Coreg Side Effects

Generic Name: carvedilol

Please note - some side effects for Coreg may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Coreg - for the Consumer

Coreg

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 Coreg:

Diarrhea; dizziness; dry eyes; fatigue; light-headedness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Coreg:

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; fainting; irregular or unusually slow heartbeat; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual leg pain; very cold or blue fingers or toes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Coreg CR 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 Coreg CR Extended-Release Capsules:

Diarrhea; dizziness; dry eyes; fatigue; headache; light-headedness; nausea; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Coreg CR Extended-Release Capsules:

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; fainting; irregular or unusually slow heartbeat; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath; sudden unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual leg pain; very cold or blue fingers or toes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Coreg Side Effects - for the Professional

Coreg

Clinical Studies Experience

Coreg has been evaluated for safety in patients with heart failure (mild, moderate, and severe), in patients with left ventricular dysfunction following myocardial infarction and in hypertensive patients. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse events reported for each of these patient populations are provided below. Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. Rates of adverse events were generally similar across demographic subsets (men and women, elderly and non-elderly, blacks and non-blacks).

Heart Failure

Coreg has been evaluated for safety in heart failure in more than 4,500 patients worldwide of whom more than 2,100 participated in placebo-controlled clinical trials. Approximately 60% of the total treated population in placebo-controlled clinical trials received Coreg for at least 6 months and 30% received Coreg for at least 12 months. In the COMET trial, 1,511 patients with mild-to-moderate heart failure were treated with Coreg for up to 5.9 years (mean 4.8 years). Both in US clinical trials in mild-to-moderate heart failure that compared Coreg in daily doses up to 100 mg (n = 765) to placebo (n = 437), and in a multinational clinical trial in severe heart failure (COPERNICUS) that compared Coreg in daily doses up to 50 mg (n = 1,156) with placebo (n = 1,133), discontinuation rates for adverse experiences were similar in carvedilol and placebo patients. In placebo-controlled clinical trials, the only cause of discontinuation >1%, and occurring more often on carvedilol was dizziness (1.3% on carvedilol, 0.6% on placebo in the COPERNICUS trial).

Table 1 shows adverse events reported in patients with mild-to-moderate heart failure enrolled in US placebo-controlled clinical trials, and with severe heart failure enrolled in the COPERNICUS trial. Shown are adverse events that occurred more frequently in drug-treated patients than placebo-treated patients with an incidence of >3% in patients treated with carvedilol regardless of causality. Median study medication exposure was 6.3 months for both carvedilol and placebo patients in the trials of mild-to-moderate heart failure, and 10.4 months in the trial of severe heart failure patients. The adverse event profile of Coreg observed in the long-term COMET study was generally similar to that observed in the US Heart Failure Trials.

Table 1. Adverse Events (%) Occurring More Frequently With Coreg Than With Placebo in Patients With Mild-to-Moderate Heart Failure (HF) Enrolled in US Heart Failure Trials or in Patients With Severe Heart Failure in the COPERNICUS Trial (Incidence >3% in Patients Treated With Carvedilol, Regardless of Causality)

	Mild-to-Moderate HF		Severe HF
	Coreg	Placebo	Coreg	Placebo
	(n = 765)	(n = 437)	(n = 1,156)	(n = 1,133)
Body as a Whole
Asthenia	7	7	11	9
Fatigue	24	22	—	—
Digoxin level increased	5	4	2	1
Edema generalized	5	3	6	5
Edema dependent	4	2	—	—
Cardiovascular
Bradycardia	9	1	10	3
Hypotension	9	3	14	8
Syncope	3	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 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%

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. The only additional adverse events reported in CAPRICORN in >3% of the patients and more commonly on carvedilol were dyspnea, anemia, and lung edema. The following adverse events were reported with a frequency of >1% but ≤3% and more frequently with Coreg: Flu syndrome, cerebrovascular accident, peripheral vascular disorder, hypotonia, depression, gastrointestinal pain, arthritis, and gout. The overall rates of discontinuations due to adverse events were similar in both groups of patients. In this database, the only cause of discontinuation >1%, and occurring more often on carvedilol was hypotension (1.5% on carvedilol, 0.2% on placebo).

Hypertension

Coreg has been evaluated for safety in hypertension in more than 2,193 patients in US clinical trials and in 2,976 patients in international clinical trials. Approximately 36% of the total treated population received Coreg for at least 6 months. Most adverse events reported during therapy with Coreg were of mild to moderate severity. In US controlled clinical trials directly comparing Coreg in doses up to 50 mg (n = 1,142) to placebo (n = 462), 4.9% of patients receiving Coreg discontinued for adverse events versus 5.2% of placebo patients. Although there was no overall difference in discontinuation rates, discontinuations were more common in the carvedilol group for postural hypotension (1% versus 0). The overall incidence of adverse events in US placebo-controlled trials increased with increasing dose of Coreg. For individual adverse events this could only be distinguished for dizziness, which increased in frequency from 2% to 5% as total daily dose increased from 6.25 mg to 50 mg.

Table 2 shows adverse events in US placebo-controlled clinical trials for hypertension that occurred with an incidence of≥1% regardless of causality, and that were more frequent in drug-treated patients than placebo-treated patients.

Table 2. Adverse Events (%) Occurring in US Placebo-Controlled Hypertension Trials (Incidence ≥1%, Regardless of Causality)*

	Coreg	Placebo
	(n = 1,142)	(n = 462)
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	—

*   Shown are events with rate >1% rounded to nearest integer.

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 heart failure.

Incidence >0.1% to ≤1%

Cardiovascular: Peripheral ischemia, tachycardia.

Central and Peripheral Nervous System: Hypokinesia.

Gastrointestinal: Bilirubinemia, increased hepatic enzymes (0.2% of hypertension patients and 0.4% of heart failure patients were discontinued from therapy because of increases in hepatic enzymes) [see Adverse Reactions (6.2)].

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

Respiratory System: Asthma [see Contraindications (4)].

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, and atypical lymphocytes.

Laboratory Abnormalities

Reversible elevations in serum transaminases (ALT or AST) have been observed during treatment with Coreg. Rates of transaminase elevations (2- to 3-times the upper limit of normal) observed during controlled clinical trials have generally been similar between patients treated with Coreg and those treated with placebo. However, transaminase elevations, confirmed by rechallenge, have been observed with Coreg. In a long-term, placebo-controlled trial in severe heart failure, patients treated with Coreg had lower values for hepatic transaminases than patients treated with placebo, possibly because improvements in cardiac function induced by Coreg led to less hepatic congestion and/or improved hepatic blood flow.

Coreg has not been associated with clinically significant changes in serum potassium, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine. No clinically relevant changes were noted in fasting serum glucose in hypertensive patients; fasting serum glucose was not evaluated in the heart failure clinical trials.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Coreg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Aplastic anemia.

Immune System Disorders: Hypersensitivity (e.g., anaphylactic reactions, angioedema, urticaria).

Renal and Urinary Disorders: Urinary incontinence.

Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonitis.

Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

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Side Effects by Body System - for Healthcare Professionals

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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