Drug-induced dementia: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database.

ABSTRACT:

Background

Dementia is a serious adverse event (AE) that requires attention in clinical practice. However, information on drug-induced dementia is limited. The U.S. FDA Adverse Event Reporting System (FAERS) serves as an important resource for identifying real-world adverse drug reactions and safety signals.

Objective

This study aimed to use FAERS data to identify drugs associated with increased dementia risk.

Design

A secondary analysis of the FAERS database was conducted using disproportionality analysis methods.

Methods

We reviewed dementia-related reports in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023, used the Medical Dictionary for Regulatory Activity to identify dementia cases and summarized the corresponding list of p

SUBMITTER: Xu L 

PROVIDER: S-EPMC11775965 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature