MID-VOLUME · HOSP-HEAVY
vigabatrin Side Effects
vigabatrin (also sold as Sabril) sits MID-VOLUME #278 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 31.5% mention hospitalization (4,439 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 14,085
- FAERS reports
FDA Adverse Event Reporting System extract for vigabatrin. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
vigabatrin: 31.5% mention hospitalization (4,439 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #278 of 524 by FAERS report count.
Mid-book FAERS page for vigabatrin (Sabril) (14,085 reports). Signature HOSP-HEAVY. Dominant age band on file: 0-17. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
SEIZURE leads 2,570 of 14,085 reports
Who reports · age peak 0-17 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 0-17 (6,034 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,350 reports, 9.6%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 852 |
| RESPIRATORY FAILURE | 81 |
| ADVERSE EVENT | 74 |
| SEIZURE | 50 |
| PNEUMONIA | 47 |
| CARDIAC ARREST | 40 |
| STATUS EPILEPTICUS | 30 |
| SUDDEN UNEXPLAINED DEATH IN EPILEPSY | 26 |
| RESPIRATORY DISTRESS | 24 |
| CARDIO-RESPIRATORY ARREST | 20 |
| ACUTE RESPIRATORY FAILURE | 19 |
| CONVULSION | 18 |
| EPILEPSY | 18 |
| RESPIRATORY ARREST | 14 |
| TOXICITY TO VARIOUS AGENTS | 14 |
| MULTIPLE-DRUG RESISTANCE | 13 |
| PYREXIA | 13 |
| RESPIRATORY DISORDER | 13 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (4,439, 31.5% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| SEIZURE | 1,114 |
| PNEUMONIA | 433 |
| HOSPITALISATION | 303 |
| VOMITING | 184 |
| STATUS EPILEPTICUS | 176 |
| SOMNOLENCE | 175 |
| PYREXIA | 167 |
| ADVERSE EVENT | 155 |
| EPILEPSY | 137 |
| CONVULSION | 131 |
| CONDITION AGGRAVATED | 125 |
| RESPIRATORY DISTRESS | 119 |
| INFANTILE SPASMS | 116 |
| PNEUMONIA ASPIRATION | 110 |
| RESPIRATORY DISORDER | 109 |
| DRUG WITHDRAWAL CONVULSIONS | 107 |
| URINARY TRACT INFECTION | 104 |
How to read vigabatrin FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 14,085 voluntary reports linked to vigabatrin (Sabril), 2004-2025. Death is listed on 1,350 (9.6%). Hospitalization appears on 4,439 (31.5%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 31.5% mention hospitalization (4,439 reports).
Read with vigabatrin
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 13,998 FAERS cases (Δ 87 lighter vs vigabatrin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 14,210 FAERS cases (Δ 125 heavier vs vigabatrin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 14,399 FAERS cases (Δ 314 heavier vs vigabatrin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 13,667 FAERS cases (Δ 418 lighter vs vigabatrin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.5 pp vs vigabatrin's DEATH-HEAVY): CASELOAD · HOSP-MID.
vigabatrin stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.