Last reviewed 2026-04-20 · How we verify

Tegretol (carbamazepine)

Tegretol (generic name: carbamazepine) is a Mood Stabilizer [EPC] Small molecule drug developed by Novartis AG (originally Geigy). It is currently FDA-approved (first approved 1968) for Partial Seizures, Generalized Tonic-Clonic Seizures, Mixed Seizure Patterns. Also known as: Tegretol, Carbatrol, Epitol.

Carbamazepine reduces polysynaptic responses and blocks post-tetanic potentiation, potentially alleviating seizures and pain.

Carbamazepine (Tegretol), marketed by Novartis AG, is a well-established treatment for partial seizures with a strong presence in the epilepsy market. Its mechanism of action, which reduces polysynaptic responses and blocks post-tetanic potentiation, provides a robust therapeutic effect for both seizures and pain. The primary risk to Tegretol's market position is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.

At a glance

Mechanism of action

Carbamazepine works by reducing excessive neuronal activity in the brain, which can lead to seizures. It does this by decreasing the number of signals that neurons send to each other (polysynaptic responses) and preventing the amplification of these signals after repeated stimulation (post-tetanic potentiation). Additionally, it can reduce pain by affecting certain nerve pathways.

Approved indications

• Partial Seizures
• Generalized Tonic-Clonic Seizures
• Mixed Seizure Patterns
• Trigeminal Neuralgia
• Glossopharyngeal Neuralgia

Boxed warnings

• WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH CARBAMAZEPINE. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH CARBAMAZEPINE UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS , LABORATORY TESTS). APLASTIC ANEMIA AND AGRANULOCYTOSIS APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5 TO 8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA. ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS. BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS.

Common side effects

• Dizziness
• Drowsiness
• Unsteadiness
• Nausea
• Vomiting
• Headache
• Fatigue
• Blurred vision
• Disturbances of coordination
• Confusion
• Gastric distress and abdominal pain
• Diarrhea

Serious adverse events

• Stevens-Johnson Syndrome (SJS)
• Toxic Epidermal Necrolysis (TEN)
• Aplastic anemia
• Agranulocytosis
• Hepatic failure
• Congestive heart failure
• Thromboembolism
• Neuroleptic malignant syndrome
• Pancreatitis
• Renal failure

Drug interactions

• Thorazine solution
• chlorpromazine solution
• liquid Mellaril
• CYP3A4 inhibitors (e.g., aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolides, fluoxetine, fluvoxamine, trazodone, omeprazole, oxybutynin, isoniazid, niacinamide, azoles, acetazolamide, verapamil, ticlopidine, grapefruit juice, protease inhibitors)
• human microsomal epoxide hydrolase inhibitors (e.g., loxapine, quetiapine, valproic acid, brivaracetam)
• CYP3A4 inducers (e.g., cisplatin, doxorubicin HCl, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline)
• agents mainly metabolized by CYP 1A2, 2B6, 2C8/9/19 and 3A4

Key clinical trials

• A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558 (Phase 1)
• Prospective Clinical Study of Nintedanib to Inhibit Endometrial Fibrosis to Prevent Recurrence of Uterine Adhesions (Phase 2)
• A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures (Phase 3)
• Phase I/II Study of Intravenous Infusion of Tetra-o-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects With Recurrent High Grade Glioma (Phase 1)
• Pharmacotherapy and Intensive Treatment (Phase 4)
• A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partia (Phase 3)
• A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder (Phase 3)
• A Phase 1, Single-Center, Open-Label, 2-Cohort, Fixed-Sequence, Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazo (Phase 1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Tegretol CI brief — competitive landscape report
• Tegretol updates RSS · CI watch RSS
• Novartis AG (originally Geigy) portfolio CI

Frequently asked questions about Tegretol

Related

• Drug class: All Mood Stabilizer [EPC] drugs
• Target: All drugs targeting Frizzled-8, Nuclear receptor subfamily 1 group I member 2, Neuronal acetylcholine receptor; alpha2/beta4
• Manufacturer: Novartis AG (originally Geigy) — full pipeline
• Therapeutic area: All drugs in Neuroscience
• Indication: Drugs for Partial Seizures
• Indication: Drugs for Generalized Tonic-Clonic Seizures
• Indication: Drugs for Mixed Seizure Patterns
• Also known as: Tegretol, Carbatrol, Epitol

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing