A total of 6,975 subjects with mild-to-severe heart failure were evaluated in placebo-controlled trials of carvedilol.
Visit DailyMed for the full Clinical Pharmacology Data.
Select Safety Information for COREG®
Do not abruptly stop taking COREG®, as it may lead to acute exacerbation of coronary artery disease upon cessation of therapy. Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Discuss these symptoms with your doctor. Tell your doctor about all the medications you take. Certain other medications may affect how COREG® works.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
Do not abruptly stop taking COREG®, as it may lead to acute exacerbation of coronary artery disease upon cessation of therapy.
Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Discuss these symptoms with your doctor.
Tell your doctor about all the medications you take. Certain other medications may affect how COREG® works.
Do not take COREG® if you have any of the following:
- Bronchial asthma or related bronchospastic conditions
- Second- or third-degree AV block.
- Sick sinus syndrome.
- Severe bradycardia (unless permanent pacemaker in place).
- Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy
- Severe hepatic (liver) impairment.
- History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of COREG®.
SIDE EFFECTS
The most commonly reported side effects were:
- Allergy
- chest pain, discomfort, tightness, or heaviness
- dizziness, lightheadedness, or fainting
- generalized swelling or swelling of the feet, ankles, or lower legs
- pain
- shortness of breath
- slow heartbeat
- weight gain
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
These highlights do not include all the information needed to use COREG® safely and effectively. See full prescribing information for COREG®.
Please read the accompanying Medication Guide for COREG®, including the information about birth defects if taken during pregnancy, and discuss it with your doctor. The physician Prescribing Information also is available.