No Thromboembolic Events Observed in RCTs of Oral Tranexamic Acid: A Systematic Review and Descriptive Synthesis

Published: 21 April 2025| Version 1 | DOI: 10.17632/3jkwnhxm36.1
Contributors:
Guilherme Kuceki, Daniela Mendez, Georgina Garza, Caroline Kruithoff, Lorena Oliveira Fonseca, Lal Karan

Description

This systematic review synthesizes data from 51 randomized controlled trials and 23 observational studies evaluating the safety of oral tranexamic acid (TXA), with a specific focus on thromboembolic events (TEs). While TXA is widely used off-label for chronic dermatologic conditions such as melasma, concerns regarding TE risk have limited its broader adoption. Our findings reveal no thromboembolic events in over 2,500 RCT participants treated with oral TXA for durations of up to 24 months, suggesting a favorable safety profile in controlled settings.

Files

Steps to reproduce

We conducted a systematic review of PubMed and CENTRAL Library databases (inception to 2025) to identify randomized controlled trials (RCTs) and observational studies where TXA was administered for multiple days by oral or intravenous route for any dermatological condition, heavy menstrual bleeding, or hemophilia.

Institutions

  • Ohio University Heritage College of Osteopathic Medicine
  • Escola Superior de Ciencias da Santa Casa de Misericordia de Vitoria
  • Universidad Autonoma de Nuevo Leon
  • Cleveland Clinic
  • OhioHealth

Categories

Dermatology, Deep Vein Thrombosis, Pulmonary Embolism, Rosacea, Hormonal Effect, Thromboembolic Disease, Melasma, Systematic Review with Meta-Analysis

Licence