Olopatadine ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Pataday, Pataday Once Daily Relief, Pataday Twice Daily Relief, Patanol, Pazeo

Medically reviewed by Drugs.com. Last updated on Jul 27, 2023.

Olopatadine ophthalmic Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Animal studies have shown reproductive toxicity. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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