A Standardized Dataset of a Spontaneous Adverse Event Reporting System [PDF]
Healthcare, 2022 One of the largest spontaneous adverse events reporting databases in the world is the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Unfortunately, researchers face many obstacles in analyzing data from the FAERS database. One
M. A. Khaleel +4 more
semanticscholar +3 more sources
Exploration of adverse event profiles for glofitamab: A disproportionality analysis using the FDA adverse event reporting system [PDF]
PLoS ONEBackgroundGlofitamab offers a promising option for the treatment of diffuse large B-cell lymphoma. It is crucial to gather comprehensive safety information of glofitamab through large-scale post market monitoring.MethodsThis study conducted a ...
Meng Zhou, Cheng Jiang, Chuanyong Su
doaj +3 more sources
Assessing taxane-associated adverse events using the FDA adverse event reporting system database
Chinese Medical Journal, 2021 . Background:. Taxanes are an essential class of antineoplastic agents used to treat various cancers and are a fundamental cause of hypersensitivity reactions. In addition, other adverse events, such as bone marrow toxicity and peripheral neuropathy, can
Dong-Hui Lao +4 more
doaj +3 more sources
Ocular Complications after COVID-19 Vaccination, Vaccine Adverse Event Reporting System
Vaccines, 2022 In December 2020, the U.S. Food and Drug Administration licensed COVID-19 vaccines for emergency use authorization. We investigated the ocular adverse event reports in patients reported to the Vaccine Adverse Event Reporting System (VAERS) following ...
Cyril N. A. Nyankerh +2 more
doaj +2 more sources
A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for etrasimod [PDF]
Frontiers in PharmacologyObjectiveTo characterize the post-marketing safety profile of etrasimod using the latest data from the FDA Adverse Event Reporting System (FAERS), and to provide a comparative analysis versus other sphingosine-1-phosphate (S1P) receptor modulators ...
Yingxiu Wu +4 more
doaj +2 more sources
Frontiers in PharmacologyBackgroundFaricimab is the first and only bispecific antibody approved by the U.S. Food and Drug Administration (FDA) for intravitreal injection. Given its increasingly widespread use in retinal vascular diseases, understanding its adverse events (AEs ...
Chang-Zhu He +5 more
doaj +3 more sources
CNS Neuroscience & Therapeutics, 2023 Objective Quetiapine, an atypical second‐generation antipsychotic drug, is approved for treatment of schizophrenia, bipolar disorder, and depression. Due to the limitations of clinical trials, the association between quetiapine and rare cardiac adverse ...
Yamin Shu +3 more
semanticscholar +3 more sources
Adverse Event Signals Associated with Beta-Lactamase Inhibitors: Disproportionality Analysis of USFDA Adverse Event Reporting System [PDF]
Journal of XenobioticsBackground: Beta-lactamase inhibitors (BLIs) are widely used with beta-lactam antibiotics to combat resistant infections, yet their safety profiles, especially for newer agents, remain underexplored.
Kannan Sridharan, Gowri Sivaramakrishnan
doaj +2 more sources
Disproportionality analysis of taste disorders using the FDA adverse event reporting system and Japanese adverse drug event report databases [PDF]
Frontiers in PharmacologyIntroductionTaste disorders, which can diminish the quality of life and potentially affect drug treatment efficacy, are adverse events that may occur with the use of various medications; however, only a few studies have comprehensively examined this ...
Yoji Kyotani +2 more
doaj +2 more sources
Indications and adverse events of teriparatide: based on FDA adverse event reporting system (FAERS)
Frontiers in PharmacologyBackgroundTeriparatide is approved for osteoporosis. Post-marketing surveillance is critical given its widespread use.ObjectiveTo investigate adverse events (AEs) associated with teriparatide using the FAERS database, compare association strengths for ...
Ming-Tao Wen +11 more
doaj +3 more sources