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Raloxifene

Evista · ATC code G03XC01

Also known as: Raloxifen · Brand names: Evista, Raloxifen Stada, Raloxifen Al, Raloxifen-Hcl Hexal, Ralien

Key facts
Active substance
Raloxifene
Drug class
Selective estrogen-receptor modulators
ATC code
G03XC01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Evista 60 mg film coated tablets
Marketing authorisation holder
Substipharm
Information as of
2026-10-27

Key facts

Raloxifene is a selective oestrogen receptor modulator (SERM) used to treat and prevent osteoporosis in postmenopausal women.

What it is used for

  • Treatment and prevention of osteoporosis in postmenopausal women
  • A significant reduction in vertebral, but not hip, fractures has been shown

Dosing

  • One tablet (60 mg) daily at any time, without regard to meals; intended for long-term use
  • Calcium and vitamin D supplements generally advised with low dietary intake
  • No dose adjustment in the elderly; caution in mild and moderate renal impairment
  • Not for use in severe renal impairment, hepatic impairment or children

Contraindications

  • Hypersensitivity; women of child-bearing potential
  • Active or past venous thromboembolism including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis
  • Hepatic impairment including cholestasis; severe renal impairment
  • Unexplained uterine bleeding; signs or symptoms of endometrial cancer

Important warnings

  • Increased risk of venous thromboembolism; discontinue for prolonged immobilisation (from 3 days before)
  • Increased stroke mortality in women with coronary heart disease or increased coronary risk; relevant with stroke risk factors
  • Any uterine bleeding during therapy is unexpected and should be investigated by a specialist
  • Triglycerides monitored with history of oestrogen-induced hypertriglyceridaemia

Side effects

  • Very common: hot flushes, flu syndrome, gastrointestinal symptoms, increased blood pressure
  • Common: leg cramps, peripheral oedema, rash, mild breast symptoms
  • Uncommon: venous thromboembolic events (the clinically most important reaction)

Interactions

  • Warfarin or other coumarins: prothrombin time monitored (modest decreases observed)
  • Calcium carbonate and antacids do not affect exposure

Pregnancy and breastfeeding

  • Only for postmenopausal women; may cause foetal harm
  • Not recommended in breast-feeding women

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Raloxifen StadaStada Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Raloxifen AlAliud Pharma Gmbh · 1 register entry
  • Raloxifen-Hcl HexalHexal Ag · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • RalienGENVEON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 13 more European countries
Cyprus
Ostiral
France
Raloxifene Arrow, Raloxifene Biogaran, Raloxifene Cristers, Raloxifene Eg, Raloxifene Sandoz, Raloxifene Zentiva, Raloxifène Viatris
Greece
Ostiral
Hungary
Clastellos, Raloxibone
Iceland
Evista, Optruma, Raloxifen Teva, Raloxifene Teva
Italy
Raloxifene Sandoz
Liechtenstein
Evista, Optruma, Raloxifen Teva, Raloxifene Teva
Netherlands
Raloxifeenhydrochloride Brillpharma, Raloxifene Hydrochloride Aurobindo
Norway
Evista, Optruma, Raloxifen Teva, Raloxifene Teva
Portugal
Raloxifeno Ciclum, Raloxifeno Exeltis, Raloxifeno Generis, Raloxifeno Sandoz, Raloxifeno Tolife
Romania
Raloxifen Arena
Spain
Raloxifeno Aurovitas, Raloxifeno Cinfamed, Raloxifeno Kern Pharma, Raloxifeno Stada, Raloxifeno Tarbis
Sweden
Raloxifen Stada

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Evista – EPAR, Product Information (OF THE TEXT DD month YYYY Detailed information on this medic). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/evista-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC G03XC.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.