Carbamazepine is an active pharmaceutical ingredient in the Carboxamide Derivatives group (N03AF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised September 26, 2025[1]
Not applicable.
How to take
GBOfficial regulatory label· revised September 26, 2025
CACanada· Health Canada
16 products
Uses
CAOfficial regulatory label· revised May 15, 2025[2]
Epilepsy:
Adults (> 18 years of age) TEGRETOL® (carbamazepine) is indicated for use as an anticonvulsant drug either alone or in combination with other anticonvulsant drugs. Carbamazepine is not effective in controlling absence, myoclonic or atonic seizures, and does not prevent the generalization of epileptic discharge.
Moreover, exacerbation of seizures may occasionally occur in patients with atypical absences.
Trigeminal Neuralgia:
Adults (> 18 years of age) TEGRETOL is indicated for the symptomatic relief of pain of trigeminal neuralgia only during periods of exacerbation of true or primary trigeminal neuralgia (tic douloureux). It should not be used preventively during periods of remission.
In some patients, TEGRETOL has relieved glossopharyngeal neuralgia. For patients who fail to respond to TEGRETOL, or who are sensitive to the drug, recourse to other accepted measures must be considered. Carbamazepine is not a simple analgesic and should not be used to relieve trivial facial pains or headaches.
USUnited States· FDA
6 products
Uses
USOfficial regulatory label· revised February 18, 2025[3]
INDICATIONS AND USAGE
Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1.
Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures.
Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS , General). Trigeminal Neuralgia Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia.
Drug interactions
Known interactions involving Carbamazepine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLPI151840649 · revised September 26, 2025
[2]Health Canada (DPD) · 00010405 · revised May 15, 2025
[3]FDA DailyMed · 047bc284-060a-4d… · revised February 18, 2025 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised September 26, 2025[1]
Not applicable.
GBOfficial regulatory label· Warnings and precautions· revised September 26, 2025[1]
Not applicable.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised September 26, 2025[1]
3. Contra-indications Not applicable.
This is not medical advice. Consult a qualified healthcare professional.
Treatment of Acute Mania and Prophylaxis in Bipolar (Manic-Depressive) Disorders:
Adults (> 18 years of age) TEGRETOL may be used as a monotherapy or as an adjunct to lithium in the treatment of acute mania or prophylaxis of bipolar (manic-depressive) disorders in patients who are resistant to or are intolerant of conventional antimanic drugs.
Carbamazepine may be a useful alternative to neuroleptics in such patients. Patients with severe mania, dysphoric mania or rapid cycling who are non-responsive to lithium may show a positive response when treated with carbamazepine.
It is important to note that these recommendations are based on extensive clinical experience and some clinical trials versus active comparison agents. 2 Recommended Dose and Dosage Adjustment, Use in PrTEGRETOL® carbamazepine tablets, PrTEGRETOL® CR carbamazepine controlled-release tablets, PrTEGRETOL® Suspension carbamazepine suspension Page 5 of 50 Unclassified / Non classifié Epilepsy, Adults and Children Over 12 Years of Age and Children 6-12 Years of Age).
Trigeminal Neuralgia:
Pediatrics (< 18 years of age) The safety and efficacy of TEGRETOL in pediatric patients (<18 years of age) have not been studied. TEGRETOL is not authorized for pediatric use in trigeminal neuralgia.
Treatment of Acute Mania and Prophylaxis in Bipolar (Manic-Depressive) Disorders:
Pediatrics (< 18 years of age) The safety and efficacy of TEGRETOL in pediatric patients (<18 years of age) have not been studied. TEGRETOL is not authorized for pediatric use in acute mania and prophylaxis in bipolar (manic-depressive) disorders.
2 Geriatrics Geriatrics (> 65 years of age) For all indications, due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of TEGRETOL should be selected with caution in elderly patients. 1 Dosing Considerations, Geriatrics.
