Calfactant: uses, dosing, side effects & brands
Calfactant is a medicine sold in the U.S. under one brand, for newborn respiratory distress syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Newborn Respiratory Distress Syndrome
- Available as
- Suspension
- Sold as
- Infasurf Preservative Free
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How calfactant is dosed
From the FDA label for Infasurf Preservative Free (application BLA020521). Other calfactant products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
2.1 Recommended Dosage The recommended dose of INFASURF is 3 mL/kg body weight at birth administered intratracheally through an endotracheal tube. INFASURF can be administered every 12 hours for a total of up to three doses. To reduce the risk of RDS in preterm neonates <29 weeks of gestational age at risk for RDS, administer INFASURF within 30 minutes after birth. 2.2 Preparation Instructions INFASURF does not require reconstitution. Do not dilute or sonicate. INFASURF does not need to reach room temperature before administration. Gently swirl or agitate the INFASURF intratracheal suspension vial for redispersion. Do not shake. Visually inspect the INFASURF intratracheal suspension for discoloration prior to administration. The color of the INFASURF intratracheal suspension should be off-white. Discard the INFASURF vial if the intratracheal suspension is discolored. Visible flecks in the intratracheal suspension and foaming at the surface are normal. Using a 20-gauge or larger needle and syringe to avoid excessive foaming, withdraw INFASURF from the vial. Discard unopened INFASURF vials stored at room temperature for more than 24 hours. Discard unused INFASURF after the initial vial entry. 2.3 Administration Instructions INFASURF should be administered by healthcare providers who are experienced in the acute care of neonates with RDS who require intubation. Two attendants…
Calfactant side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Acute Changes in Oxygenation and Lung Compliance [ see Warnings and Precautions (5.1 )] Administration-Related Adverse Reactions [see Warnings and Precautions (5.2) ] Intraventricular Hemorrhage and Periventricular Leukomalacia [ see Warnings and Precautions (5.3) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of INFASURF is based on the pooled safety population from three, randomized, active-controlled clinical trials that evaluated INFASURF to reduce the risk of respiratory distress syndrome (RDS) and rescue treatment of RDS [ see Clinical Studies (14) ], which included 1,554 preterm neonates who received at least one dose of INFASURF. The most common INFASURF administration-related adverse reactions were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). 6.2 Complications of RDS and Neurodevelopmental Outcomes Incidence of Common Complications of Prematurity The controlled trials of INFASURF…
Who shouldn’t take calfactant
None. None.
Every calfactant product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Infasurf Preservative Free.
What people report to the FDA about calfactant
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 10 reports naming calfactant, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- haematocrit decreased2 reports
- hypotension2 reports
- intraventricular haemorrhage2 reports
- intraventricular haemorrhage neonatal2 reports
- neonatal disorder2 reports
- periventricular leukomalacia2 reports
- pulmonary haemorrhage2 reports
- activated partial thromboplastin time prolonged1 reports
Read these as a signal, not a rate. A report does not mean calfactant caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is calfactant?
Infasurf Preservative Free (Calfactant) is a medication used to treat Newborn Respiratory Distress Syndrome.
Can you take calfactant with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run calfactant against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does calfactant come in?
Across the brands we track, calfactant is currently marketed as suspension, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic calfactant?
We do not currently list a generic-labelled calfactant product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Calfactant: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/calfactant
- MLA
- “Calfactant: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/calfactant.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for calfactant on DailyMed (NIH) ↗.