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Serious And Otherwise Important Adverse Reactions
The following serious reactions and otherwise important adverse drug reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity [see CONTRAINDICATIONS]
- Pregnancy [see CONTRAINDICATIONS]
- Fetal Effects [see WARNINGS AND PRECAUTIONS]
- Thromboembolic Disease [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Megace® ES (megestrol acetate oral suspension, 125 mg/mL) was based on three studies of megestrol acetate oral suspension (40 mg/mL). The adverse reaction profile of these 3 studies are presented below.
Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial for megestrol acetate oral suspension are listed below by treatment group. All patients listed had at least one post baseline visit during the 1 2 study weeks.
Table 1: Adverse Events
|Percentage of Patients Reporting Adverse Events|
|Trial 1 (N=236)||Trial 2 (N=87)||Open Label Trial|
|Megestrol Acetate mg/day||0||100||400||800||0||800||1200|
|No. of Patients||N—34||N—68||N—69||N—65||N—38||N—49||N—176|
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 1 2 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
Hemic and Lymphatic System - leukopenia
Metabolic and Nutritional - LDH increased, edema and peripheral edema
Special Senses - amblyopia
Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance [see WARNINGS AND PRECAUTIONS].
Read the Megace ES (megestrol acetate) Side Effects Center for a complete guide to possible side effects
Due to the significant decrease in the exposure of indinavir by megestrol acetate, administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate [See CLINICAL PHARMACOLOGY].
Zidovudine And Rifabutin
No dosage adjustment for zidovudine and rifabutin is needed when megestrol acetate is coadministered with these drugs [See CLINICAL PHARMACOLOGY].
Read the Megace ES Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/19/2016
Additional Megace ES Information
Megace ES - User Reviews
Megace ES User Reviews
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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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