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

AU TGA pregnancy category: A
US FDA pregnancy category: Not formally assigned to a pregnancy category.

Comments:
-Some experts state that this drug should be avoided during the first trimester, and excessive use is not recommended throughout pregnancy.
-Some experts recommend that patients who are breastfeeding should consult with their healthcare provider prior to using this drug.

Animal studies have not been reported. There are no controlled data in human pregnancy.

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.

See references

The active moiety (bis-(p-hydroxyphenyl)-pyridyl-2methane) (BPHM) or its glucuronides are not excreted into the milk of healthy lactating females.

This drug should be used only if clearly needed.

Excreted into human milk: Yes

Comments:
-Some experts recommend that patients who are breastfeeding should consult with their healthcare provider prior to using this drug.
-Other authorities state that this drug may be used during lactation without special precautions.

See references