Carbamazepine
Carbamazepine is an anticonvulsant (seizure medicine) used to treat epilepsy and the nerve pain of trigeminal neuralgia, and one brand (Equetro) is also used for bipolar I disorder.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 98 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Carbamazepine is a long-trusted seizure medicine that calms overactive nerve signaling, used for epilepsy and as a usual first choice for the facial pain of trigeminal neuralgia (the Equetro brand also treats bipolar I disorder); it has been around since the late 1960s and is available generically. Dizziness, drowsiness and unsteadiness are common at first, which is why the dose starts low and climbs slowly. Its boxed warning covers rare but life-threatening skin reactions and serious blood disorders, so treat a new rash, mouth sores, fever, sore throat or easy bruising as urgent, especially in the first few months. Never stop it suddenly, because that can trigger seizures.
Clinical pearls
- If you have Asian ancestry, ask about the HLA-B*1502 gene test before starting, since carriers face much higher skin reaction risk.
- It weakens hormonal birth control and blood thinners like apixaban and rivaroxaban, so tell every prescriber you take it.
- Avoid grapefruit juice, and flag new prescriptions for clarithromycin, erythromycin or azole antifungals, which raise carbamazepine levels.
- Expect regular blood tests, and report new confusion, headache or more seizures, which can signal low sodium, especially in older adults.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Carbamazepine can cause life-threatening skin reactions and serious blood disorders.
Serious skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) are rare. The risk is about 10 times higher in some Asian countries. People with ancestry in at-risk populations should be screened for the HLA-B*1502 gene variant before starting. If positive, carbamazepine should not be used unless the benefit clearly outweighs the risk.
Aplastic anemia and agranulocytosis (very low blood cell counts) can also occur. The risk is 5 to 8 times higher than in the general population, though still low. Blood tests are done before and during treatment. Watch for fever, sore throat, bruising, bleeding, mouth ulcers or unusual tiredness, and call your doctor right away.
Patient information guide A plain-language walkthrough of Carbamazepine, written from its FDA label.
What Carbamazepine is used for
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Carbamazepine treats several conditions, depending on the product.
- Epilepsy: partial seizures with complex symptoms, generalized tonic-clonic (grand mal) seizures, and mixed seizure patterns. It does not appear to control absence (petit mal) seizures.
- Pain of true trigeminal neuralgia; beneficial results have also been reported in glossopharyngeal neuralgia.
- Equetro (extended-release capsule) only: acute manic or mixed episodes of bipolar I disorder.
How Carbamazepine works
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Carbamazepine appears to work by reducing certain nerve responses that spread seizure activity and pain signals. In animals it reduced seizures and nerve pain. Its exact mechanism is unknown, and it is chemically unrelated to other seizure medicines.
Its main breakdown product, carbamazepine-10,11-epoxide, also has seizure-controlling activity in animals. Its importance in people has not been established.
Carbamazepine dosage
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Carbamazepine is taken by mouth as tablets, chewable tablets, liquid, or extended-release tablets or capsules. Doses start low and rise gradually, and are adjusted to each person.
- Several labels say to take it with meals.
- Carbatrol may be taken with or without food.
- Extended-release products are for twice-daily use.
- Equetro and Carbatrol capsules can be opened and sprinkled on soft food. Do not crush or chew them or the beads.
- Do not stop suddenly. Follow your prescriber and product label.
