Carvedilol Side Effects

Brand Names: Coreg CR, Coreg

Please note - some side effects for Carvedilol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Carvedilol - for the Consumer

Carvedilol

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Carvedilol:

Diarrhea; dizziness; dry eyes; fatigue; headache; lightheadedness; nausea; numbness or tingling of the hands or feet; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; disorientation; fainting; fever; irregular or unusually slow heartbeat; persistent or severe vision changes; severe dizziness; shortness of breath; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding.

Carvedilol Extended-Release Capsules

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Carvedilol Extended-Release Capsules:

Diarrhea; dizziness; dry eyes; fatigue; headache; lightheadedness; nausea; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; cold or numb legs or feet; disorientation; fainting; fever; irregular or unusually slow heartbeat; persistent or severe vision changes; severe dizziness; shortness of breath; sudden unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual leg pain.

Carvedilol Side Effects - for the Professional

Carvedilol

Most common adverse events (6.1):

• Heart failure and left ventricular dysfunction following myocardial infarction (≥ 10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase
• Hypertension (≥ 5%): Dizziness

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Generics Inc., USA at 1(888)721-7115 or www.glenmarkgenerics.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

General

In placebo-controlled trials, carvedilol monotherapy was discontinued due to adverse events in 4.9% of patients versus 5.2% of placebo patients.

In a review of heart failure trials, beta-blockers (i.e., carvedilol, metoprolol, bisoprolol) were associated with increased risks of hypotension, dizziness, and bradycardia, but not fatigue compared with placebo. In addition, beta-blocker therapy was associated with fewer overall all-cause withdrawals and less heart failure deterioration than placebo.

Cardiovascular

Patients with liver disease complicated by ascites are at greater risk of systemic hypotension associated with the use of carvedilol as this drug is a potent portal hypotensive agent.

The incidence of dizziness or hypotension is increased by hypovolemia (dehydration, over-diuresis) and thus may be a more common problem in diuretic-treated subjects and the elderly.

Cardiovascular side effects have included bradycardia (9% to 10%), hypotension (9% to 14%), syncope (3% to 8%), angina pectoris (2% to 6%), edema generalized (5% to 6%), edema dependent (4%), peripheral edema (2% to 7%), leg edema (greater than 1% to less than or equal to 3%), postural hypotension (1% to less than or equal to 3%), myocardial ischemia (less than 1%), tachycardia (less than 1%), fluid overload (greater than 1% to less than or equal to 3%), aggravated angina pectoris (greater than 1% to less than or equal to 3%), palpitations (greater than 1% to less than or equal to 3%), hypertension (greater than 1% to less than or equal to 3%), AV block (greater than 1% to less than or equal to 3%), bundle branch block (less than 1%), peripheral vascular disorder (greater than 1% to less than or equal to 3%), peripheral ischemia (greater than 0.1% to less than or equal to 1%), and cerebrovascular accident (greater than 1% to less than or equal to 3%). Cardiovascular side effects including cardiac failure have been reported rarely.

Nervous system

The incidence of dizziness or hypotension is increased by hypovolemia (dehydration, over-diuresis) and thus may be a more common problem in diuretic-treated subjects and the elderly.

Nervous system side effects have included dizziness (24% to 32%), headache (5% to 8%), hypesthesia (greater than 1% to less than or equal to 3%), cerebrovascular accident (greater than 1% to less than or equal to 3%), vertigo (greater than 1% to less than or equal to 3%), paresthesia (greater than 1% to less than or equal to 3%), hypokinesia (greater than 0.1% to less than or equal to 1%), neuralgia (less than 0.1%), paresis (less than 0.1%), tinnitus (greater than 0.1% to less than or equal to 1%), dry mouth (greater than 0.1% to less than or equal to 1%), sweating increased (greater than 0.1% to less than or equal to 1%), cerebrovascular disorder (less than or equal to 0.1%), convulsions (less than or equal to 0.1%), migraine (less than or equal to 0.1%), and decreased hearing (less than or equal to 0.1%).

Respiratory

Respiratory side effects have included increased cough (5% to 8%), rales (4%), dyspnea (greater than 3%), lung edema (greater than 3%), asthma (greater than 0.1% to less than or equal to 1%), bronchospasm (less than or equal to 0.1%), pulmonary edema (less than or equal to 0.1%), and respiratory alkalosis (less than or equal to 0.1%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (5% to 12%), nausea (4% to 9%), vomiting (1% to 6%), gastrointestinal pain (greater than 1% to less than or equal to 3%), melena (greater than 0.1% to less than 1%), periodontitis (greater than 0.1% to less than 1%), and GI hemorrhage (less than 0.1%).

