Safety

A selection of COREG® safety information for your patients. Full important safety information can be found here.

Contraindications

  • Bronchial asthma or related bronchospastic conditions. (4)
  • Second- or third-degree AV block. (4)Sick sinus syndrome. (4)
  • Severe bradycardia (unless permanent pacemaker in place). (4)
  • Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. (4)Severe hepatic impairment. (2.44)
  • History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. (4)

Warnings and Precautions

  • Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. (5.1)
  • Bradycardia, hypotension, worsening heart failure/fluid retention may occur.
  • Reduce the dose as needed. (5.25.35.4)
  • Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid β-blockers. (4)
  • However, if deemed necessary, use with caution and at lowest effective dose. (5.5)
  • Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemia or worsen hyperglycemia. (5.6)

Adverse Reactions

In clinical trials, the most frequently reported cause for discontinuation for carvedilol was dizziness (6.1). This was not the only adverse event reported: for a full list of all reported adverse events for clinical and post-market timeframes, click here.

To report SUSPECTED ADVERSE REACTIONS contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.