Raloxifene
Selective Estrogen Receptor Modulators
Sold as Evista · Optruma
- Drug class
- Selective Estrogen Receptor Modulators
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 10
Overview
Plain-language summary, compiled from the cited regulatory records
Raloxifene is a medication classified as a Selective Estrogen Receptor Modulator [1]. It functions as both an estrogen agonist and antagonist [1].
Raloxifene hydrochloride is approved for specific uses in postmenopausal women. It is indicated for the treatment and prevention of osteoporosis [1]. Additionally, it is approved to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis [1]. It is also indicated to reduce the risk of invasive breast cancer in postmenopausal women who are considered at high risk for the disease [1]. It is important to note that raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer itself [1].
This medication is available under several brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 6 | May 15, 2026 |
| EU European Union | EMA | 3 | January 27, 2026 |
| US United States | FDA | 1 | February 17, 2024 |
GBUnited Kingdom· MHRA
6 products
Uses
Evirex is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. 1).
How to take
EUEuropean Union· EMA
3 products
Uses
Optruma is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. 1).
How to take
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE Raloxifene hydrochloride is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. 1 ) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
2 ) Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. 3 ) Important Limitations: Raloxifene hydrochloride tablets are 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.
2) ] . 3) ] . 4) ] . 4) ] . Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known. 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.
Drug interactions
Known interactions involving Raloxifene. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL157640094 · revised January 17, 2025
- [2]European Medicines Agency · EMEA/H/C/000185 · revised January 27, 2026
- [3]FDA DailyMed · 0f7d1f81-374f-4a… · revised February 17, 2024 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.