Selective Oestrogen Receptor Modulator (SERM) — Osteoporosis Pregnancy: Only for use in postmenopausal women and must not be taken by women of childbearing potential; raloxifene may cause foetal harm when administered to a pregnant woman, and a patient who becomes pregnant or uses it mistakenly during pregnancy should be informed of the potential hazard to the foetus. It is unknown whether raloxifene or its metabolites are excreted in human milk and a risk to the newborn/infant cannot be excluded, so clinical use cannot be recommended in breast-feeding women.

Raloxifene

Brand names: Evista

Raloxifene is a selective oestrogen receptor modulator (SERM) used for the prevention and treatment of postmenopausal osteoporosis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One 60 mg tablet daily (the fetched product is 'Raloxifene hydrochloride 60mg film-coated tablets')

Route: Oral — may be taken at any time of the day without regard to meals

Frequency: Once daily

Fetched SPC: https://www.medicines.org.uk/emc/product/10406/smpc. Due to the nature of the disease process, the medicine is intended for long-term use. Calcium and vitamin D supplements are generally advised in women with a low dietary intake. ELDERLY: no dose adjustment is necessary. HEPATIC IMPAIRMENT: should not be used in patients with hepatic impairment (also a contraindication). PAEDIATRIC: should not be used in children of any age; there is no relevant use in the paediatric population — no paediatric dose is stated, so none is recorded here. The US label in the same bundle agrees on one 60 mg tablet daily, and adds that for the indications relating to risk of invasive breast cancer the optimum duration of treatment is not known, and that postmenopausal women require an average of 1500 mg/day of elemental calcium with a recommended vitamin D intake of 400 to 800 IU daily.

Dose adjustments

Renal

Should not be used in patients with severe renal impairment (contraindicated). In patients with moderate and mild renal impairment the medicine should be used with caution. No specific reduced dose is stated.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Must not be used in women of childbearing potential
Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis
Hepatic impairment, including cholestasis
Severe renal impairment
Unexplained uterine bleeding; should not be used in patients with signs or symptoms of endometrial cancer

Side effects

Vasodilatation (hot flushes) — very common
Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and dyspepsia — very common; flu syndrome and increased blood pressure — very common
Headache including migraine, leg cramps, rash, peripheral oedema, mild breast symptoms such as pain, enlargement and tenderness — common
Venous thromboembolic events including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis and arterial thromboembolic reactions — uncommon (occurred in less than 1% of treated patients and are the clinically most important adverse reactions)
Fatal strokes and thrombocytopenia — uncommon

Interactions

Cholestyramine and other anion exchange resins — reduce the absorption and enterohepatic cycling of raloxifene; concomitant use is not recommended (US labelling §7; the UK SPC §4.5 was not captured in this bundle)
Warfarin and other warfarin derivatives — monitor prothrombin time more closely when starting or stopping raloxifene (US labelling §7)
Other highly protein-bound drugs such as diazepam, diazoxide and lidocaine — use with caution; raloxifene is more than 95% bound to plasma proteins (US labelling §7)
Systemic oestrogens — concomitant use is not recommended (US labelling §5.6)

Clinical monograph

How it works

It acts as an oestrogen agonist on bone, reducing bone resorption and increasing bone mineral density, while behaving as an oestrogen antagonist in breast and uterine tissue.

Prescribing in practice

It increases the risk of venous thromboembolism and is contraindicated in women with active or past venous thromboembolic disease; it should be stopped during prolonged immobilisation.
Unlike oestrogen, it does not relieve menopausal vasomotor symptoms and may worsen hot flushes.
It reduces the incidence of vertebral fractures but has not been shown to reduce non-vertebral or hip fractures.

Monitoring

Assess fracture risk and bone mineral density periodically, and ensure adequate calcium and vitamin D intake.

Counselling the patient

Report any leg swelling, pain, breathlessness or chest pain promptly as these may signal a clot.
Tell your team if you are due to have surgery or will be immobile for a prolonged period.
This medicine does not treat hot flushes and may make them worse.

Evidence & guidelines

The MORE trial demonstrated a reduction in vertebral fracture risk in postmenopausal women with osteoporosis.

Reference: MORE Trial (NEJM 1999); RUTH Trial (NEJM 2006); NICE TA160 (Raloxifene); NOGG Osteoporosis Guidelines; SPC Evista; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways