Important Safety Information

Estradiol Gel — Important Safety Information

Important safety information for topical estradiol gel — how to apply, transfer precautions, estrogen-related warnings, and side effects.

Last reviewed:

Estradiol Gel is a compounded product prepared by a U.S.-licensed compounding pharmacy following an individualized medical evaluation. Compounded drugs are not reviewed by the FDA for safety or effectiveness. This summary does not replace guidance from your prescribing clinician.

How to use

  • Apply the prescribed amount to clean, dry, intact skin (such as the upper arm or inner thigh) once daily, or as directed.
  • Allow the gel to dry fully before dressing, and wash your hands thoroughly after applying.
  • Do not apply to the breasts or to irritated or broken skin.
  • The gel is flammable until dry — keep away from open flame while applying.

Avoid transfer to others

  • Skin-to-skin contact can transfer estradiol to others. Let the gel dry and cover the area with clothing.
  • Keep children and pets away from the application site. Wash the area if close contact is expected.

Before you start

  • Tell your clinician about your full medical history, allergies, and all medications and supplements you take.
  • Do not use if you are pregnant, may be pregnant, or are breastfeeding.
  • Share any history of blood clots, stroke, heart attack, breast or uterine cancer, liver disease, or unexplained vaginal bleeding.

Important warnings

  • Estrogens may increase the risk of blood clots, stroke, and certain cancers. When you have a uterus, estrogen is generally prescribed together with a progestogen to help protect the uterine lining.
  • Seek emergency care (call 911) for sudden chest pain, shortness of breath, pain or swelling in a leg, sudden severe headache, vision changes, or weakness, numbness, or trouble speaking.

Possible side effects

  • Application-site reactions, breast tenderness, headache, nausea, bloating, mood changes, or vaginal spotting.
  • Report any unusual or persistent side effects to your clinician promptly.

Precautions

  • Store as directed and keep out of reach of children. Do not stop or change your dose on your own.

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please reach out to your EOS Health-affiliated provider if you have any questions or concerns.