A real-world pharmacovigilance analysis of acute renal failure associated with sacubitril/valsartan based on FDA Adverse Event Reporting System (FAERS).

ABSTRACT:

Background

The renal safety profile of sacubitril/valsartan remains debated in clinical practice. To address this uncertainty, we conducted a pharmacovigilance analysis of acute renal adverse events associated with sacubitril/valsartan using the FDA Adverse Event Reporting System (FAERS) database.

Methods

Using data from the FAERS database, we conducted an observational pharmacovigilance study from the first quarter (Q1) of 2015 to the fourth quarter of 2024 (Q4). The disproportionality analysis was performed using four algorithms: the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS).

Results

A total of 16,144,939 adverse events (AEs) were av

SUBMITTER: Wang S 

PROVIDER: S-EPMC12527209 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature