MID-VOLUME · HOSP-HEAVY
primidone Side Effects
primidone (also sold as Mysoline) sits MID-VOLUME #322 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 31.3% mention hospitalization (3,062 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 9,782
- FAERS reports
FDA Adverse Event Reporting System extract for primidone. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
primidone: 31.3% mention hospitalization (3,062 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #322 of 524 by FAERS report count.
Mid-book FAERS page for primidone (Mysoline) (9,782 reports). Signature HOSP-HEAVY. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2002–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
FALL leads 651 of 9,782 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (1,922 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (850 reports, 8.7%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 289 |
| COMPLETED SUICIDE | 162 |
| TOXICITY TO VARIOUS AGENTS | 60 |
| CARDIAC ARREST | 35 |
| PNEUMONIA | 35 |
| RENAL FAILURE | 33 |
| FALL | 30 |
| DYSPNOEA | 29 |
| CARDIO-RESPIRATORY ARREST | 28 |
| ASTHENIA | 24 |
| FATIGUE | 24 |
| RESPIRATORY ARREST | 24 |
| ANAEMIA | 23 |
| CARDIAC FAILURE CONGESTIVE | 22 |
| HEPATIC FAILURE | 22 |
| RESPIRATORY FAILURE | 22 |
| CONDITION AGGRAVATED | 20 |
| DECREASED APPETITE | 20 |
| DIARRHOEA | 20 |
| HYPERTENSION | 20 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (3,062, 31.3% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FALL | 376 |
| PNEUMONIA | 249 |
| TREMOR | 191 |
| DIARRHOEA | 186 |
| ASTHENIA | 173 |
| DYSPNOEA | 171 |
| NAUSEA | 169 |
| DRUG INTERACTION | 166 |
| FATIGUE | 157 |
| WEIGHT DECREASED | 147 |
| DIZZINESS | 146 |
| URINARY TRACT INFECTION | 138 |
| PAIN | 127 |
| VOMITING | 126 |
| PYREXIA | 118 |
| GAIT DISTURBANCE | 111 |
| HEADACHE | 110 |
| SOMNOLENCE | 102 |
How to read primidone FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 9,782 voluntary reports linked to primidone (Mysoline), 2002-2025. Death is listed on 850 (8.7%). Hospitalization appears on 3,062 (31.3%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 31.3% mention hospitalization (3,062 reports).
Read with primidone
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 9,780 FAERS cases (Δ 2 lighter vs primidone); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 9,764 FAERS cases (Δ 18 lighter vs primidone); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 9,877 FAERS cases (Δ 95 heavier vs primidone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 9,899 FAERS cases (Δ 117 heavier vs primidone); 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 53.4 pp vs primidone's DEATH-HEAVY): CASELOAD · HOSP-MID.
primidone stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.