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Letrozole

Femara, Letrofam, Letrozol +pharma, Letrozol Accord · ATC code L02BG04

Also known as: Letrozol, Femara · Brand names: Letrofam, Letrozol +pharma, Letrozol Accord, Letrozol Bluefish, Letrozol Denk, Letrozol Genericon, Letrozol Ratiopharm, Letrozol Sandoz, Letrozol Stada, Letrozol Viatris, Letrozole Actavis, Letro-Cell, Letrohexal, Letropuren, Lortanda …

Key facts
Active substance
Letrozole
Drug class
Aromatase inhibitors
ATC code
L02BG04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

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

What it is used for

  • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
  • Extended adjuvant treatment after 5 years of adjuvant tamoxifen therapy
  • First-line treatment of hormone receptor positive or unknown, locally advanced or metastatic breast cancer
  • Advanced breast cancer with disease progression after antiestrogen therapy

Dosing

  • One 2.5 mg tablet once a day, without regard to meals
  • Adjuvant: optimal duration unknown, median treatment duration in studies 5 years; discontinue at relapse
  • Advanced disease: continue until tumor progression
  • Cirrhosis with severe hepatic dysfunction: reduce the dose by 50%, i.e. 2.5 mg every other day; no adjustment in mild to moderate hepatic impairment
  • Renal impairment with creatinine clearance ≥10 mL/min: no adjustment

Contraindications

  • Pregnancy
  • Known hypersensitivity to the active substance or any excipient

Important warnings

  • Bone effects: decreases in bone mineral density; consider monitoring
  • Cholesterol: hypercholesterolemia in 52.3% on letrozole vs 28.6% on tamoxifen; consider monitoring serum cholesterol
  • Severe hepatic impairment with cirrhosis: about twice the exposure, so dose reduction is recommended
  • Fatigue, dizziness and somnolence: caution when driving or using machinery
  • Embryo-fetal toxicity: effective contraception during therapy and for at least 3 weeks after the last dose

Side effects

  • Hypercholesterolemia (52.3%), hot flashes (33.5%), arthralgia/arthritis (25.4%)
  • Bone fractures, night sweats, weight increase, nausea
  • Fatigue, myalgia, dizziness

Interactions

  • Tamoxifen: reduces letrozole plasma levels by 38% on average
  • No clinical experience in combination with other anticancer agents

Pregnancy and breastfeeding

  • Contraindicated; postmarketing cases of spontaneous abortion and congenital birth defects reported
  • Do not breastfeed during treatment and for at least 3 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

  • FemaraNovartis Pharma Gmbh · 1 register entry
  • LetrofamG.L. Pharma Gmbh · 1 register entry
  • Letrozol +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Letrozol AccordAccord Healthcare B.V. · 1 register entry
  • Letrozol BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • Letrozol DenkDenk Pharma Gmbh & Co. Kg · 1 register entry
  • Letrozol GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Letrozol RatiopharmTeva B.V · 1 register entry
  • Letrozol SandozSandoz Gmbh · 2 register entries
  • Letrozol StadaStada Arzneimittel Gmbh · 1 register entry
  • Letrozol ViatrisViatris Limited · 1 register entry
  • Letrozole ActavisActavis Group Ptc Ehf. · 1 register entry

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

Germany

  • FemaraNovartis Pharma Gmbh · 1 register entry
  • Letro-CellStadapharm Gmbh · 1 register entry
  • LetrohexalHexal Ag · 1 register entry
  • LetropurenEugia Pharma (Malta) Limited · 1 register entry
  • Letrozol1 A Pharma Gmbh, Abz-Pharma Gmbh, Ratiopharm Gmbh, Winthrop Arzneimittel Gmbh, Bluefish Pharmaceuticals Ab, Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Accord Healthcare B.V., Amarox Pharma Gmbh, Aristo Pharma Gmbh (Art 57), Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Teva Gmbh, Sun Pharmaceuticals Germany Gmbh · 16 register entries
  • LortandaTad Pharma Gmbh · 1 register entry

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

Turkey

  • FemaraNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
  • FemveonGENVEON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • LetrasanDEVA HOLDİNG A.Ş. · 1 register entry
  • LetroksBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • LetrolKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • LetuONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

