Prescription medicine
Oxcarbazepine Brand names: Trileptal, Oxtellar
Oxcarbazepine (Trileptal) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.167 per oxcarbazepine 300 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the oxcarbazepine FDA label on DailyMed (effective December 16, 2025, Novartis Pharmaceuticals Corporation); the NDA 21014 record on Drugs@FDA; every oxcarbazepine label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
Forms and strengths
- 150 mg
- 300 mg
- 600 mg
- 60 mg/ml
- 300 mg/5ml
Film-coated tablet; suspension; tablet; extended-release tablet; for suspension.
On the market
- Earliest approval on file
- January 14, 2000 Trileptal, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 32 first October 9, 2007; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 45 of which 43 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 13, 2027 Oxtellar XR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.167 per tablet Oxcarbazepine 300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 1 Class I among all firms' recalls; latest December 1, 2022; 3 more by firms not listed as its makers
- FAERS reports
- 31,342 through July 30, 2026
What is oxcarbazepine used for?
From the label: indications and usageTRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years
Conditions named in the indications of oxcarbazepine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anti-epileptic Agent.
Source: FDA drug label (Trileptal), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b), via openFDA; the full label on DailyMed
What does the patient leaflet for oxcarbazepine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRILEPTAL?Do not stop taking TRILEPTAL without first talking to your healthcare provider. Stopping TRILEPTAL suddenly can cause serious problems. TRILEPTAL can cause serious side effects, including: 1. TRILEPTAL may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include: • nausea • confusion • tiredness (lack of energy) • more frequent or more severe seizures • headache Similar symptoms that are not related to low sodium may occur from taking TRILEPTAL. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away. Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking. Your healthcare provider may do blood tests to check your sodium levels during your treatment with TRILEPTAL. 2. TRILEPTAL may also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following: • swelling of your face, eyes, lips, or tongue • painful sores in the mouth or around your eyes • trouble swallowing or breathing • yellowing of your skin or eyes • a skin rash • unusual brusing or bleeding • hives • severe fatigue or weakness • fever, swollen glands, or sore throat that do not go away or come and go • severe muscle pain • frequent infections or infections that do not go away Many people who are allergic to carbamazepine are also allergic to TRILEPTAL. Tell your healthcare provider if you are allergic to carbamazepine. 3. […]
From the patient leaflet: What should I avoid while taking TRILEPTAL?Do not drive or operate machinery until you know how TRILEPTAL affects you. TRILEPTAL may slow your thinking and motor skills. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking TRILEPTAL until you talk to your healthcare provider. TRILEPTAL taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
From the patient leaflet: How should I store TRILEPTAL?Store TRILEPTAL film-coated tablets and oral suspension at room temperature between 68°F to 77°F (20°C to 25°C). Keep TRILEPTAL film-coated tablets dry. Keep TRILEPTAL oral suspension in the original container and use within 7 weeks of first opening the bottle. Shake well before each use. Keep TRILEPTAL and all medicines out of the reach of children. General Information about the safe and effective use of TRILEPTAL. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRILEPTAL for a condition for which it was not prescribed. Do not give TRILEPTAL to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TRILEPTAL that is written for health professionals.
Source: FDA drug label (Trileptal), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b), via openFDA; the full label on DailyMed
Is there a generic for oxcarbazepine (Trileptal)?
The FDA approved the first generic oxcarbazepine on October 9, 2007. 32 generic applications are approved; 25 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists oxcarbazepine from 43 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Trileptal tablets; a patent listed only for Oxtellar XR tablets runs to April 13, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2007 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for oxcarbazepine (Trileptal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.167 per Oxcarbazepine 300 mg tablet, down 4% from $0.173 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Oxcarbazepine 300 mg tablet (generic)
- Trileptal 300 mg/5 mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Oxcarbazepine 150 mg tablet | Generic | $0.106 per tablet | $3.19 | -9% |
| Oxcarbazepine 300 mg tablet | Generic | $0.167 per tablet | $5.00 | -4% |
| Oxcarbazepine 300 mg/5 mL suspension | Generic | $0.110 per mL | n/a | -34% |
| Oxcarbazepine 600 mg tablet | Generic | $0.317 per tablet | $9.51 | -5% |
| Oxcarbazepine ER 150 mg tablet | Generic | $3.50 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $104.93 | -44% |
| Oxcarbazepine ER 300 mg tablet | Generic | $4.73 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $141.92 | -44% |
| Oxcarbazepine ER 600 mg tablet | Generic | $9.58 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $287.35 | -42% |
| Oxtellar XR 150 mg tablet | Brand | $9.02 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $270.74 | -2% |
| Oxtellar XR 300 mg tablet | Brand | $12.75 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $382.56 | +0.5% |
| Oxtellar XR 600 mg tablet | Brand | $23.30 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $698.97 | +0.1% |
| Trileptal 150 mg tablet | Brand | $5.72 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $171.65 | +3% |
| Trileptal 300 mg tablet | Brand | $10.45 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $313.63 | +3% |
| Trileptal 300 mg/5 mL suspension | Brand | $1.93 per mL | n/a | +3% |
| Trileptal 600 mg tablet | Brand | $19.33 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $579.98 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has oxcarbazepine been recalled?
