Articles with "event reporting" as a keyword



Exploring the Relationship Between Antipsychotic Drug Target Genes and Epilepsy: Evidence From Food and Drug Administration Adverse Event Reporting System Database and Mendelian Randomization

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Published in 2025 at "Brain and Behavior"

DOI: 10.1002/brb3.70467

Abstract: The effect of antipsychotic drugs on epilepsy is controversial, and we performed Food and Drug Administration Adverse Event Reporting System (FAERS) data mining and Mendelian Randomization (MR) analyses to clarify the effects of target genes… read more here.

Keywords: event reporting; food drug; drug; adverse event ... See more keywords

Cardiovascular and Metabolic Adverse Events of Endocrine Therapies in Women with Breast Cancer: A Disproportionality Analysis of Reports in the FDA Adverse Event Reporting System

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Published in 2024 at "Cancer Medicine"

DOI: 10.1002/cam4.70548

Abstract: Emerging evidence suggests potential cardiovascular toxicities from oral endocrine therapies (ETs); however, results are conflicting. This study comprehensively examined adverse reactions of ETs and investigated cardiovascular and metabolic safety signals within the FDA Adverse Event… read more here.

Keywords: event reporting; fda adverse; reporting system; adverse event ... See more keywords

Mining adverse events in large frequency tables with ontology, with an application to the vaccine adverse event reporting system

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Published in 2023 at "Statistics in Medicine"

DOI: 10.1002/sim.9684

Abstract: Many statistical methods have been applied to VAERS (vaccine adverse event reporting system) database to study the safety of COVID‐19 vaccines. However, none of these methods considered the adverse event (AE) ontology. The AE ontology… read more here.

Keywords: event reporting; vaccine adverse; adverse event; ontology ... See more keywords

From Harmful Treatment to Secondary Gain: Adverse Event Reporting in Dyspepsia and Gastroparesis

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Published in 2017 at "Digestive Diseases and Sciences"

DOI: 10.1007/s10620-017-4633-8

Abstract: IntroductionMedical management of gastroparesis and functional dyspepsia remains difficult with several recent trials showing limited or no benefit. If treatment comes with only marginal improvements, concerns about adverse events become more relevant. We therefore examined… read more here.

Keywords: adverse event; dyspepsia gastroparesis; treatment; event reporting ... See more keywords

Myocarditis and pericarditis after immunization: Gaining insights through the Vaccine Adverse Event Reporting System.

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Published in 2018 at "International journal of cardiology"

DOI: 10.1016/j.ijcard.2018.09.054

Abstract: Abstract Aim To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods Cases were extracted from VAERS (2011–2015) and assessed for causality using standardized WHO algorithm.… read more here.

Keywords: adverse event; reporting system; event reporting; vaccine adverse ... See more keywords

Antidepressants-related cardiovascular adverse events using the adverse event reporting system

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Published in 2018 at "Psychiatry Research"

DOI: 10.1016/j.psychres.2018.07.044

Abstract: The aim of this study was to evaluate clinical manifestations and the age and sex distribution of cardiovascular adverse events (CVAEs) related to antidepressants. The FDA Adverse Event Reporting System (FAERS) and Korea Adverse Event… read more here.

Keywords: reporting system; reporting; adverse event; event reporting ... See more keywords
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Signals and trends of Guillain-Barré syndrome after the introduction of live-attenuated vaccines for influenza in the US and South Korean adverse event reporting systems.

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Published in 2020 at "Vaccine"

DOI: 10.1016/j.vaccine.2020.06.038

Abstract: BACKGROUND With the advent of live-attenuated, quadrivalent, and cell-cultured vaccines for influenza, there have been discussions on the safety of these vaccines compared to conventional vaccines (such as inactivated, trivalent, and egg-cultured vaccines) because of… read more here.

Keywords: adverse event; reporting systems; vaccines influenza; event reporting ... See more keywords

Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System

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Published in 2025 at "Scientific Reports"

DOI: 10.1038/s41598-025-10924-z

Abstract: Cataract is a leading cause of irreversible vision loss, particularly among the elderly, with drug-induced cataract being an underrecognized yet significant contributor to visual impairment. This study investigates the associations between medications and cataract development… read more here.

Keywords: event reporting; cataract; fda adverse; drug induced ... See more keywords

A realworld pharmacovigilance study of trazodone based on the FDA adverse event reporting system

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Published in 2025 at "Scientific Reports"

DOI: 10.1038/s41598-025-89632-7

Abstract: To explore and analyze the potential adverse event (AE) signals of trazodone, with reference to the safe clinical use of drugs. Based on the FDA Adverse Event Reporting System (FAERS), the AE data of trazodone… read more here.

Keywords: event reporting; trazodone; fda adverse; based fda ... See more keywords
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Adverse event reporting patterns of concomitant botanical dietary supplements with CYP3A4 interactive & CYP3A4 non-interactive anticancer drugs in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS)

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Published in 2019 at "Expert Opinion on Drug Safety"

DOI: 10.1080/14740338.2019.1562546

Abstract: ABSTRACT Background: To examine the adverse event (AE) reporting patterns for concomitant Botanical Dietary Supplements (BDS) and anticancer drugs. Research design and methods: Using the 2004–2015 U.S. Food and Drug Administration Adverse Event Reporting System… read more here.

Keywords: anticancer drugs; anticancer; adverse event; event reporting ... See more keywords

Post-marketing safety concerns with elagolix: a disproportionality analysis of the FDA adverse event reporting system

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Published in 2024 at "Expert Opinion on Drug Safety"

DOI: 10.1080/14740338.2024.2351451

Abstract: ABSTRACT Objective Elagolix is approved for the treatment of moderate-to-severe pain associated with endometriosis. However, the long-term safety of elagolix in a large sample of real-world patients is unknown. Methods The U.S. Food and Drug… read more here.

Keywords: event reporting; post marketing; adverse event; reporting system ... See more keywords