Prescription medicine
Ibutilide Brand names: Corvert
Ibutilide (Corvert) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the ibutilide FDA label on DailyMed (effective January 25, 2024, Pharmacia & Upjohn Company LLC); the NDA 20491 record on Drugs@FDA; every ibutilide label on DailyMed.
Highlights of the record
FDA label of January 25, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
LIFE-THREATENING ARRHYTHMIAS–APPROPRIATE TREATMENT ENVIRONMENT.
CORVERT 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. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of CORVERT. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia ). It is essential that CORVERT 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. Patients with atrial fibrillation of more than 2 to 3 days' duration must be adequately anticoagulated, generally for at least 2 weeks. CHOICE OF PATIENTS Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm (see CLINICAL STUDIES ) and treatments to maintain sinus rhythm carry risks. Patients to be treated with CORVERT, therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of CORVERT, and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.
Used for
From the label: indications and usageCORVERT Injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm.
Forms and strengths
- 0.1 mg/ml
- 1 mg/10ml
Injection (solution).
On the market
- Earliest approval on file
- December 28, 1995 Corvert, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first January 11, 2010; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 29 through July 30, 2026
What is ibutilide used for?
From the label: indications and usageCORVERT 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 CORVERT. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.
Conditions named in the indications of ibutilide's FDA labels, with every medicine labeled for each:
From other ibutilide labelsAtrial fibrillation: INDICATIONS AND USAGE CORVERT Injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm.
FDA pharmacologic class: Antiarrhythmic.
Source: FDA drug label (Corvert), NDA020491 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective January 25, 2024 (SPL set b7d717ed-022d-4459-b5e6-098c2a8b7427), via openFDA; the full label on DailyMed
Is there a generic for ibutilide (Corvert)?
The FDA approved the first generic ibutilide on January 11, 2010. 4 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ibutilide from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2010 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ibutilide label say about other medicines?
The ibutilide label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name ibutilide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Coadministration of digoxin did not have effects on either the safety or efficacy of ibutilide in the clinical trials. |
| Magnesium sulfate | warnings | Other cases were managed with cardiac pacing and magnesium sulfate infusions. |
Other labels that name ibutilide
Source: FDA drug label (Corvert), NDA020491 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective January 25, 2024 (SPL set b7d717ed-022d-4459-b5e6-098c2a8b7427), via openFDA; the full label on DailyMed
What do FAERS reports show for ibutilide?
The FDA Adverse Event Reporting System holds 29 reports that list ibutilide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ibutilide?
2 other medicines are given the same way (intravenous) and in the same FDA class as ibutilide or labeled mainly for the same use (atrial fibrillation), the same class first. Atrial fibrillation lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sotalol | Atrial fibrillation | none listed | n/a | No current entry |
| Dextrose and heparin | Atrial fibrillation | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other antiarrhythmics
- the pharmacologic class, with prices and generics
- Ibutilide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other