Safety

Temodar (temozolomide) for Injection; vial and capsules

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

September 2015

Summary View 

ADVERSE REACTIONS

Postmarketing Experience
  • …Infections and infestations: primary and reactivated cytomegalovirus (CMV), and reactivation of hepatitis B infections including some cases with fatal outcomes.

 

June 2011

Summary View 

ADVERSE REACTIONS

Postmarketing Experience
  • There have been reported cases of hepatotoxicity including elevations of liver enzymes, hyperbillirubinemia, cholestasis, and hepatitis.

 

Page Last Updated: 10/09/2015
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