Epoprostenol sodium adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Epoprostenol sodium
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From March 2004 to June 2026, FDA received 1,793 adverse event reports that name Epoprostenol sodium. In these reports the drug is a suspect or interacting product.

In the same period, 322 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 24 reports in the 12 months to June 2026 and 130 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 24 (under 0.1%) name Epoprostenol sodium. Reports from consumers or other non-health professionals were 14.9% of the reports that name Epoprostenol sodium and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Epoprostenol sodium is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 6 reports that name Epoprostenol sodium.
In January to March 2026, FDA received 7.
In April to June 2025, FDA received 12.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 221 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,744 of the 1,793 reports (97.3%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 221 terms.

Reaction terms in the reports that name Epoprostenol sodium, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,793 reports
Dyspnoeashortness of breath	232	12.9%
Device occlusionthe device blocked	199	11.1%
Diarrhoealoose or frequent stools	197	11%
Headachehead pain	183	10.2%
Underdoseless than the intended dose	168	9.4%
Nauseafeeling sick	153	8.5%
Product administration interrupted	145	8.1%
Pain in jaw	140	7.8%
Pulmonary arterial hypertension	138	7.7%
Deaththe patient died; cause not stated by this term	130	7.3%
Right ventricular failure	113	6.3%
Hypotensionlow blood pressure	101	5.6%
Flushingsudden reddening or warmth of the skin	100	5.6%
Device related infectionan infection related to the device	96	5.4%
Vomitingbeing sick	92	5.1%
Pneumonialung infection	89	5%
Fatiguetiredness	84	4.7%
Dizzinesslight-headedness or unsteadiness	80	4.5%
Condition aggravatedthe condition being treated got worse	76	4.2%
Hospitalisationadmission to hospital	74	4.1%
Lung transplant	69	3.8%
Hypoxialow oxygen	64	3.6%
Drug ineffectivethe medicine did not work as expected	63	3.5%
Fluid retentionthe body holding extra fluid	63	3.5%
Pain in extremitypain in an arm or leg	63	3.5%
Pulmonary hypertensionhigh pressure in the lung arteries	61	3.4%
Chest pain	57	3.2%
Painpain, site not specified	57	3.2%
Anaemialow red blood cells	56	3.1%
Weight decreasedweight loss	54	3%
Malaisegeneral feeling of being unwell	53	3%
Oxygen saturation decreased	52	2.9%
Pyrexiafever	51	2.8%
Oedema peripheralswelling of the legs, ankles or hands	47	2.6%
Cardiac failureheart failure	46	2.6%
Epistaxisnosebleed	46	2.6%
Syncopefainting	46	2.6%
Vascular device infection	45	2.5%
Astheniaweakness or lack of energy	44	2.5%
Rashskin rash	43	2.4%
Drug delivery system malfunction	42	2.3%
Respiratory failurethe lungs could not supply enough oxygen	42	2.3%
Ascitesfluid in the abdomen	41	2.3%
Off label useused for a purpose or in a way not on the label	40	2.2%
Therapy change	39	2.2%
Covid-19COVID-19 infection	37	2.1%
Decreased appetitereduced appetite	36	2%
Cough	35	2%
Oedemaswelling from fluid	34	1.9%
Palpitationsawareness of the heartbeat	33	1.8%

Download all 221 terms of Epoprostenol sodium (CSV)

The counts add to more than 1,793 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Epoprostenol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Epoprostenol	Generic name	1,302
Epoprostenol sodium (this page)	Generic name	1,793
Veletri	Brand name	8,723

Sum of the separately reported names: 11,818. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Epoprostenol sodium, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	1	1	0	0	1	0	0	1	0
2006	5	5	2	0	3	0	0	1	0
2007	10	10	3	1	7	0	1	4	0
2008	10	10	1	3	6	0	0	5	0
2009	8	8	1	0	7	0	0	2	0
2010	32	31	9	1	18	0	1	11	1
2011	162	161	50	14	127	1	0	41	1
2012	229	227	68	10	197	0	0	44	2
2013	7	6	3	0	2	0	0	3	1
2014	8	6	1	0	5	0	0	2	2
2015	18	14	1	0	9	0	0	12	4
2016	19	19	8	2	11	1	0	11	0
2017	31	30	14	6	17	4	0	19	1
2018	129	128	51	0	37	2	0	90	1
2019	111	110	34	3	59	1	0	76	1
2020	132	128	24	2	76	0	0	67	4
2021	234	225	31	5	169	0	0	99	9
2022	135	130	14	2	97	3	0	60	5
2023	216	212	36	3	171	0	0	111	4
2024	209	205	15	1	164	0	0	99	4
2025	63	57	9	9	44	0	0	42	6
2026	24	24	1	3	21	0	0	20	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Epoprostenol sodium, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Epoprostenol sodium, by the year in which FDA received them
Year	Reports
2004	1
2006	5
2007	10
2008	10
2009	7
2010	23
2011	138
2012	267
2013	15
2014	14
2015	15
2016	17
2017	37
2018	122
2019	110
2020	144
2021	235
2022	153
2023	208
2024	202
2025	47
2026	13

Reports that name Epoprostenol sodium, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Epoprostenol sodium
Age	Reports	Share
Under 2	29	1.6%
2 to 11	14	0.8%
12 to 17	33	1.8%
18 to 44	391	21.8%
45 to 64	419	23.4%
65 to 74	151	8.4%
75 and over	56	3.1%
Age not given	700	39%

Sex of the patient in the reports that name Epoprostenol sodium
Sex	Reports	Share
Female	934	52.1%
Male	364	20.3%
Unknown or not given	495	27.6%

Type of reporter in the reports that name Epoprostenol sodium
Reporter	Reports	Share
Physician	612	34.1%
Pharmacist	176	9.8%
Other health professional	715	39.9%
Lawyer	0	0%
Consumer or non-health professional	268	14.9%
Not given	22	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 60.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Epoprostenol sodium record
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 reporter fills in the indication, and the field is often empty. Each share is of all 1,793 reports.

Drugs in the same reports

Other drugs that the reports of Epoprostenol sodium name, in any role, in order of name
Drug	Reports that name the two
Adcirca	226
Ambrisentan	202
Coumadin	160
Furosemide	182
Macitentan	232
Opsumit	201
Sildenafil	269
Sildenafil citrate	162
Tadalafil	211
Tracleer	152

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Epoprostenol same ingredient
Veletri same ingredient
Epoprostenol Act next in the A to Z list
Eprex next in the A to Z list
Eptifibatide next in the A to Z list
Epogen next in the A to Z list
Epzicom next in the A to Z list
Epoetin Beta next in the A to Z list
Equanil next in the A to Z list
Epoetin alfa next in the A to Z list
Equate Nicotine next in the A to Z list
Eplontersen sodium next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for Epoprostenol sodiumThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Epoprostenol sodium: adverse event reports that FDA received. https://reportedreactions.com/drug/epoprostenol-sodium/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Epoprostenol sodium as a suspect or interacting product. The 322 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Epoprostenol sodium was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Epoprostenol sodium?

No. It is a count of what people reported to FDA: 1,793 reports from March 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (39.9%), physician (34.1%) and consumer or non-health professional (14.9%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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