Results 41 to 50 of about 6,307 (191)

What is the incidence and clinical significance of dry eye disease in patients treated with immune checkpoint inhibitors? A systematic review and meta‐analysis of ocular immune‐related adverse events

Acta Ophthalmologica, Volume 104, Issue 6, Page e599-e614, September 2026.
Abstract Purpose Immune checkpoint inhibitors (ICIs) have transformed cancer therapy but may cause immune‐related adverse events (irAEs), including dry eye disease (DED). This study aimed to quantify the incidence of ICI‐associated DED and to evaluate factors contributing to variability across studies.
Kai‐Yang Chen, Hoi‐Chun Chan, Chi‐Ming Chan   +2 more
wiley   +1 more source

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

Scientific Reports, 2022
Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was
Yanchao Yin, Yamin Shu, Junru Zhu, Feie Li, Juan Li   +4 more
doaj   +1 more source

Adverse events in bedaquiline‐ and pretomanid‐based regimens for drug‐resistant tuberculosis from trial, implementation and pharmacovigilance studies

British Journal of Clinical Pharmacology, Volume 92, Issue 8, Page 2607-2623, August 2026.
Abstract The availability of safety data, particularly concerning adverse events (AEs) associated with the new shorter regimen for drug‐resistant tuberculosis (TB) containing a bedaquiline–pretomanid‐based regimen, is still limited. This systematic review aims to provide a comprehensive and updated analysis of AEs related to this new regimen by ...
Nisa Maria, Annisa Lazuardi Larasati, Indri Yuliani Hamdani, Jin‐Gun Cho, Jan‐Willem C. Alffenaar   +4 more
wiley   +1 more source

Characterization of ocular adverse events associated with crizotinib: real-world insights from the two global pharmacovigilance databases of FAERS and VigiBase

Frontiers in Oncology
To evaluate the risk of ocular adverse events (AEs) associated with crizotinib using real-world data from FAERS and VigiBase, and to characterize signal patterns through disproportionality and time-to-onset (TTO) analyses. Reports from FAERS and VigiBase
Shuai Dong, Zhi-chao Jiang, Li Gao, Rong Zhang, Yan Liu   +4 more
doaj   +1 more source

The Real‐World Safety Profile of Immune Checkpoint Inhibitors in Melanoma: FAERS Pharmacovigilance Analysis Complemented by Randomized Trial Evidence

Health Science Reports, Volume 9, Issue 8, August 2026.
ABSTRACT Background and Aims Melanoma can be effectively treated with immune checkpoint inhibitors (ICIs), but information regarding the risks of treatment‐related adverse events (trAEs), immune‐related adverse events (irAEs), and real‐world adverse events (AEs) is scarce.
Yiwei Chen, Xueyan Liang, Xiaoyu Chen, Yan Li   +3 more
wiley   +1 more source

Deciphering the Formulation‐Dependent Neurotoxicity of Irinotecan: An Integrated Pharmacovigilance and Mechanistic Study

Journal of Biochemical and Molecular Toxicology, Volume 40, Issue 8, August 2026.
Overall workflow of the study, from computational toxicology screening and FAERS‐based data mining to mechanistic prediction of neurotoxicity of irinotecan. ABSTRACT Irinotecan is a key chemotherapeutic agent, but its neurotoxicity limits its utility.
Cheng Shen, Wei Ma, Jing Lu, Yongbo Tang, Wei Cao   +4 more
wiley   +1 more source

Reported Characteristics of Anaphylaxis Associated With Glatiramer Acetate: A Pharmacovigilance Analysis of the FDA and Canadian Databases

Pharmacology Research &Perspectives, Volume 14, Issue 4, August 2026.
ABSTRACT The FDA has mandated a Boxed Warning for glatiramer acetate (GA) due to the risk of serious anaphylactic reaction. This study aimed to characterize the reported features of GA‐associated anaphylaxis. Data mining was performed using the Reporting Odds Ratio (ROR) in the FDA Adverse Event Reporting System (FAERS) database (Q1 2004–Q1 2025) and ...
Tailei Nie, Hongyu Liu, Chuanxu Cheng, Jian Li, Jiajing Lu   +4 more
wiley   +1 more source

Hepatobiliary disorders associated with TNF-α inhibitors: a pharmacovigilance analysis of FAERS and JADER

Frontiers in Immunology
IntroductionTumor necrosis factor-a (TNF-a) inhibitors are widely used for immune-mediated diseases. Their systemic adverse events (AEs) have become increasingly prominent. The hepatobiliary risks of different TNF-a inhibitors were compared in this paper
Hongyu Chen, Shirui Jiang, Jingyu Wang, Ailin Zhang, Liqin Zhu   +4 more
doaj   +1 more source

Using Pharmacovigilance Data for Signal Detection of Drug Interactions for Rosuvastatin

Basic &Clinical Pharmacology &Toxicology, Volume 139, Issue 2, August 2026.
ABSTRACT The 3‐hydroxy‐3‐methyl‐glutaryl‐coenzyme A reductase inhibitor rosuvastatin is a substrate of breast cancer resistance protein (BCRP). BCRP inhibition increases rosuvastatin plasma concentrations and may result in concentration‐dependent muscle toxicity, at worst rhabdomyolysis.
Ronja Levomäki, Päivi Hirvensalo, Aleksi Tornio, Anne M. Filppula   +3 more
wiley   +1 more source

Drug Safety During Breastfeeding: A Comparative Analysis of FDA Adverse Event Reports and LactMed^®

Pharmaceuticals
Background/Objectives: While breastfeeding is highly recommended, breastfed infants may be exposed to drugs by milk due to maternal pharmacotherapy, resulting in a risk of adverse drug events (ADE) or reactions (ADRs). The U.S.
Hülya Tezel Yalçın, Nadir Yalçın, Michael Ceulemans, Karel Allegaert   +3 more
doaj   +1 more source