Prescription medicine
Eslicarbazepine Brand names: Aptiom
Eslicarbazepine (Aptiom) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $1.68 per eslicarbazepine 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the eslicarbazepine FDA label on DailyMed (effective November 10, 2023, Sumitomo Pharma America, Inc.); the NDA 22416 record on Drugs@FDA; every eslicarbazepine label on DailyMed.
Highlights of the record
FDA label of November 10, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAPTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Forms and strengths
- 200 mg
- 400 mg
- 600 mg
- 800 mg
Tablet; kit.
On the market
- Earliest approval on file
- November 8, 2013 Aptiom, Sumitomo Pharma Am; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first June 29, 2021; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 24, 2032 Aptiom tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.68 per tablet Eslicarbazepine 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,247 through July 30, 2026
What is eslicarbazepine used for?
From the label: indications and usageAPTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Conditions named in the indications of eslicarbazepine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Aptiom), Sumitomo Pharma America, Inc., effective November 10, 2023 (SPL set 3d0c9554-eaeb-4694-8089-00133fcadce3), via openFDA; the full label on DailyMed
What does the patient leaflet for eslicarbazepine 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 APTIOM?Do not stop taking APTIOM without first talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus). 1. Like other antiepileptic drugs, APTIOM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity and talking (mania) attempt to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 2. APTIOM may 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. […]
From the patient leaflet: What should I avoid while taking APTIOM?Do not drive, operate heavy machinery, or do dangerous activities until you know how APTIOM affects you. APTIOM may slow your thinking and motor skills.
From the patient leaflet: How should I store APTIOM?Store APTIOM at 68 o F to 77 o F (20 o C to 25 o C). Safely throw away medicine that is out of date or no longer needed. Keep APTIOM and all medicines out of reach of children.
Source: FDA drug label (Aptiom), Sumitomo Pharma America, Inc., effective November 10, 2023 (SPL set 3d0c9554-eaeb-4694-8089-00133fcadce3), via openFDA; the full label on DailyMed
Is there a generic for eslicarbazepine (Aptiom)?
The FDA approved the first generic eslicarbazepine on June 29, 2021. 9 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists eslicarbazepine from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 7 patents for Aptiom tablets: the compound patent runs to April 21, 2026, and the last listed entry to August 24, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2021 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for eslicarbazepine (Aptiom)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.68 per Eslicarbazepine 200 mg tablet, down 52% from $3.46 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Eslicarbazepine 200 mg tablet (generic)
- Aptiom 400 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Eslicarbazepine 200 mg tablet | Generic | $1.68 per tablet | $50.27 | -52% |
| Eslicarbazepine 400 mg tablet | Generic | $1.85 per tablet | $55.52 | -57% |
| Eslicarbazepine 600 mg tablet | Generic | $2.32 per tablet | $69.71 | -54% |
| Eslicarbazepine 800 mg tablet | Generic | $1.73 per tablet | $51.77 | -55% |
| Aptiom 200 mg tablet | Brand | $44.24 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,327.29 | +3% |
| Aptiom 400 mg tablet | Brand | $44.01 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,320.21 | +2% |
| Aptiom 600 mg tablet | Brand | $44.43 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,332.78 | +3% |
| Aptiom 800 mg tablet | Brand | $44.17 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,325.00 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the eslicarbazepine label say about other medicines?
The eslicarbazepine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name eslicarbazepine. 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 | DRUG INTERACTIONS Carbamazepine: May need dose adjustment for APTIOM or carbamazepine. |
| Clobazam | drug interactions | CYP2C19 Substrates APTIOM can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and omeprazole) [see Clinical Pharmacology ( 12.3 )]. |
| Levonorgestrel | drug interactions | Because concomitant use of APTIOM and ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones, females of reproductive potential should use additional or alternative non-hormonal birth control. |
| Lovastatin | drug interactions | In vivo studies suggest that APTIOM can induce CYP3A4, decreasing plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., simvastatin, lovastatin) [see Clinical Pharmacology ( 12.3 )]. |
| Omeprazole | drug interactions | CYP2C19 Substrates APTIOM can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and omeprazole) [see Clinical Pharmacology ( 12.3 )]. |
| Oxcarbazepine | contraindications | CONTRAINDICATIONS APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions ( 5.2 , 5.3 , and 5.4 )]. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. |
| Phenobarbital | drug interactions | Higher dosage of APTIOM may be necessary and dose adjustment may be needed for phenytoin. ( 2.3 , 7.1 , 7.2 ) Phenobarbital or Primidone: |
| Phenytoin | drug interactions | Higher dosage of APTIOM may be necessary and dose adjustment may be needed for phenytoin. ( 2.3 , 7.1 , 7.2 ) Phenobarbital or Primidone: |
| Primidone | drug interactions | Higher dosage of APTIOM may be necessary and dose adjustment may be needed for phenytoin. ( 2.3 , 7.1 , 7.2 ) Phenobarbital or Primidone: |
| Simvastatin | drug interactions | In vivo studies suggest that APTIOM can induce CYP3A4, decreasing plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., simvastatin, lovastatin) [see Clinical Pharmacology ( 12.3 )]. |
Other labels that name eslicarbazepine
Source: FDA drug label (Aptiom), Sumitomo Pharma America, Inc., effective November 10, 2023 (SPL set 3d0c9554-eaeb-4694-8089-00133fcadce3), via openFDA; the full label on DailyMed
What do FAERS reports show for eslicarbazepine?
The FDA Adverse Event Reporting System holds 3,247 reports that list eslicarbazepine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 693 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 eslicarbazepine?
18 other medicines are given the same way (oral) and in the same FDA class as eslicarbazepine 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 |
|---|---|---|---|---|
| Topiramate | Seizures and epilepsy | 47 labelers | $0.0567 per tablet 100 mg tablet | No current entry |
| Lamotrigine | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Levetiracetam | Seizures and epilepsy | 63 labelers | $0.0736 per tablet 500 mg tablet | No current entry |
| Phenobarbital | Seizures and epilepsy | none listed | $0.213 per tablet 100 mg tablet | A presentation being discontinued |
| Clonazepam | Seizures and epilepsy | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Lacosamide | Seizures and epilepsy | 43 labelers | $0.174 per tablet 100 mg tablet | No current entry |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Brivaracetam | Seizures and epilepsy | 14 labelers | $0.259 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as eslicarbazepine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does eslicarbazepine compare with medicines for the same use?
2 side-by-side pages set eslicarbazepine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to eslicarbazepine
- 18 medicines for the same use
- Eslicarbazepine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other