Adverse events of ursodeoxycholic acid: a real-world pharmacovigilance study using FAERS (2004-2023).

ABSTRACT:

Background

Ursodeoxycholic acid (UDCA) has been widely used in the treatment of hepatobiliary disorders and its clinical application is more and more extensive. However, to our knowledge, there are currently no clinical and scientific studies on the safety of UDCA based on large populations. In this study, UDCA-related adverse events (AEs) were evaluated through data mining based on the FDA Adverse Event Reporting System (FAERS) database.

Methods

The AE reports induced by UDCA as the primary suspected drug were extracted from the FAERS database. Disproportionality analysis was performed to explore potential AE signals of UDCA using four robust algorithms, including reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural

SUBMITTER: Ni Y 

PROVIDER: S-EPMC12436379 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature