• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Coreg (carvedilol) 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg tablets

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


Summary View



  • Patients with a history of serious hypersensitivity reaction (e.g. Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol.


Post Marketing Experience
  • Rare reports of hypersensitivity reactions (e.g., anaphylactic reaction, angioedema, and urticaria) have been received for Coreg and Coreg CR, including cases occurring after the initiation of Coreg CR in patients previously treated with Coreg.


What are the possible side effects of COREG?
  • Rare but serious allergic reactions (including hives or swelling of the face, lips, tongue and/or throat that may cause difficulty breathing or swallowing) have happened in patients who were on Coreg. These reactions can be life-threatening.