Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7
HOS-143236 · Präparat HOS-098954
Hepatic enzyme elevations Increases in serum transaminases (AST and/or ALT) have been reported with bempedoic acid. In the phase 3 primary hyperlipidaemia studies, the incidence of elevations (≥ 3× ULN) in hepatic transaminase levels was 0.7% for patients treated with bempedoic acid and 0.3% for placebo. In the CLEAR Outcomes study, the incidence of elevations > 3× ULN in hepatic transaminase levels also occurred more frequently in bempedoic acid-treated patients (1.6%) than in placebo-treated patients (1.0%). These elevations in transaminases were not associated with other evidence of liver dysfunction (see section 4.4).
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 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 086dba18c5ae43314fe542229d5c71779b6720761ea7f435d70e5968dda57184 · Zeichen 3317–3946 im Abschnitt