Risk of drug-related aggression in pediatric populations: a pharmacovigilance analysis using the FAERS database - Report - MDSpire

Risk of drug-related aggression in pediatric populations: a pharmacovigilance analysis using the FAERS database

  • By

  • Jing Chen

  • Lilan Zhao

  • June 5, 2026

  • 0 min

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Clinical Report: Evaluating the Association Between Medications and Aggression in Children

Overview

This study identifies 31 drugs associated with pediatric aggression using the FAERS database.

Background

Aggression in children is a concern impacting mental health and development. Drug-associated aggression can exacerbate existing behavioral issues or emerge after medication exposure. This study leverages the FAERS database to identify medication-related aggression in pediatric populations.

Data Highlights

DrugSignal Strength (ROR)Case Volume
ebastine23.40N/A
perampanel17.41N/A
montelukastN/A1,392

Key Findings

  • 31 drugs exhibited positive signals for aggression in pediatric patients.
  • 45.16% of the signals were from nervous system agents, and 32.26% from respiratory agents.
  • Ebastine and perampanel had the strongest signals for aggression.
  • Most drugs showed higher adjusted reporting odds ratios (aRORs) in early childhood, except for levetiracetam, which peaked in adolescence.
  • Females generally exhibited higher risks across most agents.
  • Median time-to-onset (TTO) varied significantly.

Clinical Implications

Clinicians should be aware of the potential for aggression associated with various medications in pediatric patients, particularly in younger children and females. This necessitates careful monitoring and consideration of demographic-specific risks when prescribing these agents.

Conclusion

The findings from this study highlight the importance of pharmacovigilance in identifying drug-related aggression in children, emphasizing the need for updated regulatory labeling and clinical vigilance.

Related Resources & Content

  1. Archives of Toxicology, 2020 -- Investigating the Molecular Mechanisms Behind Mood and Cognitive Side Effects Through Pharmacovigilance Data Analysis and Functional Enrichment Techniques
  2. Drug Safety, 2014 -- Analyzing the Effects of FDA Alerts on Adverse Event Reporting Trends in the FAERS Database
  3. Drug Safety, 2014 -- Investigating the Weber Effect in the FDA's Adverse Event Reporting System (FAERS): A Study of Sixty-Two Medications Approved Between 2006 and 2010
  4. Frontiers in Pediatrics, 2026 -- Risk of Drug-Related Aggression in Pediatric Populations: A Pharmacovigilance Analysis Using the FAERS Database
  5. Drugs - Real World Outcomes — Pediatric Liver Injury Linked to Medications in Taiwan: A Review of Spontaneous Adverse Drug Reaction Reports from 1998 to 2017
  6. FDA Adverse Event Reporting System (FAERS) Database
  7. Pharmacological treatment in autism: a proposal for guidelines on common co-occurring psychiatric symptoms | BMC Medicine | Springer Nature Link
  8. Efficacy and safety of risperidone and aripiprazole in reducing severity of irritability in children with autism spectrum disorder: A randomized controlled trial - ScienceDirect
  9. Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents: A Systematic Review - NCBI Bookshelf
  10. Frontiers | Risk of Drug-Related Aggression in Pediatric Populations: A Pharmacovigilance Analysis Using the FAERS Database
  11. Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database | Acta Epileptologica | Springer Nature Link
  12. Montelukast: reminder of the risk of neuropsychiatric reactions - GOV.UK
  13. FDA Adverse Event Reporting System (FAERS) Database | FDA
  14. FDA Adverse Event Reporting System (FAERS) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to FAERS - PMC

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