Estropipate Pregnancy and Breastfeeding Warnings

Brand names: Ogen, Ogen 0.625, Ogen 1.25, Ogen 2.5, Ortho-Est

Medically reviewed by Drugs.com. Last updated on Jul 25, 2025.

Estropipate Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

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

Comments:
-If pregnancy occurs, discontinue treatment immediately; there is no indication for use during pregnancy.

Animal studies have not been reported. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens from oral contraceptives inadvertently during early pregnancy. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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

Estropipate Breastfeeding Warnings

Use caution

Excreted into human milk: Yes

Comments:
-Estrogen use during lactation has been shown to decrease the quantity and quality of breast milk.
-Detectable amounts of estrogens have been found in breast milk.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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