Does Megace (megestrol) cause side effects?
Megace is also used to treat breast cancer and weight loss associated with cancer. Progesterone is a hormone produced by the body, especially in women, that helps control the menstrual period as well as other body functions. How Megace stimulates appetite or suppresses cancer is not understood.
Common side effects of Megace include
- weight gain,
- mood swings,
- breakthrough menstrual bleeding,
- high blood pressure (hypertension), and
- excess gas (flatulence).
Serious side effects of Megace include
Megace should not be used while breastfeeding due to potential adverse effects in the infant.
What are the important side effects of Megace (megestrol)?
The most common side effects are:
- weight gain,
- mood swings,
- breakthrough menstrual bleeding,
- high blood pressure, and
- excess gas (flatulence).
Blood clots in legs and lungs may occur.
Megestrol may worsen existing diabetes or lead to new onset diabetes.
Megace (megestrol) side effects list for healthcare professionals
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
|Open Label Trial|
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.
Hemic and Lymphatic System: leukopenia
Metabolic and Nutritional: LDH increased, edema and peripheral edema
Special Senses: amblyopia
What drugs interact with Megace (megestrol)?
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. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied.
Megestrol acetate may interact with warfarin and increase International Normalized Ratio (INR). Closely monitor INR in patients taking MEGACE and warfarin.
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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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.