Animal studies are not available. There are no controlled data in human pregnancy. The Collaborative Perinatal Project monitored 1070 mother-child pairs with first trimester exposure to this drug and 3931 any time pregnancy exposures, neither of which suggested a relationship to minor or major malformations, possible associations which require independent confirmation include polydactyly, gastrointestinal defects, eye and ear defects, hydrocephaly, congenital dislocation of the hip, and malformations of the female genitalia. The background birth defect and miscarriage risk for the indicated population is not known.

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 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.

Use is not recommended.

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

Comments:
-Third trimester use may cause reactions in the newborn or premature neonates.

See references

Use is not recommended.

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

Comments:
-Antihistamines may inhibit lactation and small amounts may be secreted in breast milk.

See references