Nebenwirkungen · Zomarist
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-210486 · Präparat HOS-154523
Vildagliptin Hepatic impairment Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin. In these cases, the patients were generally asymptomatic without clinical sequelae and liver function returned to normal after discontinuation of treatment. In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations ≥ 3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively. These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice.
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Version 2025-12-05T17:36:00Z · SHA-256 6dd842a7717af651a76cb98c459aac61fb2e50cebfa9b433555d63e1a27e92c2 · Passage 832fe32fad727d50e6ebab006a94e94d73594b7284b08c3bef656141783b5698 · Zeichen 4797–5581 im Abschnitt