FDA label
What is estradiol used for?
The FDA-approved uses of estradiol, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for estradiol (patch) lists 4 uses: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause; Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause; Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure; Prevention of Postmenopausal Osteoporosis.
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Estradiol, tablet
Indications and Usage, quoted from the label by EPIC PHARMA, LLC (ANDA040275). Cross-references to other label sections are left out.
Estradiol tablets are indicated in the:
- 1.Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- 2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
- 3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
- 4.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
- 5.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
- 6.Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies).
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Source: DailyMed label, set id 9333d92f-2585-4b99-aaea-87c01c95125e, version 13, effective February 26, 2026. NDC 42806-087, one of 74 listings for this product.
Estradiol, patch
Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA075182). Cross-references to other label sections are left out.
Estradiol transdermal system continuous delivery (once-weekly) is indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use:
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure
Prevention of Postmenopausal Osteoporosis
Limitation of Use:
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Source: DailyMed label, set id e7e6da3b-8485-1382-61c9-e9b369018b98, version 16, effective June 23, 2025. NDC 0378-3349, one of 36 listings for this product.
Estradiol, gel
Indications and Usage, quoted from the label by Encube Ethicals, Inc. (ANDA218214). Cross-references to other label sections are left out.
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of UseWhen prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
Source: DailyMed label, set id 54f108d6-ddd2-4276-8508-2c8e16a65fb2, version 3, effective May 13, 2026. NDC 21922-015, one of 36 listings for this product.
Questions
What is estradiol used for?
The FDA label for estradiol (patch) lists 4 uses: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause; Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause; Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure; Prevention of Postmenopausal Osteoporosis.
What drug class is estradiol?
FDA lists estradiol in the Estrogen established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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