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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.
% of Patients Reporting
No. of Patients
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.
Cardiovascular System - cardiomyopathy and palpitation
Hemic and Lymphatic System - leukopenia
Special Senses - amblyopia
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
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.
Additional Megace ES Information
Megace ES - User Reviews
Megace ES User Reviews
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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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