Empirical estimation of under-reporting in the US Food and Drug Administration adverse event reporting system (FAERS)

YM Alatawi, RA Hansen - Expert opinion on drug safety, 2017 - Taylor & Francis
Background: To examine how closely reporting rates in the FDA Adverse Event Reporting
System (FAERS) reflect expected rates of known adverse drug events (ADEs). Methods: We …

Pharmacist‐led interventions to reduce adverse drug events in older people living in residential aged care facilities: A systematic review

S Ali, MS Salahudeen, LRE Bereznicki… - British Journal of …, 2021 - Wiley Online Library
Aims We aimed to investigate the efficacy and effectiveness of pharmacist‐led interventions
to reduce adverse drug events (ADEs) in older people living in residential aged care …

Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases

H Hatahira, J Abe, Y Hane, T Matsui, S Sasaoka… - … of pharmaceutical health …, 2017 - Springer
Background Drug-induced gingival hyperplasia (DIGH) causes problems with chewing,
aesthetics, and pronunciation, and leads to the deterioration of the patient's quality of life …

Leveraging machine learning to facilitate individual case causality assessment of adverse drug reactions

Y Cherkas, J Ide, J van Stekelenborg - Drug Safety, 2022 - Springer
Introduction Causality assessment of individual case safety reports (ICSRs) is an important
step in pharmacovigilance case-level review and aims to establish a position on whether a …

Musculoskeletal adverse events induced by immune checkpoint inhibitors: a large-scale pharmacovigilance study

H Liu, Y Li, J Li, Q Zhang, J Wu, X Li, L Meng… - Frontiers in …, 2023 - frontiersin.org
Background: The musculoskeletal toxicity of immune checkpoint inhibitors (ICIs) is receiving
increasing attention with clinical experience. Nevertheless, the absence of a systematic …

Adverse drug events associated with linezolid administration: a real-world pharmacovigilance study from 2004 to 2023 using the FAERS database

F Zou, Z Cui, S Lou, Y Ou, C Zhu, C Shu… - Frontiers in …, 2024 - frontiersin.org
Introduction: Linezolid is an oxazolidinone antibiotic that is active against drug-resistant
Gram-positive bacteria and multidrug-resistant Mycobacterium tuberculosis. Real-world …

Evaluation of the expression time of ganciclovir-induced adverse events using JADER and FAERS

G Ando, K Taguchi, Y Enoki, Y Yokoyama… - Biological and …, 2019 - jstage.jst.go.jp
Investigation of the occurrence time of adverse drug reactions helps to prevent the
development and aggravation of adverse reactions, but the expression time of ganciclovir …

From genomic spectrum of NTRK genes to adverse effects of its inhibitors, a comprehensive genome-based and real-world pharmacovigilance analysis

Z Cui, Z Zhai, D Xie, L Wang, F Cheng, S Lou… - Frontiers in …, 2024 - frontiersin.org
Introduction: The discovery of neurotrophic tyrosine receptor kinase (NTRK) gene fusions
has facilitated the development of precision oncology. Two first-generation NTRK inhibitors …

SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database

K Takada, K Taguchi, M Samura, Y Igarashi… - Journal of Infection and …, 2024 - Elsevier
Background The association between severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) mRNA vaccines and myocarditis/pericarditis in the Japanese population has …

Patients with inflammatory rheumatic diseases: quality of self-reported medical information in a prospective cohort event monitoring system

LJ Kosse, NT Jessurun, RCF Hebing… - …, 2020 - academic.oup.com
Objectives Assessment of the quality of patient-reported medical information in the Dutch
Biologic Monitor and evaluation of the representativeness of the sampled participants …