Drug-related adverse reactions in pediatric Inflammatory Bowel Disease.

Therapeutic approach to Inflammatory Bowel Disease (IBD) is complex, often involving multiple pharmacologic classes. We aimed to evaluate the prevalence of drug-related adverse reactions (ARs) associated with therapies used in pediatric IBD. Retrospective study of pediatric patients with IBD followed in a tertiary hospital from 2010-2022. Ninety-nine patients were included, 62.6% male, with a median age at diagnosis of 13 years [Interquartile range (IQR): 11-15]. The majority had Crohn's Disease (69.7%), followed by Ulcerative Colitis (21.2%) and Unclassified IBD (9.1%). The most prescribed therapies were: immunomodulators (n = 75; 75.8%), exclusive enteral nutrition (n = 61; 61.6%) and biologics (n = 58, 58.6%). During a median follow-up time of 31 months (IQR: 11-51), the incidence of ARs was 16.2% (16 ARs occurred in 14 patients). The main drug involved was azathioprine (12/16) and the most frequent AR was hepatitis (5/16). Drug discontinuation was necessary in all but one case. Seventy-five percent ARs were mild to moderate and 81.3% did not require specific treatment; all patients had clinical and/or analytical normalization. There was a positive association between the cumulative number of prescribed drugs and the occurrence of ARs (p = 0.044). The incidence of ARs was similar to the few existing previous studies. The majority of ARs were mild, but implied discontinuation of therapy or dose reduction with possible impact on disease control. This article is protected by copyright. All rights reserved.