Safety has not been established during pregnancy; use is recommended only if clearly needed and the benefit outweighs the risk.

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

Animal studies are insufficient regarding reproductive toxicity; one study showed no evidence of fetal harm, another high dose study showed a teratogenic effect in one animal species. This drug crosses the placenta and may cause tachycardia in the fetus. There are no controlled data in human pregnancy, however it has been used by a large number of pregnant women without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus being observed.

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 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.

See references

This drug should be used only if absolutely necessary.

Excreted into human milk: Yes

Comments:
-Small amounts appear in breast milk and may have antimuscarinic effects in the infant.
-Lactation may be inhibited.
-Infants are usually very sensitive to the effects of this drug.

See references