Raloxifene
Pronunciation: ral-OX-i-feen.
- Generic name
- raloxifene hydrochloride
- Drug class
- Selective estrogen receptor modulator (SERM)
- Form
- Tablet, 60 mg
- Route
- Oral
- Legal status
- Prescription-only medicine
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Evista (5), AURO-RALOXIFENE 60 (generic) (5) · Full directory
Boxed warning: Increased risk of blood clots and increased risk of death from stroke
Raloxifene carries a boxed warning (the US FDA's strongest safety warning) for two separate serious risks. First, an increased risk of blood clots: deep vein thrombosis (a clot in a deep vein, usually in the leg), pulmonary embolism (a clot that travels to the lungs), and retinal vein thrombosis (a clot in the eye) have all been reported with raloxifene. Anyone with a current or past history of any of these blood clots should not take raloxifene. Second, in a clinical trial of postmenopausal women who already had heart disease or were at increased risk of a major heart event, raloxifene was associated with an increased risk of dying from a stroke. Because of the blood clot risk, raloxifene should be stopped at least 72 hours before, and during, any period of prolonged immobility (such as after surgery or during extended bed rest), on your care team's direction -- never decide this for yourself. (1) (2) (4)
What raloxifene hydrochloride is and how it works
Raloxifene is an oral medicine (a selective estrogen receptor modulator, or SERM) used to prevent and treat osteoporosis (bone thinning) in postmenopausal women, and to reduce the risk of invasive breast cancer in certain postmenopausal women. It acts like estrogen in some tissues (such as bone) but blocks estrogen's effects in others (such as breast tissue). (1)
Raloxifene carries a genuine boxed warning for an increased risk of blood clots (deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis) and an increased risk of death from stroke in women who already have, or are at increased risk of, heart disease. It should not be used by women who have ever had a blood clot, and it is not for use during pregnancy. Anyone considering raloxifene should discuss their personal risk of blood clots and stroke with their clinician before starting, and should never adjust or restart it themselves around a period of planned immobility (such as surgery) without their care team's direction.
Mechanism of action: how raloxifene hydrochloride works
Raloxifene is a selective estrogen receptor modulator (SERM) that binds estrogen receptors, producing estrogen-agonist effects in bone (reducing bone resorption) while acting as an estrogen antagonist in breast and uterine tissue. (1) (2)
What raloxifene hydrochloride is used for
Prevention and treatment of osteoporosis after menopause
Used to prevent and treat osteoporosis (bone thinning) in postmenopausal women; shown to significantly reduce the risk of vertebral (spinal) fractures, though not hip fractures. (1) (2) (3)
Reducing invasive breast cancer risk
Used to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis, and in postmenopausal women who are otherwise at high risk of invasive breast cancer. It is not indicated for treating existing invasive breast cancer, for reducing the risk of it coming back, or for preventing noninvasive breast cancer. (1)
Before taking raloxifene hydrochloride
Do not take / not appropriate for
- Do not take raloxifene if you have a current blood clot, or have ever had one -- including deep vein thrombosis, pulmonary embolism, or a blood clot in the eye (retinal vein thrombosis). (all countries) (1) (2)
- Do not take raloxifene if you are pregnant or could become pregnant -- it is only intended for postmenopausal women and may cause fetal harm. (all countries) (1) (2)
- Do not take raloxifene if you have liver problems (including cholestasis) or severe kidney impairment, or unexplained vaginal bleeding, without your clinician's specific guidance. (all countries) (2)
Tell your clinician about
- Any personal or family history of blood clots, or of stroke or heart disease.
- Whether you have any planned surgery or a period of expected immobility, since raloxifene needs to be stopped in advance.
- Any history of liver or kidney problems, or unexplained vaginal bleeding.
- Whether you are pregnant, could become pregnant, or are breastfeeding -- raloxifene is not intended for use in these situations.
- All other medicines you take, especially cholestyramine and other medicines that affect blood clotting.
