Label Changes for:
Crestor (rosuvastatin calcium) tablets
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)
- The following adverse reactions have been identified… peripheral neuropathy
WARNINGS AND PRECAUTIONS
- Based on clinical trial data with Crestor, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus…