FDA label
What is dofetilide used for?
The FDA-approved uses of dofetilide, 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 for dofetilide lists 2 uses: Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence); Conversion of Atrial Fibrillation/Flutter.
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Dofetilide, capsule
Indications and Usage, quoted from the label by Accord Healthcare, Inc. (ANDA213338). Cross-references to other label sections are left out.
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence)
Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic.
In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES ).
Conversion of Atrial Fibrillation/Flutter
Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
Dofetilide capsules has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Source: DailyMed label, set id 4c1a5a6d-bd69-473c-8caa-d0d242b7708d, version 7, effective October 9, 2025. NDC 16729-490, one of 35 listings for this product.
Questions
What is dofetilide used for?
The FDA label for dofetilide lists 2 uses: Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence); Conversion of Atrial Fibrillation/Flutter.
What drug class is dofetilide?
FDA lists dofetilide 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.