Disproportionality analysis of biliary adverse events associated with fibrates using the JADER and FAERS databases.

ABSTRACT:

Introduction

Fibrates are effective triglyceride-lowering drugs, but they may affect bile acid metabolism, raising concerns about biliary adverse drug events (ADEs).

Objective

In this study, we used spontaneous reporting system databases to evaluate the association between fibrates and biliary ADEs. This study has been reported in accordance with the Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance guidelines.

Methods

We used data from the Japanese Adverse Drug-Event Report (JADER) and the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) databases. The signal detection metrics employed were reporting odds ratio (ROR), proportional reporting ratio, Bayesian conf

SUBMITTER: Watanabe S 

PROVIDER: S-EPMC12684286 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature