July 26, 2016
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Megace ES

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Megace ES




Megace ES Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/22/2016

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. Common side effects of Megace ES include weight gain, changes in appetite, stomach upset, diarrhea, gas, trouble sleeping (insomnia), menstrual changes or vaginal bleeding, fever, skin rash, weakness, decreased interest in sex, impotence, or trouble having an orgasm.

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

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.

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 ES 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 ES (Megestrol Acetate)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Megace ES Overview - Patient Information: Side Effects

SIDE EFFECTS: This medication can cause weight gain, changes in appetite, stomach upset, diarrhea, gas, trouble sleeping, decreased sexual ability/desire, or fever. Women may experience changes in their menstrual periods, including unpredictable bleeding. If any of these effects persist or worsen, inform your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: fast/pounding heartbeat, headache, swelling of hands/feet, fatigue.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, confusion, mental/mood changes, weakness/numbness on one side of the body, pain/redness/swelling of arms or legs, slurred speech, trouble breathing, severe or sudden vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Megace ES (Megestrol Acetate)

What is Prescribing information?

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

Megace ES FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 - User Reviews

Megace ES User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Megace ES sorted by most helpful. Patient Discussions FAQs

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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