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

USA

  • FemaraNovartis Pharmaceuticals Corporation · 1 register entry

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

Brand names in 27 more European countries
Belgium
Femara, Letrozol Sandoz, Letrozole Eg, Letrozole Teva
Bulgaria
Етрузил, Зеквипра, Летрогратис, Летрозол Nucleus, Летрозол Алуфарма, Летрозол Зентива, Летрокон, Летрофемин, Луcин, Фемара
Croatia
Avomit, Femara, Lametta, Letrilan, Letrofar, Letrozol Jgl, Letrozol Sandoz, Lortanda, Siletris, Yuxizol
Cyprus
Femara, Feremazol, Letrozole Accord, Letrozole Teva, Saderon
Czechia
Aletro, Dracenax, Etruzil, Letmylan, Letrovena, Letrozol Teva Pharma, Letrozole Sandoz, Likarda, Trozel
Denmark
Letrozol Accord, Letrozol Medical Valley, Letrozol Stada, Letrozol Teva, Letrozol Viatris
Estonia
Femara, Feremazol, Letrozole Accord, Letrozole Sanoswiss, Letrozole Teva, Lortanda
Finland
Femar, Letrolan, Letrozol Accord, Letrozol Ratiopharm, Letrozole Hexal, Letrozole Sandoz, Letrozole Stada
France
Femara, Letrozole Accord Healthcare, Letrozole Almus, Letrozole Alter, Letrozole Arrow Lab, Letrozole Biogaran, Letrozole Cristers, Letrozole Eg, Letrozole Evolugen, Letrozole Gnr, Letrozole Sandoz, Letrozole Teva, Letrozole Viatris, Letrozole Zentiva, Letrozole Zydus
Greece
Femaplex, Femara, Femazac, Feremazol, Leoncon, Letrafem, Letropen, Letrozin, Letrozole Teva, Ratroz, Religan, Stefaplex
Hungary
Etruzil, Famos, Femara, Letrovena, Letrozol Phace, Letrozole Teva, Lortanda, Picozone
Iceland
Letromal, Letrozol Actavis, Letrozole Bluefish
Ireland
Femara, Letrozole Accord Healthcare Ireland, Letrozole Bluefish, Letrozole Clonmel Healthcare, Letrozole Rowex, Letrozole Synthon, Letrozole Teva, Letrozole Viatris, Letzo
Italy
Blormat, Brestoral, Calantha, Femara, Femelix, Gosuran, Letrix, Letrozolo Almus, Letrozolo Alter, Letrozolo Aurobindo Italia, Letrozolo Doc Generici, Letrozolo Eg, Letrozolo Mylan Generics, Letrozolo P-Care, Letrozolo Pensa, Letrozolo Sandoz, Letrozolo Sun, Letrozolo Tecnigen, Letrozolo Teva, Letrozolo Zentiva, Ramates, Raziolet, Zolobrest, Zoltron
Latvia
Femara, Letrozole Sanoswiss, Letrozole Teva
Lithuania
Femara, Feremazol, Letrozole Accord, Letrozole Sanoswiss, Likarda
Luxembourg
Femara, Letrozole Eg
Malta
Femara, Feremazol, Letrozole Accord Healthcare Ireland Limited, Letrozole Pharmacare
Netherlands
Etruzil, Letrostar, Letrozin, Letrozol Accord, Letrozol Amarox, Letrozol Denk, Letrozol Devatis, Letrozol Genthon, Letrozol Glenmark, Letrozol Sandoz, Letrozol Sun, Letrozol Synthon, Letrozol Teva, Letrozol Viatris, Letrozole Sandoz
Norway
Femar, Letrozol Accord, Letrozol Medical Valley, Letrozol Teva, Letrozol Viatris
Poland
Aromek, Clarzole, Etruzil, Lametta, Letrozole Accord, Letrozole Bluefish, Letrozole Eugia, Letrozole Pharmalab, Lortanda
Portugal
Femara, Letrozol Accord, Letrozol Alter, Letrozol Amperlem, Letrozol Azevedos, Letrozol Ebrocite, Letrozol Farmoz, Letrozol Genthon, Letrozol Hikma, Letrozol Loxoprel, Letrozol Pentafarma, Letrozol Pharmacare, Letrozol Pharmakern, Letrozol Sandoz Farmacêutica, Letrozol Stada, Letrozol Tecnimede, Letrozol Teva, Letrozol Tolife, Letrozole P-Care
Romania
Elozora, Etruzil, Letrozol Accord, Letrozol Labormed, Letrozol Stada, Loosyn, Zequipra
Slovakia
Aletro, Etruzil, Letromyl, Letrovena, Letrozol Sandoz, Letrozol Stada, Letrozole Pharmacenter, Lortanda
Slovenia
Femara, Letrozol Genthon, Lortanda
Spain
Femara, Galdar, Letrozol Accord, Letrozol Almus, Letrozol Alter, Letrozol Aurovitas, Letrozol Bluefish, Letrozol Cinfa, Letrozol Combix, Letrozol Dr. Reddys, Letrozol Edigen, Letrozol Kern Pharma, Letrozol Mabo, Letrozol Normon, Letrozol Pensa Pharma, Letrozol Ratiopharm, Letrozol Sandoz, Letrozol Stada, Letrozol Sun, Letrozol Tarbis, Letrozol Tecnigen, Letrozol Teva-Ratiopharm, Letrozol Viatris, Letrozole Sandoz Farmacéutica, Loxifan, Sybali
Sweden
Letrozol Accord, Letrozol Medical Valley, Letrozol Omet Pharma, Letrozol Stada, Letrozol Teva, Letrozol Viatris, Letrozole Bluefish, Letrozole Hexal, Letrozole Sandoz

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

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

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Another question about this substance?

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

Sources

  1. U.S. Food and Drug Administration. Femara (Novartis Pharmaceuticals Corporation) – Prescribing Information, 2026-06-11. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406
  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.