Label Changes for:

Vancocin  (vancomycin hydrochloride) Capsules

December 2011

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011

 

 

ADVERSE REACTIONS (revised)

Clinical Trial Experience

  • Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice...

Postmarketing Experience

  • The following adverse reactions have been identified during post-approval use of Vancocin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure…
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