Drug · FAERS side-effect profile with label screen
Epoprostenol side effects: what 13,011 FDA adverse event reports show
Drug class
Prostanoid vasodilator
FDA label, Indications wording
Who reports
13,011 reports · 86% serious · 2,685 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Epoprostenol for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
FDA label, Indications and Usage
What it is
Epoprostenol sodium is the sodium salt of epoprostenol, formulated as a sterile lyophilized cake or powder for intravenous (IV) administration.
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 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 6Likely indication confounding 3Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 24
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 1,020 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Catheter management | 524 | 2,268.8 1,987.7–2,589.7ROR 2,364.0 · χ² 488,341 / p <1e-300 | 904.0 EB05 840.8 · IC025 +8.8 3/3 methods agree | Reporting / coding artifact | serious n=508 · 94% clinician | no trial arm names this drug |
| Catheter site pruritus | 416 | 1,475.5 1,292.6–1,684.3ROR 1,524.2 · χ² 317,095 / p <1e-300 | 739.3 EB05 681.6 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious n=362 · 94% clinician | no trial arm names this drug |
| Blood culture negative | 34 | 1,460.2 916.9–2,325.4ROR 1,464.0 · χ² 25,082 / p <1e-300 | 532.1 EB05 398.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=32 · 100% clinician | no trial arm names this drug |
| Catheter site scab | 43 | 1,138.8 770.1–1,684.1ROR 1,142.6 · χ² 27,816 / p <1e-300 | 511.8 EB05 395.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=34 · 91% clinician | no trial arm names this drug |
| Catheter site dermatitis | 15 | 1,135.0 585.2–2,201.3ROR 1,136.3 · χ² 9,263 / p <1e-300 | 358.8 EB05 230.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Catheter site rash | 182 | 1,099.6 911.0–1,327.3ROR 1,115.2 · χ² 117,420 / p <1e-300 | 608.4 EB05 537.8 · IC025 +7.6 3/3 methods agree | Labeled (related wording) related wording | serious n=164 · 92% clinician | no trial arm names this drug |
| Gastritis hypertrophic | 16 | 1,017.0 543.1–1,904.3ROR 1,018.2 · χ² 9,292 / p <1e-300 | 355.9 EB05 232.3 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial arm names this drug |
| Catheter site vesicles | 73 | 1,000.0 746.5–1,339.5ROR 1,005.6 · χ² 44,103 / p <1e-300 | 528.6 EB05 434.4 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=65 · 92% clinician | no trial arm names this drug |
| Catheter culture positive | 27 | 975.1 604.1–1,574.0ROR 977.1 · χ² 15,684 / p <1e-300 | 422.8 EB05 305.2 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=27 · 100% clinician | no trial arm names this drug |
| Catheter site irritation | 112 | 876.7 696.5–1,103.5ROR 884.3 · χ² 62,572 / p <1e-300 | 515.3 EB05 440.1 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=106 · 95% clinician | no trial arm names this drug |
| Catheter site dryness | 12 | 733.4 370.1–1,453.2ROR 734.1 · χ² 5,514 / p <1e-300 | 279.0 EB05 170.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial arm names this drug |
| Catheter site discharge | 302 | 612.1 536.6–698.2ROR 626.6 · χ² 132,580 / p <1e-300 | 430.1 EB05 390.9 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=281 · 94% clinician | no trial arm names this drug |
| Catheter site erythema | 563 | 594.8 540.8–654.3ROR 621.7 · χ² 242,447 / p <1e-300 | 426.8 EB05 398.0 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=495 · 93% clinician | no trial arm names this drug |
| Transplant evaluation | 122 | 507.5 414.2–621.8ROR 512.3 · χ² 46,360 / p <1e-300 | 362.9 EB05 312.0 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=121 | no trial arm names this drug |
| Heart and lung transplant | 30 | 486.4 323.3–732.0ROR 487.6 · χ² 10,758 / p <1e-300 | 301.1 EB05 221.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=30 | no trial arm names this drug |
| Catheter site discolouration | 26 | 464.2 300.0–718.3ROR 465.1 · χ² 8,945 / p <1e-300 | 284.3 EB05 203.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=25 · 92% clinician | no trial arm names this drug |
| Catheter site inflammation | 114 | 420.3 342.2–516.3ROR 424.0 · χ² 37,382 / p <1e-300 | 315.0 EB05 269.4 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=97 · 95% clinician | no trial arm names this drug |