How to take
CAOfficial regulatory label· revised May 15, 2025[2]
1 Dosing Considerations • TEGRETOL Suspension produces higher peak carbamazepine levels than the same dose in tablet form, it is therefore advisable to start with low doses and to increase slowly to avoid adverse reactions. 3 Pharmacokinetics.
, BID TEGRETOL (tablets) to TID TEGRETOL Suspension). • Geriatrics: Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of TEGRETOL should be selected with caution in elderly patients. 2 Recommended Dose and Dosage Adjustment), reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.
3 Pharmacokinetics, Special Populations and Conditions. 2 Recommended Dose and Dosage Adjustment Use in Epilepsy TEGRETOL may be used alone or with other anticonvulsants. A low initial daily dosage of TEGRETOL with a gradual increase in dosage is advised.
To achieve adequate control of seizures, dosage should be adjusted to the needs of the individual patient. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine should be adjusted to maintain steady state plasma concentration of about 4 - 10 mcg/mL.
See 10 CLINICAL PHARMACOLOGY. TEGRETOL should be taken with meals whenever possible. PrTEGRETOL® carbamazepine tablets, PrTEGRETOL® CR carbamazepine controlled-release tablets, PrTEGRETOL® Suspension carbamazepine suspension Page 8 of 50 Unclassified / Non classifié TEGRETOL (tablets) and TEGRETOL Suspension should be taken in 2 to 4 divided doses daily.
TEGRETOL Suspension is particularly suitable for patients who have difficulty swallowing tablets or who need initial careful adjustment of dosage. The controlled release characteristics of TEGRETOL CR (controlled-release tablets) reduce the daily fluctuations of plasma carbamazepine.
TEGRETOL CR (either whole or, if so prescribed, only half a tablet) should be swallowed unchewed with a little liquid during or after a meal. These controlled release tablets should be prescribed as a twice-daily dosage. If necessary, three divided doses may be prescribed.
Some patients have been reported to require a dosage increase when switching from TEGRETOL (tablets) to TEGRETOL CR (controlled-release tablets). Dosage adjustments should be individualized based on clinical response and, if necessary, plasma carbamazepine levels.
Adults and Children Over 12 Years of Age Initially, 100 to 200 mg once or twice a day depending on the severity of the case and previous therapeutic history. The initial dosage is progressively increased, in divided doses, until the best response is obtained.
The usual optimal dosage is 800 to 1200 mg daily. In rare instances some adult patients have received 1600 mg. As soon as disappearance of seizures has been obtained and maintained, dosage should be reduced very gradually until a minimum effective dose is reached.
Children 6-12 Years of Age Initially, 100 mg in 2 to 4 divided doses on the first day. Increase gradually by adding 100 mg per day until the best response is obtained. Dosage should generally not exceed 1000 mg daily. As soon as disappearance of seizures has been obtained and maintained, dosage should be reduced very gradually until a minimum effective dose is reached.
Combination Therapy When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except for phenytoin, which may be increased. 1 WARNINGS AND PRECAUTIONS, Special Populations: Pregnant Women and 9 DRUG INTERACTIONS.
Use in Trigeminal Neuralgia (Adults >18 years of age) The initial daily dosage should be small; 200 mg taken in 2 doses of 100 mg each is recommended. The total daily dosage can be increased by 200 mg/day until relief of pain is obtained.
This is usually achieved at dosage between 200 and 800 mg daily, but occasionally up to 1200 mg/day may be necessary. Maximum recommended dose is 1200 mg/day. As soon as relief of pain has been obtained and maintained, progressive reduction in dosage should be attempted until a minimal effective dosage is reached.
Because trigeminal neuralgia is PrTEGRETOL® carbamazepine tablets, PrTEGRETOL® CR carbamazepine controlled-release tablets, PrTEGRETOL® Suspension carbamazepine suspension Page 9 of 50 Unclassified / Non classifié characterized by periods of remission, attempts should be made to reduce or discontinue the use of TEGRETOL at intervals of not more than 3 months, depending upon the individual clinical course.
