The most commonly reported side effects of macitentan include dyspnoea, headache, and death, based on 67,011 FDA adverse event reports from 2012 to 2025.
Percentages show how often each reaction appears relative to total reports for macitentan.
These are voluntary reports and do not establish that macitentan caused these reactions.
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Other drugs that appear in adverse event reports alongside macitentan. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
Taken alongside
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
72.8% of macitentan adverse event reports involve female patients and 23.9% involve male patients. The largest age group is adult at 50%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking macitentan when the adverse event was reported.
Showing 15 of 214 indications
Macitentan is sold under the brand name Opsumit.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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