This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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

Comments:
-Treatment with vitamin K in mothers and infants who develop post-natal hemorrhage associated with use during the last few weeks of pregnancy.
-The reliability of oral or other systemic hormonal contraceptives may be affected; adequate methods of alternative contraception should be encouraged.

Animal studies have revealed evidence of congenital malformations and embryotoxicity. Cleft palate occurred at oral doses of 50 to 200 mg/kg/day, and congenital malformations (primarily spina bifida) increased in oral doses of 150 to 250 mg/kg/day; imperfect osteogenesis and embryotoxicity occurred at oral dosed up to 200 mg/kg/day. There are no controlled data in human pregnancy.

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.

See references

Animal models have revealed evidence of a potential for tumorigenicity.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics classifies this drug as compatible with breastfeeding.
-The WHO classifies this drug as compatible with breastfeeding; the breastfed infant should be monitored for jaundice.

See references