Dosing details from the FDA-approved label
From the Carbamazepine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Epilepsy: adults and children over 12 years of age
- Initial: either 200 mg twice a day for tablets and extended-release 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 extended-release tablets or a three times a day or four times a day regimen of the other formulations until the optimal response is obta
- Maximum: 1000 mg daily in children 12 to 15 years of age; 1200 mg daily in patients above 15 years of age; doses up to 1600 mg daily have been used in adults in rare instances
- Should be taken with meals; extended-release tablets must be swallowed whole, never crushed or chewed
- Epilepsy: children 6 to 12 years of age
- Initial: either 100 mg twice a day for tablets or extended-release tablets, or 1/2 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 extended-release tablets or a three times a day or four times a day regimen of the other formulations until the optimal response is obt
- Maximum: 1000 mg daily
- Suspension gives higher peak levels than the same tablet dose, so start low (1/2 teaspoon four times a day) and increase slowly
- Epilepsy: 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
- Maximum: No recommendation regarding safety can be made for doses above 35 mg/kg/24 hours
- If satisfactory response has not been achieved, plasma levels should be measured to determine whether they are in the therapeutic range
- Trigeminal neuralgia
- Initial: on the first day, either 100 mg twice a day for tablets or extended-release tablets, or 1/2 teaspoon four times a day for suspension, for a total daily dose of 200 mg
- May be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or extended-release tablets, or 50 mg (1/2 teaspoon) four times a day for suspension, only a
- Maximum: Do not exceed 1200 mg daily
- At least once every 3 months, attempt to reduce the dose to the minimum effective level or discontinue the drug
Read the label’s full dosing text
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 a 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. Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., twice a day tablets to three times a day suspension). Carbamazepine extended-release tablets are an extended-release formulation for twice a day administration. When converting patients from carbamazepine conventional tablets to carbamazepine extended-release tablets, the same total daily mg dose of carbamazepine extended-release tablets should be administered. Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed. Carbamazepine extended-release tablets should be inspected for chips or cracks. Damaged tablets, or tablets without a release portal, should not be consumed. Carbamazepine extended-release tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Carbamazepine side effects
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The most common effects, especially early in treatment, are:
Common side effects
- Dizziness
- Drowsiness
- Unsteadiness
- Nausea
- Vomiting
- Headache
- Blurred vision or double vision
- Tiredness
When to get medical help
- Get help right away for a rash, blisters, mouth sores or peeling skin, especially with fever. These can be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Call your doctor for fever, sore throat, easy bruising, tiny red spots on the skin, nosebleeds, bleeding gums or unusual tiredness. These can signal a serious blood problem.
- Seek urgent care for swelling of the face, lips, eyes or throat, or trouble breathing.
- Call your doctor for fever, rash and swollen glands, which can signal a multi-organ allergic reaction (DRESS), even without a rash.
- Report new or worse depression, unusual mood or behavior changes, or thoughts of self-harm right away.
- Call your doctor for headache, confusion, weakness, unsteadiness or more seizures, which can signal low sodium.
- Report yellowing of the skin or eyes, which can signal liver problems.
Starting at a low dose helps. Seek help for rash, signs of infection or bleeding, liver problems, or mood changes.
Carbamazepine warnings and precautions
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- Serious skin reactions (SJS/TEN): usually in the first few months; gene screening is advised for at-risk ancestry.
- Blood disorders: aplastic anemia and agranulocytosis. Blood counts are checked.
- DRESS and other allergic reactions, including anaphylaxis and angioedema.
- Suicidal thoughts: seizure medicines raise this risk slightly.
- Low sodium, especially in older adults and people on diuretics.
- Pregnancy: can cause fetal harm, including birth defects.
- Stopping suddenly can cause seizures.
Carbamazepine interactions
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Carbamazepine interacts with many medicines because it affects liver enzymes, especially CYP3A4.
- Drugs that raise its levels: azole antifungals, macrolide antibiotics, cimetidine, fluoxetine, verapamil, diltiazem, valproate, grapefruit juice.
- Drugs that lower its levels: phenytoin, phenobarbital, primidone, rifampin.
- Medicines it makes less effective: warfarin, hormonal contraceptives, rivaroxaban, apixaban, dabigatran, edoxaban, aripiprazole, tacrolimus.
- Do not combine with MAOIs, nefazodone or delavirdine.
- Lithium: higher risk of nerve-related side effects.
Interactions listed in the FDA-approved label
From the Carbamazepine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Agents highly bound to plasma protein: Carbamazepine is not highly bound to plasma proteins, so it should not cause increased free concentrations of another highly protein-bound drug.
- CYP3A4 and/or epoxide hydrolase inhibitors (e.g., cimetidine, clarithromycin, erythromycin, fluoxetine, grapefruit juice, verapamil, valproate, loxapine, quetiapine): These agents are found or expected to increase plasma levels of carbamazepine (or carbamazepine-10,11 epoxide). Adjust the carbamazepine dose and/or monitor plasma levels; a dose reduction may be necessary.
- CYP inducers (e.g., phenobarbital, phenytoin, primidone, rifampin, theophylline, felbamate, cisplatin): These agents are found or expected to decrease plasma levels of carbamazepine. A carbamazepine dose increase may be necessary.
