The fetal safety of Levetiracetam: a systematic review

Reprod Toxicol. 2014 Jul;46:40-5. doi: 10.1016/j.reprotox.2014.02.004. Epub 2014 Mar 3.


Objective: To systematically review the available published evidence on the fetal safety of Levetiracetam with focus on birth defects.

Results: Eight studies met the inclusion criteria; five pregnancy registries and one population based cohort study. A total of 27 major congenital malformations were reported among 1213 Levetiracetam monotherapy - exposed pregnant women, yielding an overall major malformation rate of 2.2% (27/1213) [95% confidence interval of 1.53-3.22]. In contrast, Levetiracetam polytherapy was associated with significantly higher malformation rate of 6.3% (34/541) [95% CI of 4.53-8.65] (P<0.001). Additionally 2 studies investigating child neurodevelopment in Levetiracetam - exposed children revealed that the measured achievements were well above those children exposed to valproic acid, and similar to unexposed controls.

Conclusions: The current evidence suggests that the overall risk of major malformation after first trimester exposure to Levetiracetam is within the population baseline risk of 1-3%, with no apparent adverse effects on long term child development.

Keywords: Adverse outcome; Birth defects; Levetiracetam; Pregnancy; Safety.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Animals
  • Anticonvulsants / toxicity*
  • Female
  • Fetal Diseases / chemically induced*
  • Fetal Diseases / pathology
  • Fetus / pathology
  • Humans
  • Levetiracetam
  • Piracetam / analogs & derivatives*
  • Piracetam / toxicity
  • Pregnancy
  • Prenatal Exposure Delayed Effects / chemically induced
  • Safety


  • Anticonvulsants
  • Levetiracetam
  • Piracetam