Pancreatitis induced by Peg-aspargase in children: a real-world pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS)
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
Fields of Study & Subjects
Pharmacovigilance and Adverse Drug Reactions
Acute Lymphoblastic Leukemia research
Drug-Induced Adverse Reactions
Publication details
- Journal / source
- Leukemia Research Reports
- Volume
- 25
- Pages
- 100562–100562
- Publication date
- 1 January 2026
- Language
- EN