ArticlePloS one2025
Safety assessment of Edaravone: A real-world adverse event analysis based on the FAERS Database.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
objectiveEdaravone is a neuroprotective agent, but the characteristics of its adverse events (AEs) remain insufficiently explored. This study aims to examine AEs associated with edaravone use by analyzing real-world data from the FDA Adverse Event Reporting System (FAERS).
methodsThis retrospective study extracted adverse event reports related to edaravone from the FAERS database, spanning from the second quarter of 2017 to the second quarter of 2024. Disproportionality analysis methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN), were employed to detect AE signals associated with edaravone use.
resultsAmong 2,931 adverse event reports (AERs) in which edaravone was identified as the primary suspected drug, 86 preferred terms (PTs) and 20 system organ classes (SOCs) were included. At the PTs level, the significant drug-related adverse events were death (n = 589, ROR = 8.64), disease progression (n = 266, ROR = 28.26) and drug ineffectiveness (n = 252, ROR = 2.16). Additionally, rare but notably strong adverse event signals were observed, including thrombosis at the catheter site thrombosi, gastric fistula, and vein collapse.
conclusionOur research found that edaravone has some overlooked adverse reactions. Further epidemiological studies are needed to more comprehensively explore and assess the risk-benefit profile of edaravone.
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