Iloprost side effects: what 923 FDA adverse event reports show

Iloprost · Aurlumyn · 31 reaction terms · 493 drug–reaction co-reports · data 2026-09-14

Drug class

Prostacycline

FDA label (Established Pharmacologic Class)

Brand names

Aurlumyn

openFDA label

Who reports

923 reports · 94% serious · 282 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

AURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes ( 1.1 ). 1.1 Frostbite AURLUMYN is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations.

FDA label, Indications and Usage

What it is

AURLUMYN contains iloprost, a synthetic analog of prostacyclin PGI 2 .

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 27 strongest signals

Reporting / coding artifact 7Not in label — unassessed 20

What the badges mean

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. 4 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
Pulmonary arterial hypertension	59	92.5 72.2–118.5ROR 98.7 · χ² 5,231 / p <1e-300	89.5 EB05 71.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 57.7	no trial data cached
Pulmonary hypertension	40	43.6 32.2–59.0ROR 45.5 · χ² 1,621 / p <1e-300	42.7 EB05 32.7 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 26.8 · 92% clinician	no trial data cached
Premature delivery	20	28.5 18.4–43.9ROR 29.1 · χ² 503 / p 1e-111	27.8 EB05 19.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 15.1 · ♀ 100% (drug 72%) · 100% clinician	no trial data cached
Premature baby	35	26.4 19.1–36.5ROR 27.4 · χ² 830 / p 8e-183	26.0 EB05 19.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.9 · 97% clinician	no trial data cached
Haematotoxicity	9	22.1 11.5–42.3ROR 22.3 · χ² 161 / p 4e-37	20.7 EB05 10.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.8	no trial data cached
Iron deficiency anaemia	8	19.8 9.9–39.5ROR 20.0 · χ² 125 / p 3e-29	18.0 EB05 8.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Caesarean section	10	19.4 10.4–35.9ROR 19.6 · χ² 156 / p 4e-36	18.1 EB05 9.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Cardiomegaly	8	14.7 7.4–29.3ROR 14.8 · χ² 89 / p 2e-21	12.2 EB05 5.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Erythema multiforme	6	14.6 6.6–32.5ROR 14.7 · χ² 63 / p 9e-16	11.0 EB05 4.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Multiple organ dysfunction syndrome	17	13.9 8.7–22.2ROR 14.1 · χ² 190 / p 1e-43	13.0 EB05 8.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Cyanosis (blue skin from low oxygen)	9	13.0 6.8–24.9ROR 13.1 · χ² 88 / p 3e-21	10.7 EB05 5.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Disseminated intravascular coagulation	8	12.9 6.5–25.7ROR 13.0 · χ² 76 / p 1e-18	10.3 EB05 4.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Haemoptysis	15	12.2 7.4–20.2ROR 12.4 · χ² 143 / p 2e-33	11.0 EB05 6.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Pulmonary oedema	24	12.2 8.2–18.1ROR 12.5 · χ² 236 / p 2e-53	11.5 EB05 7.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · 100% clinician	no trial data cached
Cardiogenic shock	7	11.2 5.3–23.3ROR 11.2 · χ² 55 / p 6e-14	8.2 EB05 3.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Drug ineffective for unapproved indication	27	11.0 7.6–16.0ROR 11.3 · χ² 237 / p 1e-53	10.3 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9 · 96% clinician	no trial data cached
Hyperthyroidism	7	11.0 5.3–23.0ROR 11.1 · χ² 54 / p 1e-13	8.0 EB05 3.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Transfusion	5	10.8 4.5–25.9ROR 10.9 · χ² 35 / p 1e-9	6.9 EB05 2.8 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Infusion site pain	6	10.7 4.8–23.7ROR 10.8 · χ² 43 / p 2e-11	7.3 EB05 3.2 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Exposure during pregnancy	29	10.6 7.4–15.2ROR 10.9 · χ² 244 / p 3e-55	9.9 EB05 7.0 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7 · ♀ 100% (drug 72%) · 100% clinician	no trial data cached
Cardiac failure (heart failure)	35	9.9 7.2–13.7ROR 10.3 · χ² 272 / p 2e-61	9.3 EB05 6.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.1 · 97% clinician	no trial data cached
Drug effect less than expected	6	9.7 4.4–21.5ROR 9.7 · χ² 38 / p 3e-10	6.6 EB05 3.0 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Maternal exposure during pregnancy	36	9.3 6.7–12.8ROR 9.6 · χ² 259 / p 1e-58	8.7 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2 · ♀ 97% (drug 72%) · 100% clinician	no trial data cached
