What the label lists and what reports show
Selexipag side effects
Selexipag's FDA label lists its adverse reactions in its own words. FAERS holds 25,685 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 headache (6,740 reports).
- Generic listed
Check it at the source: the selexipag FDA label on DailyMed (effective May 28, 2026, Actelion Pharmaceuticals US, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of UPTRAVI?The most common side effects of UPTRAVI in adults and children include: headache diarrhea jaw pain nausea muscle pain vomiting pain in arms or legs flushing Additional common side effects of UPTRAVI in adults include: pain in joints rash low red blood cell count decreased appetite redness, pain, or swelling at the injection site Additional common side effect in children includes stomach (abdominal) pain. These are not all of the possible side effects of UPTRAVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Actelion Pharmaceuticals US, Inc., effective May 28, 2026 (SPL set a7a23b87-f892-4e2c-8e2e-ebf841220f90), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsAdverse reactions in adult and pediatric patients occurring more frequently (≥5%) on UPTRAVI compared to placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing. Additional adverse reaction occurring in pediatric patients more frequently (≥5%) on UPTRAVI compared to placebo is abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actelion at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. …
Table 3: Adverse Reactions
| Adverse Reaction | UPTRAVI N=575 | Placebo N=577 |
|---|---|---|
| Headache | 65% | 32% |
| Diarrhea | 42% | 18% |
| Jaw pain | 26% | 6% |
| Nausea | 33% | 18% |
| Myalgia | 16% | 6% |
| Vomiting | 18% | 9% |
| Pain in extremity | 17% | 8% |
| Flushing | 12% | 5% |
| Arthralgia | 11% | 8% |
| Anemia | 8% | 5% |
| Decreased appetite | 6% | 3% |
| Rash | 11% | 8% |
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.
Source: FDA drug label, Actelion Pharmaceuticals US, Inc., effective May 28, 2026 (SPL set a7a23b87-f892-4e2c-8e2e-ebf841220f90), via openFDA; the full label on DailyMed
What do FAERS reports show?
25,685 reports list selexipag among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,847 are coded as a death and 12,615 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?
- Selexipag: 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