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Megestrol (Megestrol Acetate) - Side Effects and Adverse Reactions

 
 



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 megestrol acetate oral suspension.

ADVERSE EVENTS % of Patients Reporting
Trial 1 (N=236) Trial 2 (N=87) Open
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
Label Trial
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 included thromboembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS sections).

Drug label data at the top of this Page last updated: 2010-11-24

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