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Selective oestrogen receptor modulator (SERM) Pregnancy: Contraindicated in pregnancy and not indicated for use in females of reproductive potential. Based on its mechanism of action it may block important functions of oestrogen at all stages of pregnancy; animal studies showed abortion, fetal anomalies and delayed or disrupted parturition at doses at or below the maximum recommended human dose (US label §4.2, §8.1).

Raloxifene hydrochloride

Brand names: Evista

Raloxifene is a selective oestrogen receptor modulator (SERM) used to prevent and treat postmenopausal osteoporosis, and to reduce the risk of invasive breast cancer in some higher-risk postmenopausal women.

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
Route: Oral
Frequency: Once daily
Source: US FDA prescribing information (openFDA/DailyMed) §2.1 — no eMC/UK SPC content was available in this bundle, so verify against the current UK SPC before use. May be administered at any time of day without regard to meals. For the indications relating to risk of invasive breast cancer, the optimum duration of treatment is not known. Calcium and vitamin D: for either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate — postmenopausal women require an average of 1,500 mg/day of elemental calcium (intake above 1,500 mg has not shown additional bone benefit, and above 2,000 mg is associated with increased risk of hypercalcaemia and kidney stones); recommended vitamin D intake is 400 to 800 IU daily, with more for those at increased risk of insufficiency. No maximum dose is stated. Geriatric: no dose adjustment needed. Hepatic impairment: use with caution. Premenopausal women: use is not recommended. Discontinue 72 hours prior to and during prolonged immobilisation. Paediatric: safety and effectiveness in paediatric patients have not been established.

Dose auto-extracted from 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

  • Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis
  • Pregnancy — may cause fetal harm

Side effects

  • Hot flushes
  • Leg cramps
  • Peripheral oedema
  • Flu syndrome and arthralgia
  • Sweating
  • Serious: venous thromboembolism (DVT, pulmonary embolism, retinal vein thrombosis) and increased risk of death due to stroke in women with documented coronary heart disease or at increased risk for major coronary events

Interactions

  • Cholestyramine (and, anticipated, other anion exchange resins) — concomitant use is not recommended; reduces absorption and enterohepatic cycling of raloxifene
  • Warfarin and other warfarin derivatives — monitor prothrombin time more closely when starting or stopping raloxifene
  • Other highly protein-bound drugs (e.g. diazepam, diazoxide, lidocaine) — use with caution; raloxifene is more than 95% bound to plasma proteins

Clinical monograph

How it works

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

Prescribing in practice

  • It increases the risk of venous thromboembolism and should be stopped before and during prolonged immobilisation; avoid in women with a history of venous thromboembolic events.
  • It does not relieve menopausal vasomotor symptoms and may worsen hot flushes, so is not suitable for that purpose.
  • Reduces vertebral fracture risk but, unlike bisphosphonates, has not been shown to reduce non-vertebral or hip fractures.

Monitoring

No routine blood monitoring is required, but review thrombotic risk and bone density periodically and reassess if prolonged immobility is anticipated.

Counselling the patient

  • Stay mobile and tell your team in advance about planned surgery or long periods of bed rest.
  • This tablet will not help hot flushes and may make them worse.
  • Seek urgent help for a swollen, painful calf, chest pain or sudden breathlessness.

Evidence & guidelines

The MORE trial demonstrated reduced vertebral fracture risk with raloxifene in postmenopausal osteoporosis, and NICE includes it among options for secondary prevention.

Reference: NICE TA161; 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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