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Objective <p>To assess the behavioral adverse effects associated with the use of levetiracetam in drug-naïve children with epilepsy, either as monotherapy or as part of anti-seizure medications polytherapy.</p> Methods <p>This prospective cohort study was conducted in the pediatrics department of a public hospital from October 3, 2024, to July 26, 2025. Typically developing children aged 4–12&#xa0;years with epilepsy were consecutively enrolled, if they were being planned to be initiated on levetiracetam therapy, either as monotherapy or as an add-on therapy. Behavioral problems were assessed prior to starting levetiracetam using Strength and Difficulties Questionnaire (SDQ) and Child Behavior Checklist (CBCL) and repeated at 14 (+ 3) days and 6 (+ 1) weeks of follow-up.</p> Results <p>The study included 60 children with mean (SD) age of 7.75 (2.48) years. At enrollment, behavioral problems were not observed in any child (scores in the normal range). Proportion of those with behavioral problems in any sub-domain in either of the tools at follow-up was 3.3% at 14&#xa0;days and 11.7% (95% CI 5.77–22.18%) at 6&#xa0;weeks. Behavioral problems based on total scores, of either tool, were present in 6.7% (95% CI 2.6–16.0%) at 6-week follow-up. Behavioral adverse effects were found to be statistically associated with use of higher doses of levetiracetam (&gt; 30&#xa0;mg/kg/day), with dose and total CBCL scores [<i>r</i> (95% CI) = 0.542 (0.33–0.70); <i>P</i> &lt; 0.001] and total SDQ scores [<i>r</i> (95% CI) = 0.515 (0.30–0.68); <i>P</i> &lt; 0.001] showing significant correlation. The discontinuation rate was 1.7% (<i>n</i> = 1).</p> Conclusion <p>There is a need of close surveillance for neurobehavioral morbidity in children with epilepsy receiving levetiracetam, especially those receiving high doses.</p>

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Behavioral Adverse Effects During Initial Six Weeks of Levetiracetam Therapy in Children with Epilepsy: A Prospective Cohort Study

  • 期刊论文

  • 发表日期：

    2026年1月23日

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  • Saphibanrisa Rea Shabong,
  • Devendra Mishra,
  • Monica Juneja,
  • Madiha Rehman,
  • Manu Kumar Shetty,
  • Kumar Harshvardhan

摘要

Objective

To assess the behavioral adverse effects associated with the use of levetiracetam in drug-naïve children with epilepsy, either as monotherapy or as part of anti-seizure medications polytherapy.

Methods

This prospective cohort study was conducted in the pediatrics department of a public hospital from October 3, 2024, to July 26, 2025. Typically developing children aged 4–12 years with epilepsy were consecutively enrolled, if they were being planned to be initiated on levetiracetam therapy, either as monotherapy or as an add-on therapy. Behavioral problems were assessed prior to starting levetiracetam using Strength and Difficulties Questionnaire (SDQ) and Child Behavior Checklist (CBCL) and repeated at 14 (+ 3) days and 6 (+ 1) weeks of follow-up.

Results

The study included 60 children with mean (SD) age of 7.75 (2.48) years. At enrollment, behavioral problems were not observed in any child (scores in the normal range). Proportion of those with behavioral problems in any sub-domain in either of the tools at follow-up was 3.3% at 14 days and 11.7% (95% CI 5.77–22.18%) at 6 weeks. Behavioral problems based on total scores, of either tool, were present in 6.7% (95% CI 2.6–16.0%) at 6-week follow-up. Behavioral adverse effects were found to be statistically associated with use of higher doses of levetiracetam (> 30 mg/kg/day), with dose and total CBCL scores [r (95% CI) = 0.542 (0.33–0.70); P < 0.001] and total SDQ scores [r (95% CI) = 0.515 (0.30–0.68); P < 0.001] showing significant correlation. The discontinuation rate was 1.7% (n = 1).

Conclusion

There is a need of close surveillance for neurobehavioral morbidity in children with epilepsy receiving levetiracetam, especially those receiving high doses.