Animal studies have revealed evidence of post-implantation loss, decreased fetal weight, and an increased incidence of offspring mortality when this drug was given during organogenesis at maternally toxic levels. There are no controlled data in human pregnancy.

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 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.

Use is not recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Some manufacturers make no recommendation regarding use during pregnancy.
-Use of adequate methods of contraception should be encouraged.
-Some manufacturers state that use is not recommended in patients of reproductive potential who are not using adequate methods of contraception.

See references

There are no data regarding the effects of this drug on breastfed infants or milk production.

Animal models given 500 mg/kg/day from gestation day 6 to lactation day 20 had an increase in pup mortalities on postnatal days 0 to 4. Behavioral and functional development in exposed pups were not affected.

Use is not recommended and 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: Unknown
Excreted into animal milk: Unknown

Comment: Breastfed infants should be monitored for constipation.

See references