Last reviewed 2026-04-20 · How we verify

RALOXIFENE HYDROCHLORIDE

At a glance

Approved indications

No approved indications tracked.

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

• Hot flashes
• Leg cramps
• Peripheral edema
• Flu syndrome
• Arthralgia
• Sweating

Serious adverse events

• Venous thromboembolism (deep venous thrombosis, pulmonary embolism, retinal vein thrombosis)

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)
• XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial) (NA)
• Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome (PHASE3)
• A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189) (PHASE3)
• XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study) (NA)
• Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• RALOXIFENE HYDROCHLORIDE CI brief — competitive landscape report
• RALOXIFENE HYDROCHLORIDE updates RSS · CI watch RSS