ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Pharmacovigilance Signal Detection of Psychiatric Adverse Events Induced by Third-Generation Antiepileptic Drugs in Children
Provisionally accepted
- Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, Beijing, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Objective: The present study was a retrospective pharmacovigilance analysis to identify pharmacovigilance signals of psychiatric adverse events (AEs) associated with the clinical use of third-generation antiepileptic drugs (AEDs) in children, thereby providing a reference for clinical drug selection and pharmaceutical care. Methods: The data were obtained from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Reports involving patients under 18 years old were retrieved using the generic and brand names of four drugs: lacosamide, perampanel, brivaracetam, and eslicarbazepine. Positive safety signals were detected using the Reporting Odds Ratio (ROR) method and the Bayesian Confidence Propagation Neural Network (BCPNN) method for further analysis. The number of AEs ≥3 cases, ROR value 95% confidence interval (CI) lower limit >1 and information component 25 (IC025) must be above 0 was considered statistically significant. Results: Lacosamide and eslicarbazepine acetate demonstrated relatively lower signals of psychiatric AEs, while brivaracetam was associated with a certain degree of psychiatric risk. In contrast, perampanel requires heightened clinical vigilance due to its potential to induce severe psychiatric and behavioral abnormalities, particularly aggression, suicidal ideation, and homicidal ideation. The most significant psychiatric safety signals for perampanel, based on ROR, were homicidal ideation ROR = 23.51 [9.72, 56.89]), aggression (ROR = 17.81 [13.85, 22.92]), and psychotic disorders (ROR = 16.94 [9.57, 29.99]). Conclusion: The findings of this study provide a reference for clinical selection of third-generation AEDs. When initiating treatment in children, clinicians should consider the differential psychiatric risk profiles of these third-generation AEDs, monitor potential psychiatric side effects and adjust prescriptions promptly.
Keywords: Children, antiepileptic drugs, FAERS database, psychiatric, Adverse Reactions
Received: 24 Sep 2025; Accepted: 06 Nov 2025.
Copyright: © 2025 Sun, Chen, Li, Xia, Li, Chen, Liu, Pang and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Hua Chen, blw_blw@126.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.