Prophylactic use of the drug in trigeminal neuralgia is not recommended. TEGRETOL is not authorized for pediatric use in trigeminal neuralgia. Use in Mania and Bipolar (Manic-Depressive) Disorders (Adults >18 years of age) The initial daily dosage should be low, 200 to 400 mg/day, administered in divided doses, although higher starting doses of 400 to 600 mg/day may be used in acute mania.
This dose may be gradually increased until patient symptomatology is controlled or a total daily dose of 1600 mg is achieved. Increments in dosage should be adjusted to ensure optimal patient tolerability. The usual dose range is 400 to 1200 mg/day administered in divided doses.
Doses used to achieve optimal acute responses and tolerability should be continued during maintenance treatment. When given in combination with lithium and neuroleptics, the initial dosage should be low, 100 mg to 200 mg daily, and then increased gradually.
A dose higher than 800 mg/day is rarely required when given in combination with neuroleptics and lithium, or with other psychotropic drugs such as benzodiazepines. Plasma levels […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised May 15, 2025[2]
). Relapse and aggravation of the symptomatology on the 2nd or 3rd day after overdose, due to delayed absorption, should be anticipated.
Respiratory System: respiratory depression, pulmonary edema. Cardiovascular System: tachycardia, hypotension/hypertension, conduction disturbance with widening of QRS complex, syncope in association with cardiac arrest. Gastrointestinal System: nausea, vomiting, delayed gastric emptying, reduced bowel motility.
Musculoskeletal System:
There have been some cases which reported rhabdomyolysis in association with carbamazepine toxicity. Renal Function: urinary retention, oliguria or anuria; fluid retention, and water intoxication. Laboratory Findings: hyponatremia, hypokalemia, leukocytosis, reduced white cell count, metabolic acidosis, hyperglycemia, glycosuria, acetonuria, increased muscle creatine phosphokinase.
Treatment of Overdosage There is no known specific antidote to TEGRETOL. Evacuate the stomach, with an emetic or by gastric lavage and then administer activated charcoal. Delay in evacuating the stomach may result in delayed absorption, leading to relapse during recovery from intoxication.
Hemodialysis is the effective treatment modality in the management of the carbamazepine overdose. Vital signs, including electrocardiogram to detect any cardiac arrhythmias or conduction defects, should be watched and symptomatic treatment should be administered as required.
Hyperirritability or convulsions should be appropriately managed by standard medical care. Hyponatremia should be appropriately managed by standard medical care. Shock (circulatory collapse) should be treated with supportive measures, including intravenous fluids, oxygen, and corticosteroids.
Charcoal hemoperfusion has been recommended. For management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669). PrTEGRETOL® carbamazepine tablets, PrTEGRETOL® CR carbamazepine controlled-release tablets, PrTEGRETOL® Suspension carbamazepine suspension Page 11 of 50 Unclassified / Non classifié 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging.
Availability of Dosage Forms TEGRETOL tablets 200 mg are white, round, flat-faced and bevel-edged. One side bears the imprint “CG”, the other “G/K” and a score. Available in bottles of 100. TEGRETOL CR controlled-release tablets 200 mg are beige-orange, oval and slightly biconvex.
C/G engraved on one side and H/C engraved on the other. Fully bisected on both sides. Available in bottles of 100. TEGRETOL CR controlled-release tablets 400 mg are brown-orange, oval and slightly biconvex. CG/CG engraved on one side and ENE/ENE engraved on the other.
Fully bisected on both sides. Available in bottles of 100. TEGRETOL Suspension 100 mg/5mL is orange. Available in bottles of 450 mL. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General TEGRETOL should not be used in conjunction with the antiretroviral agent delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of nonnucleoside reverse transcriptase inhibitors.
4 Drug-Drug Interactions. Anticholinergic effects Like other tricyclic compounds, carbamazepine has a moderate anticholinergic action which is Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral tablets; 200 mg Carmellose sodium, cellulose compounds, magnesium stearate, silicon dioxide.
