FDA label
What is anastrozole used for?
The FDA-approved uses of anastrozole, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for anastrozole lists 3 uses: Adjuvant Treatment; First-Line Treatment; Second-Line Treatment.
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Anastrozole, tablet
Indications and Usage, quoted from the label by Accord Healthcare Inc. (ANDA090568). Cross-references to other label sections are left out.
Adjuvant Treatment
Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
First-Line Treatment
Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
Second-Line Treatment
Anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets.
Source: DailyMed label, set id 03586c40-eb32-45c5-beb7-6762a6b78790, version 11, effective February 11, 2026. NDC 16729-035, one of 29 listings for this product.
Questions
What is anastrozole used for?
The FDA label for anastrozole lists 3 uses: Adjuvant Treatment; First-Line Treatment; Second-Line Treatment.
What drug class is anastrozole?
FDA lists anastrozole in the Aromatase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.