Tegretol XR Side Effects
Generic Name: carbamazepine
Note: This document contains side effect information about carbamazepine. Some of the dosage forms listed on this page may not apply to the brand name Tegretol XR.
Some side effects of Tegretol XR 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 carbamazepine: oral capsule extended release, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release
Along with its needed effects, carbamazepine (the active ingredient contained in Tegretol XR) 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 carbamazepine:More common
- Blurred vision or double vision
- continuous back-and-forth eye movements
- Actions that are out of control
- behavioral changes (especially in children)
- confusion, agitation, or hostility (especially in the elderly)
- diarrhea (severe)
- feeling of unreality
- feeling sad or empty
- headache (continuing)
- increase in seizures
- lack of appetite
- loss of balance control
- loss of interest or pleasure
- muscle trembling, jerking, or stiffness
- nausea and vomiting (severe)
- other problems with muscle control or coordination
- sense of detachment from self or body
- shakiness and unsteady walk
- shuffling walk
- stiffness of the limb
- sudden, wide mood swings
- talking, feeling, and acting with excitement
- thoughts or attempts of killing oneself
- trouble concentrating
- trouble sleeping
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- unusual drowsiness
- Black, tarry stools
- blood in the urine or stools
- bone or joint pain
- chest pain
- cough or hoarseness
- darkening of the urine
- difficulty with speaking or slurred speech
- frequent urination
- irregular, pounding, or unusually slow heartbeat
- lower back or side pain
- mental depression with restlessness and nervousness or other mood or mental changes
- muscle or stomach cramps
- nosebleeds or other unusual bleeding or bruising
- numbness, tingling, pain, or weakness in the hands and feet
- pain, tenderness, swelling, or bluish color in the leg or foot
- painful or difficult urination
- pale stools
- pinpoint red spots on the skin
- rapid weight gain
- ringing, buzzing, or other unexplained sounds in the ears
- skin rash, hives, or itching
- sore throat, chills, and fever
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, hands, feet, or lower legs
- swollen or painful glands
- sudden decrease in the amount of urine
- tightness in the chest
- troubled breathing
- uncontrolled body movements
- unusual tiredness or weakness
- visual hallucinations (seeing things that are not there)
- yellow eyes or skin
Some side effects of carbamazepine 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
- Dizziness (mild)
- drowsiness (mild)
- nausea or vomiting (mild)
- Accidental injury
- aching joints or muscles
- acid or sour stomach
- back pain
- dryness of the mouth
- increased sensitivity of the skin to sunlight (skin rash, itching, redness or other discoloration of the skin, or severe sunburn)
- increased sweating
- irritation or soreness of the tongue or mouth
- itching skin
- lack or loss of strength
- loss of hair
- loss of memory
- problems with memory
- sexual problems in males
- stomach pain, upset, or discomfort
For Healthcare Professionals
Applies to carbamazepine: compounding powder, oral capsule extended release, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release
A single case of chemical pancreatitis has been reported in association with carbamazepine (the active ingredient contained in Tegretol XR) intoxication.
Very common (10% or more): Nausea (29%), vomiting (18%), constipation (10%)
Postmarketing reports: Gastric distress, abdominal pain, diarrhea, anorexia, glossitis, stomatitis
Frequency not reported: Hyponatremia, pancreatitis
Carbamazepine increases the rate of T4 and T3 metabolism and may lead to hypothyroidism in patients with hypothyroidism who are being treated with T4. Carbamazepine may also cause a 20% to 40% decrease in serum total and free T4 concentrations and a smaller decrease in serum total and free T3 concentrations in patients who have no thyroid disease.
Chronic administration of carbamazepine may increase total cholesterol and HDL cholesterol levels. Carbamazepine may also transiently increase serum triglyceride and LDL cholesterol levels. One study has suggested that demeclocycline may be useful in prophylaxis of carbamazepine-induced hyponatremia.
Thrombocytopenia is the most common hematologic effect of carbamazepine (the active ingredient contained in Tegretol XR) and may be either mild and transient or severe. Significant decreases in white blood cell counts may occur although the values may still be within the normal range. Often counts will return to baseline during continued therapy, and therefore, discontinuation of carbamazepine may not be necessary. Dose reductions may also result in normalization of white blood cell counts. Aplastic anemia has been reported (although many of the reported cases had confounding exposures to other medications). The manufacturer reports an incidence of 2 per 1,000,000 patients for aplastic anemia and 6 per 1,000,000 patients for agranulocytosis. Cases of reticulocytosis have been reported rarely in association with carbamazepine therapy as well. In addition, cases of hemolytic anemia and erythroid arrest have been reported.
Both humoral and nonimmune mechanisms have been implicated in the etiology of carbamazepine-induced bone marrow suppression.
Frequency not reported: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, anemia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda, thrombophlebitis, thromboembolism (e.g., pulmonary embolism), adenopathy or lymphadenopathy
Frequency not reported: Various forms of heart block, hypotension, electrocardiographic changes, cardiac tamponade, congestive heart failure, edema, aggravation of hypertension, aggravation of coronary artery disease
Most of the cases of cardiovascular effects reported have occurred in patients receiving carbamazepine for trigeminal neuralgia. The reported effects included congestive heart failure, edema, hypotension, syncope and arrhythmias. In general, the doses were titrated quickly because of severe pain. Many of the doses were higher than those used to treat epilepsy. Many of the reported cardiovascular effects resolved after discontinuation of carbamazepine.
Increased sympathetic activity in the setting of seizure-induced hypoxia could predispose a patient to sudden unexpected death in epilepsy (SUDEP).
Rigidity and oculogyric crises have been reported. Euphoria has also been reported and has led to abuse of carbamazepine (the active ingredient contained in Tegretol XR) in some patients. Impairment of psychomotor function has been noted in association with use of the liquid suspension of carbamazepine. Additionally, impaired cognition, exacerbations of focal seizures and asterixis have been reported in association with carbamazepine treatment. One case of a lingual-facial-buccal extrapyramidal reaction has also been described.
One study has suggested that gradual withdrawal of carbamazepine over ten days results in significantly fewer generalized tonic-clonic seizures compared to rapid withdrawal over four days.
One study has suggested that the epoxide metabolite of carbamazepine may be responsible for the occasional occurrence of seizure exacerbations in patients receiving carbamazepine.
Very common (10% or more): Dizziness (44%), somnolence (32%), ataxia (15%)
Common (1% to 10%): Asthenia (8%), speech disorder (6%), tremor (3%), twitching (2%), vertigo (2%)
Frequency not reported: Drowsiness, disturbances of coordination, confusion, headache, fatigue, neuroleptic malignant syndrome, fever and chills, suicidal behavior and ideation, confusion, speech disturbances, abnormal involuntary movements, tinnitus
Frequency not reported: Multiorgan hypersensitivity reactions occurring days to weeks or months after initiating treatment
Rash and pruritus often resolve after discontinuation of carbamazepine therapy. Both cases of lupus-like syndrome resolved after discontinuation of carbamazepine. Stevens-Johnson syndrome, erythema multiforme, and a mononucleosis-like syndrome have also been reported.
Frequency not reported: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure
Alterations in liver function tests may progress to hepatotoxicity including cholangitis, granuloma formation, fever and hepatocellular necrosis. Discontinuation of carbamazepine often results in improvement in laboratory abnormalities and liver injury.
Frequency not reported: Renal failure
Frequency not reported: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia
Dangerous, sometimes fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine (the active ingredient contained in Tegretol XR) therapy are significantly more common in patients with the human leukocyte antigen (HLA) allele, HLA-B 1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B 1502 is present should be screened for the HLA-B 1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients who test positive for HLA-B 1502.
Common (1% to 10%): Pruritus (8%), rash (7%), paresthesia (2%)
Rare (less than 0.1%): Alopecia (0.01%)
Frequency not reported: Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, unusual bruising, pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomycosis
Common (1% to 10%): Blurred vision (6%)
Postmarketing reports: Diplopia, oculomotor disturbances, nystagmus, photosensitivity, blurred vision, visual hallucinations, transient diplopia, scattered punctate cortical lens opacities, increased intraocular pressure as well as conjunctivitis
Frequency not reported: Disorders mimicking lymphoma
Postmarketing reports: One case of aseptic meningitis, with myoclonus and peripheral eosinophilia, was reported in a patient taking carbamazepine (the active ingredient contained in Tegretol XR) in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine
Common (1% to 10%): Abnormal thinking (2%)
Frequency not reported: Depression with agitation, talkativeness
Frequency not reported: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, impotence, albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine, rare reports of impaired male fertility and/or abnormal spermatogenesis
Frequency not reported: Inappropriate antidiuretic hormone (ADH) secretion syndrome, water intoxication, with decreased serum sodium (hyponatremia) and confusion
Postmarketing reports: Aching joints and muscles, leg cramps
Postmarketing reports: Lupus erythematosus-like syndrome, hyperacusis
More about Tegretol XR (carbamazepine)
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