Dofetilide: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Dofetilide. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| 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 across placebo-controlled trial tables summarized in current labeling.
Labeled uses
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.
Medical disclaimer: Always consult a qualified healthcare professional about any medication.