FDA label

What is propafenone used for?

The FDA-approved uses of propafenone, 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: “Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.”

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Propafenone Hydrochloride, capsule, extended release

Indications and Usage, quoted from the label by Upsher-Smith Laboratories, LLC (ANDA212744). Cross-references to other label sections are left out.

Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.

Usage Considerations:

  • The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.
  • Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
  • The effect of propafenone on mortality has not been determined [see Boxed Warning].

Source: DailyMed label, set id 8aa6f58a-2980-4caa-9c54-d55d69d5d132, version 6, effective December 11, 2025. NDC 0832-0740, one of 24 listings for this product.

Propafenone Hydrochloride, tablet, coated

Indications and Usage, quoted from the label by ANI Pharmaceuticals, Inc. (ANDA076550). Cross-references to other label sections are left out.

Propafenone Hydrochloride Tablets are indicated to:

  • prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease.
  • prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease.
  • treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.

Usage Considerations:

  • The use of Propafenone Hydrochloride Tablets in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use Propafenone Hydrochloride Tablets to control ventricular rate during AF.
  • Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
  • The use of Propafenone Hydrochloride Tablets in patients with chronic atrial fibrillation has not been evaluated.
  • Because of the proarrhythmic effects of Propafenone Hydrochloride Tablets, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.
  • The effect of propafenone on mortality has not been determined.

Source: DailyMed label, set id 8d1be333-be2b-4064-86a4-c2ad9ad07b83, version 4, effective September 12, 2025. NDC 62559-230, one of 15 listings for this product.

Questions

What is propafenone used for?

The FDA label says: “Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.”

What drug class is propafenone?

FDA lists propafenone 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.

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