Nebenwirkungen · Isturisa
Isturisa 1 mg film-coated tablets Isturisa 5 mg film-coated tablets Isturisa 10 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7
HOS-142183 · Präparat HOS-098768
Summary of the safety profile A total of 210 patients with Cushing´s disease has been treated with osilodrostat in the pivotal Phase III studies. The most frequent (incidence ≥ 10%) adverse reactions reported in the pivotal Phase III studies (C2301 and C2302) with Isturisa were adrenal insufficiency (see section 4.4 Warnings and precaution), fatigue, oedema, vomiting, nausea, decreased appetite headache, dizziness, hypotension, arthralgia, myalgia, tachycardia and blood testosterone increased. The safety profile of Isturisa was generally consistent across all types of Cushing’s syndrome studied in clinical trials.
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