576 - Adverse Event Reports for Glucagon-Like Peptide-1 Receptor Agonists in Children and Adolescents

Publication Number: 4564.576

Brice Koons, University of Oklahoma College of Medicine, Tulsa, OK, United States; Brianna Fleshman, University of Oklahoma College of Medicine, TULSA, OK, United States; Amy D. Hendrix-Dicken, University of Oklahoma School of Community Medicine, Tulsa, OK, United States; Lamiaa Ali, University of Oklahoma College of Medicine, Tulsa, OK, United States; Michelle Condren, University of Oklahoma College of Medicine, tulsa, OK, United States

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have become an increasingly utilized treatment option for pediatric obesity and type 2 diabetes. Though GLP-1 RA use in children is growing, data on safety and adverse effects is limited in this population.

Objective: This study aimed to identify and categorize adverse event reports to the FDA related to GLP-1 RA use in pediatric patients.

Design/Methods: A retrospective review of pediatric (0 up to 18 years) adverse event reports involving GLP-1 RAs from 01/01/2015-09/25/2025 was conducted using the FDA Adverse Events Reporting System (FAERS). The GLP-1 RAs included in the database search were exenatide, liraglutide, semaglutide, dulaglutide, lixisenatide, albiglutide, and tirzepatide, along with their respective brand names and recombinant forms. Duplicate reports, reports with unknown age, and fetal exposures were excluded. Cases involving multiple suspected ingredients were reviewed and removed if a GLP-1 was not the offending agent. Since age was not reported consistently, it was transformed to a categorical variable. The defined age groups were 5 or less, 6-8, 9-11, 12-14, 15-17, and 18 years of age. Adverse reactions were categorized according to the affected body systems and/or general concerns. Descriptive statistics were conducted.

Results: A total of 204 adverse event reports met study inclusion criteria with a steady upward trend in number of reports each year (Figure 1). The majority of individuals had ages ranging from 15-17 years (n=79, 38.7%), 18 years (n=52, 25.5%), or ‘5 or less’ (n=41, 20.1%). Most reports were from consumers (n=129, 63.2%) and included semaglutide (n=83, 40.7%) or tirzepatide (n=42, 20.6%). The most common adverse reaction types were gastrointestinal (n=98, 48.0%), administration errors (n=58, 28.4%), nervous system (n=38, 18.6%; Figure 2), and off-label use (n=38, 18.6%). Over half of the reports were classified as serious (n=120, 58.8%) with four (2.0%) resulting in death, and 32.4% resulting in hospitalization (n=66; Figure 3).

Conclusion(s): While gastrointestinal symptoms are a well-known side effect to GLP-1 RA use, the frequency of nervous system side effects as well as administration errors and off-label use merits further consideration. Additionally, many reports occurred in an age group without FDA approval. While causation cannot be ascertained by FDA FAERs data, it is important that healthcare providers give comprehensive education regarding safe storage and remain vigilant for emergence of adverse effects.

Figure 1. Number of GLP-1 adverse event reports over time
Figure 1.pdfTrends in the frequency of GLP-1 RA-related adverse event reports using FDA FAERs from January 2015 to September 2025.

Figure 2. Adverse event report outcome
Figure 2.pdfThe percentage of GLP-1 RA-related adverse event reports that fell into each outcome category.

Figure 3. Adverse events included in greater than or equal to 10% of reports
Figure 3.pdfThe percentage of adverse event reports that included each of the adverse event categories. Note that 11 of the 20 adverse event categories were included in this figure.