Adverse effects on the embryonic development of rabbits have been observed and the incidence of gallbladder agenesis or small gallbladder was increased with doses approximately 40 times expected human exposure. This drug was not teratogenic in rats. Sulfonylureas may enter the fetal circulation and may cause neonatal hypoglycemia. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

Use is not recommended

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

See references

Use is not recommended

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

Comments: If used, monitor blood glucose in the breastfed infant.

Due to lack of information on the use of this drug during lactation, an alternate drug may be preferred, especially in newborn or preterm infants. Studies in lactating rats have shown this drug is excreted into milk with a milk to plasma ratio of approximately 1:4. Some authorities do not feel it is a reason to discontinue breastfeeding if this drug is required by the mother. This drug is a weak acid and highly protein bound, therefore, it may not pass into breastmilk in clinically important amounts.

See references