Tegretol XR Side Effects

Generic Name: carbamazepine

Note: This page contains side effects data for the generic drug carbamazepine. It is possible that some of the dosage forms included below may not apply to the brand name Tegretol XR.

It is possible that some side effects of Tegretol XR may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to carbamazepine: oral capsule extended release, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release

As well as its needed effects, carbamazepine (the active ingredient contained in Tegretol XR) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking carbamazepine, check with your doctor immediately:

More common
  • Blurred vision or double vision
  • continuous back-and-forth eye movements
Less common
  • Actions that are out of control
  • behavioral changes (especially in children)
  • confusion, agitation, or hostility (especially in the elderly)
  • diarrhea (severe)
  • discouragement
  • drooling
  • fear
  • feeling of unreality
  • feeling sad or empty
  • headache (continuing)
  • increase in seizures
  • irritability
  • 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
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
  • unusual drowsiness
Rare
  • 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
  • fainting
  • 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
  • rigidity
  • 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
  • trembling
  • troubled breathing
  • uncontrolled body movements
  • unusual tiredness or weakness
  • visual hallucinations (seeing things that are not there)
  • yellow eyes or skin

Some carbamazepine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Dizziness (mild)
  • drowsiness (mild)
  • lightheadedness
  • nausea or vomiting (mild)
Less common or rare
  • Accidental injury
  • aching joints or muscles
  • acid or sour stomach
  • back pain
  • belching
  • constipation
  • diarrhea
  • dryness of the mouth
  • headache
  • heartburn
  • increased sensitivity of the skin to sunlight (skin rash, itching, redness or other discoloration of the skin, or severe sunburn)
  • increased sweating
  • indigestion
  • 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
  • sleepiness
  • 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

Gastrointestinal

Very common (10% or more): Nausea (29%), vomiting (18%), constipation (10%)
Postmarketing reports: Gastric distress, abdominal pain, diarrhea, anorexia, glossitis, stomatitis[Ref]

A single case of chemical pancreatitis has been reported in association with carbamazepine intoxication.[Ref]

Endocrine

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 (the active ingredient contained in Tegretol XR) 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.[Ref]

Frequency not reported: Hyponatremia, pancreatitis[Ref]

Hematologic

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[Ref]

Thrombocytopenia is the most common hematologic effect of carbamazepine 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.[Ref]

Cardiovascular

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[Ref]

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).[Ref]

Nervous system

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[Ref]

Rigidity and oculogyric crises have been reported. Euphoria has also been reported and has led to abuse of carbamazepine 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.[Ref]

Hypersensitivity

Frequency not reported: Multiorgan hypersensitivity reactions occurring days to weeks or months after initiating treatment[Ref]

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.[Ref]

Hepatic

Frequency not reported: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure[Ref]

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.[Ref]

Renal

Frequency not reported: Renal failure[Ref]

Respiratory

Frequency not reported: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia[Ref]

Dermatologic

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[Ref]

Dangerous, sometimes fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine 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.[Ref]

Ocular

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[Ref]

Oncologic

Frequency not reported: Disorders mimicking lymphoma[Ref]

Immunologic

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[Ref]

Psychiatric

Common (1% to 10%): Abnormal thinking (2%)
Frequency not reported: Depression with agitation, talkativeness[Ref]

Genitourinary

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

Metabolic

Frequency not reported: Inappropriate antidiuretic hormone (ADH) secretion syndrome, water intoxication, with decreased serum sodium (hyponatremia) and confusion

Musculoskeletal

Postmarketing reports: Aching joints and muscles, leg cramps

Other

Postmarketing reports: Lupus erythematosus-like syndrome, hyperacusis[Ref]

References

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