Calfactant: Side Effects, Uses & Monitoring
INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS.
- Data source
- FDA labeling via NIH DailyMed (label 315c128a…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Apnea | 61% |
| Patent ductus arteriosus | 48% |
| Intracranial hemorrhage | 31% |
| Sepsis | 22% |
| Pulmonary air leaks | 22% |
| Pulmonary interstitial emphysema | 17% |
| Pulmonary hemorrhage | 7% |
| Necrotizing enterocolitis | 5% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.
Frequently Asked Questions
What is Calfactant used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Calfactant?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Calfactant. Individual risk varies.
Does Calfactant require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Calfactant.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.