Prescription medicine
Rufinamide Brand names: Banzel
Rufinamide (Banzel) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.203 per mL (Rufinamide 40 mg/mL suspension) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the rufinamide FDA label on DailyMed (effective December 15, 2022, Eisai Inc.); the NDA 21911 record on Drugs@FDA; every rufinamide label on DailyMed.
Highlights of the record
FDA label of December 15, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageI NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
Forms and strengths
- 200 mg
- 400 mg
- 40 mg/ml
Film-coated tablet; suspension; tablet.
On the market
- Earliest approval on file
- November 14, 2008 Banzel, Eisai Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first May 16, 2016; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 11 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.203 per mL Rufinamide 40 mg/mL suspension
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2021 0 Class I among all firms' recalls; latest March 13, 2025
- FAERS reports
- 2,575 through July 30, 2026
What is rufinamide used for?
From the label: indications and usageI NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults
Source: FDA drug label (Banzel), Eisai Inc., effective December 15, 2022 (SPL set 0a3fa925-1abd-458a-bd57-4ae780a1ef2d), via openFDA; the full label on DailyMed
What does the patient leaflet for rufinamide 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 BANZEL?Do not stop taking BANZEL without first talking to your healthcare provider. Stopping BANZEL suddenly can cause serious problems. BANZEL can cause serious side effects, including: 1. Like other antiepileptic drugs, BANZEL 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 attempt to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 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. Do not stop BANZEL without first talking to a healthcare provider. Stopping BANZEL suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). 2. BANZEL may cause you to feel sleepy, tired, weak, dizzy, or have problems with coordination and walking.
From the patient leaflet: What should I avoid while taking BANZEL?Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking BANZEL until you talk to your healthcare provider. BANZEL taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive, operate heavy machinery, or do other dangerous activities until you know how BANZEL affects you. BANZEL can slow your thinking and motor skills.
From the patient leaflet: How should I store BANZEL?Store BANZEL tablets and oral suspension at 59ºF to 86ºF (15ºC to 30ºC). Tablets Keep BANZEL tablets in a dry place. Oral Suspension Replace the cap securely after opening. Keep BANZEL Oral Suspension in an upright position. Use BANZEL Oral Suspension within 90 days of first opening the bottle. Keep BANZEL and all medicines out of the reach of children. General Information about the safe and effective use of BANZEL Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BANZEL for a condition for which it was not prescribed. Do not give BANZEL to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about BANZEL. If you would like more information, talk with your doctor. […]
Source: FDA drug label (Banzel), Eisai Inc., effective December 15, 2022 (SPL set 0a3fa925-1abd-458a-bd57-4ae780a1ef2d), via openFDA; the full label on DailyMed
Is there a generic for rufinamide (Banzel)?
The FDA approved the first generic rufinamide on May 16, 2016. 15 generic applications are approved; 15 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 rufinamide from 11 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.
- 2008 earliest approval on file
- 2016 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for rufinamide (Banzel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.203 per mL (Rufinamide 40 mg/mL suspension), down 45% from $0.368 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.
- Rufinamide 40 mg/mL suspension (generic)
- Banzel 40 mg/mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rufinamide 200 mg tablet | Generic | $0.881 per tablet | $26.43 | -39% |
| Rufinamide 40 mg/mL suspension | Generic | $0.203 per mL | n/a | -45% |
| Rufinamide 400 mg tablet | Generic | $1.39 per tablet | $41.74 | -12% |
| Banzel 200 mg tablet | Brand | $12.61 per tablet | $378.31 | no change |
| Banzel 40 mg/mL suspension | Brand | $3.65 per mL | n/a | -0.2% |
| Banzel 400 mg tablet | Brand | $25.18 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $755.48 | -0.5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has rufinamide been recalled?
The FDA's Enforcement Report lists 4 recalls naming rufinamide since 2021: 0 Class I (the most serious), 4 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| July 21, 2023 | Class II | Aurobindo Pharma USA Inc. | cGMP deviations: Batch was released prior to approval. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rufinamide label say about other medicines?
The rufinamide label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name rufinamide. 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 | AED Co-administered: Carbamazepine; Influence of Rufinamide on AED concentration a): Decrease by 7 to 13% b); Influence of AED on Rufinamide concentration: Decrease by 19 to 26% Dependent on dose of carbamazepine |
| Lamotrigine | drug interactions | AED Co-administered: Lamotrigine; Influence of Rufinamide on AED concentration a): Decrease by 7 to 13% b); Influence of AED on Rufinamide concentration: No Effect |
| Phenobarbital | drug interactions | AED Co-administered: Phenobarbital; Influence of Rufinamide on AED concentration a): Increase by 8 to 13% b); Influence of AED on Rufinamide concentration: Decrease by 25 to 46% c) ’ d) Independent of dose or concentration of phenobarbital |
| Phenytoin | drug interactions | AED Co-administered: Phenytoin; Influence of Rufinamide on AED concentration a): Increase by 7 to 21% b); Influence of AED on Rufinamide concentration: Decrease by 25 to 46% c) ’ d) Independent of dose or concentration of phenytoin |
| Primidone | drug interactions | AED Co-administered: Primidone; Influence of Rufinamide on AED concentration a): Not Investigated; Influence of AED on Rufinamide concentration: Decrease by 25 to 46% c) ’ d) Independent of dose or concentration of primidone |
| Topiramate | drug interactions | AED Co-administered: Topiramate; Influence of Rufinamide on AED concentration a): No Effect; Influence of AED on Rufinamide concentration: No Effect |
Other labels that name rufinamide
Source: FDA drug label (Banzel), Eisai Inc., effective December 15, 2022 (SPL set 0a3fa925-1abd-458a-bd57-4ae780a1ef2d), via openFDA; the full label on DailyMed
What do FAERS reports show for rufinamide?
The FDA Adverse Event Reporting System holds 2,575 reports that list rufinamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 151 are coded as a death and 714 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 next?
- Rufinamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other