Contents
Side Effects of Megace (megestrol)
Megace (megestrol) is a synthetic form of progesterone, a female hormone used to stimulate appetite in patients with AIDS who have poor appetite or unexplained weight loss.
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 and other body functions. How Megace stimulates appetite or suppresses cancer is not understood.
Common side effects of Megace include:
- diarrhea
- weight gain
- nausea
- rash
- impotence
- insomnia
- mood swings
- sweating
- breakthrough menstrual bleeding
- high blood pressure (hypertension)
- excess gas (flatulence)
Serious side effects of Megace include:
- blood clots in legs and lungs
- worsening of diabetes or new onset diabetes
Megace may interact with indinavir, reducing blood concentrations. Consider increasing the dose of Megace.
Megace may cause birth defects and should not be used during pregnancy. Use contraception while taking Megace.
Megace should not be used while breastfeeding due to potential adverse effects in the infant.
Important Side Effects of Megace (megestrol)
The most common side effects are:
- diarrhea
- weight gain
- nausea
- rash
- impotence
- insomnia
- mood swings
- sweating
- breakthrough menstrual bleeding
- high blood pressure
- 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 occurring in at least 5% of patients in any arm of the clinical trials are listed below. These events should be considered when prescribing Megace Oral Suspension.
ADVERSE EVENTS % of Patients Reporting
| Megestrol Acetate, mg/day No. of Patients |
Trial 1(N=236) | Trial 2 (N=87) | Open Label Trial | ||||
| 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 occurring in 1% to 3% of patients enrolled in the clinical trials are listed below by body system. Events occurring less than 1% are not included. No significant differences were found between patients treated with megestrol acetate and placebo.
Body as a Whole: abdominal pain, chest pain, infection, moniliasis, and sarcoma
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
Postmarketing
Postmarketing reports associated with Megace Oral Suspension include thromboembolic phenomena like thrombophlebitis and pulmonary embolism, and glucose intolerance.
Drug Interactions with Megace (megestrol)
Pharmacokinetic studies show no significant alterations in the pharmacokinetics of zidovudine or rifabutin when administered with megestrol acetate. 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). Monitor INR closely in patients taking MEGACE and warfarin.
Summary
Megace (megestrol) is a synthetic form of progesterone, a female hormone used to stimulate appetite in patients with AIDS who have poor appetite or unexplained weight loss. Megace is also used to treat breast cancer and weight loss associated with cancer. Common side effects of Megace include diarrhea, weight gain, nausea, rash, impotence, insomnia, mood swings, sweating, breakthrough menstrual bleeding, high blood pressure (hypertension), and excess gas (flatulence). Megace may cause birth defects and should not be used during pregnancy. Megace should not be used while breastfeeding due to potential adverse effects in the infant.
Megace (megestrol) is a synthetic form of progesterone, a female hormone used to stimulate appetite in patients with AIDS who have poor appetite or unexplained weight loss. Megace is also used to treat breast cancer and weight loss associated with cancer. Common side effects of Megace include diarrhea, weight gain, nausea, rash, impotence, insomnia, mood swings, sweating, breakthrough menstrual bleeding, high blood pressure (hypertension), and excess gas (flatulence). Megace may cause birth defects and should not be used during pregnancy. Megace should not be used while breastfeeding due to potential adverse effects in the infant.
