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Estradiol

Estrofem, Estrogel, Femseven, Linoladiol · ATC code G03CA03

Also known as: Östradiol · Brand names: Estrofem, Estrogel, Femseven, Linoladiol, Montadiol, Rewellfem, Dermestril, Estramon, Estreva, Estrifam, Estring, Fem7, Femoston Mono, Gynokadin, Lenzetto …

Key facts
Active substance
Estradiol
Drug class
Estrogen
ATC code
G03CA03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than “synthetic” estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders.)

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Key facts

Estradiol is an oestrogen. Per the US label (tablets) it is used for menopausal symptoms, hypoestrogenism, palliation of certain cancers and prevention of osteoporosis.

What it is used for

  • Moderate to severe vasomotor symptoms of menopause
  • Moderate to severe vulvar and vaginal atrophy of menopause (consider topical vaginal products if this is the only indication)
  • Hypoestrogenism due to hypogonadism, castration or primary ovarian failure
  • Palliation of metastatic breast cancer and advanced androgen-dependent prostate cancer
  • Prevention of osteoporosis in women at significant risk for whom non-estrogen medications are not appropriate

Dosing

  • Lowest effective dose for the shortest duration; re-evaluate periodically
  • Women with a uterus should also receive a progestin
  • Menopausal symptoms: usually 1 to 2 mg daily, cyclic (e.g. 3 weeks on and 1 week off)
  • Hypoestrogenism: initially 1 to 2 mg daily, adjusted as needed
  • Breast cancer (palliation): 10 mg three times daily for at least three months
  • Prostate cancer (palliation): 1 to 2 mg three times daily

Contraindications

  • Undiagnosed abnormal genital bleeding
  • Breast cancer (except selected metastatic cases) or oestrogen-dependent neoplasia
  • Active or past DVT or pulmonary embolism; active or recent arterial thromboembolic disease (e.g. stroke, myocardial infarction)
  • Liver disease, hypersensitivity, known or suspected pregnancy

Important warnings

  • Boxed warning: increased risk of endometrial cancer; investigate abnormal vaginal bleeding
  • Boxed warning: not for prevention of cardiovascular disease; WHI reported increased risks of MI, stroke, invasive breast cancer, pulmonary emboli and DVT
  • Discontinue immediately if a cardiovascular or thromboembolic event occurs or is suspected
  • Manage risk factors (hypertension, diabetes, tobacco use, obesity) appropriately

Side effects

  • Changes in bleeding pattern, breakthrough bleeding, spotting; breast tenderness and pain
  • Nausea, vomiting, bloating; gallbladder disease
  • Headache, migraine, dizziness, mood disturbances
  • Venous thrombosis, pulmonary embolism, myocardial infarction, stroke, increased blood pressure

Pregnancy and breastfeeding

  • Contraindicated in known or suspected pregnancy; no indication in pregnancy

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 →

Common questions – ask Medelix

For patients

Patient information (US)

Patient information (US) →

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

  • EstrofemNovo Nordisk Pharma Gmbh · 1 register entry
  • EstrogelBesins Healthcare · 1 register entry
  • FemsevenTheramex Ireland Limited · 1 register entry
  • LinoladiolPharmazeutische Fabrik Montavit Ges.M.B.H. · 1 register entry
  • MontadiolPharmazeutische Fabrik Montavit Ges.M.B.H. · 1 register entry
  • RewellfemGedeon Richter Plc. · 1 register entry

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

Germany

  • DermestrilExeltis Germany Gmbh · 5 register entries
  • Estradiol1 A Pharma Gmbh, Bayer Vital Gmbh · 2 register entries
  • EstramonHexal Ag · 2 register entries
  • EstrevaTheramex Ireland Limited · 1 register entry
  • EstrifamNovo Nordisk Pharma Gmbh · 1 register entry
  • EstringPfizer Pharma Gmbh · 1 register entry
  • Fem7Theramex Ireland Limited · 1 register entry
  • Femoston MonoTheramex Ireland Limited · 1 register entry
  • GynokadinBesins Healthcare Germany Gmbh · 2 register entries
  • LenzettoGedeon Richter Plc. · 1 register entry
  • Linoladiol NDr. August Wolff Gmbh & Co. Kg Arzneimittel · 1 register entry
  • ProgynovaBayer Vital Gmbh · 2 register entries
Show all 15 brand names
  • Sisare Gel MonoOrion Corporation · 1 register entry
  • Sisare MonoOrion Corporation · 1 register entry
  • VagiruxGedeon Richter Plc. · 1 register entry

