FDA label
What is exemestane used for?
The FDA-approved uses of exemestane, 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 exemestane (tablet, film coated) lists 2 uses: Adjuvant Treatment of Postmenopausal Women; Advanced Breast Cancer in Postmenopausal Women.
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Exemestane, tablet, film coated
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA216454). Cross-references to other label sections are left out.
Adjuvant Treatment of Postmenopausal Women
Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy.
Advanced Breast Cancer in Postmenopausal Women
Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Source: DailyMed label, set id e24b08eb-4693-41c7-81cb-b536947f7070, version 2, effective April 25, 2025. NDC 59651-516, one of 5 listings for this product.
Exemestane, tablet
Indications and Usage, quoted from the label by Upsher-Smith Laboratories, Inc. (ANDA209208). Cross-references to other label sections are left out.
Adjuvant Treatment of Postmenopausal Women
Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies ].
Advanced Breast Cancer in Postmenopausal Women
Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies ].
Source: DailyMed label, set id f8bd17b4-5289-45bb-8095-de89dc8d39ed, version 8, effective February 26, 2025. NDC 0832-0595, one of 4 listings for this product.
Questions
What is exemestane used for?
The FDA label for exemestane (tablet, film coated) lists 2 uses: Adjuvant Treatment of Postmenopausal Women; Advanced Breast Cancer in Postmenopausal Women.
What drug class is exemestane?
FDA lists exemestane 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.