Macitentan: adverse event reports filed with FDA

5,746

reports as suspect product

0% of all reports · about 442 a year

103

reports, 12 months to June 2026

196 in the 12 months before

93.8%

marked serious by the reporter

72.7% across the class

19.5%

record death among outcomes, as reported

1,123 reports · not verified by FDA

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 Macitentan reports recording the termmedian drug in endothelin receptor antagonist

1. Dyspnoeashortness of breath15.4%887
2. Deaththe patient died; cause not stated by this term12.3%704
3. Pneumonialung infection8.4%485
4. Headachehead pain7.8%451
5. Diarrhoealoose or frequent stools6%346
6. Pulmonary arterial hypertension5.8%334
7. Fluid retentionthe body holding extra fluid5.7%330
8. Fatiguetiredness5.5%317
9. Nauseafeeling sick5.4%312
10. Hypotensionlow blood pressure5.1%294
11. Dizzinesslight-headedness or unsteadiness4.6%262
12. Oxygen saturation decreased3.8%216
13. Oedema peripheralswelling of the legs, ankles or hands3.7%215
14. Malaisegeneral feeling of being unwell3.7%214
15. Vomitingbeing sick3.4%198
16. Anaemialow red blood cells3.3%192
17. Condition aggravatedthe condition being treated got worse3.3%190
18. Astheniaweakness or lack of energy3.1%180
19. Chest painchest pain3.1%180
20. Falla fall3.1%180
21. Hospitalisationadmission to hospital3.1%180
22. Peripheral swellingswelling of the arms or legs3.1%180
23. Painpain, site not specified3%174
24. Drug ineffectivethe medicine did not work as expected3%172
25. Pulmonary oedemafluid in the lungs2.9%169
26. Coughcough2.8%163
27. Pain in extremitypain in an arm or leg2.7%158
28. Syncopefainting2.6%150
29. Off label useused for a purpose or in a way not on the label2.5%141
30. Weight increasedweight gain2.3%133

Top 30 of 872 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 6 drugs in the endothelin receptor antagonist 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 192,634 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 78.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,746 reports.

Drugs most often listed in the same reports

Other products listed in reports where Macitentan 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

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 endothelin receptor antagonist class

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.

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 Macitentan as a suspect or interacting product; reports listing it only as a concomitant medication (1,256) 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.