How to take raloxifene hydrochloride
- Raloxifene is taken as one 60 mg tablet by mouth once a day, at any time of day, with or without food.
- It is intended for long-term daily use as directed by your clinician for osteoporosis prevention/treatment or breast cancer risk reduction.
- If you have surgery planned or expect a period of prolonged immobility, your care team will tell you when to stop raloxifene (generally at least 72 hours beforehand) and when it is safe to restart -- never decide this yourself.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
If you miss a dose, take it as soon as you remember on that day, then continue your normal daily schedule -- do not double up doses. If you are unsure, contact your clinician or pharmacist for guidance rather than adjusting the schedule yourself.
Overdose
Seek urgent medical attention for a suspected overdose. Reported effects of raloxifene overdose have included leg cramps and dizziness; seek care promptly for any of these or for signs of a blood clot (see serious warnings below). (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Hot flushes (hot flashes).
What to notice: Hot flushes (hot flashes).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Leg cramps.
What to notice: Leg cramps.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Joint pain (arthralgia) and swelling (peripheral edema).
What to notice: Joint pain (arthralgia) and swelling (peripheral edema).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Flu-like symptoms and sweating.
What to notice: Flu-like symptoms and sweating.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of a blood clot (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis) — boxed_warning
Symptoms: Swelling, warmth, redness, or pain in one leg; sudden shortness of breath or chest pain (possible sign of a clot in the lungs); sudden vision changes in one eye.
Action: Seek emergency medical help immediately -- these can be signs of a blood clot, which raloxifene carries a boxed-warning risk for. (1)
Signs of a stroke — boxed_warning
Symptoms: Sudden numbness or weakness of the face, arm, or leg (especially on one side of the body), sudden confusion or trouble speaking, sudden trouble seeing, sudden severe headache, or difficulty walking.
Action: Call emergency services immediately -- raloxifene carries a boxed-warning increased risk of death from stroke in women with, or at increased risk of, heart disease. (1)
Planned surgery or prolonged immobility — high caution
Symptoms: Not applicable -- this is a planning precaution rather than a symptom to watch for.
Action: Tell every clinician involved in planning surgery or an extended period of bed rest that you take raloxifene; it is generally stopped at least 72 hours beforehand and restarted only once you are fully mobile again, on your care team's instruction. (1)
Signs of a serious allergic reaction — emergency
Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.
Action: Seek emergency medical help immediately. (1)
Interactions
- Cholestyramine reduces the absorption of raloxifene and should not be taken at the same time; discuss timing with your clinician or pharmacist if you are prescribed both. (2)
- Other medicines that affect blood clotting, or hormone therapies, should be discussed with your clinician before starting raloxifene because of the added blood clot risk. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Raloxifene is contraindicated in pregnancy and in women who could become pregnant -- it is intended only for postmenopausal women. (1) (2) (3) (4) (5) (6)
Breastfeeding
Not intended for use while breastfeeding; discuss with your clinician if this applies to you. (1) (2) (3) (4) (5) (6)
Children
Not approved or studied for use in children. (1) (2) (3) (4) (5) (6)
Elderly
Studied specifically in postmenopausal women, who are typically older adults; no separate age-based dose adjustment beyond the standard 60 mg daily dose, but individual risk factors for blood clots and stroke should be assessed by a clinician before starting. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
Contraindicated in hepatic impairment, including cholestasis, per UK/EU regulator sources reviewed for this dossier. (1) (2) (3) (4) (5) (6)
Renal_impairment
Contraindicated in severe renal impairment per UK/EU regulator sources reviewed for this dossier; use with caution and clinician guidance in lesser degrees of impairment. (1) (2) (3) (4) (5) (6)
Source_ids
US-DAILYMED-EVISTA-2026,UK-EMC-EVISTA-SMPC-2026 (1) (2) (3) (4) (5) (6)
Monitoring
Before starting
- Personal and family history of blood clots, stroke, or heart disease
- Pregnancy status
- Liver and kidney function
- Any planned surgery or period of prolonged immobility
During treatment
- Watch for and report any symptoms of a blood clot or stroke immediately (see serious warnings above).
