Poractant Alfa: uses, dosing, side effects & brands
Poractant Alfa is a surfactant 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
- Drug class
- Surfactant
- Treats
- Newborn Respiratory Distress Syndrome
- Available as
- Suspension
- Sold as
- Curosurf
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How poractant alfa is dosed
From the FDA label for Curosurf (application BLA020744). Other poractant alfa products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Before administering CUROSURF, assure proper placement and patency of endotracheal tube ( 2.1 ) Administer intratracheally either in ( 2.1 ): Two divided aliquots through a 5 French end-hole catheter; or A single bolus through secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation Initial recommended dose is 2.5 mL/kg birth weight ( 2.2 ) Up to two repeat doses of 1.25 mL/kg birth weight may be administered at approximately 12-hour intervals ( 2.2 ) Maximum total dose (initial plus repeat doses) is 5 mL/kg ( 2.2 ) See Full Prescribing Information for instructions on preparation and administration of the CUROSURF suspension ( 2.3 , 2.4 ) 2.1 Important Administration Instructions For intratracheal administration only. CUROSURF should be administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. Before administering CUROSURF, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering CUROSURF. Allow the infant to stabilize before proceeding with dosing. Administer CUROSURF either: Intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter or Intratracheally in a single bolus through the secondary lumen of a dual lumen…
Poractant Alfa side effects
Common adverse reactions associated with the administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Studies in Premature Infants with Respiratory Distress Syndrome The safety data described below reflect exposure to CUROSURF at a single dose of 2.5 mL/kg (200 mg/kg), in 78 infants of 700-2000 grams birth weight with RDS requiring mechanical ventilation and a FiO 2 ≥ 0.60 (Study 1) [see Clinical Studies ( 14.1 )]. A total of 144 infants were studied after RDS developed and before 15 hours of age; 78 infants received CUROSURF 2.5 mL/kg single dose (200 mg/kg), and 66 infants received control treatment (disconnection from the ventilator and manual ventilation for 2 minutes). Transient adverse reactions seen with the administration of CUROSURF included bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. The rates of the most common serious…
Who shouldn’t take poractant alfa
None. None.
Every poractant alfa 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: Curosurf.
Poractant Alfa recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
What people report to the FDA about poractant alfa
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 29 reports naming poractant alfa, and the FDA flagged 93% 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:
- infantile apnoea4 reports
- coagulopathy2 reports
- drug administration error2 reports
- endotracheal intubation complication2 reports
- foetal exposure during pregnancy2 reports
- intestinal perforation2 reports
- necrotising colitis2 reports
- pneumonia2 reports
Read these as a signal, not a rate. A report does not mean poractant alfa 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.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
Related calculators
Frequently asked questions
What is poractant alfa?
Curosurf (Poractant Alfa) is a surfactant used to treat Newborn Respiratory Distress Syndrome.
What kind of drug is poractant alfa?
The FDA classifies poractant alfa as a surfactant. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take poractant alfa 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 poractant alfa 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 poractant alfa come in?
Across the brands we track, poractant alfa 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 poractant alfa?
We do not currently list a generic-labelled poractant alfa 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.
Has poractant alfa been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions poractant alfa. The most recent: CUROSURF (poractant alfa) (Mar 17, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Poractant Alfa: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/poractant-alfa
- MLA
- “Poractant Alfa: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/poractant-alfa.
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 poractant alfa on DailyMed (NIH) ↗.