Dofetilide: Side Effects, Uses & Monitoring
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsule is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in p
- Data source
- FDA labeling via NIH DailyMed (label a10633a6…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Ventricular arrhythmias*^ | 15.8% |
| Ventricular tachycardia^ | 13.2% |
| Ventricular tachycardia | 12.4% |
| Headache | 11% |
| Torsade de pointes | 10.5% |
| Chest pain | 10% |
| Dizziness | 8% |
| Respiratory tract infection | 7% |
| Dyspnea | 6% |
| Nausea | 5% |
| Flu syndrome | 4% |
| Insomnia | 4% |
| Accidental injury | 3% |
| Back pain | 3% |
| Diarrhea | 3% |
| Rash | 3% |
| Abdominal pain | 3% |
| Ventricular fibrillation | 2.6% |
| Av block | 1.5% |
| Bundle branch block | 0.5% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsule is 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 capsule 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 capsule is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsule has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Conditions associated with Dofetilide in labeling
Frequently Asked Questions
What is Dofetilide used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Dofetilide?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Dofetilide. Individual risk varies.
Does Dofetilide require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Dofetilide.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.