- Tell every clinician involved in any planned surgery or extended immobility that you take raloxifene, so it can be stopped and restarted on the correct schedule.
Storage
Store tablets as directed on the product label, typically at room temperature, protected from moisture, out of reach of children.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information and UK/EU regulator sources reviewed for this dossier; verify against the current full label before prescribing.
United States
Indication: Osteoporosis prevention/treatment and breast cancer risk reduction (postmenopausal women)
Dose summary: 60 mg orally once daily, any time of day, without regard to meals.
Renal context: Not specifically dose-adjusted in the US label reviewed; UK/EU sources note caution/contraindication in significant renal impairment. (1)
United Kingdom / European Union
Indication: Osteoporosis prevention/treatment (postmenopausal women)
Dose summary: 60 mg orally once daily, with or without food.
Renal context: Contraindicated in severe renal impairment; caution in hepatic impairment including cholestasis. (2) (3)
Hepatic guidance
Contraindicated in hepatic impairment including cholestasis per UK/EU sources reviewed.
Overdose note
Reported overdose effects include leg cramps and dizziness; manage with supportive care. (1) (2)
Frequently asked questions
Why does raloxifene have a boxed warning?
Because it carries two genuine, serious risks confirmed in its official prescribing information: an increased risk of blood clots (deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis), and an increased risk of death from stroke in women who already have, or are at increased risk of, heart disease. This is why it is not used in women with a history of blood clots, and why it needs to be stopped around any period of planned immobility such as surgery. (1)
Why do I need to stop raloxifene before surgery?
Because periods of prolonged immobility (such as after surgery or during extended bed rest) further increase the already-elevated blood clot risk that raloxifene carries. Regulator guidance is to stop it at least 72 hours beforehand and restart only once you are fully mobile again, always on your care team's direction. (1)
Is raloxifene available everywhere?
It is authorised and currently supplied in the US, UK, EU, Canada, and Australia. New Zealand is a genuine exception: the manufacturer discontinued supply there, with PHARMAC confirming both an expected supply-exhaustion date before December 2025 and an official funding delisting date of 1 April 2026, so it should be considered no longer available in New Zealand rather than an active option, and affected patients there should discuss alternatives with their prescriber. (6)
References
- EVISTA (raloxifene hydrochloride) tablet -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Eli Lilly · United States · accessed 2026-07-30 · source 1
- Raloxifene hydrochloride 60mg film-coated tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Aspire Pharma Ltd · United Kingdom · accessed 2026-07-30 · source 2
- Evista, INN-raloxifene hydrochloride -- EPAREuropean Medicines Agency (EMA) -- centralised EU marketing authorisation, EPAR · European Union · accessed 2026-07-30 · source 3
- EVISTA (raloxifene hydrochloride) -- Product MonographHealth Canada product monograph, Eli Lilly Canada Inc. · Canada · accessed 2026-07-30 · source 4
- EVISTA raloxifene hydrochloride 60mg tablet blister pack -- ARTG entry 64709Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 5
- Raloxifene (Evista): Discontinuation -- PHARMAC medicine noticePHARMAC (Pharmaceutical Management Agency), New Zealand -- official medicine supply notice · New Zealand · accessed 2026-07-30 · source 6
Brand names by country
Single-ingredient raloxifene hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Evista60 mg · eli lilly and company
United Kingdom
- Raloxifene hydrochloride (branded generic) (2)MHRA licensed emc smpc confirmed · 60 mg · Aspire Pharma Ltd (PL35533/0150)
Canada
- EVISTA
Australia
New Zealand
- Evista (discontinued) (6)PHARMAC confirmed manufacturer discontinued supply delisting 2026-04-01 · 60 mg · Eli Lilly (supply discontinued)