Estradiol for menopause: FDA-approved uses, forms and warnings

Estradiol is a prescription estrogen. FDA-approved estradiol products are used to treat moderate to severe hot flashes and night sweats, and vaginal and vulvar symptoms of menopause; some are also approved to help prevent postmenopausal osteoporosis. Labels carry a boxed warning, and women with a uterus who use systemic estradiol need a progestogen.

Forms

• Systemic: tablets, skin patches, gels, sprays and a systemic vaginal ring
• Local (low-dose vaginal): creams, tablets, inserts and rings for GSM

Boxed warning (summary)

• Estrogen alone increases the risk of endometrial cancer in women with a uterus; adding a progestogen reduces this risk.
• Estrogen should not be used to prevent heart disease or dementia.
• The Women's Health Initiative reported increased risks of stroke and blood clots, and with estrogen plus progestin, breast cancer and heart attack, in women aged 50–79.
• Labels advise the lowest effective dose for the shortest time consistent with treatment goals, reassessed regularly.

Who generally should not use it (per labeling)

This summary reflects FDA-approved prescribing information. It is not a complete list of uses, warnings or side effects — read the current label and the Medication Guide or patient information from your pharmacist.

• Undiagnosed abnormal genital bleeding
• Known, suspected or past breast cancer, or estrogen-dependent cancer
• Active or past blood clots, stroke or heart attack
• Liver disease, or known pregnancy

When to talk with a healthcare professional

• Before starting, stopping or changing any medicine — only a prescriber can decide this with you.
• If you notice a side effect, or take other medicines or supplements that might interact.

When to get prompt care

• Sudden chest pain, shortness of breath, leg pain or swelling, sudden severe headache, vision changes or weakness on one side — call emergency services.

How Dot can help

If you and your clinician choose a treatment, you can log it in Dot next to your symptoms. Dot never adjusts doses or recommends medicines.

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Related topics

• Estradiol
• Menopausal hormone therapy
• Oral vs transdermal estrogen
• Vaginal estrogen
• Micronized progesterone

Sources

1. DailyMed, U.S. National Library of Medicine. Estradiol — FDA prescribing information.
2. MedlinePlus, U.S. National Library of Medicine. Estrogen: Drug Information.
3. U.S. Food and Drug Administration. Menopause: Medicines to Help You.
4. The Menopause Society. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Menopause 2022;29(7):767–794 (2022).

This page is educational and not medical advice. Dot does not diagnose or prescribe. See our editorial policy.