Coreg

[Carvedilol]

COREG Placebo (n = 1,142) (n = 462)
% occurrence % occurrence Cardiovascular
Bradycardia 2 — Postural hypotension 2 —
Peripheral Edema 1 — Central Nervous System
Dizziness 6 5 Insomnia 2 1
Gastrointestinal Diarrhea 2 1
Hematologic Thrombocytopenia 1 —
Metabolic Hypertriglyceridemia 1 —

Dyspnea and fatigue were also reported in these studies, but the rates were equal or greater in patients who received placebo. The following adverse events not described above were reported as possibly or probably related to COREG in worldwide open or controlled trials with COREG in patients with hypertension or congestive heart failure.
Incidence >0.1% to 1% Cardiovascular: Peripheral ischemia, tachycardia.

Central and Peripheral Nervous System:

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Hypokinesia.

Gastrointestinal:

Bilirubinemia, increased hepatic enzymes (0.2% of hypertension patients
and 0.4% of congestive heart failure patients were discontinued from therapy because of increases in hepatic enzymes; see Laboratory Abnormalities.

Psychiatric:

Nervousness, sleep disorder, aggravated depression, impaired concentration, abnormal thinking, paroniria, emotional lability.

Respiratory System:

Asthma (see CONTRAINDICATIONS).

Reproductive:

Male: decreased libido.

Skin and Appendages:

Pruritus, rash erythematous, rash maculopapular, rash psoriaform, photosensitivity reaction.

Special Senses:

Tinnitus.

Urinary System:

Micturition frequency increased.

Autonomic Nervous System:

Dry mouth, sweating increased.

Metabolic and Nutritional:

Hypokalemia, hypertriglyceridemia.

Hematologic:

Anemia, leukopenia.

The following events were reported in 0.1% of patients and are potentially important:

complete AV block,
bundle branch block,
myocardial ischemia,
cerebrovascular disorder,
convulsions,
migraine,
neuralgia,
paresis,
anaphylactoid reaction,
alopecia,
exfoliative dermatitis,
amnesia,
GI hemorrhage,
bronchospasm,
pulmonary edema,
decreased hearing,
respiratory alkalosis,
increased BUN,
decreased HDL,
pancytopenia,
atypical lymphocytes.

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