Risk of drug-related aggression in pediatric populations: a pharmacovigilance analysis using the FAERS database - Takeaways - 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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  • 1

    The study analyzed 7,959 pediatric reports from FAERS to identify drugs associated with aggression in children.

  • 2

    Thirty-one drugs were linked to aggression, with the highest signals found for ebastine and perampanel.

  • 3

    Aggression signals were more pronounced in younger children and females, with median time-to-onset varying by drug.

  • 4

    Drugs primarily associated with aggression included nervous system and respiratory agents, with montelukast having the highest case volume.

  • 5

    The findings highlight the need for updated regulatory labeling and increased clinical vigilance regarding pediatric drug safety.

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