FDA label
What is raloxifene used for?
The FDA-approved uses of raloxifene, 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 raloxifene hydrochloride (tablet, film coated) lists 3 uses: Treatment and Prevention of Osteoporosis in Postmenopausal Women; Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis; Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer.
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Raloxifene Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by ScieGen Pharmaceuticals Inc (ANDA206384). Cross-references to other label sections are left out.
Treatment and Prevention of Osteoporosis in Postmenopausal Women
Raloxifene hydrochloride tablets, USP is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis
Raloxifene hydrochloride tablets, USP is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer
Raloxifene hydrochloride tablets, USP is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.
The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years. Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known.
High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first- degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.
After an assessment of the risk of developing breast cancer, the decision regarding therapy with raloxifene hydrochloride tablets, USP should be based upon an individual assessment of the benefits and risks.
Raloxifene hydrochloride tablets, USP does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting raloxifene hydrochloride tablets, USP and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hydrochloride tablets, USP.
Important Limitations of Use for Breast Cancer Risk Reduction
- There are no data available regarding the effect of raloxifene on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of raloxifene hydrochloride tablets, USP.
- Raloxifene hydrochloride tablets, USP is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
- Raloxifene hydrochloride tablets, USP is not indicated for the reduction in the risk of noninvasive breast cancer.
Source: DailyMed label, set id 8152e68b-61a8-4897-8e03-900135b1dbd5, version 3, effective January 9, 2023. NDC 50228-306, one of 14 listings for this product.
Raloxifene Hydrochloride, tablet, coated
Indications and Usage, quoted from the label by Cadila Pharmaceuticals Limited (ANDA211324). Cross-references to other label sections are left out.
Treatment and Prevention of Osteoporosis in Postmenopausal Women
Raloxifene hydrochloride is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis
Raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer
Raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years. Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known. High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty. After an assessment of the risk of developing breast cancer, the decision regarding therapy with raloxifene hydrochloride tablets should be based upon an individual assessment of the benefits and risks. Raloxifene hydrochloride tablets does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting raloxifene hydrochloride tablets and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hydrochloride tablets. Important Limitations of Use for Breast Cancer Risk Reduction
- There are no data available regarding the effect of raloxifene hydrochloride tablets on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of raloxifene hydrochloride tablets.
- Raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
- Raloxifene hydrochloride tablets are not indicated for the reduction in the risk of noninvasive breast cancer.
Source: DailyMed label, set id a46bcc4f-f63d-4200-836d-a653a3c616db, version 5, effective January 19, 2022. NDC 71209-082, one of 4 listings for this product.
Questions
What is raloxifene used for?
The FDA label for raloxifene hydrochloride (tablet, film coated) lists 3 uses: Treatment and Prevention of Osteoporosis in Postmenopausal Women; Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis; Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer.
What drug class is raloxifene?
FDA lists raloxifene in the Estrogen Agonist/Antagonist 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.