MID-VOLUME · HOSP-HEAVY
clobazam Side Effects
clobazam (also sold as Onfi, Sympazan) sits MID-VOLUME #220 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 33.9% mention hospitalization (7,829 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 23,107
- FAERS reports
FDA Adverse Event Reporting System extract for clobazam. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
clobazam: 33.9% mention hospitalization (7,829 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #220 of 524 by FAERS report count.
Mid-book FAERS page for clobazam (Onfi) (23,107 reports). Signature HOSP-HEAVY. Dominant age band on file: 0-17. Educational reference only.
Counts from the openFDA FAERS extract (2002–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
SEIZURE leads 4,619 of 23,107 reports
Who reports · age peak 0-17 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 0-17 (5,637 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,511 reports, 6.5%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 439 |
| TOXICITY TO VARIOUS AGENTS | 147 |
| CARDIAC ARREST | 107 |
| SEIZURE | 98 |
| RESPIRATORY FAILURE | 87 |
| PNEUMONIA | 83 |
| STATUS EPILEPTICUS | 79 |
| COMPLETED SUICIDE | 75 |
| METABOLIC ACIDOSIS | 75 |
| SOMNOLENCE | 71 |
| SUDDEN UNEXPLAINED DEATH IN EPILEPSY | 69 |
| ARRHYTHMIA | 61 |
| OVERDOSE | 57 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 53 |
| SEPSIS | 53 |
| MULTIPLE-DRUG RESISTANCE | 52 |
| COMA | 51 |
| RESPIRATORY DISTRESS | 51 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (7,829, 33.9% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| SEIZURE | 1,647 |
| SOMNOLENCE | 600 |
| PNEUMONIA | 517 |
| DRUG INTERACTION | 495 |
| STATUS EPILEPTICUS | 398 |
| HOSPITALISATION | 352 |
| PYREXIA | 349 |
| EPILEPSY | 337 |
| FALL | 310 |
| VOMITING | 305 |
| TOXICITY TO VARIOUS AGENTS | 287 |
| CONDITION AGGRAVATED | 285 |
| FATIGUE | 250 |
| GENERALISED TONIC-CLONIC SEIZURE | 232 |
| DECREASED APPETITE | 201 |
| DIARRHOEA | 198 |
How to read clobazam FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 23,107 voluntary reports linked to clobazam (Onfi, Sympazan), 2002-2025. Death is listed on 1,511 (6.5%). Hospitalization appears on 7,829 (33.9%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 33.9% mention hospitalization (7,829 reports).
Read with clobazam
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 23,037 FAERS cases (Δ 70 lighter vs clobazam); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 23,287 FAERS cases (Δ 180 heavier vs clobazam); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 22,775 FAERS cases (Δ 332 lighter vs clobazam); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 22,750 FAERS cases (Δ 357 lighter vs clobazam); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.6 pp vs clobazam's DEATH-HEAVY): CASELOAD · HOSP-MID.
clobazam stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.