Animal models with oral administration of this drug during the period of organogenesis did not reveal evidence of adverse maternal or developmental effects at doses up to 162 times the recommended human ophthalmic dose (RHOD). Maternal toxicity, miscarriage, and reduced fetal weights were observed in some species at doses 41 times the RHOD. 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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-Studies have shown low levels of this drug in the systemic circulation after topical ocular administration.

See references