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.
How to Take It
Take Banzel with food. If you take the tablets, you can swallow them whole, break them in half, or crush them. If you take the liquid form, shake it well before each dose. Use the special syringe that comes with the medicine to measure your dose.
This is a plain-language summary of rufinamide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Banzel may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. There is no information about the safety of Banzel in breast milk.
This is a plain-language summary of rufinamide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of rufinamide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store the tablets and liquid at room temperature (77ºF). Keep them away from moisture and heat.
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
- Sleepiness 172
Sleepiness
172 reports
- Diarrhea 114
Diarrhea
114 reports
- Condition got worse 113
Condition got worse
113 reports
- Vomiting 102
Vomiting
102 reports
- Tiredness 101
Tiredness
101 reports
- Medicine interaction 99
Medicine interaction
99 reports
- Resistance to multiple medicines 91
Resistance to multiple medicines
91 reports
- Fall 82
Fall
82 reports
- Loss of appetite 81
Loss of 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) 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.
What to do: No specific dosage changes for lamotrigine are usually needed when taking these together, but you should continue to follow your doctor's prescribed schedule.
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.
What to do: You can likely take these together without adjusting the dose of topiramate, though you should always keep your doctor informed of all medications you take.
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.
What to do: No special dose adjustments for carbamazepine are typically required when starting rufinamide.
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.
What to do: Your doctor likely does not need to change your phenytoin dose because of rufinamide, but they will continue to monitor your overall seizure control.
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.
What to do: Your doctor may need to adjust the doses of both medications to ensure they are safe and effective. Watch for increased sleepiness or changes in seizure control.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is rufinamide safe during pregnancy?
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.
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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 →
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: December 15, 2022
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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