A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Megace Side Effects, and Drug Interactions - Megestrol acetate
Megace Side Effects, and Drug Interactions - Megestrol acetate
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 MEGACE Oral Suspension.
|
Adverse Events
% of Patients Reporting
|
| |
Trial 1 (N= 236)
|
Trial 2 (N= 87)
|
Open Label Trial
|
| Megestrol Acetate
mg/ day
|
Placebo 0
|
100
|
400
|
800
|
Placebo 0
|
800
|
1200
|
| No. of Patients |
N= 34
|
N= 68
|
N= 69
|
N= 65
|
N= 38
|
N= 49
|
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 Freq. |
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
MEGACE Oral Suspension included thromboembolic phenomena including
thrombophlebitis, pulmonary embolism
and glucose intolerance
(see WARNINGS and PRECAUTIONS).
DRUG INTERACTIONS
Pharmacokinetic studies show
that there are no significant
alterations in pharmacokinetic parameters of zidovudine
or with rifabutin to warrant dosage adjustment
when megesterol acetate
is administered with these drugs. The effects of zidovudine
or rifabutin on the pharmacokinetics
of megestrol acetate were not studied.
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