Ibutilide
Antiarrhythmics, Class Iii
- Drug class
- Antiarrhythmics, Class Iii
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 1
- Products on record
- 1
Overview
Plain-language summary, compiled from the cited regulatory records
Ibutilide is an antiarrhythmic medication belonging to Class III [1]. It is approved for the rapid conversion of recent-onset atrial fibrillation or atrial flutter to a normal sinus rhythm [1]. Ibutilide fumarate injection is the form used for this indication [1].
The effectiveness of ibutilide has not been established in patients whose arrhythmias have lasted longer than 90 days [1]. Patients with longer-duration atrial arrhythmias are generally less likely to respond to treatment with ibutilide fumarate [1]. Ibutilide fumarate injection can cause potentially fatal arrhythmias, and therefore, it must be administered in an environment where continuous cardiac monitoring and resuscitation equipment are available [1].
This information is derived from the product's labeling [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | November 4, 2025 |
USUnited States· FDA
1 product
Uses
INDICATIONS AND USAGE
Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to ibutilide fumarate.
The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration. LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT Ibutilide fumarate can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation.
7% of treated patients during, or within a number of hours of, use of Ibutilide fumarate. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia ). It is essential that Ibutilide fumarate be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia.
Drug interactions
Known interactions involving Ibutilide. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 0cf8724a-f0d1-4c… · revised November 4, 2025 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.