Dronedarone

What dronedarone is and how it works

Dronedarone is a multichannel blocker antiarrhythmic that helps maintain sinus rhythm and reduce atrial fibrillation (AF) hospitalisation risk in eligible patients. It carries an FDA boxed warning against use in decompensated heart failure or permanent AF due to increased mortality. (1) (2) (3) (4)

Indications, contraindications, and safety restrictions differ importantly by region. It is not suitable for patients with permanent AF, heart failure, or significant left ventricular dysfunction. Treatment must be initiated and supervised by a specialist, with regular ECG and liver-function monitoring.

Mechanism of action: how dronedarone works

Dronedarone is a multichannel blocker that inhibits potassium, sodium, and calcium channels, thereby prolonging cardiac action potential and refractory periods. It has anti‑adrenergic properties and reduces AV conduction. Unlike amiodarone, it does not contain iodine and has a different adverse effect profile. (1) (2) (3) (4)

What dronedarone is used for

Before taking dronedarone

Do not take / not appropriate for

• Do not take dronedarone if you have permanent atrial fibrillation (any duration in EU/UK/Canada; permanent AF where sinus rhythm cannot or will not be restored in US). (all regions) (1) (2) (3) (4)
• Do not take dronedarone if you have heart failure or left ventricular systolic dysfunction (any history in EU/UK/Canada; symptomatic heart failure with recent decompensation requiring hospitalisation or NYHA Class IV in US). (all regions) (1) (2) (3) (4)
• Do not take dronedarone if you have certain heart rhythm or conduction disorders (e.g., 2nd/3rd-degree AV block, complete bundle branch block, sick sinus syndrome unless paced, bradycardia <50 bpm, QTc ≥500 ms, PR >280 ms). The exact list varies by region. (all regions) (1) (2) (3) (4)
• Do not take dronedarone with certain strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) or QT-prolonging medications (e.g., certain antipsychotics, macrolides, Class I/III antiarrhythmics). The list of prohibited drugs is region-specific; always check the local label. (all regions) (1) (2) (3) (4)
• Do not take dronedarone if you have severe hepatic impairment or previous liver/lung toxicity from amiodarone. (all regions) (1) (2) (3) (4)
• Do not take dronedarone if you are pregnant or breastfeeding (outright contraindicated in EU, UK, and Canada; US advises against breastfeeding during and for 5 days after treatment, and pregnancy may cause fetal harm). (all regions) (1) (2) (3) (4)
• In the EU, UK, and Canada, do not take dronedarone with dabigatran (flatly contraindicated). In the US, dabigatran dose adjustment is required. In Canada, rivaroxaban co-administration is also avoided. (regional differences) (1) (2) (3) (4)

Tell your clinician about

• Any history of heart failure, reduced ejection fraction, or recent hospitalisation for cardiac symptoms.
• Current or past atrial fibrillation type (paroxysmal, persistent, or permanent).
• All prescribed and over-the-counter medications, including herbals (especially St. John's wort) and anticoagulants (e.g., warfarin, dabigatran, rivaroxaban).
• Liver or kidney problems, or any prior amiodarone use and associated side effects.
• Pregnancy, plans for pregnancy, or breastfeeding; effective contraception is required during treatment in all regions.
• Symptoms such as new or worsening shortness of breath, swelling, weight gain, jaundice, dark urine, or severe nausea (may indicate heart failure or liver injury).

How to take dronedarone

• Dronedarone is taken as one 400 mg tablet with the morning meal and one 400 mg tablet with the evening meal.
• Treatment must be initiated and monitored by a specialist; do not start or stop dronedarone without a prescriber's instruction.
• Swallow tablets whole; do not crush or chew.
• Avoid grapefruit juice during treatment, as it may increase drug levels.

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

Follow the exact product instructions and do not double a dose.

Overdose

If an overdose is suspected, monitor cardiac rhythm and blood pressure, and provide supportive care. Dronedarone is not removed by dialysis and no specific antidote exists. Contact a poison control centre or emergency services immediately. (1) (3) (4)

Side effects

Common side effects include gastrointestinal symptoms, bradycardia, and rash. Serious reactions require immediate medical attention.

Serious warnings

Interactions

Pregnancy, breastfeeding, kidney/liver function, age

Monitoring

Before starting

• Confirm the diagnosis, rhythm status (sinus rhythm or planned cardioversion), and that there is no permanent AF or heart failure.
• Record baseline ECG (QTc, PR, heart rate), liver function tests (LFTs), and renal function.
• Check for contraindicated co‑medications (e.g., strong CYP3A inhibitors, QT‑prolonging drugs, digoxin, certain anticoagulants).
• Ensure pregnancy is excluded in women of childbearing potential and effective contraception is in place.
• Correct electrolyte abnormalities (especially low potassium or magnesium).

During treatment

• Perform ECG at regular intervals (at least every 6 months) to detect QTc prolongation, PR interval increases, or onset of permanent AF. Discontinuation if QTc ≥500 ms or permanent AF develops is prescriber-directed, based on that ECG monitoring.
• Monitor LFTs: at baseline, after 1 week, after 1 month, and then monthly for 6 months (EU/UK/Canada) or periodically (US).
• Assess for signs and symptoms of heart failure (weight gain, oedema, dyspnoea) at every visit.
• In patients on warfarin, check INR after starting dronedarone.
• If renal function is impaired, follow the regional label for monitoring frequency; note that EU/UK require discontinuation if CrCl falls below 30 mL/min.
• If amiodarone was previously used, watch for recurrence of liver or lung toxicity.

Storage

Store according to the manufacturer's instructions on the packaging. Oral tablets are typically kept at controlled room temperature away from moisture and light. Refer to the local product label for exact storage conditions.

Frequently asked questions

References

1. MULTAQ (dronedarone) tablets — prescribing informationU.S. DailyMed (FDA label) · United States · accessed 2026-07-30 · source 1
2. Multaq 400mg film-coated tablets — Summary of Product Characteristicselectronic Medicines Compendium (UK) · United Kingdom · accessed 2026-07-30 · source 2
3. Multaq — Annex I Summary of Product CharacteristicsEuropean Medicines Agency · European Union · accessed 2026-07-30 · source 3
4. MULTAQ (dronedarone tablets) — Product MonographHealth Canada · Canada · dated 2024-10-01 · accessed 2026-07-30 · source 4
5. Multaq (dronedarone 400 mg film-coated tablet) — ARTG cancellation noticeTherapeutic Goods Administration · Australia · accessed 2026-07-30 · source 5
6. Dronedarone/Multaq — Medsafe data sheet searchNew Zealand Medicines and Medical Devices Safety Authority (Medsafe) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient dronedarone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries