Estradiol Pregnancy and Breastfeeding Warnings

Brand names: Alora, Climara, Delestrogen, Depo-Estradiol, Divigel, Dotti, Elestrin, Esclim, Estrace, Estraderm, Estradiol Patch, Estradot, Estradot 100, Estrofem, Estrogel, Evamist, Evorel, Femring, Gynodiol, Lyllana, Minivelle, Progynova, Sandrena, Vivelle, Vivelle-Dot

Medically reviewed by Drugs.com. Last updated on Feb 6, 2025.

Estradiol Pregnancy Warnings

Use is contraindicated

AU TGA pregnancy category:
-D: Oral tablets (Estrofem)
-B3: Topical gel; oral tablets (estradiol valerate)
-B1: Transdermal patches; oral tablets (estradiol hemihydrate)

US FDA pregnancy category:
-X: Estradiol oral tablets
-Not assigned: Injection; topical gel; topical spray; vaginal ring; transdermal patches/film

Risk Summary: This drug is not indicated for use during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy.

Comments:
-If pregnancy occurs, discontinue treatment immediately.

In animal studies of high dose maternal administration of synthetic estrogens, urogenital malformations were observed in the offspring. The relevance of these findings is uncertain. 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.

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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

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

Estradiol Breastfeeding Warnings

Not recommended
-According to some authorities: Use is contraindicated

Excreted into human milk: Yes

Comments:
-Estrogen use during lactation can decrease the quality and quantity of breast milk, especially if started before 6 weeks postpartum.

There is limited information to suggest that the route of administration and dosage form have an effect on the amount of drug transferred into breastmilk; vaginal use results in measurable amounts in the milk with unpredictable peak times, while transdermal administration with doses up to 200 mcg/day does not appear to increase estradiol or estriol in breastfed infants. Estrogens are present in human milk and can reduce milk production in lactating women; this reduction can occur at any time, but is less likely to occur once breast-feeding is well-established.

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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