avoided in kidney impairment.
- Tacrolimus and sirolimus: levels may rise.
Interactions listed in the FDA-approved label
From the Dronedarone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Class I or III antiarrhythmics and other QT-prolonging drugs (certain phenothiazines, tricyclic antidepressants, certain macrolide antibiotics): Coadministration of drugs prolonging the QT interval is contraindicated because of the potential risk of torsade de pointes-type ventricular tachycardia. Contraindicated; treatment with Class I or III antiarrhythmics must be stopped before starting MULTAQ.
- Digoxin: Dronedarone increases exposure to digoxin by inhibiting P-gp, digoxin can potentiate dronedarone's electrophysiologic effects, and baseline digoxin use was associated with increased risk of arrhythmic or sudden death in dronedarone-treated patients compared to placebo. Consider discontinuing digoxin. If continued, halve the dose of digoxin, monitor serum levels closely, and observe for toxicity.
- Calcium channel blockers (verapamil, diltiazem, nifedipine): Calcium channel blockers with depressant effects on the sinus and AV nodes could potentiate dronedarone's effects on conduction; verapamil and diltiazem are moderate CYP3A inhibitors that increase dronedarone exposure, and dronedarone increased calcium channel blocker exposure. Give a low dose of calcium channel blockers initially and increase only after ECG verification of good tolerability.
- Beta-blockers (including propranolol, metoprolol): Bradycardia was more frequently observed in combination with beta-blockers, and dronedarone increased the exposure of propranolol and metoprolol. Give a low dose of beta-blockers initially and increase only after ECG verification of good tolerability.
- Ketoconazole and other potent CYP3A inhibitors (itraconazole, voriconazole, ritonavir, clarithromycin, nefazodone): Exposure to dronedarone is significantly increased. Concomitant use is contraindicated.
- Grapefruit juice: Exposure to dronedarone is significantly increased. Avoid grapefruit juice beverages while taking MULTAQ.
- Rifampin and other CYP3A inducers (phenobarbital, carbamazepine, phenytoin, St. John's wort): They decrease exposure to dronedarone significantly. Avoid concomitant use.
- Simvastatin and other statins: Dronedarone increased simvastatin/simvastatin acid exposure; other statins have multiple mechanisms of interaction (CYPs and transporters). Avoid simvastatin doses greater than 10 mg once daily; follow statin label recommendations for use with CYP3A and P-gp inhibitors such as dronedarone.
- Sirolimus, tacrolimus, and other CYP3A substrates with narrow therapeutic range: Dronedarone can increase plasma concentrations of these drugs when given orally. Monitor plasma concentrations and adjust dosage appropriately.
- Dabigatran: Dronedarone increases dabigatran plasma exposures by inhibiting the P-gp transporter. In moderate renal impairment (CrCL 30–50 mL/min), reduce dabigatran dose to 75 mg twice daily; in severe renal impairment (CrCL 15–30 mL/min), avoid concomitant use.
Read the label’s full interactions text
7 DRUG INTERACTIONS Dronedarone is metabolized by CYP3A and is a moderate inhibitor of CYP3A and CYP2D6 and has potentially important pharmacodynamic interactions ( 7 ) • Class I or III antiarrhythmics: 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): Initiate CCB with low dose and increase after ECG verification of tolerability. ( 7.1 , 7.2 , 7.3 ) • Beta-blockers: May provoke excessive bradycardia. Initiate with low dose and increase after ECG verification of tolerability. ( 7.1 , 7.3 ) • CYP3A inducers: Avoid concomitant use. ( 7.2 ) • Grapefruit juice: Avoid concomitant use. ( 7.2 ) • Statins: Avoid simvastatin doses greater than 10 mg daily. Follow label recommendations for concomitant use of other statins with a CYP3A and P-gp inhibitor like dronedarone. ( 7.3 ) • CYP3A substrates with a narrow therapeutic index (e.g., sirolimus and tacrolimus): Monitor and adjust dosage of concomitant drug as needed when used with MULTAQ. ( 7.3 ) • Warfarin: Monitor INR after initiating dronedarone in patients taking warfarin. ( 7.3 ) 7.1 Pharmacodynamic Interactions Drugs Prolonging the QT Interval (Inducing Torsade de Pointes) Coadministration of drugs prolonging the QT interval (such as certain phenothiazines, tricyclic antidepressants, certain macrolide antibiotics, and Class I and III antiarrhythmics) is contraindicated because of the potential risk of torsade de pointes–type ventricular tachycardia [see Contraindications (4) , Clinical Pharmacology (12.3) ] . Digoxin In the ANDROMEDA (patients with recently decompensated heart failure) and PALLAS (patients with permanent AF) trials baseline use of digoxin was associated with an increased risk of arrhythmic or sudden death in dronedarone-treated patients compared to placebo.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Dronedarone
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- Permanent AF or severe or recently worsened heart failure: do not use.
