ADVERSE REACTIONS
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) | Trail 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 and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS sections).
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