Pregabalin (marketed in the US as Lyrica) is approved by the US Food and Drug Administration for the treatment of epilepsy, fibromyalgia, and neuropathic pain.  It is also used off-label to treat psychiatric disorders, most commonly generalized anxiety disorder. While it is not used as frequently as other anti-epileptic drugs, we do occasionally see women taking pregabalin who are pregnant or planning to conceive.

In the Journal of Clinical Psychiatry, Dr.  Chittaranjan Andrade reviews the medical literature addressing the reproductive safety of pregabalin, including the most recent study from Mostacci and colleagues (2018).

While one of the earlier studies (Winterfeld et al, 2016) raised concerns regarding the possible teratogenicity of pregabalin, the more recent studies — Patorno et al (2017) and Mostacci et al (2018) — have not documented an increased rate of malformations associated with exposure to pregabalin in utero.  While the available data do not signal concerns regarding adverse outcomes associated with pregabalin exposure during pregnancy, the number of exposed infants included in these studies is still very small.  

Ruta Nonacs, MD PhD

Andrade C.  Safety of Pregabalin in Pregnancy. J Clin Psychiatry, Sept 2018.

Mostacci B, Poluzzi E, D’Alessandro R, et al; ESPEA Study Group. Adverse pregnancy outcomes in women exposed to gabapentin and pregabalin: data from a population-based study [published correction appears in J Neurol Neurosurg Psychiatry. 2018;89(5):e1]. J Neurol Neurosurg Psychiatry. 2018;89(2):223–224.

Patorno E, Bateman BT, Huybrechts KF, MacDonald SC, Cohen JM, Desai RJ, Panchaud A, Mogun H, Pennell PB, Hernandez-Diaz S.  Pregabalin use early in pregnancy and the risk of major congenital malformations. Neurology. 2017 Apr 26.

Winterfeld U, Merlob P, Baud D, et al. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology. 2016;86(24):2251–2257.



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