Results 11 to 20 of about 6,307 (191)

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

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

Exploring the risk of depression and suicide/self-injury in patients receiving GLP-1RAs combined with metformin versus GLP-1RA monotherapy: a real-word analysis of the FAERS database

Endocrine Connections
Objective: This study aimed to assess the latent threat of depression and suicide/self-injury associated with the combination of glucagon-like peptide-1 agonists (GLP-1RAs) and metformin versus GLP-1RAs monotherapy, through analyzing the data from the ...
Wenjun Ji, Ying Ma, Jie Fang, Linwei Chen   +3 more
doaj   +1 more source

Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis

Frontiers in Pharmacology, 2018
Multiple data sources are preferred in adverse drug event (ADEs) surveillance owing to inadequacies of single source. However, analytic methods to monitor potential ADEs after prolonged drug exposure are still lacking.
Liwei Wang, Majid Rastegar-Mojarad, Zhiliang Ji, Sijia Liu, Ke Liu, Sungrim Moon, Feichen Shen, Yanshan Wang, Lixia Yao, John M. Davis III, Hongfang Liu   +10 more
doaj   +1 more source

Cardiovascular Toxicity Associated With Bispecific Antibodies in Hematological Malignancies: A Comprehensive Pharmacovigilance Analysis

American Journal of Hematology, EarlyView.
ABSTRACT Cardiovascular adverse events (CVAEs) associated with bispecific T‐cell engaging antibodies (BsAbs) have not been systematically investigated across approved agents. In this disproportionality analysis of FAERS (December 2014–September 2025), reports listing BsAbs as the primary suspected drug (n = 7647) were compared with all other drugs in ...
Malak Munir, Ahmed Sayed, Dae Hyun Lee, Sanam Ghazi, Mustafa M. Houmsse, Saad Badat, Abdul Moeed, Avirup Guha, Daniel Addison, Narendranath Epperla   +9 more
wiley   +1 more source