Animal studies have revealed no effects on embryo-fetal development, fertility or reproductive function in males and females, and fertility in the offspring through maturation with oral administration of this drug during organogenesis at doses much higher than the recommended human dosage.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: The available data on use of this drug in pregnant women are not sufficient to inform any drug-associated risks for major birth defects and miscarriage.

Comments: Maternal use is not expected to result in fetal exposure to the drug due to negligible systemic drug absorption following oral administration.

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No lactation studies in animals have been conducted; however oral administration of this drug to animals during organogenesis through lactation produced no developmental abnormalities or effects on growth, learning and memory, or fertility in the offspring through maturation.

Safety has not been established; benefit should outweigh risk.

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

Comments: The effects in the nursing infant and on milk production are unknown.

See references