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Selective Oestrogen Receptor Modulator (SERM) — Osteoporosis Pregnancy: Contraindicated — not used in pre-menopausal or pregnant women

Raloxifene

Brand names: Evista

Adult dose

Dose: 60 mg once daily
Route: Oral
Frequency: Once daily
Max: 60 mg/day
Postmenopausal women only. Can be taken at any time of day, with or without food. Calcium and vitamin D supplementation recommended. Not effective for menopausal vasomotor symptoms (hot flushes) — can actually worsen hot flushes (oestrogen agonist in bone but antagonist in breast/uterus; antagonist effect in thermoregulatory centres).

Paediatric dose

Route:
Not licensed in children or pre-menopausal women

Dose adjustments

Renal

Use with caution in renal impairment; no dose adjustment for mild-moderate impairment

Hepatic

Avoid in hepatic impairment — raloxifene is extensively hepatically metabolised

Clinical pearls

  • MORE trial (NEJM 1999): raloxifene 60 mg daily for 3 years reduced vertebral fracture risk by 30–50% in postmenopausal women with osteoporosis — importantly, did NOT reduce hip fracture risk (key limitation versus bisphosphonates)
  • Breast cancer reduction: raloxifene reduces invasive breast cancer by 76% in the MORE trial — dual benefit in osteoporosis + breast cancer prevention makes it attractive in women with high breast cancer risk and osteoporosis
  • VTE risk: inform all patients of 3-fold increased DVT/PE risk; stop 72 hours before any prolonged immobility (elective surgery, long-haul flights); restart only when fully mobile
  • Does NOT protect against hip fractures — significant limitation; bisphosphonates or denosumab preferred when hip fracture risk is the primary concern
  • RUTH trial: increased fatal stroke risk in patients with AF — avoid in patients with pre-existing AF or high stroke risk

Contraindications

  • Pre-menopausal women (not licensed)
  • History of VTE — DVT, pulmonary embolism, retinal vein thrombosis
  • Hepatic impairment
  • Pregnancy
  • Cholestasis

Side effects

  • VTE — DVT and pulmonary embolism; 3-fold increased risk vs placebo
  • Hot flushes — worsened or precipitated
  • Leg cramps
  • Peripheral oedema
  • Rarely: fatal stroke (MORE trial — increased stroke in women with AF or established CAD)

Interactions

  • Cholestyramine — reduces raloxifene absorption significantly; avoid concurrent use
  • Warfarin — raloxifene modestly reduces prothrombin time; monitor INR
  • Ciclosporin — variable interaction; monitor levels

Monitoring

  • VTE symptoms — leg pain, shortness of breath
  • DXA scan every 2 years
  • Breast examination annually
  • Cholesterol (modest lipid benefit)

Reference: BNFc; BNF 90; MORE Trial (NEJM 1999); RUTH Trial (NEJM 2006); NICE TA160 (Raloxifene); NOGG Osteoporosis Guidelines; SPC Evista. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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