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Coreg

[Carvedilol]


Cardiac failure and dyspnea were also reported in these studies, but the rates were equal or greater in patients who received placebo. The following adverse events were reported with a frequency of > 1% but 3% and more frequently with COREG in either the US placebo-controlled trials in patients with mild-to-moderate heart failure, or in patients with severe heart failure in the COPERNICUS trial.

Incidence >1% to 3%

Text Continues Below



Body as a Whole:

Allergy, malaise, hypovolemia, fever, leg edema.

Cardiovascular:

Fluid overload, postural hypotension, aggravated angina pectoris, AV block, palpitation, hypertension.

Central and Peripheral Nervous System:

Hypesthesia, vertigo, paresthesia.

Gastrointestinal:

Melena, periodontitis.

Liver and Biliary System:

SGPT increased, SGOT increased.

Metabolic and Nutritional:

Hyperuricemia, hypoglycemia, hyponatremia, increased alkaline phosphatase, glycosuria, hypervolemia, diabetes mellitus, GGT increased, weight loss, hyperkalemia, creatinine increased.

Musculoskeletal: Muscle cramps.

Platelet, Bleeding and Clotting:

Prothrombin decreased, purpura, thrombocytopenia.

Psychiatric: Somnolence.

Reproductive, male:

Impotence.

Special Senses:

Blurred vision.

Urinary System:

Renal insufficiency, albuminuria, hematuria.

Left Ventricular Dysfunction Following Myocardial Infarction:

COREG has been evaluated for safety in survivors of an acute myocardial infarction with left ventricular dysfunction in the CAPRICORN trial which involved 969 patients who received COREG and 980 who received placebo. Approximately 75% of the patients received COREG for at least 6 months and 53% received COREG for at least 12 months. Patients were treated for an average of 12.9 months and 12.8 months with COREG and placebo, respectively.

The most common adverse events reported with COREG in the CAPRICORN trial were consistent with the profile of the drug in the US heart failure trials and the COPERNICUS trial.

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