LOW-VOLUME · HOSP-MID
rufinamide Side Effects
rufinamide (also sold as Banzel) is a LOW-VOLUME FAERS extract #440 of 524 by FAERS report count. Still opens on HOSP-MID: 27.3% mention hospitalization (675 reports).
Data updated 2026-05-15
- 2,477
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
rufinamide: 27.3% mention hospitalization (675 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #440 of 524 by FAERS report count.
Thinner FAERS extract for rufinamide (Banzel) (2,477 reports #440 of 524 by FAERS report count). 27.3% mention hospitalization (675 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2007–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
SEIZURE leads 611 of 2,477 reports
Who reports · age peak 0-17 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 0-17 (655 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (142 reports, 5.7%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 68 |
| 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
Hospitalization mid-share (675, 27.3%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| SEIZURE | 178 |
| 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 |
How to read rufinamide FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-MID)
FAERS holds 2,477 voluntary reports linked to rufinamide (Banzel), 2007-2025. Death is listed on 142 (5.7%). Hospitalization appears on 675 (27.3%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with rufinamide
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 2,477 FAERS cases (Δ 0 heavier vs rufinamide); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,450 FAERS cases (Δ 27 lighter vs rufinamide); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,439 FAERS cases (Δ 38 lighter vs rufinamide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,425 FAERS cases (Δ 52 lighter vs rufinamide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 56.4 pp vs rufinamide's DEATH-HEAVY): CASELOAD · HOSP-MID.
rufinamide stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.