Poractant Alfa side effects: what 714 FDA adverse event reports show

Poractant Alfa · Curosurf · 12 reaction terms · 220 drug–reaction co-reports · data 2026-09-14

Drug class

Surfactant

FDA label (Established Pharmacologic Class)

Brand names

Curosurf

openFDA label

Who reports

714 reports · 93% serious · 216 with death outcome · 35% female

openFDA FAERS counts, all years, deduplication not applied

Used for

CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants. ( 1 )

FDA label, Indications and Usage

What it is

Poractant alfa is an extract of natural porcine lung (pulmonary) surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight surfactant associated proteins (SP).

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 9 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 4Not in label — unassessed 3

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 3 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pneumothorax	33	61.3 43.9–85.5ROR 64.2 · χ² 1,894 / p <1e-300	59.2 EB05 44.1 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.9 · ♀ 14% (drug 35%) · 91% clinician	no trial data cached
Product complaint	34	40.1 28.9–55.6ROR 42.0 · χ² 1,256 / p 2e-275	39.2 EB05 29.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=29 · 97% clinician	no trial data cached
Product administration error	26	38.3 26.3–55.9ROR 39.7 · χ² 907 / p 1e-199	37.3 EB05 26.7 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 57.8 · 100% clinician	no trial data cached
Prescribed overdose	20	30.4 19.7–46.8ROR 31.2 · χ² 539 / p 1e-119	29.6 EB05 20.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 32.0 · 100% clinician	no trial data cached
Pulmonary hypertension	19	26.7 17.1–41.6ROR 27.4 · χ² 445 / p 5e-99	26.1 EB05 17.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Ill-defined disorder	50	24.2 18.5–31.6ROR 25.9 · χ² 1,090 / p 3e-239	24.0 EB05 18.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.6 · 98% clinician	no trial data cached
Drug effect less than expected	6	12.5 5.6–27.7ROR 12.6 · χ² 53 / p 2e-13	8.9 EB05 3.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Drug administration error	13	12.3 7.2–21.0ROR 12.5 · χ² 124 / p 5e-29	10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 20.6	no trial data cached
Premature baby	7	6.8 3.3–14.2ROR 6.9 · χ² 29 / p 3e-8	5.0 EB05 2.6 · IC025 +1.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 4.3	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Ill-defined disorder	50	24.2 18.5–31.6ROR 25.9 · χ² 1,090 / p 3e-239	24.0 EB05 18.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.6 · 98% clinician	no trial data cached
Product complaint	34	40.1 28.9–55.6ROR 42.0 · χ² 1,256 / p 2e-275	39.2 EB05 29.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=29 · 97% clinician	no trial data cached
Pneumothorax	33	61.3 43.9–85.5ROR 64.2 · χ² 1,894 / p <1e-300	59.2 EB05 44.1 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.9 · ♀ 14% (drug 35%) · 91% clinician	no trial data cached
Product administration error	26	38.3 26.3–55.9ROR 39.7 · χ² 907 / p 1e-199	37.3 EB05 26.7 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 57.8 · 100% clinician	no trial data cached
Prescribed overdose	20	30.4 19.7–46.8ROR 31.2 · χ² 539 / p 1e-119	29.6 EB05 20.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 32.0 · 100% clinician	no trial data cached
Pulmonary hypertension	19	26.7 17.1–41.6ROR 27.4 · χ² 445 / p 5e-99	26.1 EB05 17.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Drug administration error	13	12.3 7.2–21.0ROR 12.5 · χ² 124 / p 5e-29	10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 20.6	no trial data cached
Premature baby	7	6.8 3.3–14.2ROR 6.9 · χ² 29 / p 3e-8	5.0 EB05 2.6 · IC025 +1.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 4.3	no trial data cached
Drug effect less than expected	6	12.5 5.6–27.7ROR 12.6 · χ² 53 / p 2e-13	8.9 EB05 3.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Pulmonary arterial hypertension	4	8.1 3.0–21.4ROR 8.1 · χ² 18 / p 1e-5	4.8 EB05 2.0 · IC025 +0.4	Not in label — unassessed	serious PRR 5.1	no trial data cached
Device occlusion	4	8.4 3.2–22.4ROR 8.5 · χ² 19 / p 5e-6	5.0 EB05 2.0 · IC025 +0.4 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
No therapeutic response	4	9.5 3.6–25.2ROR 9.5 · χ² 23 / p 1e-6	5.5 EB05 2.2 · IC025 +0.5 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Prescribed overdose — n=20, PRR 30.4
Ill-defined disorder — n=50, PRR 24.2

✓ A hand-written Bradford Hill causality assessment exists for this drug: Erythropoiesis-stimulating agents (darbepoetin alfa) ↔ Mortality / cardiovascular risk.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Poractant Alfa?

In FDA FAERS, the most frequently co-reported reaction terms for Poractant Alfa are ill-defined disorder, pneumothorax, prescribed overdose, pulmonary hypertension, premature baby, pulmonary arterial hypertension. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Poractant Alfa have an FDA boxed warning?

No. The FDA label retrieved for Poractant Alfa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Poractant Alfa causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 99bef307-00bd-4379-9f45-ede1380e74d4, effective 20251210; matched on openfda.generic_name.exact:"PORACTANT ALFA")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 12 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.