What the label lists and what reports show
Bosentan side effects
Bosentan's FDA label lists its adverse reactions in its own words. FAERS holds 50,111 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 dyspnoea (6,000 reports).
- Generic listed
- Boxed warning
Check it at the source: the bosentan FDA label on DailyMed (effective November 17, 2025, 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 TRACLEER?TRACLEER can cause serious side effects, including: See " What is the most important information I should know about TRACLEER? " Fluid retention and swelling of your ankles and legs. TRACLEER can cause your body to hold too much water, and you may get swelling of your ankles and legs. Tell your healthcare provider if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare provider will look for the cause of this. Lower Sperm Count. Some men who take TRACLEER may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare provider if fertility is a concern for you. Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with TRACLEER. […]
Source: FDA drug label, Actelion Pharmaceuticals US, Inc., effective November 17, 2025 (SPL set 749e42fb-2fe0-45dd-9268-b43bb3f4081c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following important adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Boxed Warning, Warnings and Precautions (5.1) ] Embryo-fetal Toxicity [see Boxed Warning, Warnings and Precautions (5.3) ] Fluid Retention [see Warnings and Precautions (5.4) ] Common adverse reactions (≥3% more than placebo) for the film-coated tablet are respiratory tract infection and anemia ( 6.1 ). Common adverse reactions (≥15%) for the dispersible tablet are upper respiratory tract infections and pyrexia ( 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. …
Source: FDA drug label, Actelion Pharmaceuticals US, Inc., effective November 17, 2025 (SPL set 749e42fb-2fe0-45dd-9268-b43bb3f4081c), via openFDA; the full label on DailyMed
What do FAERS reports show?
50,111 reports list bosentan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15,952 are coded as a death and 25,004 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, 9 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?
- Bosentan: 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