Recommended Topic Related To:

Coreg

"Dec. 18, 2012 -- People who can't get their high blood pressure down with drugs may be helped by a new procedure that deactivates overactive nerves in the kidneys, a small study shows.

The procedure is already available in Europe and "...

Coreg

Coreg Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Coreg (carvedilol) is a beta-adrenergic blocking agent used to treat heart failure, hypertension, and left ventricular dysfunction after a heart attack. Generic Coreg is available and is named carvedilol. Common side effects of Coreg may include diarrhea, nausea, vomiting, weakness, headache, cough, vision changes and paresthesias.

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. Care should be taken if the patient is taking other drugs, especially those that affect blood pressure and glucose levels as these may interact with Coreg and produce hypotension or low glucose blood levels. 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. 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.

Our Coreg 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 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.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Coreg Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning and Precautions sections.

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. Taking this medication with food and 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 (Carvedilol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Coreg FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

COREG (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 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 (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 COREG (carvedilol) for at least 6 months and 30% received COREG (carvedilol) for at least 12 months. In the COMET trial, 1,511 patients with mild-to-moderate heart failure were treated with COREG (carvedilol) for up to 5.9 years (mean 4.8 years). Both in US clinical trials in mild-to-moderate heart failure that compared COREG (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 COREG (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 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 (carvedilol) 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 (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
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 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 (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%

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 (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 COREG (carvedilol) and 980 who received placebo. Approximately 75% of the patients received COREG (carvedilol) for at least 6 months and 53% received COREG (carvedilol) for at least 12 months. Patients were treated for an average of 12.9 months and 12.8 months with COREG (carvedilol) and placebo, respectively.

The most common adverse events reported with COREG (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 COREG (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).

Hypertension

COREG (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 COREG (carvedilol) for at least 6 months. Most adverse events reported during therapy with COREG (carvedilol) were of mild to moderate severity. In US controlled clinical trials directly comparing COREG (carvedilol) in doses up to 50 mg (n = 1,142) to placebo (n = 462), 4.9% of patients receiving COREG (carvedilol) 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 (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.

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
(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 -
* 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 (carvedilol) in worldwide open or controlled trials with COREG (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).

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 ≤ 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 (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 COREG (carvedilol) and those treated with placebo. However, transaminase elevations, confirmed by rechallenge, have been observed with COREG (carvedilol) . In a long-term, placebo-controlled trial in severe heart failure, patients treated with COREG (carvedilol) had lower values for hepatic transaminases than patients treated with placebo, possibly because improvements in cardiac function induced by COREG (carvedilol) led to less hepatic congestion and/or improved hepatic blood flow.

COREG (carvedilol) 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 (carvedilol) . 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.

Reports of aplastic anemia and severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme) have been rare and received only when carvedilol was administered concomitantly with other medications associated with such reactions. Rare reports of hypersensitivity reactions (e.g., anaphylactic reaction, angioedema, and urticaria) have been received for COREG (carvedilol) and COREG (carvedilol) CR®, including cases occurring after the initiation of COREG (carvedilol) CR in patients previously treated with COREG (carvedilol) . Urinary incontinence in women (which resolved upon discontinuation of the medication) and interstitial pneumonitis have been reported rarely.

Read the entire FDA prescribing information for Coreg (Carvedilol) »

A A A

Coreg - User Reviews

Coreg User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Coreg sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Hypertension

Get tips on handling your hypertension.

Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations