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Cenobamate

Cenobamate is a prescription anti-seizure medicine used to treat partial-onset seizures in adults.

Brand names XcopriXcopri Titration PackXcopri Maintenance Pack
Drug class Sodium Channel Antagonists
Rx Schedule CV Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 1 clinical label set 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 →

✓No current FDA shortage listed · checked Oct 5, 2026
Cenobamate at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Cenobamate (Xcopri) is a once-daily anti-seizure medicine for partial-onset seizures in adults that calms overactive nerves by blocking sodium channels and boosting GABA (a calming brain chemical); on the market since about 2020, it is usually added when other seizure medicines have not done enough. Sleepiness, dizziness, fatigue and double vision are common, mostly as the dose climbs, and often ease once it settles. The one rule not to bend is the slow, every-two-weeks dose increase, since rushing it led to DRESS, a serious allergic reaction, so report rash with fever or swollen glands. Also flag yellow skin, dark urine or mood changes, and never stop it suddenly.

Clinical pearls

  • Hormonal birth control may work less well on cenobamate, so add a condom or switch to a non-hormonal method.
  • If you also take phenytoin, phenobarbital, clobazam, lamotrigine or carbamazepine, expect your neurologist to adjust those doses.
  • Alcohol stacks with cenobamate’s sleepiness and dizziness, so hold off on driving until you know how the climbing doses affect you.
  • Trouble swallowing is no barrier, since the tablets can be crushed and mixed with water, and food does not matter.
How you get itPrescription only
Comes asTablet
Earliest FDA record2019
Companies listing it with the FDA1
FDA label last updatedSep 25, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Cenobamate, written from its FDA label.

What Cenobamate is used for

▾

Cenobamate is used for one condition.

  • Xcopri (cenobamate tablets) treats partial-onset seizures in adults.

How Cenobamate works

▾

The exact way cenobamate works against seizures is unknown. It reduces repeated firing of nerve cells by blocking voltage-gated sodium currents. It also enhances the calming effect of GABA at the GABA-A channel.

Cenobamate dosage

▾

Xcopri is taken by mouth once a day, with or without food. Treatment begins at a low dose and is increased slowly, about every two weeks. Do not go faster than the schedule.

  • Tablets can be swallowed whole.
  • They can also be crushed and mixed with water, then drunk right away or given through a stomach tube.
  • If you stop, the dose should be lowered gradually over at least 2 weeks unless safety problems require stopping quickly.

Follow your prescriber and the label.

Dosing details from the FDA-approved label

From the Cenobamate 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.

  • Partial-onset seizures in adults (monotherapy and adjunctive therapy)
    • Initial 12.5 mg once daily in Week 1 and 2
    • 25 mg once daily in Week 3 and 4
    • 50 mg once daily in Week 5 and 6
    • 100 mg once daily in Week 7 and 8
    • 150 mg once daily in Week 9 and 10
    • Maintenance 200 mg once daily from Week 11 and thereafter
    • Taken orally once daily with or without food
    • If needed based on clinical response and tolerability, dose may be incre
    • Maximum: 400 mg once daily
    • The recommended titration schedule should not be exceeded; if discontinued, reduce gradually over at least 2 weeks unless safety concerns require abrupt withdrawal
  • Patients with mild to moderate (Child-Pugh Class A to B) hepatic impairment
    • Maximum recommended dosage is 200 mg once daily
    • Maximum: 200 mg once daily
    • Not recommended in severe (Child-Pugh Class C) hepatic impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Prior to initiating XCOPRI, obtain serum transaminases (ALT and AST) and total bilirubin, if not recently available (i.e., within 3 months), to establish baseline liver function. ( 2.1 , 5.4 ) The recommended initial dosage of XCOPRI is 12.5 mg once daily, titrated to the recommended maintenance dosage of 200 mg once daily. The recommended titration schedule should not be exceeded. The maximum dosage is 400 mg once daily. ( 2.2 ) Hepatic impairment: For patients with mild or moderate hepatic impairment, the maximum recommended dosage is 200 mg once daily. ( 2.3 , 8.7 , 12.3 ) XCOPRI can be taken whole or the tablets can be crushed. The crushed tablet can be mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. ( 2.4 ) 2.1 Assessments Prior to Initiating XCOPRI Liver Function Tests Prior to initiating XCOPRI, obtain serum transaminases (ALT and AST) and total bilirubin, if not recently available (i.e., within 3 months), to establish baseline liver function [see Warnings and Precautions ( 5.4 )] . For patients with baseline hepatic impairment, dosage modifications are recommended [see Dosage and Administration ( 2.3 )] . 2.2 Recommended Dosage Monotherapy and Adjunctive Therapy XCOPRI is administered orally once daily with or without food. The recommended dosage and titration, which should not be exceeded because of the potential for serious adverse reactions [see Warnings and Precautions ( 5.2 )] , is included in Table 1 . Table 1: Recommended Dosage for Partial-Onset Seizures in Adults Initial Dosage Week 1 and 2 12.5 mg once daily Titration Regimen Week 3 and 4 25 mg once daily Week 5 and 6 50 mg once daily Week 7 and 8 100 mg once daily Week 9 and 10 150 mg once daily Maintenance Dosage Week 11 and thereafter 200 mg once daily Maximum Dosage If needed based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg once daily every two weeks to 400 mg. 400 mg once daily 2.3 Recommended Dosage in Patients with Hepatic Impairment For patients with mild to moderate (Child-Pugh Class A to B) hepatic impairment, the maximum recommended dosage is 200 mg once daily [see Use in Specific Populations ( 8.7 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Cenobamate side effects

▾

The most common side effects in studies were:

Common side effects

  • Sleepiness
  • Dizziness
  • Fatigue
  • Double vision
  • Headache
  • Nausea
  • Balance or walking problems

When to get medical help

  • Fever, rash, swollen glands or facial swelling, possibly with other symptoms. These can signal a serious allergic reaction called DRESS. Get evaluated right away.
  • Unexplained nausea, vomiting, belly pain on the upper right side, loss of appetite, yellow skin or eyes, or dark urine. These can be signs of liver injury.
  • New or worse depression, suicidal thoughts, or unusual mood or behavior changes.
  • Heavy sleepiness, trouble with coordination, confusion, or vision changes that interfere with daily life.
  • More seizures after reducing or stopping the medicine.

Other effects included nausea, balance problems, and blurred vision. Many of these were more common at higher doses. Seek help for rash with fever, signs of liver injury, mood changes, or suicidal thoughts.

Cenobamate warnings and precautions

▾
  • DRESS (serious allergic reaction): fever, rash, swollen glands, or facial swelling, sometimes with organ involvement. Rapid dose increases were linked to cases, including one death. The drug is stopped if no other cause is found.
  • Liver injury: serious cases, including liver failure needing transplant, were reported after approval. Liver tests are checked before starting.
  • QT shortening: can affect heart rhythm. It is not for people with familial short QT syndrome.
  • Suicidal thoughts: a risk with all anti-seizure medicines.
  • Sleepiness, dizziness, thinking and vision problems: avoid driving until you know how it affects you.
  • Stopping suddenly: can increase seizures.

Cenobamate interactions

▾

Cenobamate changes the levels of several other medicines.

  • Phenytoin: levels rise, so the dose may be reduced.
  • Phenobarbital and clobazam: levels rise, so doses may be reduced.
  • Lamotrigine and carbamazepine: levels fall, so doses may be raised.
  • Hormonal birth control: may be less effective, so add a non-hormonal method.
  • Alcohol and sedating medicines: add to sleepiness and sedation.
  • Other QT-shortening drugs: may add to the effect.
  • CYP2B6, CYP3A, and CYP2C19 substrates: levels can change, so doses may need adjusting.

