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U.S. Department of Health and Human Services

Safety

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Megace (Megestrol Acetate, USP) Oral Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

September 2014

Summary View

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.....
     

 

May 2013

Summary View

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.

 

April 2012

Summary View

 

PRECAUTIONS

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