Tracleer: adverse event reports filed with FDA

33,254

reports as suspect product

0.2% of all reports · about 1,478 a year

56

reports, 12 months to June 2026

137 in the 12 months before

94.1%

marked serious by the reporter

72.7% across the class

39.4%

record death among outcomes, as reported

13,115 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 Tracleer reports recording the termmedian drug in endothelin receptor antagonist

1. Deaththe patient died; cause not stated by this term24%7,967
2. Dyspnoeashortness of breath12.2%4,061
3. Pneumonialung infection6%1,980
4. Pulmonary arterial hypertension5%1,667
5. Condition aggravatedthe condition being treated got worse4.2%1,412
6. Aspartate aminotransferase increasedraised liver enzyme (AST)4.1%1,349
7. Alanine aminotransferase increasedraised liver enzyme (ALT)4%1,328
8. Fatiguetiredness3.7%1,221
9. Falla fall3.6%1,195
10. Nauseafeeling sick3.4%1,134
11. Dizzinesslight-headedness or unsteadiness3.2%1,073
12. Headachehead pain3.2%1,063
13. Fluid retentionthe body holding extra fluid3.1%1,034
14. Malaisegeneral feeling of being unwell3%1,006
15. Oedema peripheralswelling of the legs, ankles or hands3%1,004
16. Diarrhoealoose or frequent stools3%996
17. Pulmonary hypertensionhigh pressure in the lung arteries3%993
18. Vomitingbeing sick2.8%946
19. Coughcough2.8%923
20. Liver function test abnormal2.7%901
21. Pyrexiafever2.7%898
22. Syncopefainting2.6%849
23. Cardiac failure congestivecongestive heart failure2.5%842
24. Astheniaweakness or lack of energy2.5%839
25. Cardiac failureheart failure2.5%820
26. Disease progressionthe disease advanced2.5%815
27. Chest painchest pain2.4%814
28. Right ventricular failure2.4%809
29. Anaemialow red blood cells2.4%802
30. Respiratory failurethe lungs could not supply enough oxygen2.4%792

Top 30 of 2,024 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. 77.9% 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 33,254 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tracleer 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 Tracleer as a suspect or interacting product; reports listing it only as a concomitant medication (7,219) 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.