Interactions listed in the FDA-approved label

From the Cenobamate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Phenytoin: Plasma concentrations of phenytoin increase, with a potential 2-fold increase in phenytoin levels. Gradually decrease phenytoin dosage by up to 50% as XCOPRI is being titrated.
  • Phenobarbital: Plasma concentrations of phenobarbital increase, with a potential for an increase in the risk of adverse reactions. Consider a reduction in dosage of phenobarbital, as clinically appropriate, when used concomitantly with XCOPRI.
  • Clobazam (desmethylclobazam, its active metabolite): Plasma concentrations of desmethylclobazam increase, with a potential for an increase in the risk of adverse reactions. Consider a reduction in dosage of clobazam, as clinically appropriate, when used concomitantly with XCOPRI.
  • Lamotrigine: Plasma concentrations of lamotrigine decrease, with a potential for reduced efficacy. Increase the dosage of lamotrigine, as needed, when used concomitantly with XCOPRI.
  • Carbamazepine: Plasma concentrations of carbamazepine decrease, with a potential for reduced efficacy. Increase the dosage of carbamazepine, as needed, when used concomitantly with XCOPRI.
  • CYP2B6 substrates: Plasma concentrations decrease, with a potential for reduced efficacy. Increase the dosage of CYP2B6 substrates, as needed, when used concomitantly with XCOPRI.
  • CYP3A substrates: Plasma concentrations decrease, with a potential for reduced efficacy. Increase the dosage of CYP3A4 substrates, as needed, when used concomitantly with XCOPRI.
  • CYP2C19 substrates: Plasma concentrations increase, with a potential for an increase in the risk of adverse reactions. Consider a reduction in dosage of CYP2C19 substrates, as clinically appropriate, when used concomitantly with XCOPRI.
  • Oral contraceptives: Plasma concentrations decrease, and effectiveness of hormonal oral contraceptives may be reduced. Women should use additional or alternative non-hormonal birth control while taking XCOPRI.
  • Drugs that shorten the QT interval: XCOPRI can shorten the QT interval. Caution should be used when administering XCOPRI and other drugs that shorten the QT interval.
Read the label’s full interactions text

7 DRUG INTERACTIONS Phenytoin: Gradually decrease phenytoin dosage by up to 50%. ( 7.1 ) Phenobarbital and Clobazam: Reduce dosage as needed when used concomitantly with XCOPRI. ( 7.1 ) Lamotrigine, Carbamazepine: Increase dosage as needed when used concomitantly with XCOPRI. ( 7.1 ) CYP2B6 and CYP3A Substrates: Increase dosage as needed when used concomitantly with XCOPRI. ( 7.1 ) CYP2C19 Substrates: Reduce dosage as needed when used concomitantly with XCOPRI. ( 7.1 ) Oral Contraceptives: Effectiveness of hormonal oral contraceptives may be reduced when administered concomitantly with XCOPRI. Women should use additional or alternative non-hormonal birth control. ( 7.1 ) 7.1 Effect of XCOPRI on Other Drugs Table 5 summarizes the effect of XCOPRI on other drugs [see Clinical Pharmacology ( 12.3 )] . Table 5: Pharmacokinetic Drug Interactions Drug or Substrate Type Effect of XCOPRI on Drug or Substrate Clinical Recommendation Antiepileptic Drugs lamotrigine ↓ plasma concentrations Because of a potential for reduced efficacy of these drugs, increase the dosage of lamotrigine or carbamazepine, as needed, when used concomitantly with XCOPRI. carbamazepine ↓ plasma concentrations phenytoin ↑ plasma concentrations Because of a potential 2-fold increase in phenytoin levels, gradually decrease phenytoin dosage by up to 50% as XCOPRI is being titrated. phenobarbital ↑ plasma concentrations Because of a potential for an increase in the risk of adverse reactions from these drugs, consider a reduction in dosage of phenobarbital or clobazam, as clinically appropriate, when used concomitantly with XCOPRI. desmethylclobazam, the active metabolite of clobazam ↑ plasma concentrations CYP2B6 Substrates ↓ plasma concentrations Because of a potential for reduced efficacy of these drugs, increase the dosage of CYP2B6 or CYP3A4 substrates, as needed, when used concomitantly with XCOPRI.

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 Cenobamate

▾
  • Do not use with a known allergy to cenobamate or familial short QT syndrome.
  • Liver problems: lower maximum dose for mild to moderate; not recommended for severe.
  • Kidney problems: use caution; not recommended in end-stage kidney disease on dialysis.
  • Pregnancy: animal studies showed harm; ask about the pregnancy registry.
  • Breastfeeding: no human data, so discuss it with your doctor.
  • Children: not established as safe or effective.
  • Older adults: cautious dosing is advised.

Cenobamate overdose

▾

Experience with overdose in humans is limited, and there is no specific antidote. Care focuses on supporting breathing and monitoring heart rate, rhythm, and vital signs. Contact a poison control center or get emergency help.

What Cenobamate does in the body

▾

Cenobamate shortens the QT interval (a measure of heart rhythm) in a dose-related way. In a study of healthy volunteers, no meaningful differences in attention, coordination, or memory tests were seen when it was taken with alcohol.

How your body processes Cenobamate

▾

At least 88% is absorbed after swallowing, and food does not meaningfully change this. Levels peak in about 1 to 4 hours, and steady levels build over about two weeks of daily dosing. The half-life is about 50 to 60 hours. The body breaks it down extensively in the liver, and most of it leaves in the urine as breakdown products. Liver impairment raises drug levels substantially.

