July 25, 2016
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Megestrol Acetate Oral Suspension

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Megestrol Acetate Oral Suspension

Megestrol Acetate Oral Suspension Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/20/2015

Megestrol acetate oral suspension contains a form of the female hormone progesterone and is used to treat anorexia, wasting (cachexia), or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Megestrol acetate oral suspension is available in generic form. Common side effects of megestrol acetate oral suspension include diarrhea, weight gain, changes in appetite, nausea, stomach upset, rash, impotence, touble sleeping (insomnia), mood swings, sweating, breakthrough menstrual bleeding or other changes in menstrual periods, decreased sexual ability/desire, high blood pressure, fever, and gas.

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Megestrol acetate oral suspension may interact with other drugs. Tell your doctor all medications and supplements you use. Megestrol acetate should not be used during pregnancy. It may cause fetal harm. Because of the potential for adverse effects on a nursing baby, breastfeeding should be discontinued if megestrol acetate oral suspension is required.

Our megestrol acetate oral suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Megestrol Acetate Oral Suspension FDA Prescribing Information: Side Effects
(Adverse Reactions)


Clinical Adverse Events: Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing megestrol acetate oral suspension.

% of Patients Reporting

  Trial 1
Trial 2
Megestrol Acetate
No.of Patients




Open Label Trial
Diarrhea 15 13 8 15 8 16 10
Impotence 13 14 6 14 0 14 17
Rash 19 19 4 12 3 12 16
Flatulence 19 10 1 19 3 10 16
Hypertension 10 10 0 18 0 10 14
Asthenia 13 12 3 16 8 14 15
Insomnia 10 13 4 16 0 10 11
Nausea 19 14 0 15 3 14 15
Anemia 16 13 3 15 0 10 10
Fever 13 16 4 15 3 12 11
Libido Decreased 13 14 0 15 0 12 11
Dyspepsia 10 10 3 13 5 14 12
Hyperglycemia 13 10 6 13 0 10 13
Headache 16 10 1 13 3 10 13
Pain 16 10 0 12 5 16 14
Vomiting 19 13 0 12 3 16 14
Pneumonia 16 12 0 12 3 10 11
Urinary Frequency 10 10 1 12 5 12 11

Adverse events which occurred in 1 to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo.

Body as a Whole - abdominal pain, chest pain, infection, moniliasis and sarcoma Cardiovascular System - cardiomyopathy and palpitation

Digestive System - constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis

Hemic and Lymphatic System - leukopenia

Metabolic and Nutritional - LDH increased, edema and peripheral edema

Nervous System - paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking

Respiratory System - dyspnea, cough, pharyngitis and lung disorder

Skin and Appendages - alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder

Special Senses - amblyopia

Urogenital System - albuminuria, urinary incontinence, urinary tract infection and gynecomastia

Postmarketing - Postmarketing reports associated with megestrol acetate oral suspension included throm-boembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS sections).

Read the entire FDA prescribing information for Megestrol Acetate Oral Suspension (Megestrol Acetate Oral Suspension)

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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