FDA label
What is Premarin used for?
Premarin contains estrogens conjugated. The FDA-approved uses below are 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 Premarin lists 6 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; Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease; and 2 more.
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Premarin, tablet, film coated
Indications and Usage, quoted from the label by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (NDA004782). 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
Limitations of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure
Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease
Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only)
Prevention of Postmenopausal Osteoporosis
Limitations of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
Source: DailyMed label, set id 258e1602-a3cf-4ccc-ca80-73dbbfb812ff, version 37, effective June 4, 2026. NDC 0046-1100, one of 7 listings for this product.
Premarin, injection, powder, lyophilized, for solution
Indications and Usage, quoted from the label by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (NDA010402). Cross-references to other label sections are left out.
Premarin Intravenous (conjugated estrogens, USP) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.
Premarin Intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels.
Source: DailyMed label, set id 87e2da8d-432c-4ed5-67a1-dc26294b2295, version 22, effective May 30, 2025. NDC 0046-0749, one of 1 listing for this product.
Premarin, cream
Indications and Usage, quoted from the label by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (NDA020216). Cross-references to other label sections are left out.
Treatment of Atrophic Vaginitis and Kraurosis Vulvae
Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause
Source: DailyMed label, set id 96609623-528e-4aba-cabe-7254aed816d5, version 33, effective May 30, 2025. NDC 0046-0872, one of 1 listing for this product.
Questions
What is Premarin used for?
The FDA label for Premarin lists 6 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; Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease; and 2 more.
What drug class is Premarin?
FDA lists estrogens conjugated 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.