Coreg Side Effects

Generic Name: carvedilol

Note: This document contains side effect information about carvedilol. Some of the dosage forms listed on this page may not apply to the brand name Coreg.

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

For the Consumer

Applies to carvedilol: oral capsule extended release, oral tablet

Along with its needed effects, carvedilol (the active ingredient contained in Coreg) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking carvedilol:

More common
  • Allergy
  • chest pain, discomfort, tightness, or heaviness
  • dizziness, lightheadedness, or fainting
  • generalized swelling or swelling of the feet, ankles, or lower legs
  • pain
  • shortness of breath
  • slow heartbeat
  • weight gain
Less common
  • Ankle, knee, or great toe joint pain
  • anxiety
  • arm, back, or jaw pain
  • blood in the urine
  • bloody, black or tarry stools
  • chills
  • cloudy urine
  • cold sweats
  • coma
  • confusion
  • convulsions
  • cool pale skin
  • cough
  • dark urine
  • decreased appetite
  • decreased frequency or amount of urine
  • depression
  • difficulty with breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying position
  • dry mouth
  • fainting
  • fast or irregular heartbeat
  • fever
  • flu-like symptoms
  • flushed, dry skin
  • fruit-like breath odor
  • headache, sudden and severe
  • inability to speak
  • increased blood pressure
  • increased hunger
  • increased thirst
  • increased urination
  • itching
  • joint stiffness or swelling
  • large amount of cholesterol in the blood
  • loss of appetite
  • loss of consciousness
  • lower back, side, or stomach pain
  • mental depression
  • muscle pain or cramps
  • nervousness
  • nightmares
  • noisy, rattling breathing
  • numbness or tingling in the hands, feet, or lips
  • pinpoint red or purple spots on the skin
  • pounding in the ears
  • pounding, slow heartbeat
  • rapid breathing
  • seizures
  • shakiness
  • slurred speech
  • stomachache
  • sweating
  • swelling of the fingers or hands
  • temporary blindness
  • tenderness on the upper right side of the body
  • trouble with breathing even at rest
  • unexplained weight loss
  • unusual bleeding or bruising
  • weakness in the arm and/or leg on one side of the body, sudden and severe
  • weakness or heaviness of the legs
  • yellow eyes or skin
Incidence not known
  • Sores, ulcers, or white spots on the lips or in the mouth
  • swollen or painful glands
  • wheezing

Some side effects of carvedilol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • diarrhea
  • prickling or tingling sensation
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain
  • bleeding gums
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in vision
  • cold hands and feet
  • decreased interest in sexual intercourse
  • decreased tearing
  • difficulty with moving
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • headache
  • inability to have or keep an erection
  • increased sweating
  • joint or muscle pain
  • lack or loss of strength
  • loose teeth
  • loss of sexual ability, desire, or performance
  • loss of strength or energy
  • muscle aches, stiffness, or weakness
  • nausea
  • persistent breath odor or bad taste in your mouth
  • redness and swelling of the gums
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • sore throat
  • stuffy or runny nose
  • sugar in the urine
  • trouble sleeping
  • unusual weak feeling
  • vomiting
  • weight loss

For Healthcare Professionals

Applies to carvedilol: oral capsule extended release, oral tablet

General

In placebo-controlled trials, carvedilol (the active ingredient contained in Coreg) 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 (the active ingredient contained in Coreg) 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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