This drug was not teratogenic in animal studies at oral doses up to 135 mg/kg (7400 times the maximum recommended human ophthalmic dose (MRHOD), on a mg/m2 basis). 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 be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: Not assigned.
US FDA pregnancy category: Not assigned.

Risk Summary: There are no adequate or well-controlled studies with this drug in pregnant women.

See references

Safety has not been established.

Excreted into human milk: yes (oral administration)

Comments:
-Ophthalmic use by the mother should pose little risk to the breastfed infant.
-Absorption following oral administration which is at least 100 times higher than excretion would be for the ophthalmic solution

See references