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Estradiol Pregnancy and Breastfeeding Warnings

Estradiol is also known as: Aerodiol, Alora, Climara, Climaval, Delestrogen, Depo-Estradiol, Divigel, Duragen, Elestrin, Estrace, Estraderm, Estradiol Patch, Estradot, Estradot 37.5, Estragyn LA 5, Estrofem, Estrogel, Estrogen Patches, Evamist, Femring, Minivelle, Progynova, Valergen, Vivelle, Vivelle-Dot

Medically reviewed on December 14, 2017

Estradiol Pregnancy Warnings

Animal studies using high estrogen doses have shown urogenital malformations. There are no controlled data in human pregnancy. There appears to be little or no increased risk of birth defects when estrogens and progestins as oral contraceptives were inadvertently used during early pregnancy.

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 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.

Use is contraindicated.

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

Comments:
-If pregnancy occurs, discontinue treatment immediately.
-Some products are AU TGA pregnancy category B3 or B1; the manufacturer product information should be consulted.

See references

Estradiol Breastfeeding Warnings

Use is contraindicated. (AU, UK)
Use is not recommended. (US)

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 and progestogens have been found in breast milk.

See references

References for pregnancy information

  1. "Product Information. Climara (estradiol)." Berlex, Richmond, CA.
  2. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories, Rockaway, NJ.
  3. "Product Information. Estradiol Vaginal Insert (estradiol topical)." Teva Pharmaceuticals USA, North Wales, PA.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories, Rockaway, NJ.
  3. "Product Information. Vivelle-Dot (estradiol)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

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

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