Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
-

Glucovance (glyburide and metformin HCl) tablets

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

 

Summary View November 2010

 

ADVERSE REACTIONS

Gastrointestinal
  • In postmarketing reports cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Glucovance should be discontinued if this occurs.

 

Summary View November 2009

 

*sulfonylurea agent class change

PRECAUTIONS

Glyburide
Hemolytic anemia
  • Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Glucovance belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.
-
-