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Megace ES

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Megace ES

Side Effects
Interactions

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® ES (megestrol acetate) oral suspension.

ADVERSE EVENTS
% of Patients Reporting
  Trial 1
(N=236)
Trial 2
(N=87)
Open
Label
Trial
Megestrol Acetate,
mg/day
No. of Patients
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 megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance (see WARNINGS and PRECAUTIONS sections).

Read the Megace ES (megestrol acetate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. A pharmacokinetic study demonstrated that coadministration of megestrol acetate and indinavir results in a significant decrease in the pharmacokinetic parameters (~36% for Cmax and ~28% for AUC) of indinavir. Administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate. The effects of indinavir, zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied.

Read the Megace ES Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Megace ES - User Reviews

Megace ES User Reviews

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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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