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Flecainide

Aristocor · ATC code C01BC04

Also known as: Flecainid, Flekainid, Flecainide Acetate · Brand names: Aristocor, Flecadura, Flecainidacetat Aurobindo, Flecainidacetat Puren, Flecainidacetat Stada, Tambocor

Key facts
Active substance
Flecainide
ATC code
C01BC04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Flecainide is a class IC antiarrhythmic. Per the US prescribing information, it is used to prevent certain supraventricular and life-threatening ventricular arrhythmias.

What it is used for

  • Without structural heart disease: prevention of paroxysmal supraventricular tachycardias (PSVT) and paroxysmal atrial fibrillation/flutter (PAF) with disabling symptoms
  • Prevention of documented, life-threatening ventricular arrhythmias such as sustained ventricular tachycardia (initiated in hospital)
  • Not recommended after recent myocardial infarction, in chronic atrial fibrillation or for less severe ventricular arrhythmias

Dosing

  • PSVT and PAF: start 50 mg every 12 hours, increase by 50 mg bid every four days; maximum 300 mg/day
  • Sustained VT: start 100 mg every 12 hours, increase stepwise; most need no more than 150 mg every 12 hours, maximum 400 mg/day; no loading dose
  • Increase dosage no more often than once every four days (half-life 12 to 27 hours)
  • Severe renal impairment (creatinine clearance 35 mL/min/1.73 square meters or less): start 100 mg once daily (or 50 mg bid) with frequent plasma level monitoring
  • With amiodarone: reduce the usual flecainide dose by 50%

Contraindications

  • Pre-existing second- or third-degree AV block or bifascicular block without a pacemaker
  • Cardiogenic shock
  • Known hypersensitivity to flecainide

Important warnings

  • Boxed warning: in the CAST trial after myocardial infarction, excess mortality or non-fatal cardiac arrest (5.1% vs 2.3% with placebo); risk generally unacceptable in non-life-threatening arrhythmias
  • Ventricular proarrhythmia in atrial fibrillation/flutter; new or worsened arrhythmias may occur
  • Caution with a history of heart failure or myocardial dysfunction
  • Conduction effects may occur; for further warnings see the full text

Side effects

  • Dizziness 18.9%, visual disturbances 15.9%, dyspnea 10.3%, headache 9.6%, nausea 8.9%, fatigue 7.7%
  • Palpitation 6.1%, chest pain 5.4%, asthenia, tremor, constipation, edema, abdominal pain
  • Serious: proarrhythmic effects and heart failure

Interactions

  • Amiodarone may increase flecainide levels two-fold or more; reduce the dose
  • CYP2D6 inhibitors such as quinidine might increase flecainide levels
  • Digoxin levels rise by 13% to 19%; with propranolol both levels increase

Pregnancy and breastfeeding

  • Teratogenic in rabbits; use in pregnancy only if the potential benefit justifies the risk to the fetus
  • Excreted in human breast milk at high concentrations

Summary of the official product information, written with AI on 2026-10-29. 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

Patient information (US)

This product has no separate US patient information.

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.

Austria

  • AristocorViatris Austria Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • FlecaduraViatris Germany Gmbh · 1 register entry
  • FlecainidAaa-Pharma Gmbh, 1 A Pharma Gmbh, Micro Labs Gmbh, Ratiopharm Gmbh, Zentiva Pharma Gmbh, Hexal Ag · 8 register entries
  • Flecainidacetat AurobindoPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Flecainidacetat PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Flecainidacetat StadaStadapharm Gmbh · 1 register entry
  • TambocorViatris Healthcare Gmbh · 3 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 23 more European countries
Belgium
Apocard Retard, Flecainide Retard Eg, Flecainide Retard Sandoz, Flecainide Sandoz, Flecateva Retard, Tambocor
Bulgaria
Амаритон, Фелкарид, Флеканео
Croatia
Felkarid
Cyprus
Flecardia
Czechia
Amarhyton
Denmark
Flecainid Sandoz, Flecainid Stada
Finland
Flecainide Orion, Tambocor
France
Flecaine, Flecainide
Greece
Amarhyton, Flecainide/Flexmed, Flecardia, Flecarythm, Sanocard
Iceland
Flecainid Stada, Tambocor
Ireland
Flecainide Teva, Tambocor
Italy
Almarytm, Flecainide Aurobindo, Flecainide Doc Generici, Flecainide Eg, Flecainide Sandoz, Flecainide Teva, Fleiderina, Frequil
Luxembourg
Apocard Retard, Flecainide Retard Eg, Tambocor
Malta
Flecainide Acetate Aurobindo Pharma (Malta), Tambocor
Netherlands
Flecainide Acetate Aurobindo, Flecainide Acetate Ratiopharm, Flecainide Alkaloid-Int, Flecainideacetaat, Flecaïnideacetaat, Juneflecad, Tambocor
Norway
Flecainid Sandoz, Tambocor
Poland
Flecainide Acetate Holsten
Portugal
Amarhyton, Apocard, Flecainida Generis, Juneflecad
Romania
Amarhyton, Tambocor
Slovakia
Amarhyton, Flekainid Sandoz
Slovenia
Felkarid
Spain
Apocard, Flecainida Aurovitas, Flecainida Normon, Flecard
Sweden
Tambocor

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. Flecainide Acetate (ANI Pharmaceuticals, Inc.) – Prescribing Information, 2025-07-28. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5a12889a-52ce-4dc4-9240-22d126f071ac
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.