Prescription medication · Anticonvulsant (Triazole)
rufinamide
Also sold as Banzel. Banzel is used to treat seizures linked to Lennox-Gastaut Syndrome (LGS).
Data updated 2026-05-15
- 2,477
- FDA reportsLightly reported
- 13
- InteractionsSeveral interactions
- 87% less
- Generic vs brandHuge savings
- $12.62
- Brand price (NADAC)
What the data shows
rufinamide (Banzel) is a prescription Anticonvulsant (Triazole), among the least-reported drugs the FDA tracks (2,477 FDA reports), whose generic runs roughly half the brand price or less (87% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
rufinamide (Banzel) is a prescription Anticonvulsant (Triazole). Banzel is used to treat seizures linked to Lennox-Gastaut Syndrome (LGS).
Banzel is a medicine used with other medicines to treat seizures. It is for people with Lennox-Gastaut Syndrome.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$12.62/unit
Generic Price
$1.58/unit
Generic Savings
87%
Generic Available
Yes (13 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Banzel is used to treat seizures linked to Lennox-Gastaut Syndrome (LGS).
Common side effects
Headache, Dizziness, Feeling tired
Key warnings
Banzel can cause you to have suicidal thoughts or actions.
The sections below are summarized in plain English from rufinamide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Banzel is an anticonvulsant medicine. It is thought to work by slowing down brain activity. This helps to reduce seizures.
Side Effects (from patient reports)
Based on 2,477 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for rufinamide, by number of reports
- Seizure
Seizure
611 reports
- Somnolence 172
Somnolence
172 reports
- Diarrhoea 114
Diarrhoea
114 reports
- Condition Aggravated 113
Condition Aggravated
113 reports
- Vomiting 102
Vomiting
102 reports
- Fatigue 101
Fatigue
101 reports
- Drug Interaction 99
Drug Interaction
99 reports
- Multiple-Drug Resistance 91
Multiple-Drug Resistance
91 reports
- Fall 82
Fall
82 reports
- Decreased Appetite 81
Decreased Appetite
81 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for rufinamide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where rufinamide sits
rufinamide has more FDA adverse-event reports than 16% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is rufinamide; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 2,477 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
2,477
Reports Mentioning Death
142
5.7% of reports — not proof of cause
Hospitalization Reports
675
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | SEIZURE | 611 |
| 4 | SOMNOLENCE | 172 |
| 5 | DIARRHOEA | 114 |
| 6 | CONDITION AGGRAVATED | 113 |
| 7 | VOMITING | 102 |
| 8 | FATIGUE | 101 |
| 9 | DRUG INTERACTION | 99 |
| 10 | MULTIPLE-DRUG RESISTANCE | 91 |
| 12 | FALL | 82 |
| 13 | DECREASED APPETITE | 81 |
| 14 | GENERALISED TONIC-CLONIC SEIZURE | 80 |
| 15 | PNEUMONIA | 79 |
| 16 | DRUG RESISTANCE | 77 |
| 17 | EPILEPSY | 77 |
| 18 | CONVULSION | 76 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Banzel can cause you to have suicidal thoughts or actions. Your doctor should monitor you for depression, mood changes, or suicidal thoughts. Stop taking Banzel if you have a severe allergic reaction affecting multiple organs.
Known Drug Interactions
7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Table 6: Summary of...
Mechanism: Rufinamide does not significantly change the levels of lamotrigine in your body. These two seizure medications generally do not interfere with each other's concentration.
7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Table 6: Summary of...
Mechanism: Rufinamide has very little effect on how much topiramate stays in your system. This means the two drugs do not typically interact in a way that changes their levels.
7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Table 6: Summary of...
Mechanism: Rufinamide does not have a meaningful impact on the amount of carbamazepine in your blood. The drugs do not significantly interfere with each other's processing by the body.
7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Table 6: Summary of...
Mechanism: Rufinamide has little to no effect on the blood levels of phenytoin. These medications can usually be taken together without one changing the concentration of the other.
7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Table 6: Summary of...
Mechanism: Phenobarbital makes the body process rufinamide faster, which lowers its levels in the blood. At the same time, rufinamide slows down the removal of phenobarbital, which can cause phenobarbital levels to rise.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking Banzel suddenly?
What should I do if I experience side effects?
Can I take Banzel with other medications?
How often will I see the doctor while taking Banzel?
What if I have kidney problems?
What if I have liver problems?
Can Banzel affect my birth control?
Is there a registry for women who take Banzel during pregnancy?
How will my doctor adjust my dose of Banzel?
What is the maximum dose of Banzel?
What are the common side effects of rufinamide?
Does rufinamide interact with other medications?
What drug class is rufinamide?
Is there a generic version of rufinamide?
What pregnancy or breastfeeding source fields are listed for rufinamide?
Related Medications in Anticonvulsant (Triazole)
Other drugs grouped near rufinamide - same-class peers and common alternatives.
brivaracetam
Briviact
Brivaracetam is a medicine used to treat partial-onset seizures.
Compare with rufinamide →
cannabidiol
Epidiolex
Epidiolex is a medicine that contains cannabidiol.
Compare with rufinamide →
carbamazepine
Tegretol
Carbamazepine is a medicine used to control seizures and treat nerve pain.
Compare with rufinamide →
cenobamate
Xcopri
Xcopri is a medicine used to treat partial-onset seizures in adults.
Compare with rufinamide →
clobazam
Onfi, Sympazan
Clobazam oral suspension is a medicine used with other medicines to treat seizures caused by Lennox-Gastaut syndrome.
Compare with rufinamide →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for rufinamide: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 2,477.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 5.73%.
- potassium citrate Δ 0.01 pts · 5,207 reports · Urinary Alkalinizer 5.72%death share
- nabumetone Δ 0.04 pts · 6,319 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 5.70%death share
- selenium Δ 0.05 pts · 4,079 reports · Mineral Supplement 5.79%death share
- selegiline Δ 0.07 pts · 2,896 reports · Selective MAO-B Inhibitor 5.66%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on rufinamide
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for rufinamide
The FDA label for rufinamide (sold under brand names such as Banzel) classifies it as a prescription-only medication in the Anticonvulsant (Triazole) class. Banzel is used to treat seizures linked to Lennox-Gastaut Syndrome (LGS). Official labeling lists 5 commonly reported side effects, including Headache, Dizziness, Feeling tired.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,477 voluntary reports. The database also lists 13 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $1.58 versus $12.62 for the brand - a 87% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 15, 2022
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages