Megace ES

Last reviewed on RxList: 6/3/2021
Megace ES Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Megace ES?

Megace ES (megestrol) oral suspension is a synthetic form of the hormone progesterone used to increase appetite and prevent weight loss in patients with AIDS or other diseases that cause decreased appetite and weight loss. Megace ES is also used to treat cancer of the breast or uterus.

What Are Side Effects of Megace ES?

Common side effects of Megace ES include:

Dosage for Megace ES

The recommended dosage of Megace ES is 625 mg/day (5 mL/day or 1 teaspoon daily). Megace ES should not be used during pregnancy.

What Drugs, Substances, or Supplements Interact with Megace ES?

Megace ES may interact with indinavir or insulin or oral diabetes medications. Tell your doctor all medications you use.

Megace ES During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or think you may be pregnant. Women of childbearing age should use an effective form of birth control while using this medication. Consult your doctor about using Megace ES before breastfeeding.

Additional Information

Our Megace ES (megestrol acetate) 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.

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Megace ES Consumer Information

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

Call your doctor at once if you have any of these side effects during or after your treatment with megestrol:

  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • swelling, warmth, or redness in an arm or leg;
  • increased thirst, increased urination, dry mouth, fruity breath odor;
  • weight gain (especially in your waist and upper back);
  • muscle weakness, tiredness, feeling light-headed;
  • skin discoloration, thinning skin, increased body hair; or
  • mood changes, menstrual changes, sexual changes.

Common side effects may include:

  • nausea, gas, diarrhea;
  • increased blood pressure;
  • impotence, sexual problems;
  • rash; or
  • weakness.

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 ES (Megestrol Acetate)

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Megace ES Professional Information

SIDE EFFECTS

Serious And Otherwise Important Adverse Reactions

The following serious reactions and otherwise important adverse drug reactions are discussed in greater detail in other sections of the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Megace® ES (megestrol acetate oral suspension, 125 mg/mL) was based on three studies of megestrol acetate oral suspension (40 mg/mL). The adverse reaction profile of these 3 studies are presented below.

Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial for megestrol acetate oral suspension are listed below by treatment group. All patients listed had at least one post baseline visit during the 1 2 study weeks.

Table 1: Adverse Events

  Percentage of Patients Reporting Adverse Events
Trial 1 (N=236) Trial 2 (N=87) Open Label Trial
Placebo Placebo
Megestrol Acetate mg/day 0 100 400 800 0 800 1200
No. of Patients N—34 N—68 N—69 N—65 N—38 N—49 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 1 2 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 Experience

Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance [see WARNINGS AND PRECAUTIONS].

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

© Megace ES Patient Information is supplied by Cerner Multum, Inc. and Megace ES Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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