In FAERS data from 2004Q1 to 2026Q1, TXA-associated thrombotic events differed by vessel type in demographics, indications, onset time and outcomes, and signal strength was not concordant with clinical severity, which the authors say supports enhanced attention and risk stratification in high-risk groups.
The study identified 515 thrombotic cases associated with TXA across 26 selected thrombotic terms, split almost evenly across vessel-type subgroups.
Venous thromboembolism events were the most frequent thrombotic type, led by pulmonary embolism and deep vein thrombosis.
Venous reports had a higher proportion of deaths than arterial reports.
The strongest disproportionality signals were for rare site-specific thrombotic events rather than the most frequent ones.
Venous events occurred predominantly in women treated for menorrhagia.
Arterial events arose mainly in surgical or procedural settings and had the earliest onset after exposure.
Signal strength was not concordant with clinical severity across the thrombotic spectrum.
The three vessel-type subgroups differed markedly in demographics, indications, and clinical characteristics, suggesting clinical background may shape the thrombotic phenotype.
This study analyzed reports submitted to the U.S. FDA's adverse event database from 2004 to early 2026 to look at blood clots reported in people who took tranexamic acid (TXA), a drug widely used to reduce bleeding. It found 515 clot-related cases and sorted them into arterial, venous, and mixed or unspecified types. Venous clots, especially pulmonary embolism and deep vein thrombosis, were the most common and the most often fatal: deaths were reported in 16.8% of venous reports versus 2.5% of arterial reports. The types of clots differed by patient and setting. Venous clots were reported mostly in women, often those treated for heavy menstrual bleeding. Arterial clots were more often linked to surgery or procedures and appeared much sooner after exposure, with a median of 0 days versus 7 days for venous clots. The strongest statistical signals were for rare clots, such as ovarian vein and cerebral venous sinus clots, but these were not the most common or deadliest types. This research suggests that how strongly a clot type is statistically linked to the drug does not necessarily reflect how serious it is. Because the data come from voluntary reports, they cannot prove that TXA causes these events or show how often they occur. The authors say the findings support closer attention and risk assessment in higher-risk groups.
Zou Y, Wang S, Yuan Y, Cao Y, Liu J, Guan Z. (2026). Characterizing the Thrombotic Spectrum and Clinical Phenotypes of Tranexamic Acid-Associated Adverse Events: A Pharmacovigilance Study Based on the FAERS Database.. Cardiovascular toxicology. https://doi.org/10.1007/s12012-026-10210-y