This drug should be used during pregnancy only if the benefit outweighs the risk.
-Some experts state that use is contraindicated.

AU TGA pregnancy category: B1
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

Animal studies have failed to reveal evidence of teratogenicity or fetal harm, though animal models given this drug at high doses in late gestation through lactation had changes in bone morphology and decreased pup weight gain. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown 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.

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In animal models, this drug and its metabolites are excreted into breastmilk. When administered to animal models via IV, milk levels of this drug were higher than blood levels, and pups that were exposed had decreased weight gain.

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.
-Some experts state that use is contraindicated.

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

Comment: The effects in the nursing infant are unknown.

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