ArticleFrontiers in pediatrics2026
Risk of drug-related aggression in pediatric populations: a pharmacovigilance analysis using the FAERS database.
Article in Frontiers in pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Aggression in pediatric populations poses significant risks to mental health and development, and drug-associated aggression may either exacerbate pre-existing behavioral problems or arise Methods: We conducted a retrospective disproportionality analysis of FAERS data (2004 Q1-2025 Q2) for patients <18 years. Aggression was defined using Standardized MedDRA Queries (SMQ code: 10001488). Signals were detected using four consensus algorithms (ROR, PRR, MGPS, and BCPNN). Drugs were categorized by Anatomical Therapeutic Chemical (ATC) classification. Subgroup analyses and multivariable logistic regression were used to calculate adjusted reporting odds ratios (aRORs), and TTO was evaluated to characterize temporal patterns. Results: Among 7,959 reports (67.75% male; median age: 9 years), 31 drugs exhibited positive signals, primarily nervous system (45.16%) and respiratory (32.26%) agents. Signals for tezacaftor, elexacaftor, macrogol, desloratadine, and ebastine were identified despite absent FDA label warnings. The strongest signals were for ebastine (ROR: 23.40) and perampanel (17.41), while montelukast had the highest case volume ( Conclusion: This study identifies robust signals linking multiple drugs to pediatric aggression, with elevated risks observed particularly in younger children and females. These findings underscore the need for heightened clinical vigilance, consideration of demographic-specific risks, and updated regulatory labeling to improve pediatric drug safety.
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