Estradiol topical Pregnancy and Breastfeeding Warnings
Brand names: Estrace Vaginal Cream, Estring, Imvexxy, Vagifem, Yuvafem
Medically reviewed by Drugs.com. Last updated on Aug 21, 2023.
Estradiol topical Pregnancy Warnings
Maternal administration of high-dose estrogen in animal studies has produced urogenital malformations in their offspring. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects when women have been exposed to combined estrogen and progestin oral contraceptives before conception or during early pregnancy. There are no adequate and well-controlled studies in pregnant women.
AU TGA pregnancy category B 3: 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.
This drug is not indicated for use during pregnancy
AU TGA pregnancy category: B 3
US FDA pregnancy category: Not assigned
Risk Summary: There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.
Comments:
-If pregnancy occurs, this drug should be discontinued.
Estradiol topical Breastfeeding Warnings
Not indicated for use in females of reproductive potential
Excreted into human milk: Yes
Comments: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk.
See also
- Estradiol use while Breastfeeding (in more detail)
- Estradiol Cypionate use while Breastfeeding (in more detail)
- Estradiol Valerate use while Breastfeeding (in more detail)
- estradiol vaginal local Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
References for pregnancy information
- Product Information. Estrace (estradiol). Warner Chilcott Laboratories. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Vagifem (estradiol topical). Novo Nordisk Pharmaceuticals Inc. 2017.
- Product Information. Estring (estradiol topical). Pfizer U.S. Pharmaceuticals Group. 2017.
- Product Information. Imvexxy (estradiol topical). TherapeuticsMD. 2018.
References for breastfeeding information
- Product Information. Estrace (estradiol). Warner Chilcott Laboratories. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
- Product Information. Vagifem (estradiol topical). Novo Nordisk Pharmaceuticals Inc. 2017.
- Product Information. Estring (estradiol topical). Pfizer U.S. Pharmaceuticals Group. 2017.
- Product Information. Imvexxy (estradiol topical). TherapeuticsMD. 2018.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
