Letrozole is an aromatase inhibitor indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Letrozole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Femara is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer.
Source: US FDA prescribing information
The growth of some cancers of the breast is stimulated or maintained by estrogens. Treatment of breast cancer thought to be hormonally responsive (i.e., estrogen and/or progesterone receptor positive or receptor unknown) has included a variety of efforts to decrease estrogen levels (ovariectomy, adrenalectomy, hypophysectomy) or inhibit estrogen effects (antiestrogens and progestational agents). These interventions lead to decreased tumor mass or delayed progression of tumor growth in some women. In postmenopausal women, estrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens (primarily androstenedione and testosterone) to estrone and estradiol. The suppression of estrogen biosynthesis in peripheral tissues and in the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme.
Source: US FDA prescribing information
Femara tablets are taken orally without regard to meals: Recommended dose: 2.5 mg once daily. Patients with cirrhosis or severe hepatic impairment: 2.5 mg every other day.
Source: US FDA prescribing information
Pregnancy: Letrozole can cause fetal harm. Known hypersensitivity to the active substance, or to any of the excipients. Pregnancy.
Source: US FDA prescribing information
Decreases in bone mineral density may occur. Consider bone mineral density monitoring. Increases in total cholesterol may occur. Consider cholesterol monitoring. Fatigue, dizziness, and somnolence may occur. Exercise caution when operating machinery. Embryo-Fetal Toxicity: Can cause fetal harm when administered to pregnant women. Obtain a pregnancy test in females of reproductive potential. Advise females of reproductive potential to use effective contraception.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling. Bone effects Increases in cholesterol Fatigue and Dizziness The most common adverse reactions (greater than 20%) were hot flashes, arthralgia, flushing, asthenia, edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating increased, bone pain, and musculoskeletal.
Source: US FDA prescribing information
Tamoxifen Coadministration of Femara and tamoxifen 20 mg daily resulted in a reduction of letrozole plasma levels of 38% on average (Study P015). Clinical experience in the second-line breast cancer trials (AR/BC2 and AR/BC3) indicates that the therapeutic effect of Femara therapy is not impaired if Femara is administered immediately after tamoxifen. Cimetidine A pharmacokinetic interaction study with cimetidine (Study P004) showed no clinically significant effect on letrozole pharmacokinetics. Warfarin An interaction study (P017) with warfarin showed no clinically significant effect of letrozole on warfarin pharmacokinetics. Other Anticancer Agents There is no clinical experience to date on the use of Femara in combination with other anticancer agents.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C and 30°C (59°F and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Letrozole, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Letrozole 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Femara 2.5 mg tabletOral | Novartis Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 July 1997 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Letrozole in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Letrozole and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Letrozole, including Femara.
Yes. The US FDA first approved Letrozole on 25 July 1997, according to Drugs@FDA.
No listed presentation of Letrozole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Letrozole is classified under ATC code L02BG04 (Letrozole).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.