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Calfactant Side Effects

In Summary

Commonly reported side effects of calfactant include: airway obstruction, cyanosis, and bradycardia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to calfactant: intratracheal suspension

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 child's doctor or get medical help right away if your child has 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Trouble breathing.
  • Blue or gray skin color.
  • Slow heartbeat.
  • Cough.

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 child's doctor or get medical help if your child has any side effects that bother your child 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 child's doctor. Call your child's 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 calfactant: intratracheal suspension

General

The most common adverse reactions, transient and not associated with serious complications or death, were cyanosis, airway obstruction, bradycardia, reflux of surfactant into the endotracheal tube, requirement for manual ventilation, and reintubation.

Cardiovascular

Very common (10% or more): Cyanosis (65%), patent ductus arteriosus (45%), bradycardia (34%)
Common (1% to 10%): Intraventricular hemorrhage (IVH, 7%), periventricular leukomalacia (PVL, 7%)[Ref]

Gastrointestinal

Very common (10% or more): Necrotizing enterocolitis (17%)

Nervous system

Very common (10% or more): Intracranial hemorrhage (36%), severe intracranial hemorrhage (12%)

Other

Very common (10% or more): Sepsis (28%)[Ref]

Respiratory

Very common (10% or more): Apnea (76%), airway obstruction (39%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), pulmonary air leaks (15%), pulmonary interstitial emphysema (10%)
Common (1% to 10%): Pulmonary hemorrhage (7%), reintubation (3%)[Ref]

References

1. "Product Information. Infasurf (calfactant)." ONY Inc, Amherst, NY.

Some side effects of calfactant may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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