ArticlePloS one2026
Real‑world safety evaluation of tranexamic acid: Signal detection from FAERS and VigiAccess databases.
Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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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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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTranexamic acid (TXA) is an antifibrinolytic agent commonly used to mitigate blood loss across various medical indications. Despite its widespread use, comprehensive data on its safety profile remain limited. This study aimed to systematically evaluate adverse events (AEs) associated with TXA.
methodsAdverse event reports were extracted from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) and the VigiAccess databases. Disproportionality analyses were conducted using reporting odds ratio (ROR), proportional reporting ratio (PRR), the Medicines and Healthcare products Regulatory Agency (MHRA) method, Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS).
resultsA total of 17,787 TXA-related AE reports were identified. A higher proportion of reports involved females, with older adults (≥ 65 years) accounting for the largest proportion in FAERS and younger individuals (18-44 years) in VigiAccess. Overlapping PTs, including seizures, pulmonary embolism and anaphylactic reactions, were identified. Significant differences for TXA-related AEs were found by gender, age and death outcomes. Most AEs occurred within the first month, with an early failure pattern.
conclusionThis study provides evidence to weigh risks and benefits of TXA by comprehensive assessment of safety profile for TXA. These findings provide valuable references for future pharmacovigilance research on TXA.
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