Post-marketing safety concerns with pirfenidone and nintedanib: an analysis of individual case safety reports from the FDA adverse event reporting system database and the Japanese adverse drug event report databases

Post-marketing safety concerns with pirfenidone and nintedanib: an analysis of individual case safety reports from the FDA adverse event reporting system database and the Japanese adverse drug event report databases

IntroductionTo date, only two drugs, pirfenidone and nintedanib, are approved for the treatment of patients with idiopathic pulmonary fibrosis (IPF). In addition, very few studies have reported on the safety profile of either drug in large populations. This study aims to identify and compare adverse...

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Bibliographic Details
Main Authors: Tao Wang, Zhiwei Cui, Yingyong Ou, Siyu Lou, Huayou Chen, Chengyu Zhu, Linmei Zhou, Fan Zou
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-04-01
Series:Frontiers in Pharmacology
Subjects:
pirfenidone
nintedanib
adverse drug events
disproportionality analysis
real-world analysis
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1530697/full
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https://www.frontiersin.org/articles/10.3389/fphar.2025.1530697/full

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