What the label lists and what reports show
Poractant alfa side effects
Poractant alfa's FDA label: “The rates of the most common serious complications associated with prematurity and RDS observed in Study 1 are shown in Table 1.” FAERS holds 714 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is neonatal hypoxia (120 reports).
- No generic listed
Check it at the source: the poractant alfa FDA label on DailyMed (effective December 10, 2025, Chiesi USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe rates of the most common serious complications associated with prematurity and RDS observed in Study 1 are shown in Table 1.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | CUROSURF 2.5 mL/kgn=78 | CONTROL*n=66 |
|---|---|---|
| Acquired Pneumonia | 17% | 21% |
| Acquired Septicemia | 14% | 18% |
| Bronchopulmonary Dysplasia | 18% | 22% |
| Intracranial Hemorrhage | 51% | 64% |
| Patent Ductus Arteriosus | 60% | 48% |
| Pneumothorax | 21% | 36% |
| Pulmonary Interstitial Emphysema | 21% | 38% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedCommon 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. …
Source: FDA drug label, Chiesi USA, Inc., effective December 10, 2025 (SPL set 99bef307-00bd-4379-9f45-ede1380e74d4), via openFDA; the full label on DailyMed
What do FAERS reports show?
714 reports list poractant alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 216 are coded as a death and 95 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Poractant alfa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions