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Coreg

Coreg (Carvedilol) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Coreg Side Effects Center

What Is Coreg?

Coreg (carvedilol) is a beta-adrenergic blocking agent (beta-blocker) used to treat heart failure, hypertension, and left ventricular dysfunction after a heart attack. Coreg is available in generic form.

What Are Side Effects of Coreg?

Common side effects of Coreg include

Contact your doctor if you experience serious side effects of Coreg including

Dosage for Coreg

Coreg is available in strengths of 3.125, 6.25, 12.5, or 25 mg tablets. Coreg is usually taken with food; the recommended starting dose of Coreg (carvedilol) is 3.125 mg twice daily for 2 weeks for heart failure while for other problems, the starting dose is 6.25 mg twice a day. Coreg may have serious side effects that include hypotension, chest pain, irregular heartbeat, difficult breathing and swallowing, hives or rash, swelling, and fainting. Patients with hepatic impairment should not take Coreg.

What Drugs, Substances, or Supplements Interact with Coreg?

Coreg may interact with allergy treatments (or if you are undergoing allergy skin-testing), cimetidine, cyclosporine, fluconazole, insulin or oral diabetes medications, rifampin, antidepressants, heart or blood pressure medicines, heart rhythm medications, HIV or AIDS medicines, MAO inhibitors, medicine to prevent or treat nausea and vomiting, medicine to treat psychiatric disorders, or narcotics. Tell your doctor all medications and supplements you use. Severe exacerbation of angina, heart attack and ventricular arrhythmias has been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers like Coreg. Effectiveness of COREG (carvedilol) in patients younger than 18 years of age has not been established.

Coreg During Pregnancy and Breastfeeding

There are no adequate and well-controlled studies in pregnant or breastfeeding women; Coreg may be used during pregnancy or breastfeeding only if the potential benefit justifies the potential risk to the fetus or infant.

Additional Information

Our Coreg Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Coreg Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • slow or uneven heartbeats;
  • cold feeling or numbness in your fingers or toes;
  • chest pain, dry cough, wheezing, chest tightness;
  • heart problems--swelling, rapid weight gain, feeling short of breath; or
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects may include:

  • dizziness;
  • slow heartbeats;
  • diarrhea;
  • weight gain;
  • dry eyes; or
  • problems wearing contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Coreg (Carvedilol)

 

Coreg Professional Information

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

COREG has been evaluated for safety in subjects with heart failure (mild, moderate, and severe), in subjects with left ventricular dysfunction following myocardial infarction and in hypertensive subjects. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the subjects 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 subjects 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 subjects with mild-to-moderate heart failure were treated with COREG for up to 5.9 years (mean: 4.8 years). Both in U.S. clinical trials in mild-to-moderate heart failure that compared COREG in daily doses up to 100 mg (n = 765) with 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 subjects. In placebo-controlled clinical trials, the only cause of discontinuation greater than 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 subjects with mild-to-moderate heart failure enrolled in U.S. 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 subjects than placebo-treated subjects with an incidence of greater than 3% in subjects treated with carvedilol regardless of causality. Median trial medication exposure was 6.3 months for both carvedilol and placebo subjects in the trials of mild-to-moderate heart failure and 10.4 months in the trial of subjects with severe heart failure. The adverse event profile of COREG observed in the long-term COMET trial was generally similar to that observed in the U.S. Heart Failure Trials.

Table 1. Adverse Events (%) Occurring More Frequently with COREG than with Placebo in Subjects with Mild-to-Moderate Heart Failure (HF) Enrolled in U.S. Heart Failure Trials or in Subjects with Severe Heart Failure in the COPERNICUS Trial (Incidence >3% in Subjects Treated with Carvedilol, Regardless of Causality)

Body System/ Adverse Event Mild-to-Moderate HF Severe HF
COREG
(n = 765)		 Placebo
(n = 437)		 COREG
(n = 1,156)		 Placebo
(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 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 COREG 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

COREG has been evaluated for safety in survivors of an acute myocardial infarction with left ventricular dysfunction in the CAPRICORN trial which involved 969 subjects who received COREG and 980 who received placebo. Approximately 75% of the subjects received COREG for at least 6 months and 53% received COREG for at least 12 months. Subjects 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 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 reported with a frequency of greater than 1% but less than or equal to 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 subjects. In this database, the only cause of discontinuation greater than 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 subjects in U.S. clinical trials and in 2,976 subjects 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 U.S. controlled clinical trials directly comparing COREG in doses up to 50 mg (n = 1,142) with placebo (n = 462), 4.9% of subjects receiving COREG discontinued for adverse events versus 5.2% of placebo subjects. 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 U.S. 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 U.S. placebo-controlled clinical trials for hypertension that occurred with an incidence of greater than or equal to 1% regardless of causality and that were more frequent in drug-treated subjects than placebo-treated subjects.

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

Body System/ Adverse Event COREG
(n = 1,142)		 Placebo
(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 -
a Shown are events with rate >1% rounded to nearest integer.

Dyspnea and fatigue were also reported in these trials, but the rates were equal or greater in subjects 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 subjects with hypertension or heart failure.

Incidence Greater Than 0.1% To Less Than Or Equal 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 Postmarketing Experience].

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 less than or equal to 0.1% of subjects 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 subjects 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, subjects treated with COREG had lower values for hepatic transaminases than subjects 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.

Read the entire FDA prescribing information for Coreg (Carvedilol)

&Copy; Coreg Patient Information is supplied by Cerner Multum, Inc. and Coreg Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.