The FDA's Enforcement Report lists 9 recalls naming oxcarbazepine since 2013: 1 Class I (the most serious), 7 Class II, 1 Class III; 1 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of oxcarbazepine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| December 1, 2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of foreign substance |
| September 9, 2019 | Class II | West-Ward Columbus Inc | Failed Impurities/Degradation Specificattion |
| July 1, 2014 | Class I | American Health Packaging | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug … |
| January 29, 2014 | Class II | Caraco Pharmaceutical Laboratories Ltd. | Failed Tablet Specifications: Broken Tablets Present. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD54562_1, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25 … |
| April 3, 2013 | Class II | Boehringer Ingelheim Roxane Inc | Resuspension Problems: Recalled lot did not meet resuspendability requirements. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the oxcarbazepine label say about other medicines?
The oxcarbazepine label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 41 other medicines name oxcarbazepine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Reduced dose of phenytoin may be required ( 7.1 ) Carbamazepine, Phenytoin, and Phenobarbital: |
| Eslicarbazepine | contraindications | CONTRAINDICATIONS TRILEPTAL is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [ see Warnings and Precautions (5.2, 5.3) ]. |
| Phenobarbital | drug interactions | Reduced dose of phenytoin may be required ( 7.1 ) Carbamazepine, Phenytoin, and Phenobarbital: |
| Phenytoin | drug interactions | DRUG INTERACTIONS Phenytoin: Increased phenytoin levels. |
| Rifampin | drug interactions | Drugs on TRILEPTAL Strong inducers of cytochrome P450 enzymes and/or inducers of UGT (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma/serum levels of MHD, the active metabolite of TRILEPTAL (25% to 49%) [see Clinical Pharmacology (12.3)]. |
Other labels that name oxcarbazepine
- Cabotegravir
- Cobicistat
- Dienogest and estradiol
- Dolutegravir
- Doravirine
- Drospirenone
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Etonogestrel
- Hydrocortisone
- Lenacapavir
- Norethindrone
- Perampanel
- Rilpivirine
- Sofosbuvir
- Tenofovir alafenamide
Source: FDA drug label (Trileptal), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b), via openFDA; the full label on DailyMed
What do FAERS reports show for oxcarbazepine?
The FDA Adverse Event Reporting System holds 31,342 reports that list oxcarbazepine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,175 are coded as a death and 9,792 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as oxcarbazepine?
20 other medicines are given the same way (oral) and in the same FDA class as oxcarbazepine or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Gabapentin | Seizures and epilepsy | 87 labelers | $0.0218 per capsule 100 mg capsule | No current entry |
| Lamotrigine | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Divalproex | Seizures and epilepsy | 44 labelers | $0.194 per tablet 500 mg tablet | No current entry |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
| Valproic acid | Seizures and epilepsy | 19 labelers | $0.243 per capsule 250 mg capsule | Listed; available |
| Phenytoin | Seizures and epilepsy | 23 labelers | $0.145 per capsule 100 mg capsule | No current entry |
| Primidone | Seizures and epilepsy | 21 labelers | $0.0914 per tablet 50 mg tablet | No current entry |
| Felbamate | Seizures and epilepsy | 9 labelers | $1.00 per tablet 600 mg tablet | No current entry |
Every medicine labeled for the same conditions as oxcarbazepine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does oxcarbazepine compare with medicines for the same use?
6 side-by-side pages set oxcarbazepine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to oxcarbazepine
- 20 medicines for the same use
- Other anti-seizure medicines
- the pharmacologic class, with prices and generics
- Oxcarbazepine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other