Megestrol Acetate Oral Suspension
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Megestrol Acetate Oral Suspension
Megestrol Acetate Oral Suspension Side Effects Center
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Megestrol Acetate Oral Suspension FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 megestrol acetate oral suspension.
ADVERSE EVENTS
% of Patients Reporting
| Trial 1 (N=236) |
Trial 2 (N=87) |
||||||
| 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 |
Open Label Trial 1200 N=176 |
| Diarrhea | 15 | 13 | 8 | 15 | 8 | 16 | 10 |
| Impotence | 13 | 14 | 6 | 14 | 0 | 14 | 17 |
| Rash | 19 | 19 | 4 | 12 | 3 | 12 | 16 |
| Flatulence | 19 | 10 | 1 | 19 | 3 | 10 | 16 |
| Hypertension | 10 | 10 | 0 | 18 | 0 | 10 | 14 |
| Asthenia | 13 | 12 | 3 | 16 | 8 | 14 | 15 |
| Insomnia | 10 | 13 | 4 | 16 | 0 | 10 | 11 |
| Nausea | 19 | 14 | 0 | 15 | 3 | 14 | 15 |
| Anemia | 16 | 13 | 3 | 15 | 0 | 10 | 10 |
| Fever | 13 | 16 | 4 | 15 | 3 | 12 | 11 |
| Libido Decreased | 13 | 14 | 0 | 15 | 0 | 12 | 11 |
| Dyspepsia | 10 | 10 | 3 | 13 | 5 | 14 | 12 |
| Hyperglycemia | 13 | 10 | 6 | 13 | 0 | 10 | 13 |
| Headache | 16 | 10 | 1 | 13 | 3 | 10 | 13 |
| Pain | 16 | 10 | 0 | 12 | 5 | 16 | 14 |
| Vomiting | 19 | 13 | 0 | 12 | 3 | 16 | 14 |
| Pneumonia | 16 | 12 | 0 | 12 | 3 | 10 | 11 |
| Urinary Frequency | 10 | 10 | 1 | 12 | 5 | 12 | 11 |
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 included throm-boembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS sections).
Read the entire FDA prescribing information for Megestrol Acetate Oral Suspension (Megestrol Acetate Oral Suspension) »
Additional Megestrol Acetate Oral Suspension Information
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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