Bosentan
Bosentan is a medication. FAERS contains 49,809 submissions naming this drug from 2003 through 2026; the top three reactions cited are death, dyspnoea, and pneumonia.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Bosentan. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Bosentan. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
By Age Group
Severity Outcomes
Severity flags recorded across the 49,809 FAERS submissions that named Bosentan. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Bosentan. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Bosentan. This is the authoritative source on indications, warnings, and known adverse reactions.
FDA label effective date: 2024-11-25
Disclaimer
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.