According to some authorities: As a precaution, use should be avoided.

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 and females of reproductive potential should be apprised of the potential harm to the fetus.
-Females should be advised to inform healthcare provider of known/suspected pregnancy.

Animal studies have revealed evidence of fetal developmental toxicity. After oral administration to pregnant mice during organogenesis, fetal developmental effects occurring without maternal toxicity included reduced fetal weights and increased incidence of costal cartilage anomalies at doses of 25 mg/kg/day (about 4 times the human plasma exposure at maximum recommended human dose [MRHD] based on plasma AUC comparison; after oral administration to pregnant rats during organogenesis, maternal toxicity (reduced maternal body weights), decreased fetal weights, and increased skeletal variations (including reduced ossification of the sternebrae, vertebrae, and skull) were observed at doses of 15 mg/kg/day (about 6-times the human plasma exposure at MRHD based on plasma AUC comparison). The no observed adverse effect levels for fetal toxicity in mice and maternal and fetal toxicity in rats were 5 and 2.5 mg/kg/day, respectively (about equal to the human plasma exposure at MRHD based on plasma AUC comparison for both species); oral administration to female rats during gestation and lactation showed no maternal toxicity, fetal toxicity, developmental delays, or impaired reproduction at doses up to 3.75 mg/kg/day (about equal to the human plasma exposure at MRHD based on plasma AUC comparison). There are no controlled data in human pregnancy.

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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An alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the infant.

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

Comments:
-No published data available on 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.

See references