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Anastrozole

Anastrazol Bluefish, Anastrolan, Anastrozol, Anastrozole Ratiopharm · ATC code L02BG03

Also known as: Anastrozol · Brand names: Anastrazol Bluefish, Anastrolan, Anastrozole Ratiopharm, Arimidex, Anablock, Anastropuren, Anastrozole Abz, Anazol, Aristu, Santra, Veridex

Key facts
Active substance
Anastrozole
Drug class
Aromatase inhibitors
ATC code
L02BG03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Anastrozole is an aromatase inhibitor. Per the US prescribing information, it is used in postmenopausal women with hormone receptor-positive breast cancer for adjuvant, first-line and second-line treatment.

What it is used for

  • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
  • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
  • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy

Dosing

  • One 1 mg tablet once a day, with or without food
  • Advanced breast cancer: continue until tumor progression
  • Adjuvant therapy: optimal duration unknown; in the ATAC trial anastrozole was given for five years
  • No dose adjustment in renal impairment, in elderly patients or in mild-to-moderate hepatic impairment; not studied in severe hepatic impairment

Contraindications

  • Hypersensitivity to the drug or any excipient (observed reactions include anaphylaxis, angioedema and urticaria)

Important warnings

  • Ischemic cardiovascular events: increased in women with pre-existing ischemic heart disease in the ATAC trial (17% on anastrozole vs 10% on tamoxifen); weigh risks and benefits
  • Bone effects: decrease in lumbar spine and total hip bone mineral density; consider bone mineral density monitoring
  • Cholesterol: elevated serum cholesterol more often than with tamoxifen (9% vs 3.5%)
  • Embryo-fetal toxicity: can cause fetal harm; effective contraception during therapy and for at least 3 weeks after the last dose

Side effects

  • Common (≥10%): hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash
  • Also common: osteoporosis, fractures, back and bone pain, insomnia, headache, peripheral edema, increased cough, dyspnea, pharyngitis, lymphedema
  • Serious and very rare (less than 1 in 10,000): skin reactions with lesions, ulcers or blisters; allergic reactions with swelling of the face, lips, tongue or throat; liver inflammation

Interactions

  • Tamoxifen: reduces anastrozole plasma concentration by 27% with no efficacy benefit; should not be co-administered
  • Estrogen-containing therapies: may diminish the action of anastrozole and should not be used with it

Pregnancy and breastfeeding

  • May cause fetal harm when given to a pregnant woman; verify pregnancy status before starting
  • Do not breastfeed during treatment and for 2 weeks after the last dose

Summary of the official product information, written with AI on 2026-10-29. 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

Patient information (US)

This product has no separate US patient information.

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.

Austria

  • Anastrazol BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • AnastrolanG.L. Pharma Gmbh · 1 register entry
  • Anastrozol1a Pharma Gmbh, Genericon Pharma Gesellschaft M.B.H., +pharma Arzneimittel Gmbh, Actavis Group Ptc Ehf., Viatris Limited, Accord Healthcare B.V., Amarox Pharma B.V., Sandoz Gmbh, Stada Arzneimittel Gmbh · 9 register entries
  • Anastrozole RatiopharmTeva B.V · 1 register entry
  • ArimidexLaboratoires Juvise Pharmaceuticals · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • AnablockDr. Pfleger Arzneimittel Gmbh · 1 register entry
  • AnastropurenEugia Pharma (Malta) Limited · 1 register entry
  • Anastrozol1 A Pharma Gmbh, Glenmark Arzneimittel Gmbh, Winthrop Arzneimittel Gmbh, Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Onkovis Gmbh, Accord Healthcare B.V., Aristo Pharma Gmbh (Art 57), Synthon Bv, Stadapharm Gmbh, Denk Pharma Gmbh & Co. Kg, Sun Pharmaceuticals Germany Gmbh, Aliud Pharma Gmbh · 13 register entries
  • Anastrozole AbzAbz-Pharma Gmbh · 1 register entry
  • Anastrozole RatiopharmRatiopharm Gmbh · 1 register entry
  • ArimidexLaboratoires Juvise Pharmaceuticals · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AnazolKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • ArimidexEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 1 register entry
  • AristuONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • SantraSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • VeridexDEVA HOLDİNG A.Ş. · 1 register entry

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

USA

  • ArimidexANI Pharmaceuticals, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 27 more European countries
Belgium
Anastrozol Sandoz, Anastrozol Torrefarma, Anastrozole Eg, Anastrozole Teva, Arimidex
Bulgaria
Анастрогратис, Анастрозол Алуфарма, Аримидекс, Егистрозол, Киареста, Озолан
Croatia
Anastris, Anastrozol, Anastrozole Pliva, Aremed, Arimidex, Astralis, Strazolan
Cyprus
Aremed, Arimidex, Strazolan
Czechia
Alozex, Anaprex, Anastrozol Teva, Anastrozol Viatris, Anastrozole Amarox, Anaya, Arimidex, Atrocela, Egistrozol
Denmark
Anastelb, Anastrazol "sandoz", Anastrozol Accord, Anastrozol Medical Valley, Anastrozole Amarox, Arimidex
Estonia
Anastrozole Accord, Anastrozole Elvim, Anastrozole Sanoswiss, Anastrozole Teva, Arimidex
Finland
Anastelb Stada Arzneimittel, Anastrozol Sandoz, Anastrozole Teva, Anazol, Arimidex
France
Anastrozole Accord, Anastrozole Amarox, Anastrozole Arrow, Anastrozole Biogaran, Anastrozole Bluefish, Anastrozole Cristers, Anastrozole Eg, Anastrozole Evolugen, Anastrozole Krka, Anastrozole Sandoz, Anastrozole Substipharm, Anastrozole Teva, Anastrozole Viatris, Anastrozole Zentiva, Anastrozole Zydus, Arimidex
Greece
Anastrogen, Anastrozole Demo, Anastrozole Teva, Arimidex, Avomin, Londer, Zolitrat
Hungary
Anabrest, Anastrozol Pharmacenter, Anastrozol Stada, Anastrozole Accord, Arilla, Arimidex, Atrocela, Axastrol, Ozolan
Iceland
Anastrozole Alvogen
Ireland
Agerdex, Amidex, Anastrozol Synthon, Anastrozole Accord Healthcare Ireland, Anastrozole Amarox, Anastrozole Rowa Pharmaceuticals, Anastrozole Teva, Arimidex
Italy
Adiunastrol, Anastrozolo Alter, Anastrozolo Amarox, Anastrozolo Aurobindo Italia, Anastrozolo Doc Generici, Anastrozolo Eg, Anastrozolo Mylan Generics, Anastrozolo Pensa, Anastrozolo Sandoz, Anastrozolo Sun, Anastrozolo Teva, Anastrozolo Zentiva, Antabrest, Arimidex, Eristrol, Extroplex, Griset, Raoloz, Renazole
Latvia
Anastrozole Accord, Anastrozole Elvim, Anastrozole Sanoswiss, Anastrozole Teva
Lithuania
Anastrozole Accord, Anastrozole Elvim, Anastrozole Sanoswiss, Anastrozole Teva, Arimidex
Luxembourg
Anastrozole Eg, Arimidex
Malta
Anastrozole Pls, Aremed
Netherlands
Anastrozol Accord, Anastrozol Amarox, Anastrozol Devatis, Anastrozol Pch, Anastrozol Ratiopharm, Anastrozol Sun, Anastrozol Synthon, Anastrozol Viatris, Anastrozole Pch, Arimidex, Egistrozol, Strakir, Zolzyn
Norway
Anastrozol Medical Valley, Arimidex
Poland
Anastrazol Bluefish, Anastrozole Amarox, Anastrozole Eugia, Anastrozole Teva, Arimidex, Atrozol, Axastrol, Egistrozol
Portugal
Anastrozol Accord, Anastrozol Amperlem, Anastrozol Azevedos, Anastrozol Farmoz, Anastrozol Generis, Anastrozol Germed, Anastrozol Mylan, Anastrozol Pls, Anastrozol Teva, Anastrozol Tolife, Arimidex
Romania
Anastelb, Anastrozol Amarox, Anastrozol Terapia, Anastrozol Teva, Arimidex, Egistrozol, Kyaresta
Slovakia
Anaprex, Anastrozol, Anastrozole Pharmacenter, Egistrozol
Slovenia
Arimidex
Spain
Amenur, Anastrozol Accord, Anastrozol Aurovitas, Anastrozol Cinfa, Anastrozol Combix, Anastrozol Kern Pharma, Anastrozol Liderfarm, Anastrozol Normon, Anastrozol Pensa, Anastrozol Sandoz, Anastrozol Stada, Anastrozol Sun, Anastrozol Tarbis, Anastrozol Teva-Ratio, Anastrozol Viatris, Anastrozol Vir, Arimidex
Sweden
Anastelb, Anastrozol Medical Valley, Anastrozol Sandoz, Anastrozole Accord, Anastrozole Amarox, Anastrozole Bluefish, Anastrozole Teva, Arimidex

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. Anastrozole (Yiling Pharmaceutical, Inc.) – Prescribing Information, 2025-12-29. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b3da447-8e7c-2aaa-e053-2a91aa0a2821
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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), 2026-10-29. 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. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC L02BG.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.