Animal models have failed to reveal evidence of teratogenicity and harmful effects on pregnancy, embryofetal development, parturition, and/or postnatal development. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

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

AU TGA pregnancy category: B2
US FDA pregnancy category: Not formally assigned to a pregnancy category.

See references

Use with caution.
-Some experts recommend: Use is not recommended.

Excreted into human milk: Yes

Drug concentrations in breastmilk were approximately 25% to 90% of drug concentrations in plasma.

See references