Animal studies have revealed evidence of decreased body weight, slow righting reflex, increased pre-implantation losses, and decreased implantations and fetuses occurred at doses at least 50 times the AUC in humans at the recommended daily oral dose. There are no controlled data in human pregnancy.

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.

Use is recommended only if clearly needed and the benefit outweighs the risk.

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

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When 6 patients were given 40 mg of the parent compound, the calculated expected dose of this drug in milk was approximately 0.42% of the maternal weight-adjusted dose, and the Cmax was 16 mcg/mL.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics has classified the parent compound (loratadine) as compatible with breastfeeding.

See references