Resources for You
Megace (Megestrol Acetate, USP) Oral Suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
6 ADVERSE REACTIONS
6.2 Clinical Trial Experience
- added: 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.....
8 USE IN SPECIFIC POPULATIONS
8.6 Use in Women
- Megace ES is a progesterone derivative, which may induce vaginal bleeding in women
NOTE: changes to OVERDOSAGE, Section 10
- In postmarketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with Megace® ES oral suspension. In case of overdose, appropriate supportive measures should be taken.
Use In Women (previously named “Use in HIV-Infected Women” and relocated to PRECAUTIONS)
- Megace is a progesterone derivative, which may induce vaginal bleeding in women