Animal models have revealed evidence of fetal mortality and lower fetal weight associated at high doses; however, these studies have failed to reveal teratogenic evidence. 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 unless clearly needed.

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

Risk summary: Observational studies indicate that an association of adverse events with use of this drug in pregnant women is unlikely; however, drug-associated risks cannot definitively be established or excluded by observational studies due to methodological limitations.

See references

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: Yes

Comment: The effects in the nursing infant are unknown.

Animal models have revealed evidence of tumorigenicity in carcinogenicity studies; there is a potential risk of serious adverse reactions to the nursing infant.

See references