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Estropipate Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Aug 4, 2023.

Estropipate is also known as: Ogen, Ogen 0.625, Ogen 1.25, Ogen 2.5, Ortho-Est

Estropipate Pregnancy Warnings

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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.


AU TGA pregnancy category: B1
US FDA pregnancy category: X

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

See references

Estropipate Breastfeeding Warnings

Use caution

Excreted into human milk: Yes

-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

References for pregnancy information

  1. Heinonen O, Shapiro S; Kaufman DW ed., Slone D. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, Inc. 1977;297.
  2. Product Information. Ortho-Est (estropipate). Ortho McNeil Pharmaceutical. 2001.

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993. The transfer of drugs and other chemicals into human milk. Pediatrics. 1994;93:137-50.
  2. Product Information. Ortho-Est (estropipate). Ortho McNeil Pharmaceutical. 2001.

Further information

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