How to store Cenobamate

▾

Store XCOPRI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) (See USP Controlled Room Temperature) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

122

Supplements & herbs that interact with Cenobamate

122 supplements and herbal products have documented interactions with Cenobamate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 99
  • Minor · 16
Every supplement checked against Cenobamate — ranked by severity The full interaction hub: 7 major · 99 moderate · 16 minor · every one linked to its full report. Check Cenobamate against your exact supplements

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.

1

Nutrient depletion considerations

Cenobamate has been associated with lower levels of 1 nutrient 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.

See the full Cenobamate nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Cenobamate: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Cenobamate — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

▾
Cenobamate, sold as Xcopri, treats partial-onset seizures in adults. These are seizures that begin in one part of the brain. Your prescriber will tailor how you use it.

Why does the dose go up so slowly?

▾
Raising the dose slowly lowers the chance of a serious allergic reaction called DRESS. Cases, including one death, happened with fast increases. Please stick to the schedule your prescriber gives you.

What side effects should I expect?

▾
Sleepiness, dizziness, tiredness, double vision, and headache are the most common. Be careful with driving until you know how it affects you. Call your doctor if these are hard to manage.

When should I call my doctor right away?

▾
Call for fever with a rash, swollen glands, or facial swelling. Also call for yellow skin or eyes, dark urine, upper right belly pain, or unexplained nausea and vomiting. Tell them right away about new depression or thoughts of self-harm.

Can I drink alcohol or take birth control with it?

▾
Alcohol and other sedating medicines can add to sleepiness, so be careful. Cenobamate may make hormonal birth control less effective, so use an extra or non-hormonal method too.

Can I stop it if I feel better?

▾
Please don't stop on your own. Stopping suddenly can bring on more seizures. Your doctor will lower the dose gradually over at least 2 weeks.

Is Cenobamate available over the counter?

▾
No. Cenobamate is a prescription medicine: every Cenobamate product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Cenobamate a controlled substance?

▾
Yes — Cenobamate is a federally controlled substance (Schedule V) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Cenobamate first available?

▾
The earliest FDA record we hold for Cenobamate is from 2019: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Cenobamate was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Cenobamate on HelloPharmacist

Detailed data & references for Cenobamate Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Cenobamate forms and strengths (how it comes)

Cenobamate is available in 1 form. 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.

Tablet

By mouth
Brands Xcopri
How this form is used
What it may be used for
  • Xcopri is used to treat partial-onset seizures in adults.
Important instructions
  • Xcopri is taken by mouth once daily, with or without food.
  • Xcopri tablets can be taken whole or crushed.
  • Crushed Xcopri can be mixed in water and drunk right away, or given through a nasogastric (stomach) tube.
  • Do not store the Xcopri and water mixture for later use.
Available strengths 6 strengths
20 FDA-listed product records ⓘ

Cenobamate on the U.S. market: products, makers and brands

How Cenobamate 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.

1 company lists 11 Cenobamate product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Xcopri, Xcopri Titration Pack, Xcopri Maintenance Pack; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
3
Brand names
11
FDA-listed product records ⓘ
2019
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Kit (20) · Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Cenobamate is used (Medicaid data)

A general measure of how commonly Cenobamate 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 Cenobamate 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.

139,992
Medicaid prescriptions filled (Q1–Q4 2025)
$198.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cenobamate prescribed? Of the 1,601 medications we measure, Cenobamate ranks #452 by Medicaid prescriptions — more than 72% of them.

Where Cenobamate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cenobamate 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.

The 200 mg oral tablet is the most-dispensed Cenobamate product — about 37% of these Medicaid prescriptions.

cenobamate 200 MG Oral Tablet Most dispensed

51,265 Medicaid prescriptions (Q1–Q4 2025) 37% of Cenobamate prescriptions shown $73.6M gross reimbursement (before rebates) ≈ $1,436 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2283511

cenobamate 100 MG Oral Tablet

28,529 Medicaid prescriptions (Q1–Q4 2025) 20% of Cenobamate prescriptions shown $40.1M gross reimbursement (before rebates) ≈ $1,407 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2283503

cenobamate 150 MG Oral Tablet

23,589 Medicaid prescriptions (Q1–Q4 2025) 17% of Cenobamate prescriptions shown $38M gross reimbursement (before rebates) ≈ $1,610 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2283507

cenobamate 50 MG Oral Tablet

19,813 Medicaid prescriptions (Q1–Q4 2025) 14% of Cenobamate prescriptions shown $28.5M gross reimbursement (before rebates) ≈ $1,437 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2265695

cenobamate 25 MG Oral Tablet

5,389 Medicaid prescriptions (Q1–Q4 2025) 4% of Cenobamate prescriptions shown $8.4M gross reimbursement (before rebates) ≈ $1,567 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2283522