6, pluronic polyol, potassium sorbate, propylene glycol, sucrose, sorbitol, water, xanthan gum. PrTEGRETOL® carbamazepine tablets, PrTEGRETOL® CR carbamazepine controlled-release tablets, PrTEGRETOL® Suspension carbamazepine suspension Page 12 of 50 Unclassified / Non classifié responsible for some of its side effects.
Because of its anticholinergic action, carbamazepine should be given cautiously, if at all, to patients with increased intraocular pressure or urinary retention. 5 Post-Market Adverse Reactions) which may lead to falls and, consequently fractures or other injuries.
For patients with diseases, conditions, or medications that could exacerbate these effects, complete risk assessment of fall should be considered recurrently for patients on long-term TEGRETOL treatment. Bone Disorders Long-term use of antiepileptics such as carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrigine and sodium valproate is associated with a risk of decreased bone mineral density that may lead to weakened or brittle bones.
Carcinogenesis and Mutagenesis Long-term toxicity studies in rats indicated a potential carcinogenic risk. See 16 NON-CLINICAL TOXICOLOGY. Therefore, the possible risk of the drug must be weighed against the potential benefits before prescribing TEGRETOL to individual patients.
Cardiovascular TEGRETOL should be used cautiously in patients with a history of coronary artery disease, organic heart disease, or congestive heart failure. Carbamazepine may suppress ventricular automaticity due to its membrane-depressant effect, similar to that of quinidine and […]
CAOfficial regulatory label· Warnings and precautions· revised May 15, 2025[2]
, Pregnancy 04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ...............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ...............................................................................................................
1 Pregnant Women ........................................................................................ 2 Breastfeeding .............................................................................................. 3 Pediatrics ....................................................................................................
4 Geriatrics .................................................................................................... 36 PrTEGRETOL® carbamazepine tablets, PrTEGRETOL® CR carbamazepine controlled-release tablets, PrTEGRETOL® Suspension carbamazepine suspension Page 4 of 50 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Epilepsy: Adults (> 18 years of age) TEGRETOL® (carbamazepine) is indicated for use as an anticonvulsant drug either alone or in combination with other anticonvulsant drugs.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised May 15, 2025[2]
TEGRETOL is contraindicated in: • Patients who are hypersensitive to carbamazepine or to any of the components of the tablets or suspension. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. g. amitriptyline, trimipramine, imipramine, or their analogues or metabolites).
• Patients with hepatic disease, a history of bone-marrow depression, a history of hepatic porphyria (acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda), or serious blood disorder. • Conjunction with, or immediately after, a monoamine oxidase (MAO) inhibitor.
See 9 DRUG INTERACTIONS. • Conjunction with itraconazole and voriconazole. See 9 DRUG INTERACTIONS. • Patients presenting atrioventricular heart block. See 7 WARNINGS AND PRECAUTIONS, Cardiovascular. PrTEGRETOL® carbamazepine tablets, PrTEGRETOL® CR carbamazepine controlled-release tablets, PrTEGRETOL® Suspension carbamazepine suspension Page 6 of 50 Unclassified / Non classifié
This is not medical advice. Consult a qualified healthcare professional.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
How to take
USOfficial regulatory label· revised February 18, 2025[3]
DOSAGE AND ADMINISTRATION (SEE TABLE BELOW) Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions).
Because the extent to which this occurs with other liquid medications is not known, Carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents. Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests).
Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level.
Medication should be taken with meals. Since a given dose of Carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: ½ teaspoon four times a day and to increase slowly to avoid unwanted side effects.
, twice a day tablets to three times a day suspension). Tegretol-XR is an extended-release formulation for twice a day administration. When converting patients from Carbamazepine conventional tablets to Tegretol-XR, the same total daily mg dose of Tegretol-XR should be administered.
