Hepatobiliary adverse drug reactions during treatment with olaparib: an analysis of data from the EudraVigilance reporting system.

ABSTRACT:

Background

olaparib is a Poly ADP-Ribose Polymerase inhibitor approved for the treatment of BRCA-mutated tumors, and has been associated with hepatotoxicity, as highlighted by the Pharmacovigilance Risk Assessment Committee.

Objectives and methods

to describe Drug-Induced Liver Injury (DILI) cases related to olaparib stratifying them by liver damage origin in "cholestatic", "cytolytic", "mixed", "liver related investigation" and "not specified" cases, by analyzing data from EudraVigilance (EV) database.

Results

344 Individual Case Safety Reports (ICSRs) reporting olaparib-induced liver injury cases were retrieved from the EV. They referred more frequently to female patients belonging to the age group 18-64 years. The majority of ICSRs (66.0%) reported serious Adverse

SUBMITTER: Veliscu EM 

PROVIDER: S-EPMC12827739 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature