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.