Other Cenobamate products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

11,407 Medicaid prescriptions (Q1–Q4 2025) 8% of Cenobamate prescriptions shown $9.8M gross reimbursement (before rebates) ≈ $860 per prescription (gross)

Summed across the 5 of 16 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 Cenobamate, 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 10 of 22 listed Cenobamate NDCs with Medicaid activity.

Compare Cenobamate products

A representative set of FDA-listed product records for Cenobamate — 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
💊Tablet
12.5 mg Oral SK Life Science, Inc. NDA View NDC →
25 mg Oral SK Life Science, Inc. NDA View NDC →
50 mg Oral SK Life Science, Inc. NDA View NDC →
100 mg Oral SK Life Science, Inc. NDA View NDC →
150 mg Oral SK Life Science, Inc. NDA View NDC →
200 mg Oral SK Life Science, Inc. NDA View NDC →
💊Kits
— Oral SK Life Science, Inc. × 5 listings NDA View NDC →

Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Cenobamate NDCs →

Cenobamate 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 Cenobamate — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Cenobamate are seizure, fatigue, somnolence; about 38% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

8,296
Reports mentioning it
38%
Reported as serious
12
Distinct effects shown
Most reported effects
Seizure
2,450
Fatigue
831
Somnolence
807
Dizziness
653
Fall
458
Headache
380
Drug Interaction
354
Feeling Abnormal
297
Gait Disturbance
281
Balance Disorder
255
Age groups
Adult · 143Elderly · 10Child · 9Neonate · 5Adolescent · 5Infant · 3

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 Cenobamate 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.

Cenobamate FDA approval history

How Cenobamate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Cenobamate was first approved by the FDA in 2019 (Brand: XCOPRI · Sk Life). It remains available in U.S. pharmacies today.

2019
Brand approved
Brand: XCOPRI · Sk Life
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Cenobamate 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 no Cenobamate recalls since July 2021.

✅No Cenobamate recalls on record since July 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.

Ingredient (IN) Cenobamate RxCUI 2265690 1 dose form · 6 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2265694 In current FDA listings
    Clinical drug / strength (SCD) 12.5 MG RxCUI 2283520 25 MG RxCUI 2283522 50 MG RxCUI 2265695 100 MG RxCUI 2283503 150 MG RxCUI 2283507 200 MG RxCUI 2283511

Look up RxCUI 2265690 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.

💵 What Cenobamate 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.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 25 mg $39.88 per tablet NDC details & price history
Tablet, Film Coated · Oral 50 mg $39.86 per tablet NDC details & price history
Tablet, Film Coated · Oral 100 mg $39.87 per tablet NDC details & price history
Tablet, Film Coated · Oral 150 mg $39.86 per tablet NDC details & price history
Tablet, Film Coated · Oral 200 mg $39.88 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full 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.

Cenobamate brand names

Cenobamate is sold under 3 brand names in the FDA directory — Xcopri, Xcopri Titration Pack, Xcopri Maintenance Pack. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Xcopri Xcopri Titration Pack Xcopri Maintenance Pack

Who makes Cenobamate: manufacturers and labelers

One company lists Cenobamate products with the FDA. By number of product records, the largest are SK Life Science, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

SK Life Science, Inc. 11

Cenobamate drug class (RxNorm)

Cenobamate belongs to the Other antiepileptics class.

Drug family (ATC) Other antiepileptics
How it works Sodium Channel Antagonists, Cytochrome P450 2B6 Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inducers

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 Cenobamate 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.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 25, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cenobamate.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cenobamate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
11
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
SK Life Science, Inc.
Linked label effective
Sep 25, 2025
Composite sections available
25
Linked SPL Set ID
565c2126-57ae-4e29-b443-723bbe7e2072
Linked SPL Document ID
8e4ae306-0c50-4fe9-92fd-f79be8299f4e
Open the linked representative label on DailyMed ↗

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. SK Life Science, Inc. 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 →