What the label lists and what reports show
Epoprostenol side effects
Epoprostenol's FDA label: “Most common adverse reactions during: - Dose Initiation and Escalation: Nausea, vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia ( 6.1 ) - Chronic Dosing …” FAERS holds 13,014 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 dyspnoea (2,777 reports).
- Generic listed
Check it at the source: the epoprostenol FDA label on DailyMed (effective November 28, 2022, Actelion Pharmaceuticals US, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions during: - Dose Initiation and Escalation: Nausea, vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia ( 6.1 ) - Chronic Dosing: Headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, please contact: JANSSEN at 1-800-526-7736 (1-800 JANSSEN) or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.
Table 8: Adverse Events during Dose Initiation and Escalation
| Reaction | Epoprostenol (n=391) |
|---|---|
| Flushing | 58% |
| Headache | 49% |
| Nausea/vomiting | 32% |
| Hypotension | 16% |
| Anxiety, nervousness, agitation | 11% |
| Chest pain | 11% |
| Dizziness | 8% |
| Bradycardia | 5% |
| Abdominal pain | 5% |
| Musculoskeletal pain | 3% |
| Dyspnea | 2% |
| Back pain | 2% |
| Sweating | 1% |
| Dyspepsia | 1% |
| Hypesthesia/paresthesia | 1% |
| Tachycardia | 1% |
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, continuedMost common adverse reactions during: - Dose Initiation and Escalation: Nausea, vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia ( 6.1 ) - Chronic Dosing: Headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, please contact: JANSSEN at 1-800-526-7736 (1-800 JANSSEN) or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, adverse events were classified as follows: (1) adverse events during dose initiation and escalation, (2) adverse events during chronic dosing, and (3) adverse events associated with the drug delivery system. Adverse Events during Dose Initiation and Escalation During early clinical trials, epoprostenol was increased in 2-ng/kg/min increments until the patients developed symptomatic intolerance. …
Source: FDA drug label, Actelion Pharmaceuticals US, Inc., effective November 28, 2022 (SPL set df502787-46ec-4dd1-a2c0-be90f6d95a5d), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,014 reports list epoprostenol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,685 are coded as a death and 8,725 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 21 reactions below, 10 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?
- Epoprostenol: 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