Bosentan: adverse event reports filed with FDA

8,308

reports as suspect product

0% of all reports · about 373 a year

621

reports, 12 months to June 2026

591 in the 12 months before

57.6%

marked serious by the reporter

72.7% across the class

14.7%

record death among outcomes, as reported

1,218 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 Bosentan reports recording the termmedian drug in endothelin receptor antagonist

1. Dyspnoeashortness of breath8.4%698
2. Off label useused for a purpose or in a way not on the label7.9%658
3. Deaththe patient died; cause not stated by this term7.6%635
4. Product dose omission issuea dose was missed7.1%591
5. Fatiguetiredness5%417
6. Hospitalisationadmission to hospital3.8%315
7. Malaisegeneral feeling of being unwell3.5%292
8. Headachehead pain3.4%286
9. Drug ineffectivethe medicine did not work as expected3.3%278
10. Adverse eventan unwanted medical event, type not specified3.3%272
11. Pneumonialung infection3.1%258
12. Diarrhoealoose or frequent stools2.8%231
13. Product use issuea problem in how the product was used2.8%229
14. Condition aggravatedthe condition being treated got worse2.6%216
15. Covid-19COVID-19 infection2.5%205
16. Nauseafeeling sick2.3%195
17. Dizzinesslight-headedness or unsteadiness2.3%188
18. Coughcough2.2%179
19. Pulmonary arterial hypertension2.2%179
20. Hypotensionlow blood pressure2%164
21. Dyspnoea exertional1.9%157
22. Therapy interrupted1.9%155
23. Chest painchest pain1.8%152
24. Vomitingbeing sick1.8%149
25. Falla fall1.8%148
26. Anaemialow red blood cells1.7%143
27. Cardiac failureheart failure1.6%137
28. Fluid retentionthe body holding extra fluid1.6%133
29. Pulmonary hypertensionhigh pressure in the lung arteries1.6%131
30. Product dose omissiona dose was missed1.6%130

Top 30 of 912 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. 80.7% 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 8,308 reports.

Drugs most often listed in the same reports

Other products listed in reports where Bosentan 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 Bosentan as a suspect or interacting product; reports listing it only as a concomitant medication (2,085) 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.