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U.S. Department of Health and Human Services

Safety

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

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

 

January 2014

Summary View

ADVERSE REACTIONS

6.1 Clinical Trials Experience 
  • updated to assign frequencies to the adverse reactions in Tables 2 and 3

 

May 2013

Summary View

7 DRUG INTERACTIONS

7.2 Adrenergic and Serotonergic Agents
  • Linezolid has the potential for interaction with adrenergic and serotonergic agents. [see Warnings and Precautions (5.3, 5.6) and Clinical Pharmacology (12.3)]

 

December 2009

Summary View

 

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.