Generic name
Epoprostenol sodium: adverse event reports filed with FDA
1,793 reports list it as a suspect or interacting product, 2004–2026.
- 1,793
- reports as suspect product
- 0% of all reports · about 80 a year
- 24
- reports, 12 months to June 2026
- 130 in the 12 months before
- 97.4%
- marked serious by the reporter
- 57.4% across all reports
- 21%
- record death among outcomes, as reported
- 376 reports · not verified by FDA
Between March 2004 and June 2026, 1,793 adverse event reports received by FDA list epoprostenol sodium, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (322) are left out of every figure here.
In the 12 months to June 2026, 24 reports listed it, down 82% from 130 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 80 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded dyspnoea (12.9%), device occlusion (11.1%) and diarrhoea (11%). A report can list several reactions, so shares add to more than 100%; 537 different terms appear across these reports. Dyspnoea is recorded in 12.9% of these reports, against 2.7% of all reports in the database.
97.4% of the reports are marked serious by the reporter; 21% record death among the outcomes and 69.6% record hospitalisation, as reported. 39.9% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (23.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Epoprostenol sodium reports recording the termall reports in the database
- Dyspnoeashortness of breath12.9%232
- Device occlusionthe device blocked11.1%199
- Diarrhoealoose or frequent stools11%197
- Headachehead pain10.2%183
- Underdoseless than the intended dose9.4%168
- Nauseafeeling sick8.5%153
- Pain in jaw7.8%140
- Deaththe patient died; cause not stated by this term7.3%130
- Right ventricular failure6.3%113
- Hypotensionlow blood pressure5.6%101
- Flushingsudden reddening or warmth of the skin5.6%100
- Device related infectionan infection related to the device5.4%96
- Vomitingbeing sick5.1%92
- Pneumonialung infection5%89
- Fatiguetiredness4.7%84
- Dizzinesslight-headedness or unsteadiness4.5%80
- Condition aggravatedthe condition being treated got worse4.2%76
- Hospitalisationadmission to hospital4.1%74
- Lung transplant3.8%69
- Hypoxialow oxygen3.6%64
- Drug ineffectivethe medicine did not work as expected3.5%63
- Fluid retentionthe body holding extra fluid3.5%63
- Pain in extremitypain in an arm or leg3.5%63
- Pulmonary hypertensionhigh pressure in the lung arteries3.4%61
- Chest painchest pain3.2%57
- Painpain, site not specified3.2%57
- Anaemialow red blood cells3.1%56
- Weight decreasedweight loss3%54
Top 30 of 537 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 60.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pulmonary arterial hypertension | 1,128 | 62.9% |
| Pulmonary hypertension | 308 | 17.2% |
| Maternal exposure during pregnancy | 7 | 0.4% |
| Portopulmonary hypertension | 7 | 0.4% |
| Thrombosis prophylaxis | 7 | 0.4% |
| Heritable pulmonary arterial hypertension | 4 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,793 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Epoprostenol sodium reports |
|---|---|---|
| Sildenafil | 269 | 15% |
| Macitentan | 232 | 12.9% |
| Adcirca | 226 | 12.6% |
| Tadalafil | 211 | 11.8% |
| Ambrisentan | 202 | 11.3% |
| Opsumit | 201 | 11.2% |
| Furosemide | 182 | 10.2% |
| Sildenafil citrate | 162 | 9% |
| Coumadin | 160 | 8.9% |
| Tracleer | 152 | 8.5% |
Other products listed in reports where Epoprostenol sodium is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Epoprostenol sodium | All reports |
|---|---|---|
| Reports as suspect product | 1,793 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 24 | 1,332,454 |
| Marked serious | 97.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 210 | 91 |
| Hospitalisation recorded, per 1,000 reports | 696 | 213 |
| Consumer-filed share | 14.9% | 45.8% |
| Top term, share of reports | Dyspnoea 12.9% | 2.7% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Epoprostenol sodium reports
How many adverse event reports has FDA received for Epoprostenol sodium?
1,793 reports list Epoprostenol sodium as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 24 of them arrived in the latest 12 months. Another 322 list it only as a concomitant medication.
What reactions are recorded in Epoprostenol sodium reports?
dyspnoea (12.9%), device occlusion (11.1%), diarrhoea (11%), headache (10.2%) and underdose (9.4%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Epoprostenol sodium was responsible.
How serious are the reports?
97.4% are marked serious by the reporter. Among the outcomes recorded, 21% of reports include death and 69.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (39.9%), physician (34.1%) and consumer or non-health professional (14.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Epoprostenol sodium rising?
24 reports in the 12 months to June 2026, down 82% from 130 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Epoprostenol sodium was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Epoprostenol sodium?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Epoprostenol sodium as a suspect or interacting product; reports listing it only as a concomitant medication (322) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.