TEGRETOL-XR (carbamazepine)
TEGRETOL-XR is indicated for the treatment of Epilepsy; Partial Seizures; Generalized Tonic-Clonic Seizures; Trigeminal Neuralgia; Glossopharyngeal Neuralgia.
How TEGRETOL-XR Works
While the precise mechanism of action remains unknown, carbamazepine is chemically distinct from other anticonvulsants and exerts its effects by modulating neural responses. It acts by reducing polysynaptic responses and blocking post-tetanic potentiation within the nervous system. The drug also depresses thalamic potential and various bulbar and polysynaptic reflexes. Additionally, its principal metabolite, carbamazepine-10, 11-epoxide, has demonstrated anticonvulsant activity in animal models.
Details
- Status
- Prescription
- First Approved
- 1996-03-25
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
TEGRETOL-XR Approval History
What TEGRETOL-XR Treats
5 indicationsTEGRETOL-XR is approved for 5 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Partial Seizures
- Generalized Tonic-Clonic Seizures
- Trigeminal Neuralgia
- Glossopharyngeal Neuralgia
TEGRETOL-XR Boxed Warning
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 S...
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
TEGRETOL-XR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TEGRETOL-XR
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Clinical Trial Registry
55 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07570082 | CRN04894-131 | Ph 1 | recruiting | Drug-Drug Interaction Study of Atumelnant in Healthy Participants |
| NCT07446400 | 359-201-00015 | Ph 1 | recruiting | A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together |
| NCT06909162 | INCB123667-102 | Ph 1 | recruiting | A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants |
| NCT07449390 | AP31969-M103 | Ph 1 | active not recruiting | Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole |
| NCT07542847 | 323-201-00007 | Ph 1 | completed | A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women |
| NCT07198035 | C4551007 2025-522331-34-00 | Ph 1 | completed | A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144 |
| NCT07395024 | 3082-CL-0102 | Ph 1 | recruiting | A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults |
| NCT05248945 results posted | MS200527_0108 2021-003381-13 | Ph 1 | completed | DDI Study of Evobrutinib and Carbamazepine |
| NCT04840888 results posted | 18204 J2J-MC-JZLD | Ph 1 | completed | A Study of LY3484356 in Healthy Female Participants |
| NCT06028464 results posted | 1479-0011 2022-503046-50-00 | Ph 1 | completed | A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood |
| NCT07100964 | 1305-0119 2025-521279-30-00, U1111-1320-6353 | Ph 1 | completed | A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood |
| NCT06547164 | D8532C00006 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants |
| NCT06071442 | D7841C00012 ALXN2050-HV-111 | Ph 1 | completed | Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine |
| NCT06914869 | X4P-001-004 | Ph 1 | completed | Drug-Drug Interaction Potential of Mavorixafor |
| NCT06847464 | EDP 323-005 | Ph 1 | completed | A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323. |
| NCT06633419 | 5684-012 MK-5684-012 | Ph 1 | completed | A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012) |
| NCT06671405 | D7960C00011 | Ph 1 | completed | An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions |
| NCT06345794 | DCE853103 J5C-MC-FOAG, DCE853103 | Ph 1 | completed | A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants |
| NCT05552196 | CR109254 2022-000502-97, 67896153MSC1001 | Ph 1 | completed | A Study of Ponesimod in Healthy Adult Participants |
| NCT05840952 | ALG-097558-701 | Ph 1 | completed | 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 |
| NCT06596668 | 3543-020 MK-3543-020 | Ph 1 | completed | Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020) |
| NCT06751017 | 2315T1612 | Ph 1 | completed | A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants |
| NCT06849219 | NO.F.2-81/2024-GENL/77/JPMC | Ph 4 | active not recruiting | Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia |
| NCT06672900 | ALG-000184-204 | Ph 1 | active not recruiting | A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers |
| NCT05860933 | LOXO-RAS-22002 J3M-OX-JZQD | Ph 1 | completed | A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants |
| NCT06370728 | 18621 J2A-MC-GZPJ | Ph 1 | completed | A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants |
| NCT06348888 | 22250 | Ph 1 | completed | A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants |
| NCT05965219 | CVL-231-HV-1010 | Ph 1 | completed | A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants |
| NCT05213481 results posted | MS200095_0051 2021-003546-20 | Ph 1 | completed | Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants |
| NCT06005688 PK | C4891011 2023-505881-27 | Ph 1 | completed | A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants |
| NCT05932303 | IM027-1007 | Ph 1 | completed | A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants |
| NCT04962230 results posted | C4671014 | Ph 1 | completed | Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir |
| NCT05994807 | DCE806103 | Ph 1 | completed | A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants |
| NCT05824143 | CVL-865-HV-1003 | Ph 1 | completed | Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants |
| NCT04330248 | CR108763 2019-003473-26, 42756493NAP1001 | Ph 1 | completed | A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants |
| NCT05594602 | EDP 235-002 | Ph 1 | completed | Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects. |
| NCT05581823 | CVL-751-1005 | Ph 1 | completed | Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants |
| NCT02623504 | VAL-EQP-001 | Ph 4 | terminated | DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder |
| NCT05205447 | LOXO-IDH-21005 I9Y-OX-JDHF | Ph 1 | terminated | Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants |
| NCT05028608 | 21667 2021-000309-26 | Ph 1 | completed | A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years. |
| NCT02870283 results posted | 09-013 | Ph 4 | completed | Cost- Effectiveness and Quality of Life Assessment in Mood Disorder |
| NCT04610879 CASTLE | CASTLE 2018-003893-29, RP-PG-0615-20007 | Ph 4 | terminated | Changing Agendas on Sleep, Treatment and Learning in Epilepsy |
| NCT01707407 DDI | CC-4047-CP-008 | Ph 1 | completed | A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects |
| NCT02912364 results posted | 34098 | Ph 4 | completed | Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02705768 | T/IM -NF/Pharm/15/30 | Ph 4 | completed | Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures |
| NCT01954121 results posted | N01364 | Ph 3 | completed | Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures |
| NCT01089855 | CTEG111ZMA01 | Ph 4 | completed | Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain |
| NCT02214615 results posted | SW0023 | Ph 4 | completed | Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations |
| NCT01365403 | BP25263 | Ph 1 | completed | A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers |
Showing 50 of 55 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TEGRETOL-XR FDA Label Details
Indications & Usage
FDA Label (PDF)TEGRETOL-XR is indicated for the treatment of Epilepsy; Partial Seizures; Generalized Tonic-Clonic Seizures; Trigeminal Neuralgia; Glossopharyngeal Neuralgia.
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 PE...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.