Drugs › Prostacyclin receptor agonist
Generic name
Selexipag: adverse event reports filed with FDA
2,317 reports list it as a suspect or interacting product, 2015–2026. Class: Prostacyclin receptor agonist.
- 2,317
- reports as suspect product
- 0% of all reports · about 204 a year
- 75
- reports, 12 months to June 2026
- 242 in the 12 months before
- 91.7%
- marked serious by the reporter
- 76.8% across the class
- 9.5%
- record death among outcomes, as reported
- 219 reports · not verified by FDA
Between March 2015 and June 2026, 2,317 adverse event reports received by FDA list selexipag, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (484) are left out of every figure here.
In the 12 months to June 2026, 75 reports listed it, down 69% from 242 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 204 reports a year and 0% of the 20,646,523 reports in the database, and 12% of the reports for the prostacyclin receptor agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are headache (22.6%), diarrhoea (18.3%) and dyspnoea (17.1%). A report can list several reactions, so shares add to more than 100%; 620 different terms appear across these reports. Headache is recorded in 22.6% of these reports, about the same share as in the median prostacyclin receptor agonist drug (27.1%).
91.7% of the reports are marked serious by the reporter (76.8% across the class); 9.5% record death among the outcomes and 59.7% record hospitalisation, as reported. 58.4% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (25.6%). 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 Selexipag reports recording the termmedian drug in prostacyclin receptor agonist
- Headachehead pain22.6%523
- Diarrhoealoose or frequent stools18.3%423
- Dyspnoeashortness of breath17.1%396
- Nauseafeeling sick14.6%339
- Pain in jaw10.2%237
- Fatiguetiredness10%232
- Vomitingbeing sick9.1%211
- Painpain, site not specified9%209
- Dizzinesslight-headedness or unsteadiness8.9%207
- Hypotensionlow blood pressure7.3%170
- Myalgiamuscle pain7.2%167
- Pain in extremitypain in an arm or leg6.8%158
- Pneumonialung infection6.3%147
- Hospitalisationadmission to hospital6.2%143
- Product dose omission issuea dose was missed6%139
- Off label useused for a purpose or in a way not on the label6%138
- Arthralgiajoint pain5.9%137
- Fluid retentionthe body holding extra fluid5.6%129
- Malaisegeneral feeling of being unwell5.1%118
- Decreased appetitereduced appetite5%115
- Abdominal pain upperupper stomach pain4.9%114
- Deaththe patient died; cause not stated by this term4.9%114
- Abdominal painstomach or belly pain4.7%108
- Oxygen saturation decreased4.5%104
- Flushingsudden reddening or warmth of the skin4.4%101
- Syncopefainting4.4%101
- Oedema peripheralswelling of the legs, ankles or hands4.3%100
- Weight decreasedweight loss3.9%90
- Astheniaweakness or lack of energy3.8%88
Top 30 of 620 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 median share across the 2 drugs in the prostacyclin receptor agonist class; 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 19,293 reports in the class. 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. 69.7% 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 | 1,527 | 65.9% |
| Pulmonary hypertension | 358 | 15.5% |
| Heritable pulmonary arterial hypertension | 9 | 0.4% |
| Right-to-left cardiac shunt | 4 | 0.2% |
| Systemic scleroderma | 3 | 0.1% |
| Adverse drug reaction | 2 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,317 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Selexipag reports |
|---|---|---|
| Macitentan | 700 | 30.2% |
| Tadalafil | 492 | 21.2% |
| Ambrisentan | 376 | 16.2% |
| Adempas | 304 | 13.1% |
| Adcirca | 275 | 11.9% |
| Opsumit | 262 | 11.3% |
| Sildenafil citrate | 218 | 9.4% |
| Furosemide | 201 | 8.7% |
| Eliquis | 181 | 7.8% |
| Sildenafil | 181 | 7.8% |
Other products listed in reports where Selexipag 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 | Selexipag | Prostacyclin receptor agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 2,317 | 19,293 | 20,646,523 |
| Share of that pool | — | 12% | 0% |
| Reports, latest 12 months | 75 | — | 1,332,454 |
| Marked serious | 91.7% | 76.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 95 | 203 | 91 |
| Hospitalisation recorded, per 1,000 reports | 597 | 505 | 213 |
| Consumer-filed share | 24.2% | 20.7% | 45.8% |
| Top term, share of reports | Headache 22.6% | median 27.1% | 3% |
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."
Other drugs in the prostacyclin receptor agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Uptravi | generic | 16,976 | 955 | 74.8% |
Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.
Questions about Selexipag reports
How many adverse event reports has FDA received for Selexipag?
2,317 reports list Selexipag as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 75 of them arrived in the latest 12 months. Another 484 list it only as a concomitant medication.
What reactions are recorded in Selexipag reports?
headache (22.6%), diarrhoea (18.3%), dyspnoea (17.1%), nausea (14.6%) and pain in jaw (10.2%). 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 Selexipag was responsible.
How serious are the reports?
91.7% are marked serious by the reporter. Among the outcomes recorded, 9.5% of reports include death and 59.7% 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 (58.4%), consumer or non-health professional (24.2%) and physician (15.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Selexipag rising?
75 reports in the 12 months to June 2026, down 69% from 242 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 Selexipag 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 Selexipag?
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 Selexipag as a suspect or interacting product; reports listing it only as a concomitant medication (484) 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.