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Megace

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Megace

Megace Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Megace (megestrol acetate, USP) Oral Suspension is used to treat loss of appetite and weight loss because of disease, and is also used in the treatment of advanced breast cancer and endometrial cancer. It is a man-made chemical similar to the female hormone progesterone. This medication is available in generic form. Common side effects include weight gain, changes in appetite, stomach upset, diarrhea, gas, trouble sleeping, decreased sexual ability/desire, or fever. Women may experience changes in menstrual periods, including unpredictable bleeding.

The recommended adult initial dosage of Megace Oral Suspension is 800 mg/day (20 mL/day). Megace may interact with insulin or oral diabetes medicine and may decrease the effects of these medications, and blood sugar levels may increase. If you have diabetes, monitor blood sugar and talk to your doctor if you notice unusual changes. Tell your doctor all medications you use. Megace must not be used during pregnancy. It may cause harm to a fetus. Women of childbearing age should use birth control while using this medication. This medication may pass into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.

Our Megace (megestrol acetate, USP) 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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Megace in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Megace (Megestrol Acetate) »

What is Prescribing information?

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

Megace FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 MEGACE Oral Suspension.

ADVERSE EVENTS % of Patients Reporting

Megestrol Acetate, mg/day No. of Patients Trial 1
(N=236)
Trial 2
(N=87)
Open Label Trial
Placebo 0
N=34
100
N=68
400
N=69
800 N=65 Placebo 0
N=38
800
N=49
1200
N=176
Diarrhea 15 13 8 15 8 6 10
Impotence 3 4 6 14 0 4 7
Rash 9 9 4 12 3 2 6
Flatulence 9 0 1 9 3 10 6
Hypertension 0 0 0 8 0 0 4
Asthenia 3 2 3 6 8 4 5
Insomnia 0 3 4 6 0 0 1
Nausea 9 4 0 5 3 4 5
Anemia 6 3 3 5 0 0 0
Fever 3 6 4 5 3 2 1
Libido Decreased 3 4 0 5 0 2 1
Dyspepsia 0 0 3 3 5 4 2
Hyperglycemia 3 0 6 3 0 0 3
Headache 6 10 1 3 3 0 3
Pain 6 0 0 2 5 6 4
Vomiting 9 3 0 2 3 6 4
Pneumonia 6 2 0 2 3 0 1
Urinary Frequency 0 0 1 2 5 2 1

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 MEGACE Oral Suspension include thromboembolic phenomena including thrombophlebitis and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS).

Read the entire FDA prescribing information for Megace (Megestrol Acetate) »

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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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