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U.S. Department of Health and Human Services


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Claforan Sterile (cefotaxime for injection, USP) and Injection (cefotaxime injection, USP)

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


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View



Post-Marketing Experience

  • Cutaneous: (reworded, no additions) As with other cephalosporins, isolated cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have
    been reported.
  • Liver: (minor text deleted- no new addition) Hepatitis, jaundice, cholestasis, elevations of gamma GT and bilirubin