Last reviewed 2026-04-20 · How we verify

Evista (RALOXIFENE)

Raloxifene binds to estrogen receptors, acting as an agonist in bone and an antagonist in uterine and breast tissues.

Evista (Raloxifene) is a small molecule estrogen agonist/antagonist developed by Lilly, targeting the estrogen receptor. It is used to treat postmenopausal osteoporosis and prevent breast carcinoma in postmenopausal women. Evista was FDA-approved in 1997 and is now off-patent with multiple generic manufacturers. Key safety considerations include an increased risk of blood clots and stroke. As a selective estrogen receptor modulator, Evista mimics estrogen in some tissues while blocking its effects in others.

At a glance

Mechanism of action

Raloxifene is a selective estrogen receptor modulator (SERM) that can either activate or block estrogenic pathways depending on the tissue. In bone, it acts like estrogen, reducing bone loss and increasing bone density. In the uterus and breast, it blocks estrogen's effects, potentially reducing cancer risk.

Approved indications

• Postmenopausal osteoporosis
• Prevention of Breast Carcinoma

Boxed warnings

• 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 [see Warnings and Precautions (5.1) ] . Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride [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 (5.1) . Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride (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) .

Common side effects

• Breast cancer
• Endometrial cancer
• Retinal vein thrombosis
• Bone density decreased
• Femur fracture
• Deep vein thrombosis
• Pulmonary embolism
• Spinal compression fracture
• Hip fracture
• Retinal vein occlusion
• Thoracic vertebral fracture
• Fall

Key clinical trials

• Pharmacogenomics ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms (PHASE2,PHASE3)
• New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia (PHASE2)
• Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain (PHASE2)
• A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer (PHASE1)
• XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial) (NA)
• Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database
• Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome (PHASE3)
• Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090) (PHASE4)

Primary sources

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