Label Changes for:

Crestor (rosuvastatin calcium) tablets

July 2014

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) 

 

July 2014

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reactions have been identified… peripheral neuropathy 

 

August 2013

 

WARNINGS AND PRECAUTIONS

Endocrine Effects
  • Based on clinical trial data with Crestor, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus…
 
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