Renal

Renal side effects have included renal insufficiency (greater than 1% to less than or equal to 3%), and albuminuria (greater than 1% to less than or equal to 3%).

Hematologic

Hematologic side effects have included thrombocytopenia (greater than 1% to less than or equal to 3%), purpura (greater than 1% to less than or equal to 3%), hypovolemia (greater than 1% to less than or equal to 3%), prothrombin decreased (greater than 1% to less than or equal to 3%), anemia (greater than 0.1% to less than or equal to 1%), leucopenia (greater than 0.1% to less than or equal to 1%), pancytopenia (less than or equal to 0.1%), atypical lymphocytes (less than or equal to 0.1%). Decreases in hematocrit, red blood cells, and hemoglobin concentration have also been reported. Rarely, aplastic anemia has been reported in postmarketing experience.

Dermatologic

Dermatologic side effects have included pruritus (0.1% to less than or equal to 1%), rash erythematous (0.1% to less than or equal to 1%), rash maculopapular (0.1% to less than or equal to 1%), rash psoriaform (0.1% to less than or equal to 1%), photosensitivity reactions (0.1% to less than or equal to 1%), exfoliative dermatitis (less than 0.1%), and alopecia (less than 0.1%).

Hepatic

Hepatic side effects have included SGPT increased (greater than 1% to less than or equal to 3%), SGOT increased (greater than 1% to less than or equal to 3%), and increased hepatic enzymes (greater than 0.1% to less than or equal to 1%). Elevations in serum transaminases (ALT or AST) have also been reported. At least one case of hepatotoxicity has been reported.

Genitourinary

Genitourinary side effects have included impotence (greater than 1% to less than or equal to 3%), decreased libido (male) (greater than 0.1% to less than or equal to 1%), micturition frequency increased (greater than 0.1% to less than or equal to 1%), and hematuria (greater than 1% to less than or equal to 3%). Rarely, genitourinary side effects including urinary incontinence in women have been reported in postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included allergy (greater than 1% to less than or equal to 3%), and anaphylactoid reaction (less than or equal to 0.1%). Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hypersensitivity reactions (including anaphylactic reactions, angioedema, and urticaria) have been reported in postmarketing experience.

Metabolic

Metabolic side effects have included hyperglycemia (5% TO 12%), weight increase (10% TO 12%), BUN increase (6%), NPN increased (6%), hypercholesterolemia (1% TO 4%), edema peripheral (2% TO 7%). Metabolic side effects reported greater than 1% to less than 3% have included hyperuricemia, hypoglycemia, hyponatremia, increased alkaline phosphatase, glycosuria, hypervolemia, diabetes mellitis, GGT increased, weight loss, and creatinine increased. Metabolic side effects reported greater than 0.1% to less than or equal to 1% have included hypokalemia and hypertriglyceridemia.

Psychiatric

Psychiatric side effects have included somnolence (greater than 1% to less than or equal to 3%), insomnia (1% to 3% or greater), nervousness (greater than 0.1% to less than or equal to 1%), sleep disorder (greater than 0.1% to less than or equal to 1%), aggravated depression (greater than 0.1% to less than or equal to 1%), impaired concentration (greater than 0.1% to less than or equal to 1%), abnormal thinking (greater than 0.1% to less than or equal to 1%), paranoia (greater than 0.1% to less than or equal to 1%), emotional lability (greater than 0.1% to less than or equal to 1%), and aggravated depression (greater than 1% to less than or equal to 3%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (1% to 6%), muscle cramps (greater than 1% to less than or equal to 3%), gout (greater than 1% to less than or equal to 3%), hypotonia (greater than 1% to less than or equal to 3%), and arthritis (greater than 1% to less than or equal to 3%).

Ocular

Ocular side effects have included abnormal vision (5%) and blurred vision (greater than 1% to less than or equal to 3%).

Other

Other side effects have included fatigue (24%), asthenia (7% to 11%), digoxin level increased (2% to 5%), malaise (greater than 1% to less than or equal to 3%), fever (greater than 1% to less than or equal to 3%), and flu syndrome (greater than 1% and less than or equal to 3%).

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