Tegretol-XR tablets must be swallowed whole and never crushed or chewed. Tegretol-XR tablets should be inspected for chips or cracks. Damaged tablets, or tablets without a release portal, should not be consumed. Tegretol-XR tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool.
Epilepsy (SEE INDICATIONS AND USAGE) Adults and children over 12 years of age-Initial : Either 200 mg twice a day for tablets and XR tablets, or 1 teaspoon four times a day for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a twice a day regimen of Tegretol-XR or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained.
Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances.
Maintenance :
Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.
Children 6 to 12 years of age-Initial :
Either 100 mg twice a day for tablets or XR tablets, or ½ teaspoon four times a day for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a twice a day regimen of Tegretol-XR or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained..
Dosage generally should not exceed 1000 mg daily.
Maintenance :
Adjust dosage to the minimum effective level, usually 400 to 800 mg daily. Children under 6 years of age-Initial : 10 to 20 mg/kg/day twice a day or three times a day as tablets, or four times a day as suspension . Increase weekly to achieve optimal clinical response administered three times a day or four times a day.
Maintenance :
Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range.
No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Combination Therapy :
Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions, and Pregnancy).
Trigeminal Neuralgia (SEE INDICATIONS AND USAGE) Initial :
On the first day, either 100 mg twice a day for tablets or XR tablets or ½ teaspoon four times a day for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or XR tablets, or 50 mg (½ teaspoon) four times a day for suspension, only as needed to achieve freedom from pain.
Do not exceed 1200 mg daily.
Maintenance :
Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.
Dosage Information Initial Dose Subsequent Dose MaximumDaily Dose Indication Tablet* XR † Suspension Tablet* XR † Suspension Tablet* XR † Suspension Epilepsy Under 6 yr 10-20 mg/kg/day twice a day or 3 times of day 10-20 mg/kg/day 4 times a day Increase weekly to achieve optimal clinical response, 3 times a day or 4 times a day Increase weekly to achieve optimal clinical response, 3 times a day or 4 times a day 35mg/kg/24hr (see Dosage and Administration section above) 35 mg/kg/24 hr (see Dosage and Administration section above) 6-12 yr 100 mg twice a day (200 mg/day) 100 mg twice a day (200 mg/day) ½ tsp 4 times a day (200 mg/day) Add up to 100 mg/day at weekly intervals 3 times a day or 4 times a day Add 100 mg/day at weekly intervals, twice a day Add up to 1 tsp (100 mg)/day at weekly intervals, 3 times a day or 4 times a day 1000mg/24 hr Over 12 yr 200 mg twice a day(400 mg/day) 200 mg twice a day (400 mg/day) 1 tsp 4 times a day (400 mg/day) Add up to 200 mg/day at weekly intervals, 3 times a day or 4 times a day Add up to 200 mg/day at weekly intervals, twice a day Add up to 2 tsp (200 mg)/day at weekly intervals, 3 times a day or 4 times a day 1000 mg/24 hr (12-15 yr) 1200 mg/24 hr (>15 yr) 1600 mg/24 hr (adults, in rare instances) Trigeminal Neuralgia 100 mg twice a day(200 mg/day) 100 mg twice a day (200 mg/day) ½ tsp 4 times a day (200 mg/day) Add up to 200 mg/day in increments of 100 mg every 12 hr Add up to 200 mg/day in increments of 100 mg every 12 hr Add up to 2 tsp (200 mg)/day in increments of 50 mg (½ tsp) 4 times a day 1200mg/24 hr * Tablet = conventional tablets † XR = Tegretol-XR extended-release tablets
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 2,383 reports total. [4]
Off Label Use 234
Drug Ineffective 204
Drug Interaction 187
Nausea 148
Seizure 144
Toxicity To Various Agents 138
Vomiting 137
Somnolence 130
Drug Reaction With Eosinophilia And Systemic Symptoms 129
Dizziness 124
Condition Aggravated 113
Rash 93
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised February 18, 2025[3]
ADVERSE REACTIONS
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 severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING), the liver, 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 have been reported:
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, onychomadesis and hirsutism.
In certain cases, discontinuation of therapy may be necessary. , pulmonary embolism), 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, very rare cases of hepatic failure.
Pancreatic :
Pancreatitis.
Respiratory System :
Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.
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 rare reports of impaired male fertility and/or abnormal spermatogenesis.
Testicular atrophy occurred in rats receiving carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 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 and higher. Relevance of these findings to humans is unknown.
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.
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, increased intraocular pressure (see WARNINGS, General) 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. Decreased levels of plasma calcium have been reported. Osteoporosis has 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.
To report SUSPECTED ADVERSE REACTIONS, contact Nivagen Pharmaceuticals, Inc. gov/medwatch.
USOfficial regulatory label· Warnings and precautions· revised February 18, 2025[3]
WARNINGS
Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations.
However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
SJS/TEN and HLA-B*1502 Allele Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B*1502.
The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity. Across Asian populations, notable variation exists in the prevalence of HLA-B*1502.
Greater than 15% of the population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2% to 4%, but higher in some groups.
HLA-B*1502 is present in less than 1% of the population in Japan and Korea. , Caucasians, African-Americans, Hispanics, and Native Americans). Prior to initiating carbamazepine therapy, testing for HLA-B*1502 should be performed in patients with ancestry in populations in which HLA-B*1502 may be present.
In deciding which patients to screen, the rates provided above for the prevalence of HLA-B*1502 may offer a rough guide, keeping in mind the limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised February 18, 2025[3]
CONTRAINDICATIONS
Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc.
Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.
Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
This is not medical advice. Consult a qualified healthcare professional.
Carbamazepine is not effective in […]
Carbamazepine should not be used in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Tested patients who are found to be negative for the allele are thought to have a low risk of SJS/TEN (see BOXED WARNING and PRECAUTIONS , Laboratory Tests ).
Over 90% of carbamazepine treated patients who will experience SJS/TEN have this reaction within the first few months of treatment. This information may be taken into consideration in determining the need for screening of genetically at-risk patients currently on carbamazepine.
The HLA-B*1502 allele has not been found to predict risk of less severe adverse cutaneous reactions from carbamazepine such as maculopapular eruption (MPE) or to predict Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Chinese ancestry taking other antiepileptic drugs associated with SJS/TEN, including phenytoin. Consideration should be given to avoiding use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable.
Hypersensitivity Reactions and HLA-A*3101 Allele Retrospective case-control studies in patients of European, Korean, and Japanese ancestry have found a moderate association between the risk of developing hypersensitivity reactions and the presence of HLA-A*3101, an inherited allelic variant of the HLA-A gene, in patients using carbamazepine.
These hypersensitivity reactions include SJS/TEN, maculopapular eruptions, and Drug Reaction with Eosinophilia and Systemic Symptoms (see DRESS/Multiorgan hypersensitivity below). HLA-A*3101 is expected to be carried by more than 15% of patients of Japanese, Native American, Southern Indian (for example, Tamil Nadu) and some Arabic ancestry; up to about 10% in patients of Han Chinese, Korean, European, Latin American, and other Indian ancestry; and up to about 5% in African-Americans and patients of Thai, Taiwanese, and Chinese (Hong Kong) ancestry.
The risks and benefits of carbamazepine therapy should be weighed before considering carbamazepine in patients known to be positive for HLA-A*3101. Application of HLA genotyping as a screening tool has important limitations and must never substitute for appropriate clinical vigilance and patient management.
Many HLA-B*1502-positive and HLA-A*3101-positive patients treated with carbamazepine will not develop SJS/TEN or other hypersensitivity reactions, and these reactions can still occur infrequently in HLA-B*1502-negative and HLA-A*3101-negative patients of any ethnicity.
The role of other possible factors in the development of, and morbidity from, SJS/TEN and other hypersensitivity reactions, such as antiepileptic drug (AED) dose, compliance, concomitant medications, comorbidities, and the level of dermatologic monitoring, have not been studied.
Aplastic Anemia and Agranulocytosis Aplastic anemia and agranulocytosis have been reported in association with the use of carbamazepine (see BOXED WARNING). Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with carbamazepine. Some of these events have been fatal or life-threatening.
DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.
Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. , fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately.
Carbamazepine should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Hypersensitivity Hypersensitivity reactions to carbamazepine have been reported in patients who previously experienced this reaction to anticonvulsants including phenytoin, primidone, and phenobarbital.
If such history is present, benefits and risks should be carefully considered and, if carbamazepine is initiated, the signs and symptoms of hypersensitivity should be carefully monitored. Patients should be informed that about a third of patients who have had hypersensitivity reactions to carbamazepine also experience hypersensitivity reactions with oxcarbazepine (Trileptal®).
Anaphylaxis and Angioedema Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelid have been reported in patients after taking the first or subsequent doses of Carbamazepine. Angioedema associated with laryngeal edema 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. These patients should not be rechallenged with the drugs. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including carbamazepine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 7) of suicidal thinking or behavior compared to patients randomized to placebo.
24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication.
The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs. 9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing carbamazepine or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.
Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. General Carbamazepine has shown mild anticholinergic activity that may be associated with increased intraocular pressure; therefore, patients with increased intraocular pressure should be closely observed during therapy.
Because of the relationship of the drug to other tricyclic compounds, the possibility of activation of a latent psychosis and, in elderly patients, of confusion or agitation should be borne in mind. , acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).
Acute attacks have been reported in such patients receiving carbamazepine therapy. Carbamazepine administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria.
As with all antiepileptic drugs, carbamazepine should be withdrawn gradually to minimize the potential of increased seizure frequency. Hyponatremia can occur as a result of treatment with carbamazepine. In many cases, the hyponatremia appears to be caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
The risk of developing SIADH with carbamazepine treatment appears to be dose-related. Elderly patients and patients treated with diuretics are at greater risk of developing hyponatremia. Signs and symptoms of hyponatremia include headache, new or increased seizure frequency, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls.
Consider discontinuing carbamazepine in patients with symptomatic hyponatremia. Usage in Pregnancy Carbamazepine can cause fetal harm when administered to a pregnant woman. Epidemiological data suggest that there may be an association between the use of carbamazepine during pregnancy and congenital malformations, including spina bifida.
, craniofacial defects, cardiovascular malformations, and anomalies involving various body systems). Developmental delays based on neurobehavioral assessments have been reported. When treating or counseling women of childbearing potential, the prescribing physician will wish to weigh the benefits of therapy against the risks.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Retrospective case reviews suggest that, compared with monotherapy, there may be a higher prevalence of teratogenic effects associated with the use of anticonvulsants in combination therapy.
Therefore, if therapy is to be continued, monotherapy may be preferable for pregnant women. In humans, transplacental passage of carbamazepine is rapid (30 to 60 minutes), and the drug is accumulated in the fetal tissues, with higher levels found in liver and kidney than in brain and lung.
5 to 4 times the MHDD on a mg/m2 basis. In rat teratology studies, 2 of 135 offspring showed kinked ribs at 250 mg/kg and 4 of 119 offspring at 650 mg/kg showed other anomalies (cleft palate, 1; talipes, 1; anophthalmos, 2). In reproduction studies in rats, nursing offspring demonstrated a lack of weight gain and an unkempt appearance at a maternal dosage level of 200 mg/kg.
Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.
In individual cases where the severity and frequency of the seizure disorder are such that removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
Tests to detect defects using currently accepted procedures should be considered a part of routine prenatal care in childbearing women receiving carbamazepine. There have been a few cases of neonatal seizures and/or respiratory depression associated with maternal carbamazepine and other concomitant anticonvulsant drug use.