- Aripiprazole: Carbamazepine decreases aripiprazole levels through CYP induction. When carbamazepine is added, double the aripiprazole dose; if carbamazepine is withdrawn, reduce the aripiprazole dose.
- Nefazodone: Concomitant use results in plasma concentrations of nefazodone and its active metabolite insufficient to achieve a therapeutic effect. Coadministration is contraindicated.
- Hormonal contraceptives (oral and levonorgestrel subdermal implant): Plasma hormone concentrations may be decreased, which may render the contraceptives less effective; breakthrough bleeding and unintended pregnancies have been reported. Consider alternative or back-up methods of contraception.
- Rivaroxaban, apixaban, dabigatran, edoxaban: Expected to decrease plasma concentrations of these anticoagulants, possibly insufficient for the intended therapeutic effect. In general, coadministration should be avoided.
- Phenytoin: Phenytoin plasma levels have been reported to both increase and decrease in the presence of carbamazepine. Carefully monitor phenytoin plasma levels following co-medication.
- Lithium: Concomitant administration may increase the risk of neurotoxic side effects.
- Chloroquine and mefloquine: Anti-malarial drugs may antagonize the activity of carbamazepine.
Read the label’s full interactions text
Drug Interactions Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following: Agents Highly Bound to Plasma Protein: Carbamazepine is not highly bound to plasma proteins; therefore, administration of carbamazepine extended-release capsules to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug. Agents that Inhibit Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase: Carbamazepine is metabolized mainly by cytochrome P450 (CYP) 3A4 to the active carbamazepine 10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Therefore, the potential exists for interaction between carbamazepine and any agent that inhibits CYP3A4 and/or epoxide hydrolase. Agents that are CYP3A4 inhibitors that have been found, or are expected, to increase plasma levels of carbamazepine extended-release capsules include, for example, the following: Acetazolamide, aprepitant, azole antifungals (e.g., ketoconazole, itraconazole, fluconazole, voriconazole), cimetidine, ciprofloxacin, clarithromycin, dalfopristin, danazol, dantrolene, delavirdine, diltiazem, erythromycin, fluoxetine, fluvoxamine, grapefruit juice, ibuprofen, isoniazid, loratadine, macrolides, nefazodone, niacinamide, nicotinamide, olanzapine, omeprazole, oxybutynin, protease inhibitors, propoxyphene, quinine, quinupristin, ticlopidine, troleandomycin, valproate, verapamil, zileuton. Human microsomal epoxide hydrolase has been identified as the enzyme responsible for the formation of the 10,11-transdiol derivative from carbamazepine-10,11 epoxide. Coadministration of inhibitors of human microsomal epoxide hydrolase may result in increased carbamazepine-10,11 epoxide plasma concentrations.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Carbamazepine
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- Do not use with bone marrow depression, or allergy to carbamazepine or tricyclic antidepressants.
- Tell your doctor about liver disease, porphyria, high eye pressure or past blood reactions to drugs.
- Pregnancy: can harm the baby; discuss alternatives and folic acid.
- Breastfeeding: it passes into milk; a few infants had liver or feeding problems.
- Equetro has not been established for bipolar disorder or trigeminal neuralgia in children.
- Older adults: cautious dosing, higher risk of low sodium and confusion.
Carbamazepine overdose
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Too much carbamazepine can cause drowsiness or coma, breathing problems, seizures, fast heartbeat, low blood pressure and vomiting. Symptoms often start within 1 to 3 hours. There is no specific antidote. Get emergency help right away, where treatment focuses on removing the drug and supporting breathing, heart function and blood pressure.
What Carbamazepine does in the body
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In animals, carbamazepine reduced seizures and abolished pain from nerve stimulation. It appears to reduce polysynaptic responses (nerve signals relayed across multiple connections) and dampen certain reflexes. Its exact mechanism is unknown.
How your body processes Carbamazepine
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Carbamazepine is mostly broken down in the liver, mainly by CYP3A4, into an active metabolite. It induces its own metabolism, so its half-life shortens from about 25 to 65 hours at first to 12 to 17 hours with repeated doses. This takes 3 to 5 weeks. About 76% is bound to plasma proteins, and most is cleared in urine (72%) and stool (28%).
Liquid peaks fastest (about 1.5 hours), tablets in 4 to 5 hours, and extended-release tablets in 3 to 12 hours.
