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Methotrexate toxicity and intolerance in paediatric inflammatory bowel disease: A retrospective cohort study

Eva Vermeer1,2,3, Eveline L Soetens1, Eduard A Struys4

  • 1Department of Paediatric Gastroenterology, Emma Children's Hospital, Amsterdam University Medical Centre, Amsterdam, the Netherlands.

Journal of Pediatric Gastroenterology and Nutrition
|November 30, 2025
PubMed
Abstract

Insights

Methotrexate (MTX) adverse events (AEs) like liver and blood toxicities are common in pediatric inflammatory bowel disease (IBD) but rarely severe. Male sex, MTX dose, and oral administration impact AE risk.

Area of Science:

  • Pediatric Gastroenterology
  • Pharmacovigilance
  • Inflammatory Bowel Disease Research

Background:

  • Methotrexate (MTX) is a common treatment for pediatric inflammatory bowel disease (IBD).
  • Routine monitoring for MTX-induced adverse events (AEs), including hepatotoxicity and myelotoxicity, is standard practice.
  • Limited data exist on the incidence and predictors of these AEs in pediatric IBD patients.

Purpose of the Study:

  • To determine the incidence of MTX-induced AEs in children with IBD.
  • To identify factors associated with the development of these adverse events.
  • To inform clinical monitoring and management strategies for MTX therapy in pediatric IBD.

Main Methods:

  • Retrospective monocentre cohort study of pediatric IBD patients initiating MTX (2010-2023).
  • Data collected included demographics, disease characteristics, therapy details, and laboratory results.
  • AEs evaluated included biochemical toxicity (hepatotoxicity, myelotoxicity) and gastrointestinal symptoms (nausea, vomiting), with severity graded using standard criteria.

Main Results:

  • The study included 207 pediatric IBD patients; 41% experienced hepatotoxicity and 21% myelotoxicity.
  • Nausea was reported in 46% of patients, and 38% discontinued MTX due to AEs.
  • Predictors of biochemical toxicity included male sex and lower MTX dose, while nausea was linked to male sex, oral administration, and higher MTX dose.

Conclusions:

  • MTX-induced AEs are frequent in pediatric IBD but typically mild.
  • Male sex, MTX dosage, and route of administration (oral vs. subcutaneous) are significant factors influencing AE risk.
  • These findings highlight the need for personalized monitoring and management of MTX therapy in pediatric IBD.
Keywords:
Crohn's diseaseadverse eventshepatotoxicitymyelotoxicityulcerative colitis

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