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

Turkey

  • AkrofollineBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • Climara ForteBAYER TÜRK KİMYA SAN. LTD. ŞTİ. · 2 register entries
  • EstrofemNOVO NORDİSK SAĞLIK ÜRÜNLERİ TİC LTD. ŞTİ. · 1 register entry
  • FemijelKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • VagifemNOVO NORDİSK SAĞLIK ÜRÜNLERİ TİC LTD. ŞTİ. · 2 register entries

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

USA

  • ClimaraBayer HealthCare Pharmaceuticals Inc. · 1 register entry
  • EstringPfizer Laboratories Div Pfizer Inc · 1 register entry
  • LyllanaAmneal Pharmaceuticals LLC · 1 register entry
  • YuvafemAmneal Pharmaceuticals LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 28 more European countries
Belgium
Dermestril, Dermestril®, Estradiol Besins, Estreva, Estrofem, Feminova, Feminova75, Lenzetto, Oestrogel, Progynova, Rewellfem, Systen, Vagifem
Bulgaria
Естрогел, Естрофем, Лензето, Линоладиол N
Croatia
Estradiol Besins, Estrofem, Lenzetto, Linoladiol, Vagifem, Vagirux
Cyprus
Vagifem
Czechia
Estradiol Besins, Estrahexal, Estrofem, Lenzetto, Linoladiol N, Neofollin, Vagifem, Vagirux
Denmark
Divigel, Ercostrol, Estradiol Sandoz, Estring, Estrofem, Estrogel, Lenzetto, Menovag, Oestablet, Rewellfem, Vagifem, Vivelle Dot, Østradiol Dlf
Estonia
Divigel, Estradiol Besins, Estrofem, Lenzetto, Linoladiol N, Vagifem, Vagirux
Finland
Divigel, Estradot, Estrena, Estring, Estrofem, Estrogel, Lenzetto, Menovag, Orestra, Progynova, Vagidonna, Vagifem, Vagirux, Zumenon
France
Dermestril, Estradiol Exeltis, Estreva, Estring, Femsept, Oestrodose, Oestrogel, Oromone, Provames, Thais, Thaissept, Vagirux
Greece
Lenzetto, Vagifem, Vagirux
Hungary
Divigel, Estradiol Besins, Estrofem, Lenzetto, Linoladiol, Rewellfem, Vagifem, Vagirux
Iceland
Estradiol Hexal, Estring, Estrofem, Estrogel, Femanest, Lenzetto, Rewellfem, Vagidonna, Vagifem, Vivelle Dot
Ireland
Divigel, Estradiol Sun, Estradot, Estrofem, Evorel, Fematab, Lenzetto, Oestrogel Pump-Pack, Vagifem, Vagirux
Italy
Dermestril, Estraderm Mx, Estreva, Estring, Femseven, Lenzetto, Progynova, Sandrena, Vagifem, Vagirux
Latvia
Estradiol Besins, Estrofem, Lenzetto, Linoladiol N, Vagifem, Vagirux
Liechtenstein
Rewellfem
Lithuania
Divigel, Estradiol Besins, Estrofem, Lenzetto, Linoladiol N, Vagifem, Vagirux
Luxembourg
Dermestril, Dermestril®, Estradiol Besins, Estreva, Estrofem, Lenzetto, Oestrogel, Progynova, Rewellfem, Systen, Vagifem
Malta
Estradiol Sandoz, Fematab, Lenzetto, Oestrogel Pump-Pack, Vagifem, Vagirux
Netherlands
Cetura, Estradiol Sandoz, Lenzetto, Oestrogel, Progynova, Systen, Vagifem, Vagirux, Zumenon
Norway
Estradiol Hexal, Estradot, Estrogel, Lenzetto, Menovag, Progynova, Vagidonna, Vagifem
Poland
Divigel, Estreva, Estrofem, Fem, Lenzetto, Oestrogel, Systen, Vagifem, Vagirux
Portugal
Dermestril, Estradot, Estreva, Estrofem, Femsete, Formyra, Lenzetto, Vagifem, Zumenon
Romania
Estradiol Besins, Lenzetto
Slovakia
Estradiol Besins, Estrofem, Lenzetto, Neofollin, Vagirux
Slovenia
Estradiol Besins, Estrofem, Lenzetto, Vagifem, Vagirux
Spain
Divigel, Estraderm Matrix, Estradiol Besins, Estradiol Meriestra, Estradot, Estring, Evopad, Lenzetto, Oestraclin, Progynova, Vagifem, Vagirux
Sweden
Divigel, Estradiol Besins, Estradiol Sun, Estradot, Estrogel, Femanest, Lenzetto, Menovag, Oestring, Progynon, Vagidonna, Vagifem, Vagirux

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. U.S. Food and Drug Administration. Estradiol (NorthStar Rx LLC) – Prescribing Information, 2025-11-11. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1c2cd11a-e010-20b2-e063-6294a90a52d5
  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. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC G03CA.

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.