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Coreg CR Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Coreg CR (carvedilol phosphate) is used to treat heart failure and hypertension (high blood pressure). It is also used to treat or prevent heart attack. It is a beta-blocker. Common side effects include dizziness, lightheadedness, drowsiness, diarrhea, or tiredness.
Coreg CR is an extended-release capsule intended for once-daily administration in doses ranging from 10 mg to 80 mg. Coreg CR may interact with allergy treatments (or allergy skin-testing), clonidine, cyclosporine, digoxin, fluconazole, guanabenz, rifampin, insulin or oral diabetes medications, antidepressants, beta-blockers, MAO inhibitors, heart medications, medicine for asthma or other breathing disorders, cold medicines, stimulant medicines, or diet pills. Tell your doctor all medications you use. During pregnancy, Coreg CR should be used only when prescribed. Based on information from related drugs, this medication may pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Our Coreg CR (carvedilol phosphate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Coreg CR in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these 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 serious side effect such as:
- feeling like you might pass out;
- slow or uneven heartbeats;
- chest pain, dry cough, wheezing, chest tightness, trouble breathing;
- feeling short of breath, even with mild exertion;
- swelling, rapid weight gain;
- numbness or cold feeling in your hands and feet;
- loss of bladder control;
- pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
- high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- dizziness, drowsiness;
- nausea, vomiting, diarrhea;
- dry eyes;
- feeling weak or tired;
- joint pain;
- cough; or
- decreased sex drive, impotence, or difficulty having an orgasm.
Read the entire detailed patient monograph for Coreg CR (Carvedilol Phosphate Extended-Release) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Coreg CR Overview - Patient Information: Side Effects
Dizziness, lightheadedness, drowsiness, diarrhea, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. The risk of dizziness is highest within 1 hour after you take your dose. Starting treatment with a low dose and slowly increasing your dose as directed by your doctor help to reduce the risk of dizziness.
This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: very slow heartbeat, severe dizziness, fainting, unusual weakness, change in the amount of urine, numbness/tingling of the hands/feet, blue fingers/toes, easy bruising/bleeding, mental/mood changes (such as confusion, depression), seizures.
Although this medication may be used to treat heart failure, some people may rarely develop new or worsening symptoms of heart failure, especially at the start of carvedilol treatment. Tell your doctor right away if you develop any of these serious side effects: swelling of the hands/ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Coreg CR (Carvedilol Phosphate Extended-Release)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Coreg CR FDA Prescribing Information: Side Effects
Clinical Trials Experience
Carvedilol 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 reflecting the use of either COREG CR or immediate-release carvedilol 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). COREG CR has been evaluated for safety in a 4-week (2 weeks of immediate-release carvedilol and 2 weeks of COREG CR) clinical study (n = 187) which included 157 patients with stable mild, moderate, or severe chronic heart failure and 30 patients with left ventricular dysfunction following acute myocardial infarction. The profile of adverse events observed with COREG CR in this small, short-term study was generally similar to that observed with immediate-release carvedilol. Differences in safety would not be expected based on the similarity in plasma levels for COREG CR and immediate-release carvedilol.
The following information describes the safety experience in heart failure with immediate-release carvedilol.
Carvedilol 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 carvedilol for at least 6 months and 30% received carvedilol for at least 12 months. In the COMET trial, 1,511 patients with mild-to-moderate heart failure were treated with carvedilol for up to 5.9 years (mean 4.8 years). Both in US clinical trials in mild-to-moderate heart failure that compared carvedilol 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 carvedilol 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 2 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 carvedilol observed in the long-term COMET study was generally similar to that observed in the US Heart Failure Trials.
Table 2: Adverse Events (%) Occurring More Frequently With
Immediate-Release Carvedilol 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|
(n = 765)
(n = 437)
(n = 1,156)
(n = 1,133)
|Body as a Whole|
|Digoxin level increased||5||4||2||1|
|Central Nervous System|
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 carvedilol 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%
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.
Reproductive, male: Impotence.
Special Senses: Blurred vision.
Left Ventricular Dysfunction Following Myocardial Infarction
The following information describes the safety experience in left ventricular dysfunction following acute myocardial infarction with immediate-release carvedilol.
Carvedilol 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 carvedilol and 980 who received placebo. Approximately 75% of the patients received carvedilol for at least 6 months and 53% received carvedilol for at least 12 months. Patients were treated for an average of 12.9 months and 12.8 months with carvedilol and placebo, respectively.
The most common adverse events reported with carvedilol 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 carvedilol: 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).
COREG CR was evaluated for safety in an 8-week double-blind trial in 337 subjects with essential hypertension. The profile of adverse events observed with COREG CR was generally similar to that observed with immediate-release carvedilol. The overall rates of discontinuations due to adverse events were similar between COREG CR and placebo.
Table 3: Adverse Events (%) Occurring More Frequently With COREG CR Than
With Placebo in Patients With Hypertension (Incidence ≥ 1% in Patients
Treated With Carvedilol, Regardless of Causality)
(n = 253)
(n = 84)
The following information describes the safety experience in hypertension with immediate-release carvedilol.
Carvedilol 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 carvedilol for at least 6 months. In general, carvedilol was well tolerated at doses up to 50 mg daily. Most adverse events reported during carvedilol therapy were of mild to moderate severity. In US controlled clinical trials directly comparing carvedilol monotherapy in doses up to 50 mg (n = 1,142) to placebo (n = 462), 4.9% of carvedilol patients 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 was found to increase with increasing dose of carvedilol. 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 as single or divided doses.
Table 4 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 4: Adverse Events (% Occurrence) in US Placebo-Controlled
Hypertension Trials With Immediate-Release Carvedilol (Incidence ≥ 1% in Patients
Treated With Carvedilol, Regardless of Causality)*
(n = 1,142)
(n = 462)
|Central Nervous System|
|* 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 carvedilol in worldwide open or controlled trials with carvedilol 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].
Psychiatric: Nervousness, sleep disorder, aggravated depression, impaired concentration, abnormal thinking, paroniria, emotional lability.
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.
Reversible elevations in serum transaminases (ALT or AST) have been observed during treatment with carvedilol. 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 carvedilol and those treated with placebo. However, transaminase elevations, confirmed by rechallenge, have been observed with carvedilol. In a long-term, placebo controlled trial in severe heart failure, patients treated with carvedilol had lower values for hepatic transaminases than patients treated with placebo, possibly because carvedilol-induced improvements in cardiac function led to less hepatic congestion and/or improved hepatic blood flow.
Carvedilol therapy 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.
The following adverse reactions have been identified during post-approval use of COREG® or COREG CR. 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.
Renal and Urinary Disorders: Urinary incontinence.
Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonitis.
Read the entire FDA prescribing information for Coreg CR (Carvedilol Phosphate Extended-Release) »
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