Results 1 to 10 of about 9,302 (232)

Postmarketing reporting patterns of Candida-related events associated with bimekizumab and selective IL-17A inhibitors in psoriasis: a FAERS and JADER pharmacovigilance study [PDF]

Frontiers in Pharmacology
BackgroundCandida-related events are established labelled events during IL-17 pathway inhibition. The remaining pharmacovigilance question is how Candida phenotypes are represented in spontaneous reports for bimekizumab and selective IL-17A inhibitors ...
Hao Zhong, Yongjian Liu, Yingyu Yu, Yige Yu, Guihao Hou   +4 more
doaj   +2 more sources

Safety profile of entrectinib in NSCLC: Multi-source pharmacovigilance analysis using FAERS and JADER. [PDF]

PLoS ONE
BackgroundEntrectinib is effective for ROS1-positive non-small cell lung cancer (NSCLC), but its postmarketing safety profile remains incompletely characterized outside clinical trials. We conducted a dual-database pharmacovigilance study to characterize
JiaLe Yang, JiaWen Liu, GuanBo Zhao, HeChen Li, Ge Sun   +4 more
doaj   +2 more sources

Respiratory system toxicity induced by immune checkpoint inhibitors: A real-world study based on the FDA adverse event reporting system database

Frontiers in Oncology, 2022
BackgroundImmune checkpoint inhibitors (ICIs), the treatment of multiple cancer types, can be associated with respiratory system adverse events (AEs).
Chanjuan Cui, Lei Deng, Wenqing Wang, Xiayang Ren, Yanfeng Wang, Wei Cui   +5 more
doaj   +1 more source

Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible

TH Open, 2018
Whether aggressive prolonged dual antiplatelet therapy (DAPT) promotes solid cancer risks remains a critical unsolved issue. Since the evidence from randomized trials, affiliated U.S.
Victor Serebruany, Moo Hyun Kim, Christian Thevathasan, Thomas Marciniak   +3 more
doaj   +1 more source

Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act

Health Services Research & Managerial Epidemiology, 2021
Background As part of the accelerated approval of mifepristone as an abortifacient in 2000, the Food and Drug Administration (FDA) required prescribers to report all serious adverse events (AEs) to the manufacturer who was required to report them to the ...
Christina A. Cirucci, Kathi A. Aultman, Donna J. Harrison   +2 more
doaj   +1 more source

The Safety of the Novel Oral Cortisol Synthesis Inhibitor Osilodrostat: A Study Based on the FAERS Database

Xiehe Yixue Zazhi
ObjectiveTo evaluate the safety of the novel oral cortisol synthesis inhibitor osilodrostat in the treatment of Cushing syndrome (CS) through data mining of real-world databases.MethodsData on adverse drug events (ADEs) of osilodrostat from January 1 ...
LIU Yuke, TAN Huiwen
doaj   +1 more source

Analysis of anticholinergic adverse effects using two large databases: The US Food and Drug Administration Adverse Event Reporting System database and the Japanese Adverse Drug Event Report database.

PLoS ONE, 2021
IntroductionAnticholinergic adverse effects (AEs) are a problem for elderly people. This study aimed to answer the following questions. First, is an analysis of anticholinergic AEs using spontaneous adverse drug event databases possible?
Junko Nagai, Yoichi Ishikawa
doaj   +1 more source

A Real-World Disproportionality Analysis of Olaparib: Data Mining of the Public Version of FDA Adverse Event Reporting System

Clinical Epidemiology, 2022
Yamin Shu,1 Xucheng He,2 Yanxin Liu,3 Pan Wu,4 Qilin Zhang5 1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China; 2Department of Pharmacy, Pengzhou Second ...
Shu Y, He X, Liu Y, Wu P, Zhang Q
doaj  

Automatically Recognizing Medication and Adverse Event Information From Food and Drug Administration’s Adverse Event Reporting System Narratives

JMIR Medical Informatics, 2014
BackgroundThe Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) is a repository of spontaneously-reported adverse drug events (ADEs) for FDA-approved prescription drugs.
Polepalli Ramesh, Balaji, Belknap, Steven M, Li, Zuofeng, Frid, Nadya, West, Dennis P, Yu, Hong   +5 more
doaj   +1 more source

Assessing post-marketing safety of PDE5Is in erectile dysfunction: real-world evidence from the FDA adverse event reporting system

Asian Journal of Andrology
Erectile dysfunction (ED) is a common condition affecting men worldwide. The U.S. Food and Drug Administration (FDA) has approved phosphodiesterase type 5 inhibitors (PDE5Is), including sildenafil, tadalafil, vardenafil, and avanafil, for treating ED ...
Zi-Hao Zhao, Yang Xiong, Wei Wang, Chang-Jing Wu, Jiu-Hong Yuan   +4 more
doaj   +1 more source