Label Changes for:

Zyvox (linezolid) tablets, IV injection, and oral suspension

December 2009

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2009

PRECAUTIONS 

Drug Interactions
  • update an observed reduction in linezolid plasma concentrations when co-administered with rifampin in a Phase 1 drug interaction study conducted in healthy volunteers

ADVERSE REACTIONS 

Postmarketing Experience
  • Superficial tooth discoloration and tongue discoloration have been reported with the use of linezolid. The tooth discoloration was removable with professional dental cleaning (manual descaling) in cases with known outcome.
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