Rufinamide
Carboxamide Derivatives
Sold as Inovelon · BANZEL
- Drug class
- Carboxamide Derivatives
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 17
- FDA reports (12 mo)
- 153
Overview
Plain-language summary, compiled from the cited regulatory records
Rufinamide is a medication belonging to the carboxamide derivative drug class [1]. It is approved for use as an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome (LGS) in both pediatric patients aged 1 year and older, and in adults [1].
In the United States, rufinamide is marketed under the brand name Banzel [1]. In the past 12 months, there have been 153 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include seizures, off-label use, drug ineffectiveness, somnolence, and hospitalizations [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 9 | February 20, 2026 |
| CA Canada | Health Canada | 5 | March 13, 2026 |
| US United States | FDA | 2 | May 17, 2023 |
| EU European Union | EMA | 1 | April 15, 2025 |
GBUnited Kingdom· MHRA
9 products
Uses
Rufinamide Tablets are indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
How to take
CACanada· Health Canada
5 products
Uses
37 Auro-Rufinamide Product Monograph Page 3 of 40 PrAuro-Rufinamide Rufinamide Tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Non-medicinal Ingredients Oral Tablet; 200 mg and 400 mg Microcrystalline cellulose, Lactose Monohydrate, Corn Starch, Croscarmellose sodium, Hypromellose Methocel E5 LV premium, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Magnesium Stearate, titanium dioxide, polyethylene glycol, talc and iron oxide red.
INDICATIONS AND CLINICAL USE Auro-Rufinamide (rufinamide) is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years of age and older and in adults. In a placebo-controlled clinical trial of 12 weeks in duration in patients with Lennox-Gastaut syndrome, Rufinamide decreased the frequency of total seizures, tonic-atonic seizures (drop attacks), and seizure severity (see CLINICAL TRIALS).
Auro-Rufinamide is not indicated for the treatment of any other type of seizure disorder.
USUnited States· FDA
2 products
Uses
1 I 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 ( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
How to take
Drug interactions
Known interactions involving Rufinamide. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 423. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL252980397 · revised June 6, 2025
- [2]Health Canada (DPD) · 02545985 · revised March 22, 2025
- [3]FDA DailyMed · 0a3fa925-1abd-45… · revised December 15, 2022 [PDF]
- [4]European Medicines Agency · EMEA/H/C/000660 · revised April 15, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.