Animal studies have revealed no evidence of teratogenicity with doses 205 times the maximum human dose. Increased fetal resorption and decreased fetal weight were observed at high parenteral doses that resulted in maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: A
US FDA pregnancy category: B

See references

Use is considered acceptable; caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comment:
To limit systemic absorption, apply pressure to the tear duct at the corner of the eye for at least 1 minute after eye drop instillation; blot excess solution with tissue.

Maternal systemic absorption is expected to be very low. While it is unknown if this drug is excreted into milk, if excreted it would be poorly absorbed from the infant's gastrointestinal tract. The National Heart, Lung and Blood Institute, National Asthma Education, and Prevention Program Asthma and Pregnancy Working Group consider this drug to be acceptable during breastfeeding.

See references