- Heart block, sick sinus syndrome, very slow heart rate or long QT/PR interval: do not use unless the label's exception applies (a working pacemaker).
- Severe liver impairment: do not use.
- Allergy to dronedarone or any ingredient: do not use.
- Pregnancy: may cause fetal harm. Use effective contraception during treatment and for 5 days afterward.
- Breastfeeding: avoid during treatment and for 5 days after the last dose.
- Children under 18: safety and effectiveness have not been established.
- Older adults: efficacy and safety were similar to younger adults.
- Kidney impairment: no dose change is needed, but kidney function is monitored.
Dronedarone overdose
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If too much is taken, cardiac rhythm and blood pressure should be monitored, and treatment is supportive and based on symptoms. There is no specific antidote. It is not known whether dialysis removes the drug.
What Dronedarone does in the body
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Dronedarone causes concentration-dependent increases in the QT and PR intervals on an ECG (heart tracing). At the usual dosing with food, the estimated increases are about 15 ms and 12 ms. In a small study, doses higher than the standard one were not more effective and were less well tolerated.
How your body processes Dronedarone
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Dronedarone is poorly absorbed on an empty stomach (about 4%), but absorption rises to about 15% with a high-fat meal. Levels peak in 3 to 6 hours with food, and steady state is reached in 4 to 8 days. It is broken down mainly by the liver enzyme CYP3A, and most of it leaves in the feces. The elimination half-life is 13 to 19 hours. Exposure is about 30% higher in women and 23% higher in people 65 and older.
How to store Dronedarone
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Store at room temperature between 68°F to 77°F (20°C to 25°C): excursions permitted to 59°F–86°F (15°C–30°C), .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dronedarone
203 supplements and herbal products have documented interactions with Dronedarone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 11
- Moderate · 155
- Minor · 37
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Dronedarone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dronedarone — the kind of thing our pharmacy team would talk through with you at the counter.
What is Multaq for?
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How should I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I drink grapefruit juice or take other medicines with it?
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Is it safe in pregnancy?
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Is Dronedarone available over the counter?
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When was Dronedarone first available?
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Who makes Dronedarone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dronedarone on HelloPharmacist
Dronedarone forms and strengths (how it comes)
Dronedarone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Multaq is used to reduce the risk of hospitalization for atrial fibrillation in people in sinus rhythm with a history of paroxysmal or persistent AF.
- Multaq is taken by mouth as one tablet with the morning meal and one tablet with the evening meal.
- Multaq should be started only after Class I or III antiarrhythmics and strong CYP3A inhibitors such as ketoconazole have been stopped.
- Before starting Multaq, females who could become pregnant should be confirmed not to be pregnant.
Dronedarone on the U.S. market: products, makers and brands
How Dronedarone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 2 Dronedarone product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2009. Brand names on the directory include Multaq; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Dronedarone is used (Medicaid data)
A general measure of how commonly Dronedarone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dronedarone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dronedarone prescribed? Of the 1,601 medications we measure, Dronedarone ranks #918 by Medicaid prescriptions — more than 43% of them.
Utilization by Dronedarone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dronedarone 400 MG Oral Tablet
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 854856
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dronedarone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 8 listed Dronedarone NDCs with Medicaid activity.
Compare Dronedarone products
A representative set of FDA-listed product records for Dronedarone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 400 mg | Oral | Cardinal Health 107, LLC | NDA | View NDC → |
| 400 mg | Oral | Sanofi-Aventis U.S. LLC | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Dronedarone NDCs →
Dronedarone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dronedarone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dronedarone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Dronedarone FDA approval history
How Dronedarone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dronedarone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Dronedarone recalls since July 2021.
✅No Dronedarone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 233698 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 854855In current FDA listingsClinical drug / strength (SCD) 400 MGRxCUI 854856
Look up RxCUI 233698 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Dronedarone supply and shortage status
Whether Dronedarone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Dronedarone costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 400 mg | $13.19 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Dronedarone brand names
Dronedarone is sold under one brand name in the FDA directory — Multaq. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dronedarone: manufacturers and labelers
2 companies list Dronedarone products with the FDA. By number of product records, the largest are Cardinal Health 107, LLC, Sanofi-Aventis U.S. LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dronedarone drug class (RxNorm)
Dronedarone belongs to the Antiarrhythmic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Dronedarone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cardinal Health is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →