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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Generic drug name: carbamazepine (kar ba MAZ e peen)
Brand name(s): CARBATROL, EPITOL, EQUETRO, TEGRETOL, TEGRETOL XR, TERIL
GENERIC: available FAMILY: Drugs for Epilepsy
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Carbamazepine crosses the placenta in pregnant women and causes malformations, including spina bifida and heart defects. Taking more than one drug for epilepsy increases the risk. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

Breast-feeding Warning

Carbamazepine is excreted in human milk. Because of the potential for serious adverse effects in nursing infants, you should not take this drug while nursing.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

See full prescribing information for complete boxed warning.

SERIOUS DERMATOLOGIC REACTIONS AND CARRIERS OF HLA-B*1502 GENE

SERIOUS AND SOMETIMES FATAL SKIN REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. PATIENTS OF CHINESE ANCESTRY WHO CARRY A PARTICULAR GENE KNOWN AS HLA-B*1502 HAVE FOUND TO HAVE THE HIGHEST RISK OF DEVELOPING SJS/TEN WHEN TAKING THE DRUG. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH TEGRETOL. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH TEGRETOL UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS, LABORATORY TESTS).

APLASTIC ANEMIA AND AGRANULOCYTOSIS

APLASTIC ANEMIA AND AGRANULOCYTOSIS [bone marrow toxicity resulting in failure to make red cells and white cells, respectively] HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5–8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA.

ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA (low white blood cell count) HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.

BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON TEGRETOL ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY.

DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS.

Facts About This Drug [top]

Carbamazepine (CARBATROL, TEGRETOL) is used to treat some forms of epilepsy (partial and generalized tonic-clonic [grand mal] seizures) and to treat a form of excruciating facial pain called trigeminal neuralgia or tic douloureux. This drug is not a simple painkiller and should not be used to treat general aches or pains. The Medical Letter on Drugs and Therapeutics has long listed carbamazepine as the mainstay of treatment for trigeminal neuralgia.[1]

Patients over age 60 generally will...

Carbamazepine (CARBATROL, TEGRETOL) is used to treat some forms of epilepsy (partial and generalized tonic-clonic [grand mal] seizures) and to treat a form of excruciating facial pain called trigeminal neuralgia or tic douloureux. This drug is not a simple painkiller and should not be used to treat general aches or pains. The Medical Letter on Drugs and Therapeutics has long listed carbamazepine as the mainstay of treatment for trigeminal neuralgia.[1]

Patients over age 60 generally will need to take less than the usual adult dose. These patients should ask their doctors about starting with a daily dose of 50 milligrams to prevent harmful adverse effects, especially mental confusion and slowed pulse. Patients should call their doctors if either of these adverse effects occurs. Patients taking carbamazepine for neuralgia should be working with a doctor to reduce their dose every few months to see if a smaller dose will relieve symptoms.

Side effects

Blood cell abnormalities

In rare cases, carbamazepine can cause serious, and sometimes fatal, blood cell abnormalities. These disorders can usually be treated if detected early. Any patient taking carbamazepine who experiences any of the following symptoms should call his or her doctor immediately: fever and sore throat, ulcers in the mouth, easy bruising or skin rashes.[2]

Before starting to use carbamazepine, patients should have a complete blood count to be certain that they do not have any potential blood abnormalities that could be worsened by the drug. 

Severe allergic reactions

Rare cases of anaphylaxis and angioedema (a condition that involves sudden severe swelling of tissues in the throat, tongue, lips and eyelids, which can interfere with breathing) have been reported in patients after taking the first or subsequent doses of carbamazepine. Angioedema associated with swelling in the throat can be fatal. If a patient develops any of these reactions after treatment with carbamazepine, the drug should be discontinued and an alternative treatment started.

Suicidal behavior and thoughts

Antiepileptic drugs, including carbamazepine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with carbamazepine should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

Grapefruit juice interaction

A 2005 Medical Letter article noted an interaction between carbamazepine and grapefruit juice. According to the article, grapefruit juice affects the intestine’s ability to metabolize many drugs, including carbamazepine, leading to higher than expected and sometimes dangerous levels of the drug in the blood.

Liver tumors

Carbamazepine causes malignant liver tumors in female rats and benign tumors of the testicles in male rats.[3]

Regulatory actions surrounding  carbamazepine 

2007: In December, the Food and Drug Administration (FDA) issued a warning that carbamazepine therapy can result in dangerous (and sometimes fatal) skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis) in patients with a particular genetic ancestry. This reaction occurs most commonly in patients with ancestry across broad areas of Asia, including South Asian Indians. Before starting carbamazepine therapy, patients with Asian ancestry should be screened for a particular gene called HLA-B*1502 that could predispose them to these skin reactions.[4]

2008: The FDA issued a warning that there have been reports of suicidal behavior or ideation associated with the use of antiepileptic drugs, including carbamazepine. According to the study, patients receiving these drugs had twice the risk of suicidal behavior or ideation as patients receiving a placebo. This increased risk was observed as early as one week after starting the drug and continued through 24 weeks.[5]

In December 2008, FDA issued another advisory in which it stated that it had completed its analysis of reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders and other conditions. Based on the outcome of this review, the FDA is requiring that all manufacturers of drugs in this class include a warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.[6]

Before You Use This Drug [top]

Do not use if you have or have had:

  • certain types of seizures (atypical or generalized absence seizures, atonic seizures, or myoclonic seizures)
  • heart block
  • blood disorders
  • bone marrow depression

