Raloxifene — $0 with Membership

Related medications

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Also listed for Osteoporosis

• Alendronate
• Ibandronate
• Risedronate

Other medications in Musculoskeletal

• Acetaminophen
• Allopurinol
• Celecoxib
• Colchicine
• Diclofenac
• Febuxostat
• Indomethacin
• Meloxicam

What Raloxifene is approved for (FDA label)

Raloxifene hydrochloride tablet, USP is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. (1.1) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2) . Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3) Important Limitations: Raloxifene hydrochloride is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. (1.3) 1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1 , 14.2) ]. 1.2 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3) ]. 1.3 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies (14.4) ]. 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 [see Clinical Studies (14.4) ]. Twenty-seven percent of the participants received drug for 5 years.

Source: Read the full FDA label on DailyMed. Label effective date: May 13, 2024.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Raloxifene (FDA label)

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets [see Warnings and Precautions (5.1) ]. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride tablets [see Contraindications (4.1) ]. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke [see Warnings and Precautions (5.2) and Clinical Studies (14.5) ]. WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE See full prescribing information for complete boxed warning. Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets (5.1) . Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride tablets (4.1) . Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke (5.2 , 14.5) .

Source: FDA prescribing information (DailyMed). Set ID: f5c25553-1546-451d-8069-c0f484c47741. SPL document ID: 18588c41-973d-4ebc-e063-6294a90a5eed. Label effective date: May 13, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Raloxifene (FDA label)

60 mg, White film coated round biconvex tablets (not scored) de-bossed with IG on one side and 256 on the other. Tablets (not scored): 60 mg (3)

Source: FDA prescribing information (DailyMed). Set ID: f5c25553-1546-451d-8069-c0f484c47741. SPL document ID: 18588c41-973d-4ebc-e063-6294a90a5eed. Label effective date: May 13, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Raloxifene (FDA label)

Adverse reactions (>2% and more common than with placebo) include: hot flashes, leg cramps, peripheral edema, flu syndrome, arthralgia, sweating. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to raloxifene hydrochloride tablets in 8429 patients who were enrolled in placebo-controlled trials, including 6666 exposed for 1 year and 5685 for at least 3 years.

Source: FDA prescribing information (DailyMed). Set ID: f5c25553-1546-451d-8069-c0f484c47741. SPL document ID: 18588c41-973d-4ebc-e063-6294a90a5eed. Label effective date: May 13, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Raloxifene (FDA label)

Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. (4.1) Pregnancy (4.2 , 8.1) 4.1 Venous Thromboembolism Raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see Warnings and Precautions (5.1) ]. 4.2 Pregnancy Raloxifene hydrochloride tablets are contraindicated in pregnancy, as it may cause fetal harm [see Use in Specific Populations (8.1) ].

Source: FDA prescribing information (DailyMed). Set ID: f5c25553-1546-451d-8069-c0f484c47741. SPL document ID: 18588c41-973d-4ebc-e063-6294a90a5eed. Label effective date: May 13, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Raloxifene (FDA label)

Venous Thromboembolism: Increased risk of deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. Discontinue use 72 hours prior to and during prolonged immobilization. (5.1 , 6.1) Death Due to Stroke: Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. No increased risk of stroke was seen in this trial.

Source: FDA prescribing information (DailyMed). Set ID: f5c25553-1546-451d-8069-c0f484c47741. SPL document ID: 18588c41-973d-4ebc-e063-6294a90a5eed. Label effective date: May 13, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Raloxifene (FDA label)

Cholestyramine: Use with raloxifene hydrochloride tablets is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. (7.1 , 12.3) Warfarin: Monitor prothrombin time when starting or stopping Raloxifene hydrochloride tablets. (7.2 , 12.3) Highly Protein-Bound Drugs: Use with Raloxifene hydrochloride tablets with caution. Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. Raloxifene hydrochloride is more than 95% bound to plasma proteins. (7.3 , 12.3) 7.1 Cholestyramine Concomitant administration of cholestyramine with raloxifene hydrochloride tablets is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect.

Source: FDA prescribing information (DailyMed). Set ID: f5c25553-1546-451d-8069-c0f484c47741. SPL document ID: 18588c41-973d-4ebc-e063-6294a90a5eed. Label effective date: May 13, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.