Animal studies have revealed evidence of embryofetal toxicity. IV administration of this drug to pregnant rabbits during organogenesis (days 6 to 18 of gestation) resulted in visceral abnormalities (including abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, dilatation of the ureter) and increased abortion at 32 mg/kg, a dose equal to 4 times the recommended human dose (based on body surface area comparison). In rats, this drug and/or its metabolites were shown to cross the placenta and distribute to the fetus. 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.

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

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

Risk summary: Based on results from animal studies, this drug may cause fetal harm when used during pregnancy; insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Pregnant women should be apprised of the potential harm to the fetus.

See references

Caution is recommended.
-According to some authorities: A decision should be made to continue/discontinue breastfeeding or continue/discontinue the drug, taking into account the importance of the drug to the mother.

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

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.

See references