Studies in pregnant animals with subcutaneous administration of this drug at 4000 times the maximum recommended human dose (MRHD) of 10 mg/day during organogenesis did not result in adverse effects on embryofetal development. Additionally, doses at 2500 times the MRHD during pregnancy and lactation did not result in adverse effects on pre- and postnatal development in rats. No adverse effects were noted in fertility or reproductive performance in rats at doses 2800 times MRHD. 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; benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: There are no adequate data on the developmental risk associated with the use in pregnant women; no adverse developmental or reproductive effects were observed in animal studies.

Comments:
-Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

See references

Safety has not been established.

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

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.

See references