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Digibind Side Effects

Generic Name: digoxin immune fab

Note: This document contains side effect information about digoxin immune fab. Some of the dosage forms listed on this page may not apply to the brand name Digibind.

For the Consumer

Applies to digoxin immune fab: intravenous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Cough.
  • A fast heartbeat.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to digoxin immune fab: injectable powder for injection, injectable solution

General

The most common adverse events were worsening congestive heart failure, hypokalemia, and worsening atrial fibrillation.[Ref]

Cardiovascular

Very common (10% or more): Worsening congestive heart failure (13%)

Common (1% to 10%): Atrial fibrillation, transient postural hypertension[Ref]

Metabolic

Very common (10% or more): Hypokalemia (13%)[Ref]

Local

Common (1% to 10%): Phlebitis of the infusion-site vein[Ref]

Renal

Common (1% to 10%): Renal failure[Ref]

Renal failure occurred in one patient and was determined to be likely due to loss of digoxin inotropic support in combination with the patients underlying medical condition.[Ref]

Respiratory

Pulmonary edema and bilateral pleural effusion occurred in one patient and was determined to be likely due to loss of digoxin inotropic support in combination with the patients underlying medical condition.[Ref]

Common (1% to 10%): Pulmonary edema, bilateral pleural effusion[Ref]

References

1. "Product Information. DigiFab (digoxin immune FAB)." BTG International Inc, West Conshohocken, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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