Animal studies in rats and rabbits showed no fetal toxicity or malformation at doses up to 8 and 10 times the maximum recommended dose (MRHD) of 50 mg, respectively. Oral administration of this drug to pregnant and lactating rats did not cause any fetal or maternal toxicities at doses up to 9 times the MRHD. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians and pregnant women are encouraged to register by calling 1-833-400-9611.

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: There is no data on use of this drug in pregnant women to inform a drug-related risk, including the risk of fetal harm or reproductive effects.

Comments:
-A pregnancy exposure registry is available.

See references

Benefit should outweigh risk.

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.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Infants exposed through breastmilk should be monitored for excessive sedation.

See references