Megestrol Acetate Oral Suspension (Megestrol Acetate Oral Suspension) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Megestrol Acetate Oral Suspension

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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).

DRUG INTERACTIONS

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.

Last reviewed on RxList: 6/3/2008
This monograph has been modified to include the generic and brand name in many instances.