Safety

Zosyn (piperacillin and tazobactam for injection, USP) and Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)

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

December 2015

Summary View

WARNINGS AND PRECAUTIONS

Skin Reactions
  • drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)

ADVERSE REACTIONS

Post-Marketing Experience
  • drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)

 

September 2013

Summary View

5 WARNINGS AND PRECAUTIONS

5.2 Serious Skin Reactions
  • Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal  necrolysis, have been reported in patients receiving ZOSYN. If patients develop a skin rash they should be monitored closely and ZOSYN discontinued if lesions progress.

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience
  • Skin and Appendages— added ..... Stevens-Johnson syndrome, toxic epidermal necrolysis

 

Page Last Updated: 01/13/2016
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