A few cases of neonatal vomiting, diarrhea, and/or decreased feeding have also been reported in association with maternal carbamazepine use. These symptoms may represent a neonatal withdrawal syndrome. To provide information regarding the effects of in utero exposure to carbamazepine, physicians are advised to recommend that pregnant patients taking carbamazepine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. org/. PRECAUTIONS General Before initiating therapy, a detailed history and physical examination should be made. Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients carbamazepine has been associated with increased frequency of generalized convulsions (see INDICATIONS AND USAGE ).
Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac conduction disturbance, including second-and third-degree AV heart block; cardiac, hepatic, or renal damage; adverse hematologic or hypersensitivity reaction to other drugs, including reactions to other anticonvulsants; or interrupted courses of therapy with carbamazepine.
AV heart block, including second-and third-degree block, have been reported following carbamazepine treatment. This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances.
Hepatic effects, ranging from slight elevations in liver enzymes to rare cases of hepatic failure have been reported (see ADVERSE REACTIONS and PRECAUTIONS , Laboratory Tests ). In some cases, hepatic effects may progress despite discontinuation of the drug.
In addition rare instances of vanishing bile duct syndrome have been reported. This syndrome consists of a cholestatic process with a variable clinical course ranging from fulminant to indolent, involving the destruction and disappearance of the intrahepatic bile ducts.
Some, but not all, cases are associated with features that overlap with other immunoallergenic syndromes such as multiorgan hypersensitivity (DRESS syndrome) and serious dermatologic reactions. As an example there has been a report of vanishing bile duct syndrome associated with Stevens-Johnson syndrome and in another case an association with fever and eosinophilia.
Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended that patients given the suspension be started on lower doses and increased slowly to avoid unwanted side effects (see DOSAGE AND ADMINISTRATION ).
Carbamazepine suspension contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance. Information for Patients Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking carbamazepine.
Patients should be made aware of the early toxic signs and symptoms of a potential hematologic problem, as well as dermatologic, hypersensitivity or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice.
The patient should be advised that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use.
Patients should be advised that serious skin reactions have been reported in association with carbamazepine. In the event a skin reaction should occur while taking carbamazepine, patients should consult with their physician immediately (see WARNINGS ).
Patients should be advised that anaphylactic reactions and angioedema may occur during treatment with Carbamazepine (see WARNINGS ). Advise patients to immediately report signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their healthcare provider.
Patients, their caregivers, and families should be counseled that AEDs, including carbamazepine, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Behaviors of concern should be reported immediately to healthcare providers. Carbamazepine may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or nonprescription medications or herbal products.
Caution should be exercised if alcohol is taken in combination with carbamazepine therapy, due to a possible additive sedative effect. Since dizziness and drowsiness may occur, patients should be cautioned about the hazards of operating machinery or automobiles or engaging in other potentially dangerous tasks.
Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see WARNINGS , Usage in Pregnancy subsection).
Laboratory Tests For genetically at-risk patients (see WARNINGS), high-resolution ‘HLA-B*1502 typing’ is recommended. The test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are detected.
Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, 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. Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with this drug since liver damage may occur (see PRECAUTIONS , General and ADVERSE REACTIONS ).
Carbamazepine should be discontinued, based on clinical judgment, if indicated by newly occurring or worsening clinical or laboratory evidence of liver dysfunction or hepatic damage, or in the case of active liver disease. Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are recommended since many phenothiazines and related drugs have been shown to cause eye changes.
Baseline and periodic complete urinalysis and BUN determinations are recommended for patients treated with this agent because of observed renal dysfunction. Monitoring of blood levels (see CLINICAL PHARMACOLOGY ) has increased the efficacy and safety of anticonvulsants.
This monitoring may be particularly useful in cases of dramatic increase in seizure frequency and for verification of compliance. In addition, measurement of drug serum levels may aid in determining the cause of toxicity when more than one medication is being used.
Thyroid function tests have been reported to show decreased values with carbamazepine administered alone. Interference with some pregnancy tests has been reported.