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rufinamide

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Brand names: Banzel

Anticonvulsant (Triazole) Rx

Banzel is a medicine used with other medicines to treat seizures. It is for people with Lennox-Gastaut Syndrome.

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.

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.

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.

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.

Storage

Store the tablets and liquid at room temperature (77ºF). Keep them away from moisture and heat.

Side Effects (from patient reports)

Based on 1,994 FDA adverse event reports.

Seizure
611
Medicine not working
374
Using medicine for unapproved condition
217
Sleepiness
172
Diarrhea
114
Condition got worse
113
Vomiting
102
Tiredness
101
Medicine interaction
99
Resistance to multiple medicines
91

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

Death-Related Reports

142

Hospitalization Reports

675

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 833 (48%)
Male 886 (51%)

Age Distribution

0–17 655
18–44 450
45–64 60
65–74 7
75+ 3

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 SEIZURE 611
2 DRUG INEFFECTIVE 374
3 OFF LABEL USE 217
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
11 PRODUCT USE IN UNAPPROVED INDICATION 83
12 FALL 82
13 DECREASED APPETITE 81
14 GENERALISED TONIC-CLONIC SEIZURE 80
15 PNEUMONIA 79

Reactions in Death Reports

DEATH 68
OFF LABEL USE 20
SEIZURE 20
RESPIRATORY FAILURE 17
SUDDEN UNEXPLAINED DEATH IN EPILEPSY 16
STATUS EPILEPTICUS 14
FATIGUE 9
AGGRESSION 8
ASTHENIA 8
BODY TEMPERATURE FLUCTUATION 8

Reactions in Hospitalization Reports

SEIZURE 178
DRUG INEFFECTIVE 80
OFF LABEL USE 70
PNEUMONIA 69
HOSPITALISATION 60
VOMITING 52
STATUS EPILEPTICUS 43
CONVULSION 35
SOMNOLENCE 35
PYREXIA 33

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 dru...

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 dru...

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 dru...

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 dru...

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 dru...

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.

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Common Questions

Can I stop taking Banzel suddenly?
No, you should not stop taking Banzel suddenly. Talk to your doctor before stopping, as this could cause more seizures.
What should I do if I experience side effects?
Tell your doctor if you have any side effects while taking Banzel.
Can I take Banzel with other medications?
Talk to your doctor about all the medicines you take, including over-the-counter drugs and supplements.
How often will I see the doctor while taking Banzel?
Your doctor will want to see you regularly to check how well the medicine is working and to monitor for side effects.
What if I have kidney problems?
Tell your doctor if you have kidney problems. Your doctor may need to adjust your dose.
What if I have liver problems?
Banzel is not recommended for people with severe liver problems. Talk to your doctor if you have liver problems.
Can Banzel affect my birth control?
Yes, Banzel can make hormonal birth control less effective. Use other forms of birth control while taking Banzel.
Is there a registry for women who take Banzel during pregnancy?
Yes, there is a pregnancy registry. You can enroll by calling 1-888-233-2334.
How will my doctor adjust my dose of Banzel?
Your doctor will slowly increase your dose of Banzel over time until the seizures are controlled.
What is the maximum dose of Banzel?
The maximum dose of Banzel is 3200 mg per day.
What are the common side effects of rufinamide?
The most commonly reported side effects of rufinamide include Headache, Dizziness, Feeling tired, Feeling sleepy, Nausea. Based on 1,994 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does rufinamide interact with other medications?
Yes, rufinamide has 13 known drug interactions. Notable interactions include lamotrigine, topiramate, carbamazepine. Always inform your doctor about all medications you are taking.
What drug class is rufinamide?
rufinamide belongs to the Anticonvulsant (Triazole) drug class. It requires a prescription (Rx). Banzel is used to treat seizures linked to Lennox-Gastaut Syndrome (LGS).
Is there a generic version of rufinamide?
Yes, generic rufinamide is available from 13 manufacturers. The generic costs $1.58 per unit compared to $12.62 for the brand version, saving approximately 87%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is rufinamide safe during pregnancy?
Banzel may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 1,994 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

All federal data sources used on this page