How to store Carbamazepine
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Store Carbamazepine Tablets USP, (Chewable) at 20° to 25°C (68° to 77°F) . Protect from light and moisture. Dispense in tight, light-resistant container (USP).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Carbamazepine
284 supplements and herbal products have documented interactions with Carbamazepine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 12
- Moderate · 235
- Minor · 37
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Carbamazepine has been associated with lower levels of 11 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 5
- Moderate · 6
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Carbamazepine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Carbamazepine — the kind of thing our pharmacy team would talk through with you at the counter.
What is carbamazepine for?
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How should I take it?
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What side effects are normal?
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When should I call my doctor right away?
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Does it interact with other medicines?
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Is it safe in pregnancy?
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Is Carbamazepine available over the counter?
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When was Carbamazepine first available?
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Who makes Carbamazepine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Carbamazepine on HelloPharmacist
Carbamazepine forms and strengths (how it comes)
Carbamazepine is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Extended-release tablet
How this form is used
- Carbamazepine extended-release tablets are used for epilepsy and trigeminal neuralgia pain.
- Carbamazepine extended-release tablets are made for twice-daily use.
Tablet
How this form is used
- Epitol tablets are used for epilepsy and trigeminal neuralgia pain.
- Tegretol is used for epilepsy and trigeminal neuralgia pain.
- Epitol should be taken with meals.
Extended-release capsule
How this form is used
- Carbatrol is used for epilepsy and trigeminal neuralgia pain.
- Equetro is used for acute manic or mixed episodes of bipolar I disorder, trigeminal neuralgia pain and epilepsy.
- Carbatrol may be taken with or without food, twice daily.
- Carbatrol capsules may be swallowed whole or opened and the beads sprinkled on soft food like applesauce.
- Equetro capsules may be swallowed whole or opened and sprinkled over food.
- Do not crush or chew Carbatrol or Equetro capsules or beads.
Chewable tablet
How this form is used
- Carbamazepine chewable tablets are used for epilepsy and trigeminal neuralgia pain.
Oral suspension
How this form is used
- Tegretol suspension is used for epilepsy and trigeminal neuralgia pain.
- Tegretol suspension should not be taken at the same time as other liquid medicines or diluents.
- Tegretol suspension forms a precipitate with liquid chlorpromazine or thioridazine.
Carbamazepine on the U.S. market: products, makers and brands
How Carbamazepine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
44 companies list 155 Carbamazepine product records with the FDA, mostly as extended-release tablet, tablet, extended-release capsule; the earliest marketing or approval year on record is 1968. Brand names on the directory include Carbatrol, Epitol, Equetro and 4 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Carbamazepine is used (Medicaid data)
A general measure of how commonly Carbamazepine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Carbamazepine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Carbamazepine prescribed? Of the 1,601 medications we measure, Carbamazepine ranks #272 by Medicaid prescriptions — more than 83% of them.
Utilization by Carbamazepine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
carbamazepine 200 MG Oral Tablet Most dispensed
Summed across the 18 of 140 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308979
12 HR carbamazepine 200 MG Extended Release Oral Tablet
Summed across the 8 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 402505
12 HR carbamazepine 400 MG Extended Release Oral Tablet
Summed across the 9 of 57 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 402506
carbamazepine 100 MG Chewable Tablet
Summed across the 4 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308973
12 HR carbamazepine 300 MG Extended Release Oral Capsule
Summed across the 3 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200131
12 HR carbamazepine 200 MG Extended Release Oral Capsule
Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200133
12 HR carbamazepine 100 MG Extended Release Oral Tablet
Summed across the 7 of 46 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199378
carbamazepine 20 MG/ML Oral Suspension
Summed across the 3 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308976
12 HR carbamazepine 100 MG Extended Release Oral Capsule
Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 388311
carbamazepine 200 MG Chewable Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197442
Other Carbamazepine products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 4 of 76 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Carbamazepine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 63 of 476 listed Carbamazepine NDCs with Medicaid activity.
