Megestrol Acetate

Megestrol Acetate

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Questions & Answers

Side Effects & Adverse Reactions

Megestrol acetate may cause fetal harm when administered to a pregnant woman. Fertility and reproduction studies with high doses of megestrol acetate have shown a reversible feminizing effect on some male rat fetuses. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

The use of megestrol in other types of neoplastic disease is not recommended.

(See also Precautions: Carcinogenesis, Mutagenesis, and Impairment of Fertility section.)

The glucocorticoid activity of megestrol acetate tablets has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of megestrol. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic megestrol therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (eg., surgery, infection).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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.


Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.


There is currently no drug history available for this drug.

Other Information

Megestrol acetate, is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The empirical formula is C24 H32O4 and the structural formula is represented as follows:

Structural formula

Megestrol acetate tablets are supplied for oral administration containing 20 mg or 40 mg megestrol acetate and the following inactive ingredients: acacia, colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and starch (corn).

Megestrol Acetate Manufacturers

  • Roxane Laboratories, Inc
    Megestrol Acetate Tablet [Roxane Laboratories, Inc]
  • State Of Florida Doh Central Pharmacy
    Megestrol Acetate Tablet [State Of Florida Doh Central Pharmacy]
  • Udl Laboratories, Inc.
    Megestrol Acetate Tablet [Udl Laboratories, Inc.]
  • Par Pharmaceutical Inc
    Megestrol Acetate Tablet [Par Pharmaceutical Inc]
  • Major Pharmaceuticals
    Megestrol Acetate Tablet [Major Pharmaceuticals]
  • Physicians Total Care, Inc.
    Megestrol Acetate Tablet [Physicians Total Care, Inc.]
  • Cardinal Health
    Megestrol Acetate Tablet [Cardinal Health]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Megestrol Acetate Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Barr Laboratories Inc.
    Megestrol Acetate Tablet [Barr Laboratories Inc.]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Megestrol Acetate Tablet [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Cardinal Health
    Megestrol Acetate Tablet [Cardinal Health]
  • Cardinal Health
    Megestrol Acetate Tablet [Cardinal Health]

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