Table 4_Sex- and age-stratified pharmacovigilance of methotrexate-associated adverse events in pediatric leukemia: a FAERS-based study.xlsx

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%).</p>Conclusion<p>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.</p>