Foetal exposure during pregnancy	33	9.2 6.6–12.9ROR 9.5 · χ² 235 / p 2e-53	8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6 · 97% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	6	9.1 4.1–20.1ROR 9.1 · χ² 35 / p 1e-9	6.1 EB05 2.9 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Drug administration error	7	5.1 2.4–10.7ROR 5.1 · χ² 19 / p 6e-6	4.0 EB05 2.1 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.2	no trial data cached
Intentional overdose	8	2.9 1.4–5.7ROR 2.9 · χ² 8 / p 0.002	2.6 EB05 1.4 · IC025 +0.2	Reporting / coding artifact	serious PRR 1.8	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
Pulmonary arterial hypertension	59	92.5 72.2–118.5ROR 98.7 · χ² 5,231 / p <1e-300	89.5 EB05 71.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 57.7	no trial data cached
Pulmonary hypertension	40	43.6 32.2–59.0ROR 45.5 · χ² 1,621 / p <1e-300	42.7 EB05 32.7 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 26.8 · 92% clinician	no trial data cached
Maternal exposure during pregnancy	36	9.3 6.7–12.8ROR 9.6 · χ² 259 / p 1e-58	8.7 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2 · ♀ 97% (drug 72%) · 100% clinician	no trial data cached
Cardiac failure (heart failure)	35	9.9 7.2–13.7ROR 10.3 · χ² 272 / p 2e-61	9.3 EB05 6.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.1 · 97% clinician	no trial data cached
Premature baby	35	26.4 19.1–36.5ROR 27.4 · χ² 830 / p 8e-183	26.0 EB05 19.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.9 · 97% clinician	no trial data cached
Foetal exposure during pregnancy	33	9.2 6.6–12.9ROR 9.5 · χ² 235 / p 2e-53	8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6 · 97% clinician	no trial data cached
Exposure during pregnancy	29	10.6 7.4–15.2ROR 10.9 · χ² 244 / p 3e-55	9.9 EB05 7.0 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7 · ♀ 100% (drug 72%) · 100% clinician	no trial data cached
Drug ineffective for unapproved indication	27	11.0 7.6–16.0ROR 11.3 · χ² 237 / p 1e-53	10.3 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9 · 96% clinician	no trial data cached
Pulmonary oedema	24	12.2 8.2–18.1ROR 12.5 · χ² 236 / p 2e-53	11.5 EB05 7.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · 100% clinician	no trial data cached
Premature delivery	20	28.5 18.4–43.9ROR 29.1 · χ² 503 / p 1e-111	27.8 EB05 19.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 15.1 · ♀ 100% (drug 72%) · 100% clinician	no trial data cached
Multiple organ dysfunction syndrome	17	13.9 8.7–22.2ROR 14.1 · χ² 190 / p 1e-43	13.0 EB05 8.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Haemoptysis	15	12.2 7.4–20.2ROR 12.4 · χ² 143 / p 2e-33	11.0 EB05 6.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Caesarean section	10	19.4 10.4–35.9ROR 19.6 · χ² 156 / p 4e-36	18.1 EB05 9.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Cyanosis (blue skin from low oxygen)	9	13.0 6.8–24.9ROR 13.1 · χ² 88 / p 3e-21	10.7 EB05 5.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Haematotoxicity	9	22.1 11.5–42.3ROR 22.3 · χ² 161 / p 4e-37	20.7 EB05 10.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.8	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.

Pulmonary arterial hypertension — n=59, PRR 92.5
Pulmonary hypertension — n=40, PRR 43.6
Premature delivery — n=20, PRR 28.5
Premature baby — n=35, PRR 26.4
Pulmonary oedema — n=24, PRR 12.2
Cardiac failure — n=35, PRR 9.9

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 Iloprost?

In FDA FAERS, the most frequently co-reported reaction terms for Iloprost are pulmonary arterial hypertension, pulmonary hypertension, cardiac failure, premature baby, pulmonary oedema, premature delivery. 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 Iloprost have an FDA boxed warning?

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

Do FAERS signals prove that Iloprost 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 34036fc0-6832-d066-e063-6394a90a18a4, effective 20260813; matched on openfda.generic_name.exact:"ILOPROST")
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, 31 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.