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Label Changes for:

Caduet (amlodipine besylate/atorvastatin calcium) Tablets

May 2008

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008


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


Sections Modified Summary of Changes to Contraindications and Warnings


  • Skeletal Muscle


  • Drug Interactions
    • Studies with Atorvastatin
    • The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased...