Sumatriptan Pregnancy and Breastfeeding Warnings

Brand names: Alsuma, Imitrex, Imitrex Nasal, Imitrex Statdose, Onzetra Xsail, Sumavel DosePro, Tosymra, Zecuity, Zembrace SymTouch

Medically reviewed by Drugs.com. Last updated on Aug 4, 2025.

Sumatriptan Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: Malformative risk with the use of this drug in pregnant women is unlikely.

Animal studies have revealed evidence of embryolethality, fetal abnormalities (decreased body weight, decreased ossification, skeletal abnormalities, cervicothoracic vascular defects, umbilical vascular defects), decreased fetal body weight, and pup mortality. There are no controlled data in human pregnancy.

The use of sumatriptan has been reported during postmarketing surveillance. There were major birth defects reported (excluding fetal death and induced abortions without reported defects and all spontaneous pregnancy losses); however, the data are insufficient to be conclusive.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Sumatriptan Breastfeeding Warnings

Use with caution

Excreted into human milk: Yes (subcutaneous injection)

Comments:
-The effects in the nursing infant are unknown.
-Infant exposure can be minimized by avoiding breastfeeding for at least 8 to 12 hours after treatment with this drug.

Sumatriptan has poor oral bioavailability, decreasing infant exposure to the drug. Because of the low levels of sumatriptan in breastmilk, amounts ingested by the infant are small. Sumatriptan would not be expected to cause any adverse effects in most breastfed infants.

Peak milk level of sumatriptan averaged 87.2 mcg/L and occurred 2.5 hours after a single subcutaneous dose in 5 women who had been breastfeeding for 11 to 28 weeks. The mean half-life in milk was reported as 2.2 hours.

See references

Further information

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