Animal studies have shown fetal loss, decreased pup weights, and skeletal abnormalities at a subcutaneous dose that was approximately 2 times the maximum recommended daily intranasal dose in adults. There are no adequate and well-controlled studies in pregnant women.

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 pregnancy only if the benefit outweighs the risk to the fetus.

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

Comments:
-Intranasal glucocorticosteroids such as this drug should be considered because of the lower systemic effects, compared to oral glucocorticosteroids.
-Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. These infants should be observed.

See references

Benefit should outweigh risk.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references