Use is not recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: B

Animal studies in rats and rabbits have failed to reveal evidence of embryotoxicity or teratogenicity; however, in rabbits, resorptions were observed, and in rats, increases in prenatal losses occurred during organogenesis at doses up to 9 times the exposure in humans. There are no controlled data in human pregnancy. Because abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

The effects in the nursing infant are unknown.

This drug and/or its metabolites have been found in the milk of lactating rats with levels reaching 10 times the maternal plasma levels. Less than 2% of a dose is absorbed from the mother's gastrointestinal tract making the likelihood of it reaching the infant through breast milk unlikely. However since there is no information in women using this drug while breastfeeding, alternate therapy should be considered.

See references