Animal studies using the topical formulation have not been reported. Animal studies with oral formulations have revealed evidence of abortion and early delivery, reduced gestation length, increased late resorptions, fetal deaths, reduced body weight, and increased postnatal pup mortality. There are no controlled data in human pregnancy.

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 not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: Postmarketing reports suggest that malformative risk with use of this drug in pregnant women is unlikely.

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (when administered IV)

Comments:
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches breast milk after using eye drops.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.

See references