Nebenwirkungen · Tracleer
Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-109945 · Präparat HOS-093279
In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2 486 patients were treated with bosentan at daily doses ranging from 100 mg to 2 000 mg and 1 838 patients were treated with placebo. The mean treatment duration was 45 weeks. Adverse reactions were defined as events occurring in at least 1% of patients on bosentan and at a frequency at least 0.5% more than on placebo. The most frequent adverse reactions are headache (11.5%), oedema / fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia / haemoglobin decrease (9.9%).
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