Nebenwirkungen · Forxiga
Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11–12
HOS-125384 · Präparat HOS-096051
11 In the DECLARE study, the numbers of patients with events suggestive of volume depletion were balanced between treatment groups: 213 (2.5%) and 207 (2.4%) in the dapagliflozin and placebo groups, respectively. Serious adverse events were reported in 81 (0.9%) and 70 (0.8%) in the dapagliflozin and placebo group, respectively. Events were generally balanced between treatment groups across subgroups of age, diuretic use, blood pressure and angiotensin converting enzyme inhibitors (ACE-I)/angiotensin II type 1 receptor blockers (ARB) use. In patients with eGFR < 60 mL/min/1.73 m2 at baseline, there were 19 events of serious adverse events suggestive of volume depletion in the dapagliflozin group and 13 events in the placebo group.
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 2026-03-12T16:11:00Z · SHA-256 a32f3f48ad3ffeffd85467179c7cd7d2f4f8e65c471ebf5e9fcd92a61c71299a · Passage 0910faca71453e24d2190ad5bb38ade13756088602f632b9ae7b09822a8c0499 · Zeichen 14313–15054 im Abschnitt