Class III antiarrhythmic Pregnancy: Not recommended during pregnancy or in women of childbearing potential not using contraception; use effective contraception during treatment and for 7 days after the final dose. Do not breast-feed during treatment and for 7 days after the final dose.

Dronedarone

Brand names: Multaq

Dronedarone is a multichannel antiarrhythmic drug used to maintain sinus rhythm in adults with non-permanent atrial fibrillation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 400 mg twice daily

Route: Oral

Frequency: Twice daily - one tablet with the morning meal and one tablet with the evening meal

Treatment should be initiated and monitored only under specialist supervision. Treatment with Class I or III antiarrhythmics (flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting. Swallow tablet whole; do not divide. Avoid grapefruit juice. If a dose is missed, take the next dose at the regular scheduled time - do not double the dose.

Dose adjustments

Renal

No dose adjustment required in mild or moderate renal impairment; contraindicated in severe renal impairment (CrCl <30 mL/min).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or excipients
Second/third-degree AV block, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction defects or sick sinus syndrome (except with a functioning pacemaker)
Bradycardia <50 bpm
Permanent AF of >=6 months (or unknown duration) where sinus rhythm restoration is no longer pursued
Unstable haemodynamic conditions; history of or current heart failure or left ventricular systolic dysfunction
Liver/lung toxicity related to previous amiodarone use
Co-administration with potent CYP3A4 inhibitors or with dabigatran; QTc Bazett >=500 ms; severe hepatic impairment; severe renal impairment (CrCl <30 mL/min)

Side effects

Diarrhoea
Nausea and vomiting
Abdominal pain / dyspepsia
Fatigue and asthenia
Blood creatinine increased and QTc Bazett prolonged

Interactions

Potent CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone, ritonavir) - contraindicated
Dabigatran - contraindicated
Class I and III antiarrhythmics and other QT-prolonging / torsades-inducing drugs (phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine, certain oral macrolides) - contraindicated
Digoxin and anticoagulants - monitoring required
Grapefruit juice - avoid

Clinical monograph

How it works

It is a benzofuran derivative with mixed class I to IV antiarrhythmic actions, blocking sodium, potassium and calcium channels and exerting antiadrenergic effects to stabilise cardiac rhythm.

Prescribing in practice

It is contraindicated in permanent atrial fibrillation and in heart failure or left ventricular systolic dysfunction, where it has been associated with increased mortality and cardiovascular events.
Hepatotoxicity, including cases of serious liver injury, has been reported, so liver function should be checked as advised by the MHRA.
As an enzyme inhibitor it interacts with several drugs including digoxin and certain statins, and it can raise serum creatinine without a true fall in renal function.

Monitoring

Monitor cardiac rhythm, liver function and pulmonary and renal status, and reassess for progression to permanent atrial fibrillation.

Counselling the patient

Report yellowing of the skin or eyes, dark urine, or unusual tiredness.
Report breathlessness or new cough, which should be investigated.
Attend for scheduled blood tests and rhythm checks.

Evidence & guidelines

The ATHENA trial supported dronedarone's role in non-permanent atrial fibrillation, while the PALLAS trial demonstrated harm in permanent atrial fibrillation, which informs MHRA-restricted use.

Reference: NICE TA197; ESC AF guidelines; MHRA Drug Safety Update; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways