Megestrol Side Effects

Some side effects of megestrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to megestrol: oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking megestrol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

• nausea, vomiting, dizziness, weakness, or feeling like you might pass out;

• sudden numbness or weakness, especially on one side of the body;

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or

• high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion).

Less serious side effects of megestrol may include:

• upset stomach;

• vaginal bleeding;

• mild skin rash;

• weakness,

• sleep problems (insomnia); or

• decreased interest in sex, impotence, trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to megestrol: compounding powder, oral suspension, oral tablet

Endocrine

Endocrine side effects including cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushings syndrome have been reported in association of chronic use of megestrol. Adrenal insufficiency has also been reported in patients receiving or being withdrawn from chronic megestrol therapy in both the stressed and non-stressed state. Adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol therapy. Hot flashes have also been reported.

The possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol who presents with signs and/or symptoms suggestive of hypoadrenalism in either the stressed or non-stressed state.

General

General side effects including a significant risk of weight gain (secondary to increased appetite), mood changes, malaise, asthenia, and lethargy have been reported.

Cardiovascular

Cardiovascular side effects including thrombophlebitis, heart failure, edema, deep vein thrombosis, and hypertension have been reported.

Hematologic

Hematologic side effects including a significant risk to develop blood clots have been reported.

Blood clots are particularly a risk in cancer patients and others susceptible to clotting.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been reported.

Genitourinary

Genitourinary side effects including breakthrough menstrual bleeding have been reported.

Respiratory

Respiratory side effects including pulmonary embolism (sometimes fatal) and dyspnea have been reported.

Dermatologic

Dermatologic side effects including alopecia, sweating, and rash have been reported.

Musculoskeletal

Musculoskeletal side effects have included at least two patients with severe osteoporosis complicated by multiple vertebral fractures experienced while the patients were receiving high-dose megestrol therapy.

Nervous system

Nervous system side effects including carpal tunnel syndrome have been reported.

Oncologic

Oncologic side effects including tumor flare (with or without hypercalcemia) have been reported. Long term animal studies have reported an increased risk for both benign and malignant tumors of the breast.

Other

Other side effects including a possible case of megestrol withdrawal syndrome have been reported.

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