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Safety profiles of dasatinib in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS

Yuanyuan Yang1, Weihao Ma1, Hongbo Fu1

  • 1Department of Pharmacy of the Second Affiliated Hospital, Shantou University Medical College, No. 69 Dongxia North Road, Jinping District, Shantou 515041, Guangdong, China.

Japanese Journal of Clinical Oncology
|October 2, 2025
PubMed

Insights

This study analyzed Food and Drug Administration Adverse Event Reporting System data for pediatric dasatinib use. It identified potential new safety concerns and highlighted the need for enhanced pharmacovigilance in children.

Area of Science:

  • Pediatric Oncology
  • Pharmacovigilance
  • Drug Safety

Background:

  • Dasatinib is approved for pediatric Philadelphia chromosome-positive leukemias.
  • Comprehensive pediatric safety data for dasatinib are limited.
  • This study addresses the need for detailed safety information in young patients.

Purpose of the Study:

  • To evaluate adverse events (AEs) in pediatric patients treated with dasatinib.
  • To characterize the safety profile of dasatinib in a pediatric population.
  • To identify potential new safety concerns using real-world data.

Main Methods:

  • Analysis of Food and Drug Administration Adverse Event Reporting System (FAERS) data from Q1 2014 to Q4 2024.
  • Disproportionality analysis to identify statistically significant AE reporting patterns.
  • Focus on adverse events in pediatric patients receiving dasatinib.

Main Results:

  • 382 pediatric cases involving dasatinib were reported.
  • Common AEs included general disorders, gastrointestinal issues, and injury-related events.
  • Novel AEs like hemorrhagic enterocolitis and hydrocephalus were identified; off-label use was also noted.

Conclusions:

  • Enhanced pharmacovigilance and monitoring are crucial for pediatric dasatinib use.
  • Proactive safety surveillance can improve clinical outcomes in pediatric patients.
  • Findings support the safe use of dasatinib in children with appropriate monitoring.
Abstract

Keywords:
FAERSadverse eventsdasatinibpediatric patientspharmacovigilance

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