New Research on Levetiracetam Safety in Young Children — What Parents Should Know

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Researchers have consistently found that levetiracetam — one of the most commonly prescribed antiepileptic drugs in young children — carries a distinctive side-effect profile that many parents encounter but are not always warned about in advance.

We were not warned. We noticed the changes ourselves — the irritability that arrived three weeks after the Lerace Syrup started, the nights that became harder to settle. When I mentioned it to the neurologist, she nodded. “It happens,” she said. “Let us know if it becomes unmanageable.”

This article is an attempt to put the information before the fact, for families who are about to start levetiracetam or who are currently navigating its effects.

What This Research Examined

The most comprehensive analysis comes from a meta-analysis published in Seizure in 2015 by Verrotti, Prezioso, Di Sabatino, Franco, Chiarelli, and Zaccara — analysing all available double-blind, randomised placebo-controlled trials of levetiracetam across all ages, examining adverse events significantly more common with levetiracetam than placebo.

A second key study — published in Epilepsia in 2018 by Guilfoyle et al. — examined how individual differences in children affected their likelihood of experiencing behavioural side effects from AEDs, including levetiracetam.

What They Found

South Asian mother carefully giving liquid medication to toddler with medicine dropper

Behavioural side effects are real and statistically significant. Verrotti et al. found that irritability and aggression were significantly more common in children on levetiracetam than placebo across multiple RCTs. The effect was more pronounced in younger children.

Somnolence is the most commonly reported adverse event overall. Drowsiness was reported significantly more often, particularly in the first weeks.

Children with pre-existing hyperactivity may be at higher risk. Guilfoyle et al. found that children with higher hyperactivity scores before treatment were significantly more likely to experience behavioural adverse effects. If your child already has attention or behavioural challenges, this should be part of the conversation before starting.

The effects are not universal. Many children tolerate levetiracetam without significant behavioural change. Individual responses vary.

Pyridoxine (Vitamin B6) may help. A small clinical study (Major et al., 2008, PMID 18647662) found that pyridoxine supplementation was associated with improvement in levetiracetam-related behavioural side effects in some children. Evidence is limited but worth discussing with your neurologist.

Our Commentary

Pediatric neurologist showing research results to attentive South Asian parents

This research confirms what many parents have experienced but sometimes been hesitant to name: the behavioural changes are not imagined. They are real, documented, and more common in young children than prescribing information always makes clear.

If your child starts levetiracetam, watch for and write down any changes in mood, sleep, irritability, or temperament. “My child became much more irritable three weeks after starting” is specific clinical information. It may lead to a dose adjustment, a different medication, or a conversation about pyridoxine supplementation.

What to Ask Your Doctor

Healthy happy South Asian toddler running in sunlit garden, mother watching proudly
  • Given my child’s age and profile, how likely are they to experience behavioural side effects?
  • What specific changes should I record in the first four weeks?
  • Does my child’s level of hyperactivity increase their risk?
  • At what point would you consider adjusting the dose or switching medication?
  • Is pyridoxine supplementation something we should discuss?
  • What should I do if the behavioural changes feel unmanageable before the next appointment?

Read this study on PubMed →


This article is written for informational purposes only and does not constitute medical advice. Always consult your neurologist, pediatrician, or qualified healthcare provider for diagnosis and treatment decisions specific to your situation.


Bibliography: 1. Verrotti A et al. Seizure. 2015. https://pubmed.ncbi.nlm.nih.gov/26362377/ 2. Guilfoyle SM et al. Epilepsia. 2018. https://pubmed.ncbi.nlm.nih.gov/29114859/ 3. Major P et al. Epilepsy Behav. 2008. https://pubmed.ncbi.nlm.nih.gov/18647662/

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