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dronedarone

Multaq · ATC code C01BD07

Brand names: Multaq, Dronedaron Al, Dronedaron Aristo, Dronedaron Beta, Dronedaron Puren, Dronedaron Ratiopharm

Key facts
Active substance
dronedarone
ATC code
C01BD07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
MULTAQ 400 mg film-coated tablets
Marketing authorisation holder
Sanofi Winthrop Industrie
Information as of
2026-10-27

Key facts

Dronedarone (MULTAQ) is an antiarrhythmic agent. It is used for maintenance of sinus rhythm after successful cardioversion in adult, clinically stable patients with paroxysmal or persistent atrial fibrillation.

What it is used for

  • Maintenance of sinus rhythm after cardioversion in paroxysmal or persistent AF (adults, clinically stable)
  • Due to its safety profile, only after alternative treatment options have been considered
  • Not for patients with left ventricular systolic dysfunction or heart failure

Dosing

  • 400 mg twice daily: one tablet with the morning meal and one with the evening meal
  • Stop Class I or III antiarrhythmics before starting; switching from amiodarone under specialist supervision
  • No dose adjustment in mild or moderate hepatic impairment or in non-severe renal impairment
  • Patients ≥75 years with co-morbidities: monitor ECG and signs of heart failure regularly
  • Do not take with grapefruit juice; do not double a missed dose

Contraindications

  • Second- or third-degree AV block, complete bundle branch block, sinus node dysfunction (unless a functioning pacemaker is present)
  • Bradycardia <50 bpm
  • Permanent AF; haemodynamically unstable conditions
  • History of, or current, heart failure or left ventricular systolic dysfunction
  • Liver or lung toxicity from previous amiodarone; severe hepatic or renal impairment (CrCl <30 ml/min)
  • Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir)

Important warnings

  • Regular assessment of cardiac, hepatic and pulmonary function
  • Excess cardiovascular death, stroke and heart failure in a study in permanent AF; ECG at least every 6 months, stop if permanent AF develops
  • New or worsening heart failure has been reported
  • Monitor co-administered digoxin and anticoagulants

Side effects

  • Most frequent: diarrhoea (9%), nausea (5%), vomiting (2%), fatigue and asthenia (7%)
  • Discontinuation due to adverse reactions in 11.8% of patients, mostly gastrointestinal

Interactions

  • Metabolised by CYP3A4; inhibitors and inducers alter levels
  • Moderate CYP3A4, mild CYP2D6 and potent P-gp inhibitor: may raise levels of their substrates
  • Pharmacodynamic interactions with beta-blockers, calcium antagonists and digitalis; caution with drugs inducing torsades de pointes

Pregnancy and breastfeeding

  • Not recommended during pregnancy; women of childbearing potential must use effective contraception during treatment and for 7 days after the final dose

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • MultaqSanofi Winthrop Industrie · EMEA/H/C/001043

Source: European Medicines Agency (EMA), product information

Germany

  • Dronedaron AlAliud Pharma Gmbh · 1 register entry
  • Dronedaron AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Dronedaron BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Dronedaron PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Dronedaron RatiopharmRatiopharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Brand names in 11 more European countries
Croatia
Dronedaron Pliva
Denmark
Dronedaron Aristo, Dronedarone Stada
Finland
Dronedarone Stada
Hungary
Dronedaron Aristo, Dronedaron Ratiopharm, Dronedaron Teva, Dronedarone Stada
Iceland
Dronedarone Stada, Dronedarone Teva, Multaq
Italy
Dronedarone Aristo, Dronedarone Aurobindo
Liechtenstein
Multaq
Norway
Dronedaron Aristo, Dronedarone Teva, Multaq
Portugal
Dronedarona Generis
Spain
Dronedarona Aristo, Dronedarona Aurovitas, Dronedarona Teva
Sweden
Dronedaron Aristo, Dronedarone Stada, Dronedarone Teva

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Multaq – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/multaq-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.