FDA label
What is flecainide acetate used for?
The FDA-approved uses of flecainide acetate, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “In patients without structural heart disease, flecainide is indicated for the prevention of”
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Flecainide Acetate, tablet
Indications and Usage, quoted from the label by Amneal Pharmaceuticals of New York LLC (ANDA075442). Cross-references to other label sections are left out.
In patients without structural heart disease, flecainide is indicated for the prevention of
- paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms
- paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.
Flecainide is also indicated for the prevention of
- documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician, are life-threatening.
Use of flecainide for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.
Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.
Flecainide should not be used in patients with recent myocardial infarction (see Boxed WARNINGS ).
Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended (see Boxed WARNINGS ).
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide favorably affects survival or the incidence of sudden death.
Source: DailyMed label, set id ee9595d5-08a1-4529-9215-ddc3c7f929c4, version 11, effective June 11, 2026. NDC 53746-641, one of 56 listings for this product.
Questions
What is flecainide acetate used for?
The FDA label says: “In patients without structural heart disease, flecainide is indicated for the prevention of”
What drug class is flecainide acetate?
FDA lists flecainide acetate in the Antiarrhythmic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.