Animal studies in mice and rabbits showed no embryofetal developmental toxicity during organogenesis with an exposure up to 23 times higher than human exposure at the recommended human dose (RHD). Mice pre and postnatal developments studies showed no maternal toxicity at exposures up to 24 times higher than RHD. A decrease in fertility of male mice was observed due to testicular toxicity. 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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No available data on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-There are no data on the effect of this drug on human fertility.

See references

Use is not recommended.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Due to the potential for variola virus transmission through direct contact with the breastfed infant, breastfeeding is not recommended in patients with smallpox.

See references