Nebenwirkungen · Darunavir Krka
Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 23
HOS-225746 · Präparat HOS-217490
During the clinical development program (N=2 613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction. The total mean treatment duration for subjects was 95.3 weeks. The most frequent adverse reactions reported in clinical studies and as spontaneous reports are diarrhoea, nausea, rash, headache and vomiting. The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis and pyrexia.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-01-28T02:00:00Z · SHA-256 42a250050090ba77cfec6bb0ff0fc9dbbb4e1a422df7d45e8efc6fc459616a05 · Passage 5f15030637b5d03f48f185cf59bc27008b798095287608751fca0b0e708e453c · Zeichen 31–646 im Abschnitt