rufinamide Side Effects
Also known as: Banzel
Analysis of 2,477 adverse event reports submitted to the FDA from 2007 to 2025.
Total Reports
2,477
Death-Related
142
5.7% of reports
Hospitalizations
675
27.3% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 142 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | 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 |
| DEPRESSED MOOD | 8 |
| HALLUCINATION, AUDITORY | 8 |
| PSYCHOTIC DISORDER | 8 |
| ANXIETY | 7 |
| ATONIC SEIZURES | 7 |
| CARDIAC ARREST | 7 |
| CRYING | 7 |
| EMOTIONAL DISORDER | 7 |
| FEAR | 7 |
| GENERALISED ONSET NON-MOTOR SEIZURE | 7 |
Reactions in Hospitalization Reports
Top reactions in 675 reports where hospitalization was an outcome.
| Reaction | 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 |
| WEIGHT DECREASED | 33 |
| DRUG INTERACTION | 31 |
| FATIGUE | 31 |
| URINARY TRACT INFECTION | 30 |
| NAUSEA | 29 |
| PNEUMONIA ASPIRATION | 28 |
| AGGRESSION | 27 |
| RESPIRATORY FAILURE | 25 |
| CONDITION AGGRAVATED | 24 |
| DIARRHOEA | 24 |
Nearby — Related Medications
What the FAERS Data Reveals About rufinamide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,477 voluntary reports linked to rufinamide and its brand equivalents (Banzel), spanning 2007 through 2025. Of those, 142 (5.7%) listed death as an outcome and 675 (27.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 48% were female and 51% male; age distribution skews toward 0-17, with 655 reports in that bracket. The single most reported reaction is seizure with 611 submissions, followed by drug ineffective and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.