No adverse developmental effects were observed in animal studies. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: Animal reproduction studies with this drug at doses up to 4 and 7 times the human dose, respectively, have revealed no harm to the fetus. The administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours.

Comments:
-This drug has been used in cesarean section delivery but, because of its solubility and lack of protein binding, it readily and rapidly traverses the placenta.

See references

Caution is recommended.

Excreted into human milk: Yes (in very small amounts)

Comments:
-Data indicate that no waiting period is required before resuming breastfeeding after a single dose of this drug.
-When a combination of anesthetics is used, follow the recommendations for the most problematic medication.

See references