This drug is not recommended during pregnancy and in patients of childbearing potential not using contraception.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: No adequate human data available on use of this drug in pregnant women to inform a drug-related risk; in animal studies, embryofetal survival was reduced in rats, but not in rabbits.

Animal studies have revealed evidence of embryofetal harm. In rats, at oral doses of at least 100 mg/kg/day (exposures about half the human exposure at the recommended human dose [RHD]), decreased number of viable fetuses and increased early resorptions and postimplantation losses were observed; while intermittent reduced body weight gain was seen in pregnant rats at doses of at least 200 mg/kg/day, this drug had no effect on embryofetal growth or development at doses up to 400 mg/kg/day (exposures similar to those seen in humans at the RHD). In rabbits, at oral doses up to 100 mg/kg/day (exposures about half the human exposure at the RHD), no significant toxicological effects on embryofetal growth or development were observed. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

According to some authorities: Breastfeeding is not recommended during use of this drug.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered. A risk to the nursing child cannot be excluded.

See references