Adverse drug events associated with tiotropium: a real-world pharmacovigilance study of FDA adverse event reporting system database.

ABSTRACT:

Introduction

Tiotropium, a long-acting muscarinic antagonist, is commonly employed for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma. While its efficacy has been validated through numerous randomized controlled trials, safety concerns in real-world post-marketing settings necessitate further evaluation.

Aim

This study aimed to analyze the adverse events (AEs) associated with tiotropium reported in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to identify potential safety signals.

Methods

A retrospective analysis was conducted on adverse reaction reports related to tiotropium in the FAERS database from the first quarter of 2004 to the fourth quarter of 2024. The AE names in the FAERS databas

SUBMITTER: Rui Y 

PROVIDER: S-EPMC12425831 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature