Nebenwirkungen · Tracleer
Tracleer 32 mg dispersible tablets · Abschnitt 4.8 · PDF-Seite 34–35
HOS-109999 · Präparat HOS-093279
34 mediastinal disorders Gastrointestinal disorders Common Gastrooesophageal reflux disease Diarrhoea Hepatobiliary disorders Very common Abnormal liver function test (see section 4.4) Uncommon Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4) Rare Liver cirrhosis, liver failure1 Skin and subcutaneous disorders Common Erythema General disorders and Very common Oedema, fluid retention5 administration site conditions 1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data. 2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo. 3 Headache was reported in 11.5% of patients on bosentan and 9.8% of patients on placebo. 4 These types of reactions can also be related to the underlying disease. 5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
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Version 2024-10-25T15:01:00Z · SHA-256 eddfcd40df26bd01c2c7847da53c544c94e0bafb8bcc62374b5c7788669470bc · Passage 0d4ce76875e793e405878266aacc4cf7765b552a6fefb4e6fe9f06c543c6aba7 · Zeichen 3111–4993 im Abschnitt