Clinical Trials: Adverse Event (AE) Frequency:
AE's occurring at ≥10% are described as very common.
AE's occurring at ≥1% and <10% are described as common.
AE's occurring at ≥0.1% and <1% are described as uncommon.
AE's occurring at ≥0.01% and <0.1% are described as rare.
AE's occurring at <0.01% are described as very rare including isolated cases.
The frequency of adverse experiences is not dose-dependent, with the exception of dizziness, abnormal vision and bradycardia.
Undesirable effects in chronic heart failure:
Adverse experiences most frequently observed in the carvedilol group in clinical trials in congestive heart failure patients and not seen at an equivalent incidence among placebo treated patients are described as follows.
Central nervous system:
Very common: dizziness, headaches are usually mild and occur particularly at the start of treatment. Asthenia (including fatigue) also occurs very commonly.
Common: bradycardia, postural hypotension, hypotension, oedema (including generalised, peripheral, dependent and genital oedema, oedema of the legs, hypervolaemia and fluid overload).
Uncommon: syncope (including presyncope), AV-block and cardiac failure during up-titration.
Common: nausea, diarrhoea and vomiting.
Leucopenia has been reported in isolated cases.
Common: weight increase and hypercholesterolemia. Hyperglycaemia, hypoglycaemia and worsening control of blood glucose are also common in patients with pre-existing diabetes mellitus (see General under Precautions).
Common: vision abnormalities.
Rare: renal failure and renal function abnormalities in patients with diffuse vascular disease and/or impaired renal function (see General under Precautions).
Undesirable effects in hypertension and the long term management of coronary heart disease:
The profile of adverse events associated with the use of carvedilol in the treatment of hypertension and the long-term management of coronary heart disease is consistent with that observed in chronic heart failure. The incidence of adverse events in these patient populations is lower, however.
Adverse experiences reported in clinical trials in patients with hypertension and coronary heart disease are: Central nervous system:
Common: dizziness, headaches and fatigue, which are usually mild and occur particularly at the beginning of treatment.
Uncommon: depressed mood, sleep disturbance, paraesthesia.
Common: bradycardia, postural hypotension and uncommonly syncope, especially at the beginning of treatment.
Uncommon: disturbances of peripheral circulation (cold extremities, PVD, exacerbation of intermittent claudication and Raynauds phenomenon), AV-block, angina pectoris (including chest pain), symptoms of heart failure and peripheral oedema.
Common: asthma and dyspnea in predisposed patients.
Rare: stuffy nose.
Common: gastro-intestinal upset (with symptoms such as nausea, abdominal pain, diarrhoea).
Uncommon: constipation and vomiting.
Skin and appendages:
Uncommon: skin reactions (e.g. allergic exanthema, dermatitis, urticaria and pruritus).
Blood chemistry and haematology:
Isolated cases of increases in ALAT, ASAT and gamma GT, thrombocytopenia and leucopenia have been reported.
Common: pain in the extremities.
Common: reduced lacrimation and eye irritation.
Uncommon: cases of sexual impotence and disturbed vision.
Rare: dryness of the mouth and disturbances of micturition.
Isolated cases of allergic reactions have been reported.
Post Marketing: Metabolism and nutrition disorders:
Due to the β-blocking properties, it is also possible for latent diabetes mellitus to become manifest, manifest diabetes to be aggravated, and blood glucose counter-regulation to be inhibited.
Skin and subcutaneous tissue disorders:
Renal and urinary disorders:
Isolated cases of urinary incontinence in women, which resolved upon discontinuation of the medication, have been reported.