Safety assessment of tolvaptan: real-world adverse event analysis using the FAERS database.

ABSTRACT:

Objective

This study aims to analyze the adverse drug events (ADEs) associated with tolvaptan in the Food and Drug Administration Adverse Event Reporting System database from the fourth quarter of 2009 to the second quarter of 2024.

Methods

After standardizing the data, various signal detection techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were employed for analysis.

Results

Among the 7,486 ADE reports where tolvaptan was the primary suspected drug, a total of 196 preferred terms were identified, spanning 24 different system organ classes. Specifically, hepatobiliary disorders, renal and urinary disorders, and metabolic and nutritional disorde

SUBMITTER: Cao P 

PROVIDER: S-EPMC11754202 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature