Abstract
This study analyzed FAERS data to evaluate pegaspargase safety in pediatric acute lymphoblastic leukemia treatment. Among 21,161,817 reports, 847 identified pegaspargase as the primary suspect drug, revealing adverse events (AEs) across 26 organ systems. Disproportionality analysis identified four previously unlisted AEs. Critically, pegaspargase-associated pancreatitis incidence showed significant age-dependence (χ²=8.219, p < 0.05). These findings address the knowledge gap in real-world, long-term pediatric safety profiles and provide crucial clinical references for safer medication use in children.