| Catheter site warmth | 31 | 417.5 281.2–619.8ROR 418.5 · χ² 9,872 / p <1e-300 | 274.8 EB05 202.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=28 · 90% clinician | no trial arm names this drug |
| Catheter site swelling | 144 | 299.9 251.2–358.1ROR 303.2 · χ² 35,837 / p <1e-300 | 244.3 EB05 212.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=136 · 94% clinician | no trial arm names this drug |
| Device alarm issue | 282 | 299.1 263.7–339.3ROR 305.7 · χ² 70,274 / p <1e-300 | 247.7 EB05 224.4 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=244 · 94% clinician | no trial arm names this drug |
| Paracentesis | 96 | 296.8 238.8–368.8ROR 299.0 · χ² 23,598 / p <1e-300 | 238.4 EB05 201.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=96 · 94% clinician | no trial arm names this drug |
| Catheter site erosion | 13 | 264.8 147.3–476.3ROR 265.1 · χ² 2,707 / p <1e-300 | 170.7 EB05 106.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Catheter placement | 256 | 257.1 225.6–293.1ROR 262.3 · χ² 56,004 / p <1e-300 | 217.9 EB05 196.4 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=243 | no trial arm names this drug |
| Catheter site pain | 341 | 250.1 223.4–279.9ROR 256.8 · χ² 72,880 / p <1e-300 | 213.6 EB05 195.2 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious n=309 · 94% clinician | no trial arm names this drug |
| Catheter removal | 46 | 239.7 175.9–326.6ROR 240.5 · χ² 9,293 / p <1e-300 | 191.9 EB05 149.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=45 | no trial arm names this drug |
| Cardiac failure high output | 29 | 223.7 151.7–329.9ROR 224.2 · χ² 5,442 / p <1e-300 | 173.9 EB05 127.0 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=29 · 97% clinician | no trial arm names this drug |
| Portopulmonary hypertension | 10 | 201.1 104.2–388.3ROR 201.3 · χ² 1,594 / p <1e-300 | 133.7 EB05 77.6 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial arm names this drug |
| Catheter site cellulitis | 31 | 201.1 138.4–292.0ROR 201.5 · χ² 5,302 / p <1e-300 | 161.0 EB05 118.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=30 · 97% clinician | no trial arm names this drug |
| Medical device change | 58 | 196.1 149.4–257.5ROR 197.0 · χ² 9,848 / p <1e-300 | 165.2 EB05 132.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=56 · 93% clinician | no trial arm names this drug |
| Catheter site haemorrhage | 253 | 184.8 162.5–210.3ROR 188.5 · χ² 41,280 / p <1e-300 | 163.7 EB05 147.4 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=232 | no trial arm names this drug |
| Acute right ventricular failure | 15 | 158.9 93.5–270.1ROR 159.1 · χ² 1,998 / p <1e-300 | 122.4 EB05 78.7 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial arm names this drug |
| Catheter site nodule | 14 | 156.7 90.5–271.2ROR 156.8 · χ² 1,832 / p <1e-300 | 119.8 EB05 75.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Catheter site infection | 328 | 155.0 138.6–173.4ROR 159.0 · χ² 45,601 / p <1e-300 | 140.2 EB05 127.9 · IC025 +6.7 3/3 methods agree | Labeled (related wording) related wording | serious n=311 · 91% clinician | no trial arm names this drug |
| Catheter site related reaction | 62 | 152.5 117.6–197.8ROR 153.2 · χ² 8,377 / p <1e-300 | 133.6 EB05 107.9 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=58 · 97% clinician | no trial arm names this drug |
| Catheter site induration | 13 | 148.6 84.2–262.3ROR 148.8 · χ² 1,611 / p <1e-300 | 113.7 EB05 70.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Abdominal cavity drainage | 35 | 145.2 102.8–205.2ROR 145.6 · χ² 4,462 / p <1e-300 | 124.3 EB05 93.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=35 · 97% clinician | no trial arm names this drug |
| Pulmonary veno-occlusive disease | 56 | 141.0 107.4–185.2ROR 141.6 · χ² 7,023 / p <1e-300 | 124.2 EB05 99.2 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=56 · 95% clinician | no trial arm names this drug |
| Right ventricular failure | 560 | 138.8 127.5–151.0ROR 145.0 · χ² 70,345 / p <1e-300 | 127.2 EB05 118.6 · IC025 +6.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 85.1 | no trial arm names this drug |
| Pulmonary arterial hypertension | 1,105 | 132.3 124.7–140.3ROR 144.5 · χ² 132,912 / p <1e-300 | 122.0 EB05 116.1 · IC025 +6.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 82.4 | no trial arm names this drug |
| Device damage | 61 | 131.5 101.4–170.7ROR 132.1 · χ² 7,177 / p <1e-300 | 117.2 EB05 94.5 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=55 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Epoprostenol only as a background or rescue medication (NCT01266265, NCT03451591); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 2,777 | 7.9 7.7–8.2ROR 9.8 · χ² 17,235 / p <1e-300 | 7.9 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial arm names this drug |
| Headache | 2,295 | 5.9 5.7–6.1ROR 7.0 · χ² 9,642 / p <1e-300 | 5.9 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 2,170 | 5.5 5.2–5.7ROR 6.3 · χ² 8,105 / p <1e-300 | 5.4 EB05 5.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial arm names this drug |
| Nausea | 1,960 | 4.0 3.9–4.2ROR 4.5 · χ² 4,588 / p <1e-300 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial arm names this drug |
| Pain in jaw | 1,854 | 112.8 107.9–117.8ROR 131.3 · χ² 191,905 / p <1e-300 | 105.2 EB05 101.3 · IC025 +6.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 96.7 | no trial arm names this drug |
| Death | 1,325 | 2.5 2.4–2.6ROR 2.6 · χ² 1,218 / p 3e-267 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.7 | no trial arm names this drug |
| Flushing | 1,169 | 18.6 17.7–19.7ROR 20.4 · χ² 19,376 / p <1e-300 | 18.4 EB05 17.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.1 | no trial arm names this drug |
| Fatigue (tiredness) | 1,110 | 2.3 2.2–2.4ROR 2.4 · χ² 848 / p 8e-187 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial arm names this drug |
| Pulmonary arterial hypertension | 1,105 | 132.3 124.7–140.3ROR 144.5 · χ² 132,912 / p <1e-300 | 122.0 EB05 116.1 · IC025 +6.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 82.4 | no trial arm names this drug |
| Vomiting | 1,050 | 3.6 3.4–3.8ROR 3.8 · χ² 2,024 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial arm names this drug |
| Dyspnoea exertional | 970 | 42.7 40.2–45.4ROR 46.1 · χ² 38,526 / p <1e-300 | 41.6 EB05 39.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.6 | no trial arm names this drug |
| Fluid retention | 925 | 29.8 28.0–31.8ROR 32.1 · χ² 25,346 / p <1e-300 | 29.3 EB05 27.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 | no trial arm names this drug |
| Malaise (feeling unwell) | 892 | 3.3 3.1–3.5ROR 3.4 · χ² 1,434 / p <1e-300 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial arm names this drug |
| Pneumonia (lung infection) | 882 | 4.4 4.1–4.7ROR 4.7 · χ² 2,349 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial arm names this drug |
| Pain in extremity | 855 | 4.7 4.4–5.0ROR 4.9 · χ² 2,497 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial arm names this drug |
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.
- Catheter site pruritus — n=416, PRR 1,475.5
- Catheter site scab — n=43, PRR 1,138.8
- Catheter site vesicles — n=73, PRR 1,000.0
- Catheter site irritation — n=112, PRR 876.7
- Catheter site discharge — n=302, PRR 612.1
- Catheter site erythema — n=563, PRR 594.8
- Transplant evaluation — n=122, PRR 507.5
- Heart and lung transplant — n=30, PRR 486.4
- Catheter site discolouration — n=26, PRR 464.2
- Catheter site inflammation — n=114, PRR 420.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Epoprostenol ↔ Headache.
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 Epoprostenol?
In FDA FAERS, the most frequently co-reported reaction terms for Epoprostenol are dyspnoea, headache, diarrhoea, nausea, pain in jaw, flushing. 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 Epoprostenol have an FDA boxed warning?
No. The FDA label retrieved for Epoprostenol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Epoprostenol 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 db57e498-db20-45e8-8298-b0cf0811d270, effective 20250423; matched on
openfda.generic_name.exact:"EPOPROSTENOL") - 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, fieldpatient.drug.openfda.generic_name.exact, 1,060 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 - ClinicalTrials.gov API v2 (query
EPOPROSTENOL, results-bearing studies sorted by enrollment)
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.