Tell your doctor if you have or have had:

  • allergies or reaction to carbamazepine or to tricyclic antidepressants
  • pregnancy or are breast-feeding
  • previous use of this drug
  • heart problems
  • diabetes
  • glaucoma
  • alcohol dependence
  • liver problems
  • low amount of salt in the blood
  • retention of urine
  • kidney problems
  • anemia
  • behavioral problems

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Until you know how you react to this drug, do not drive or perform other activities requiring alertness. Carbamazepine can cause dizziness, drowsiness, and lack of muscle coordination.
  • Schedule regular visits with your doctor to check your progress.
  • Wear a medical identification bracelet or carry a card stating that you take carbamazepine.
  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.
  • Use proper oral hygiene.
  • Avoid alcoholic drinks.
  • Caution diabetics: Carbamazepine may increase urine sugar concentration.
  • Wear sunscreen when outdoors.
  • If using oral contraceptives, use another method of birth control instead.
  • This drug may interfere with pregnancy tests

How to Use This Drug [top]

  • Take with food.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.
  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Do not suddenly stop taking without checking with your doctor to find out if you need to taper off this drug.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

alcohol, CALAN SR, charcoal, cimetidine, clozapine, CLOZARIL, COVERA-HS, CRIXIVAN, cyclosporine, danazol, DANOCRINE, DARVON, DARVON-N, DECADRON, delavirdine, DEPAKENE/DEPAKOTE, dexamethasone, dicumarol, divalproex/valproic acid, doxycycline, EES, ELIXOPHYLLIN, ERYTHROCIN, erythromycin, ESKALITH, felbamate, FELBATOL, FLAGYL, GABITRIL, HALDOL, haloperidol, HEXADROL, ILOSONE, indinavir, INH, isoniazid, ISOPTIN SR, lithium, ketorolac, LITHOBID, LITHONATE, metronidazole, NEORAL, olanzapine, oral contraceptives, oxcarbazepine, propoxyphene, RESCRIPTOR, SANDIMMUNE, sertindole, SLO-BID, TAGAMET, THEO-24, theophylline, tiagabine, ticlodipine, TOPAMAX, topiramate, TORADOL, TRILEPTAL, verapamil, VERELAN, VIBRAMYCIN, VINCASAR, vincristine, ZYPREXA.

The use of carbamazepine in combination with the monoamine oxidase (MAO) inhibitor antidepressants is not recommended. The MAO inhibitors include drugs such as isocarboxazid (MARPLAN), phenelzine (NARDIL), and tranylcypromine (PARNATE).

Adverse Effects [top]

Call your doctor immediately if you experience:

  • behavioral changes
  • black, tarry stools
  • blood in urine or stools
  • blurred or double vision
  • bone or joint pain
  • chest pain
  • chills
  • confusion, agitation, or hostility
  • continuous back-and-forth eye movements
  • continuous headache
  • cough or hoarseness
  • cramps in abdomen or muscles
  • swelling of face, hands, feet, or lower legs
  • fainting
  • fast, slow, pounding, or irregular heartbeat
  • fever
  • low or high blood pressure
  • lower back or side pain
  • mental depression with restlessness and nervousness
  • painful or difficult urination
  • pinpoint red spots on skin
  • rapid weight gain
  • rigidity
  • increase in seizure frequency
  • severe diarrhea
  • severe nausea and vomiting
  • shortness of breath, troubled breathing, wheezing, or tightness in chest
  • skin rash, hives, or itching
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • difficulty speaking or slurred speech
  • swollen or painful glands
  • unusual bleeding, bruising, or nosebleeds
  • unusual drowsiness or tiredness
  • unusual weakness
  • ringing, buzzing, or other unexplained sounds in the ears
  • trembling
  • uncontrolled body movements
  • hallucinations
  • darkened urine
  • pale stools
  • yellow eyes or skin
  • frequent urination
  • sudden decrease in amount of urine
  • numbness, tingling, pain, or weakness in hands and feet
  • pain or bluish color of leg or foot

Call your doctor if these symptoms continue:

  • clumsiness or unsteadiness
  • confusion
  • mild dizziness or lightheadedness
  • mild drowsiness
  • mild nausea or vomiting
  • aching joints, muscles, or leg cramps
  • hair loss
  • appetite loss
  • constipation
  • increased sweating
  • diarrhea
  • dry mouth
  • irritation or soreness of tongue or mouth
  • headache
  • increased sensitivity of skin to sunlight
  • sexual problems in males
  • stomach pain or discomfort
  • unusual tiredness or weakness

Signs of overdose:

  • sudden decrease in amount of urine
  • fast or irregular heartbeat
  • convulsions
  • severe dizziness
  • severe drowsiness
  • poor control of body movements
  • overactive reflexes, followed by underactive reflexes
  • low or high blood pressure
  • motor restlessness
  • muscle twitching
  • large pupils
  • severe nausea or vomiting
  • clumsiness or unsteadiness
  • abnormal body movements
  • body spasms where head and heels are bent backward and body is bowed forward
  • irregular, slow, or shallow breathing
  • fainting
  • tremor

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • blood levels of carbamazepine
  • complete blood count, including platelet counts
  • kidney function tests
  • liver function tests
  • eye tests
  • complete urinalysis
  • calcium concentrations in blood
  • iron blood levels
  • heart exam
  • electrolyte levels

last reviewed June 30, 2021