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Corvert

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Corvert

Corvert Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Corvert (ibutilide fumarate injection) Injection is used to treat atrial fibrillation or atrial flutter. These heart rhythm disorders can lead to heart failure or stroke if not corrected. It is an anti-arrhythmic heart medication. This medication is available in generic form. Common side effects include headache, or nausea.

Dosage of Corvert is determined by the patient's weight, and is administered under physician supervision. Patients will be monitored. Corvert may interact with other heart rhythm medications including amiodarone, dofetilide, disopyramide, ibutilide, procainamide, quinidine, and sotalol. It can also interact with antihistamines including azatadine, azelastine, brompheniramine, chlorpheniramine, clemastine, hydroxyzinem, or promethazine used to treat nausea. Tell your doctor all medications you use. Corvert may be harmful to a fetus and is not recommended during pregnancy unless prescribed. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our Corvert (ibutilide fumarate injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Corvert in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Your caregivers will watch you closely with a heart monitor and other medical devices to check for serious side effects. Tell your caregivers if you feel short of breath or like you might pass out.

Less serious side effects may include:

  • headache; or
  • nausea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Corvert (Ibutilide Fumarate Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Corvert FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

CORVERT (ibutilide fumarate injection) Injection was generally well tolerated in clinical trials. Of the 586 patients with atrial fibrillation or atrial flutter who received CORVERT (ibutilide fumarate injection) in phase II/III studies, 149 (25%) reported medical events related to the cardiovascular system, including sustained polymorphic ventricular tachycardia (1.7%) and nonsustained polymorphic ventricular tachycardia (2.7%).

Other clinically important adverse events with an uncertain relationship to CORVERT (ibutilide fumarate injection) include the following (0.2% represents one patient): sustained monomorphic ventricular tachycardia (0.2%), nonsustained monomorphic ventricular tachycardia (4.9%), AV block (1.5%), bundle branch block (1.9%), ventricular extrasystoles (5.1%), supraventricular extrasystoles (0.9%), hypotension/postural hypotension (2.0%), bradycardia/sinus bradycardia (1.2%), nodal arrhythmia (0.7%), congestive heart failure (0.5%), tachycardia/sinus tachycardia/supraventricular tachycardia (2.7%), idioventricular rhythm (0.2%), syncope (0.3%), and renal failure (0.3%). The incidence of these events, except for syncope, was greater in the group treated with CORVERT (ibutilide fumarate injection) than in the placebo group.

Another adverse reaction that may be associated with the administration of CORVERT (ibutilide fumarate injection) was nausea, which occurred with a frequency greater than 1% more in ibutilide-treated patients than those treated with placebo.

The medical events reported for more than 1% of the placebo- and ibutilide-treated patients are shown in the following Table.

Treatment-Emergent Medical Events With Frequency of More Than 1% and Higher Than That of Placebo

Event Placebo
N=127
All Ibutilide
N=586
Patients Patients
n % n %
CARDIOVASCULAR
  Ventricular extrasystoles 1 0.8 30 5.1
  Nonsustained monomorphic VT 1 0.8 29 4.9
  Nonsustained polymorphic VT - - 16 2.7
  Hypotension 2 1.6 12 2.0
  Bundle branch block - - 11 1.9
  Sustained polymorphic VT - - 10 1.7
  AV block 1 0.8 9 1.5
  Hypertension - - 7 1.2
  QT segment prolonged - - 7 1.2
  Bradycardia 1 0.8 7 1.2
  Palpitation 1 0.8 6 1.0
  Tachycardia 1 0.8 16 2.7
GASTROINTESTINAL
  Nausea 1 0.8 11 1.9
CENTRAL NERVOUS SYSTEM
  Headache 4 3.1 21 3.6

In the post-cardiac surgery study (see Clinical Studies), similar types of medical events were reported. In the 1 mg ibutilide fumarate treatment group (N=70), 2 patients (2.9%) developed sustained polymorphic ventricular tachycardia and 2 other patients (2.9%) developed nonsustained polymorphic ventricular tachycardia. Polymorphic ventricular tachycardia was not reported in the 73 patients in the 0.5 mg dose group or in the 75 patients in the 0.25 mg dose group.

Read the entire FDA prescribing information for Corvert (Ibutilide Fumarate Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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