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Fertility: There is no effect on fertility in animal studies (see Pharmacology: Toxicology: Preclinical safety data: Impairment of fertility under Actions).
Pregnancy: Gabapentin crosses the human placenta.
Congenital malformations and adverse pregnancy outcomes have been reported with gabapentin use, however, there are no adequate and well-controlled studies in pregnant women and no definite conclusions can be made as to whether gabapentin is causally associated with an increased risk of congenital malformations or other adverse developmental outcomes when taken during pregnancy. The risk of birth defects is increased by a factor of 2 - 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data: Teratogenesis under Actions). The potential risk for humans is unknown. Gabapentin should be used during pregnancy only if the potential benefit to the mother clearly outweighs the potential risk to the fetus.
Lactation: Gabapentin is excreted in human milk. Because the effect on the nursing infant is unknown, caution should be exercised when gabapentin is administered to a nursing mother. Gabapentin should be used in nursing mothers only if the benefits clearly outweigh the risks.
