ArticleNaunyn-Schmiedeberg's archives of pharmacology2026
Respiratory drugs and psychiatric adverse events in children and adolescents: a pharmacovigilance study based on the FAERS database.
Article in Naunyn-Schmiedeberg's archives of pharmacology, 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
The association between respiratory drugs (RDs) and pediatric psychiatric adverse events (pAEs) remains insufficiently characterized. We aimed to characterize pAEs associated with RDs use in pediatric patients. RD-related pAE reports were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Analysis focused on pediatric patients aged 0 to 17 years. Disproportionality analysis was conducted using four algorithms, with a focus on anxiety disorders and symptoms, depressed mood disorders and disturbances, and suicidal and self-injurious behaviors. Descriptive and clinical outcome analyses were performed, along with subgroup analyses to explore potential risk differentials by age and gender. Among 6,994 cases of RD-related pAEs in pediatric patients, 16 drugs with positive signals were identified across all four algorithms, with antiallergics accounting for 75.00%. Montelukast was the most frequently reported drug (n = 6,168), primarily associated with anxiety (21.84%, reporting odds ratio [ROR] = 15.08), depression (15.86%, ROR = 12.90), and suicidal ideation (14.27%, ROR = 13.63). Promethazine demonstrated strong signals for intentional self-injury (62.99%, ROR = 127.36). The highest mortality rates were observed with hydroxyzine (50.94%) and caffeine (50.00%), while oxytetracycline (4/4, 100%) showed the highest proportions of life-threatening events. Montelukast generated signals in all age and gender groups, with the highest disproportionality observed in children aged 0 to 4 years. This study identifies statistical associations between RDs and pAEs in pediatric patients, particularly with montelukast and promethazine. The highest mortality rates were observed with hydroxyzine. These findings provide a foundation for further research but require confirmation through large-scale prospective studies.
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