Antiarrhythmic / AF 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 an oral antiarrhythmic agent, structurally related to amiodarone, used to maintain sinus rhythm in selected patients with paroxysmal or persistent 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

For maintenance of sinus rhythm in atrial fibrillation/atrial flutter. Treatment should be initiated and monitored only under specialist supervision. 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 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 multichannel blocker with class I, II, III and IV antiarrhythmic properties, prolonging the action potential and refractory period while also slowing AV nodal conduction.

Prescribing in practice

Contraindicated in permanent atrial fibrillation and in heart failure or left ventricular systolic dysfunction, where it increases mortality, and it must be stopped if AF becomes permanent.
It is a potent enzyme and transporter inhibitor with important interactions, including raising digoxin and increasing the bleeding risk and exposure with some anticoagulants, and is contraindicated with drugs that markedly prolong the QT interval.
Hepatotoxicity, including rare severe liver injury, and pulmonary toxicity have been reported, so baseline and ongoing liver function checks are required.

Monitoring

Monitor ECG (including QT interval and rhythm), liver function and renal function periodically, and review for signs of heart failure or pulmonary toxicity.

Counselling the patient

Report breathlessness, ankle swelling, weight gain or a persistent cough promptly.
Seek urgent advice for jaundice, dark urine, severe tiredness or abdominal pain.
Avoid grapefruit juice, which raises levels of this medicine.

Evidence & guidelines

MHRA and NICE advise dronedarone is contraindicated in heart failure and permanent AF following trial evidence of increased cardiovascular harm.

Reference: ATHENA Trial (Hohnloser et al. NEJM 2009); ANDROMEDA Trial; PALLAS Trial; MHRA DSU 2011 (Hepatotoxicity); ESC 2020 AF Guidelines; SPC Multaq; 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.

Pathways