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Approved (postmenopausal women) / off-label (male) — clinician-directed. For osteoporosis treatment/prevention and breast-cancer risk reduction the standard, validated dose is 60 mg once daily (the MORE, CORE, RUTH and STAR trials all used 60 mg/day; MORE also tested 120 mg/day with no clear added fracture benefit and more side effects). For off-label male gynecomastia the small published pediatric series used roughly 60 mg/day; there is no FDA-approved male dose and the male evidence is thin and retrospective.
Any time
Raloxifene hydrochloride 60 mg tablets (approved for postmenopausal osteoporosis and breast-cancer risk reduction)
Months to years
Years
Throughout use
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