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Calfactant Side Effects

In Summary

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

For the Consumer

Applies to calfactant: intratracheal suspension

Calfactant causes few side effects. There is a possibility that the baby will have breathing difficulties during the calfactant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with calfactant.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to calfactant: intratracheal suspension


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.


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]


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

Nervous system

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


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


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]


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

Not all side effects for calfactant may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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