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Carbatrol

Last reviewed on RxList: 2/8/2017
Carbatrol Side Effects Center

Last reviewed on RxList 01/18/2017

Carbatrol (carbamazepine extended-release) is used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy, and is also used to treat bipolar disorder. Carbatrol is available in generic form. Common side effects of Carbatrol include:

Other side effects of Carbatrol include:

Tell your doctor if you have serious side effects of Carbatrol including:

  • mouth sores,
  • swollen lymph nodes,
  • persistent vomiting,
  • severe stomach or abdominal pain,
  • yellowing eyes or skin,
  • dark urine,
  • changes in the amount of urine,
  • persistent or severe headache,
  • fainting,
  • fast/slow/irregular heartbeat,
  • unusual eye movements (nystagmus),
  • vision changes (such as blurred vision),
  • joint pain,
  • swelling of the ankles/feet,
  • pain/redness/swelling of the arms or legs,
  • numbness or tingling of the hands or feet,
  • sun sensitivity, or
  • signs of low levels of sodium in the blood (such as persistent nausea, extreme drowsiness, mental/mood changes including confusion, seizures).

The initial dose of Carbatrol for adults and children 12 and older is 200 mg twice daily. Dosage may be increased weekly, and should not exceed 1000 mg per day in children 12-15 years of age, 1200 mg daily in patients 15-18 years of age, and up to 1600 mg daily in adults. Many other medicines could cause a drug interaction if taken together with Carbatrol. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Carbatrol should be used only when prescribed. It may harm a fetus. Since untreated seizures are a serious condition that can harm both a pregnant woman and her fetus, do not stop taking this medication unless directed by your doctor. Prenatal tests for defects are recommended. Birth control pills, patches, implants, and injections may not work if taken with Carbatrol. Discuss birth control with your doctor. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Carbatrol (carbamazepine extended-release) 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.

Carbatrol Consumer Information

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.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • fever, tired feeling, weakness, confusion, pale skin, feeling light-headed or short of breath;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • slow, fast, or pounding heartbeats;
  • confusion, vision problems, hallucinations;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • little or no urinating;
  • swelling, rapid weight gain;
  • problems with your fingernails or toenails; 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.

Common side effects may include:

  • dizziness, drowsiness,
  • nausea, vomiting, feeling unsteady;
  • dry mouth, swollen tongue; or
  • loss of balance or coordination.

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 Carbatrol (Carbamazepine Extended-Release)

Carbatrol Professional Information

SIDE EFFECTS

General

If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive patient with epilepsy may lead to seizures or even status epilepticus with its life-threatening hazards.

The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic system and skin (see BOX WARNING), and the cardiovascular system.

The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.

The following additional adverse reactions were previously reported with carbamazepine:

Hemopoietic System

Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria.

Skin

Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, and diaphoresis. In certain cases, discontinuation of therapy may be necessary. Isolated cases of hirsutism have been reported, but a causal relationship is not clear.

Cardiovascular System

Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism, and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

Liver

Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis.

Respiratory System

Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.

Genitourinary System

Urinaryfrequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported.

Testicular atrophy occurred in rats receiving carbamazepine orally from 4-52 weeks at dosage levels of 50-400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg/day and higher. Relevance of these findings to humans is unknown.

Nervous System

Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, and hyperacusis.

There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established.

Isolated cases of neuroleptic malignant syndrome have been reported with concomitant use of psychotropic drugs.

Digestive System

Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis.

Eyes

Scattered punctate cortical lens opacities, as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes.

Musculoskeletal System

Aching joints and muscles, and leg cramps.

Metabolism

Fever and chills, inappropriate antidiuretic hormone (ADH) secretion syndrome has been reported. Cases of frank water intoxication, with decreased serum sodium (hyponatremia) and confusion have been reported in association with carbamazepine use (see PRECAUTIONS, Laboratory Tests). Decreased levels of plasma calcium have been reported.

Other

Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants.

A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Drug Abuse And Dependence

No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

Read the entire FDA prescribing information for Carbatrol (Carbamazepine Extended-Release)

Related Resources for Carbatrol

Read the Carbatrol User Reviews »

© Carbatrol Patient Information is supplied by Cerner Multum, Inc. and Carbatrol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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