Animal studies have revealed evidence of embryofetal toxicity. Pregnant rats dosed IV at up to 5 mg/kg/day (up to 0.8 times the clinical dose based on body surface area [BSA] comparison) during organogenesis showed increased resorptions and peri-implantation losses and their offspring showed incomplete ossification of the skull and torso and increased incidences of cervical rib; pregnant rabbits dosed IV at up to 6 mg/kg/day (about 2 times the clinical dose based on BSA comparison) during organogenesis showed increased fetal resorptions and increased incidence of incomplete ossification of the talus/calcaneus in offspring. In rats and rabbits, this drug crossed the placenta and was detected in fetal plasma. 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 the benefit outweighs the risk to the fetus.
-According to some authorities: Use is not recommended unless clearly needed.

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

Risk summary: Based on animal data, this drug may cause fetal harm; 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

An alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some experts: Caution is recommended.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

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

Comments:
-No data available on the clinical use of this drug during breastfeeding.
-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.
-This drug is poorly absorbed orally; it is not likely to reach the bloodstream of the infant or cause any harmful effects in the nursing infant.

See references