Compare Carbamazepine products
A representative set of FDA-listed product records for Carbamazepine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Chewable tablet | ||||
| 100 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 100 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 100 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 100 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 100 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 💊Extended-release capsule | ||||
| 100 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 300 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 200 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 300 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 100 mg | Oral | AvPAK | ANDA | View NDC → |
| 200 mg | Oral | AvPAK | ANDA | View NDC → |
| 300 mg | Oral | AvPAK | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 300 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 100 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 200 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 300 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 200 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 300 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 100 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 200 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 300 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 100 mg | Oral | Validus Pharmaceuticals LLC | NDA | View NDC → |
| 200 mg | Oral | Validus Pharmaceuticals LLC | NDA | View NDC → |
| 300 mg | Oral | Validus Pharmaceuticals LLC | NDA | View NDC → |
| 💊Oral suspension | ||||
| 100 mg/5 mL | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Atlantic Biologicals Corps | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Chartwell Governmental & Specialty RX, LLC. | ANDA | View NDC → |
| 200 mg/10 mL | Oral | Chartwell Governmental & Specialty RX, LLC. | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 200 mg/10 mL | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 100 mg/5 mL | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 200 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 200 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 200 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 200 mg | Oral | AvPAK | ANDA | View NDC → |
| 200 mg | Oral | Bionpharma Inc., | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 200 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 200 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 200 mg | Oral | direct rx | ANDA | View NDC → |
| 200 mg | Oral | Golden State Medical Supply, Inc. × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 200 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 100 mg | Oral | Nivagen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Nivagen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 200 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 200 mg | Oral | Remedyrepack Inc. × 5 listings | ANDA | View NDC → |
| 200 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
| 100 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 200 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 200 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
Showing 83 of 155 products — FDA National Drug Code Directory. See every product, package size and price: browse all 155 Carbamazepine NDCs →
Carbamazepine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Carbamazepine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Carbamazepine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Carbamazepine FDA approval history
How Carbamazepine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Carbamazepine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 4 Carbamazepine recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Markete… Lots: Lot #: a) GS067429, GS068091, Exp 5/31/2028; b) GS067430, GS068090, Exp 5/31/2028 FDA record D-0771-2026 →
- Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC… Lots: Lot #: 1024078, Exp. Date 08/31/2026 FDA record D-0675-2025 →
- Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 079… Lots: Batch: 4J11G002 Exp. 08/2024 FDA record D-0365-2022 →
- Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking R… Lots: Lot R01562; Exp. 10/2022 FDA record D-0807-2021 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2002 6 dose forms · 17 strengths
-
Dose form (SCDF) Chewable Tablet RxCUI 371257In current FDA listings -
Dose form (SCDF) Extended Release Oral Capsule RxCUI 485799In current FDA listingsClinical drug / strength (SCD) 12 HR carbamazepine 100 MGRxCUI 38831112 HR carbamazepine 200 MGRxCUI 20013312 HR carbamazepine 300 MGRxCUI 200131 -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 438301In current FDA listingsClinical drug / strength (SCD) 12 HR carbamazepine 100 MGRxCUI 19937812 HR carbamazepine 200 MGRxCUI 40250512 HR carbamazepine 400 MGRxCUI 402506150 MGRxCUI 434286300 MGRxCUI 434285600 MGRxCUI 434287 -
Dose form (SCDF) Oral Suspension RxCUI 371259In current FDA listingsClinical drug / strength (SCD) 20 MG/MLRxCUI 308976 -
Dose form (SCDF) Oral Tablet RxCUI 371260In current FDA listings -
Dose form (SCDF) Rectal Suppository RxCUI 371258No current FDA listingClinical drug / strength (SCD) 125 MGRxCUI 103941250 MGRxCUI 103942
Look up RxCUI 2002 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Carbamazepine supply and shortage status
Whether Carbamazepine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Carbamazepine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Extended Release · Oral | 200 mg | $3.25 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 100 mg | $1.63 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 400 mg | $6.49 per tablet | NDC details & price history |
| Tablet · Oral | 200 mg | $3.04 per tablet | NDC details & price history |
| Capsule, Extended Release · Oral | 300 mg | $4.70 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 200 mg | $1.05 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 100 mg | $3.65 per capsule | NDC details & price history |
| Suspension · Oral | 100 mg/5 mL | $0.437 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Carbamazepine brand names
Carbamazepine is sold under 7 brand names in the FDA directory — Carbatrol, Epitol, Equetro, Tegretol and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Carbamazepine: manufacturers and labelers
44 companies list Carbamazepine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Remedyrepack Inc., Sun Pharmaceutical Industries, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 20 more on the FDA NDC directory.
Carbamazepine drug class (RxNorm)
Carbamazepine belongs to the Mood Stabilizer class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Carbamazepine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Validus Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →