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U.S. Department of Health and Human Services

Safety

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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

 

CONTRAINDICATIONS

  • 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.

ADVERSE REACTIONS

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.

PATIENT INFORMATION

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.