"Dec. 2, 2010 -- Babies born to women who take the antiseizure drug carbamazepine have a more than twofold increased risk for the birth defect spina bifida, a study shows.
But researchers say the drug still has less risk of birth defects"...
Tegretol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tegretol (carbamazepine) is used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. It is also used to treat bipolar disorder. Tegretol is an anticonvulsant. This medication is available in generic form. Common side effects include nausea, vomiting, dizziness, drowsiness, or unsteadiness as your body adjusts to this medication.
The starting dose of Tegretol to treat epilepsy in adults and children over 12 years of age is 200 mg twice daily for tablets and XR tablets, or 1 tsp 4 times daily for suspension (400 mg/day). Usual maintenance dose is 800-1200 mg daily. The starting dose to treat trigeminal neuralgia is 100 mg twice daily for tablets or XR tablets, or ½ tsp 4 times daily for suspension, for a total daily dose of 200 mg. Control of pain is maintained in most patients with 400-800 mg daily. Consult your doctor for pediatric doses. Many other medicines interact with Tegretol. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Tegretol should be used only when prescribed. It may harm a fetus. Since untreated seizures are a serious condition that can harm a pregnant woman and her baby, do not stop taking this medication unless directed by your doctor. If you are pregnant, prenatal care including tests for defects is recommended. Hormonal birth control may not work if taken with this medication. Discuss birth control with your doctor. This medication passes into breast milk. Consult your doctor before breast-feeding.
Our Tegretol (carbamazepine) 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.
Tegretol 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.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have a serious side effect such as:
- pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
- fever, chills, sore throat, mouth and throat ulcers;
- easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;
- confusion, agitation, vision problems, hallucinations;
- feeling short of breath, swelling of your ankles or feet;
- urinating less than usual;
- jaundice (yellowing of the skin or eyes); 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:
- feeling dizzy, drowsy, or unsteady;
- nausea, vomiting, diarrhea, constipation, stomach pain;
- headache, ringing in your ears;
- dry mouth, swollen tongue; or
- joint or muscle pain, leg cramps.
Read the entire detailed patient monograph for Tegretol (Carbamazepine) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tegretol Overview - Patient Information: Side Effects
Nausea, vomiting, dizziness, drowsiness, or unsteadiness may occur as your body adjusts to this medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
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 immediately if any of these unlikely but serious side effects occur: swelling of the ankles/feet, fatigue, fast/slow/irregular heartbeat, persistent or severe headache, fainting, trouble urinating, change in the amount of urine, decreased sexual ability, unusual eye movements (nystagmus), vision changes, hearing problems, pain/redness/swelling of the arms or legs, numbness/tingling of the hands/feet, sun sensitivity, joint pain, hair loss.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea or vomiting, severe stomach/abdominal pain, yellowing eyes and skin, dark urine, swollen glands, persistent mouth sores.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, trouble breathing.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Tegretol (Carbamazepine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tegretol FDA Prescribing Information: Side Effects
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 epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.
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 low dosage recommended.
The following additional adverse reactions have been reported:
Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, anemia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda.
Skin: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING), Acute Generalized Exanthematous Pustulosis (AGEP), 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 and onychomadesis. 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 (e.g., pulmonary embolism), and adenopathy or lymphadenopathy.
Genitourinary System: Urinary frequency, 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. There have been very rare reports of impaired male fertility and/or abnormal spermatogenesis.
Testicular atrophy occurred in rats receiving Tegretol orally from 4-52 weeks at dosage levels of 50-400 mg/kg/day. Additionally, rats receiving Tegretol 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 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, hyperacusis, neuroleptic malignant syndrome.
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 both with and without concomitant use of psychotropic drugs.
Eyes: Scattered punctate cortical lens opacities, increased intraocular pressure 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 Tegretol use (see PRECAUTIONS, Laboratory Tests). Decreased levels of plasma calcium leading to osteoporosis have been reported.
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 Tegretol, nor is there evidence of psychological or physical dependence in humans.
Read the entire FDA prescribing information for Tegretol (Carbamazepine) »
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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.
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