Exemestane Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


1.1 Adjuvant Treatment of Postmenopausal Women

Exemestane is 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 for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)].

1.2 Advanced Breast Cancer in Postmenopausal Women

Exemestane is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2)].


There is currently no drug history available for this drug.

Other Information

Exemestane Tablets for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C20H24O2 and its structural formula is as follows:

Exemestane structural formula

The active ingredient is a white to slightly yellow powder with a molecular weight of 296.41. Exemestane is freely soluble in tetrahydrofuran and dimethylformamide; soluble in acetone, acetonitrile, methanol, and ethyl acetate; sparingly soluble in ethanol; very slightly soluble in nhexane and insoluble in water.

Each Exemestane Tablet contains the following inactive ingredients: mannitol, copovidone, crospovidone, silicified microcrystalline cellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol 400, and hypromellose.

Exemestane Manufacturers

  • American Health Packaging
    Exemestane Tablet [American Health Packaging]
  • Greenstone Llc
    Exemestane Tablet, Sugar Coated [Greenstone Llc]
  • Alvogen Inc.
    Exemestane Tablet [Alvogen Inc. ]
  • Roxane Laboratories, Inc
    Exemestane Tablet, Film Coated [Roxane Laboratories, Inc]

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