ArticleFrontiers in medicine2026
Sex- and age-stratified pharmacovigilance of methotrexate-associated adverse events in pediatric leukemia: a FAERS-based study.
Article in Frontiers in medicine, 2026. 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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Abstract
Background: Pediatric leukemia (PL) is a common malignant tumor in childhood. Methotrexate (MTX) is a widely used chemotherapeutic agent for the treatment of this disease. This study was based on the FAERS database and explored the adverse reaction signals of MTX in the treatment of PL. Methods: This study retrieved reports of adverse drug events (ADEs) related to MTX in the treatment of PL from the FAERS database (Q1 2018-Q1 2025). The disproportionality approach, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was employed to detect ADE signals. Subgroup analyses were conducted by gender and age groups (infants: <1 year; toddlers: 1-3 years; preschoolers: 4-6 years; school-age: 7-10 years; adolescents: 11-17 years), and time-to-onset of ADEs was analyzed using Weibull distribution fitting. Results: A total of 2,907 reports of ADEs associated with MTX treatment for PL were included. Among these reports, males accounted for the highest proportion (58.3%); the main outcome of ADEs was hospitalization (41.9%). At the SOC level, nervous system disorders accounted for the largest number of reports; at the PT level, febrile neutropenia had the highest report count. Among gender-related ADE signals, confusional state showed greater reporting disproportionality in males. In the age-stratified analysis, the leading PTs varied across age groups; 6 signals were detected in all age groups, and reports describing events within 0-30 days accounted for the highest proportion (72.1%). Conclusion: This study identified prominent reporting signals for nervous system disorders, with febrile neutropenia, neurotoxicity, and mucositis among the most frequently reported PTs. Reports involving males and adolescents accounted for larger proportions, and 72.1% of reports with available onset data described events within 30 days. These findings are hypothesis-generating pharmacovigilance signals and do not establish incidence, comparative clinical risk, or causality.
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