3

8

5

 
Angina pectoris
2

3

6

4

Central Nervous System

 
Dizziness
32

19

24

17

 
Headache
8

7

5

3

Gastrointestinal

 
Diarrhea
12

6

5

3

 
Nausea
9

5

4

3

 
Vomiting
6

4

1

2
Metabolic
Hyperglycemia
12

8

5

3
Weight increase
10

7

12

11
BUN increased
6

5

—

—
NPN increased
6

5

—

—
Hypercholesterolemia
4

3

1

1
Edema peripheral
2

1

7

6

Musculoskeletal

 
Arthralgia
6

5

1

1

Respiratory
Cough increased
8

9

5

4

 
Rales
4

4

4

2

Vision

 
Vision abnormal
5

2

—

—
Cardiac failure and dyspnea were also reported in these trials, but the rates were equal or greater in subjects who received placebo.
The following adverse events were reported with a frequency of greater than 1% but less than or equal to 3% and more frequently with carvedilol in either the U.S. placebo-controlled trials in subjects with mild-to-moderate heart failure or in subjects with severe heart failure in the COPERNICUS trial.
Incidence greater than 1% to less than or equal to 3%
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
The following information describes the safety experience in left ventricular dysfunction following acute myocardial infarction with immediate-release carvedilol.
Carvedilol has been eva luated for safety in survivors of an acute myocardial infarction with left ventricular dysfunction in the CAPRICORN trial which involved 969 subjects who received carvedilol and 980 who received placebo. Approximately 75% of the subjects received carvedilol for at least 6 months and 53% received carvedilol for at least 12 months. Subjects were treated for an average of 12.9 months and 12.8 months with carvedilol and placebo, respectively.
The most common adverse events reported with carvedilol in the CAPRICORN trial were consistent with the profile of the drug in the U.S. heart failure trials and the COPERNICUS trial. The only additional adverse events reported in CAPRICORN in greater than 3% of the subjects and more commonly on carvedilol were dyspnea, anemia, and lung edema. The following adverse events were re