Ketotifen ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Alaway, Claritin Eye, Eye Itch Relief, Refresh Eye Itch Relief, Thera Tears Allergy Eye Itch Relief, Visine All Day Eye Itch Relief, Zaditor, Zyrtec Itchy Eye Drops

Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.

Ketotifen ophthalmic Pregnancy Warnings

Animal studies have revealed evidence of pre- and postnatal mortality, including a slight decrease in body weight gain in the first four days after birth, when maternally toxic oral doses of 50 mg/kg/day were administered. These studies have not revealed evidence of teratogenicity. There are no controlled data in human pregnancy.

Fertility studies have revealed a trend for a decrease in male fertility when male rats were administered daily doses of greater than or equal to 2 mg/kg/day.

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.

Caution is recommended; this drug should be used during pregnancy only if the benefit to the mother outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

See references

Ketotifen ophthalmic Breastfeeding Warnings

Animal studies have revealed excretion of this drug into maternal milk following oral administration, however, it is unknown whether topical ophthalmic administration results in excretion into human breast milk.

Use is considered acceptable; caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

Further information

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