LOW-VOLUME · HOSP-HEAVY
safinamide Side Effects
safinamide (also sold as Xadago) is a LOW-VOLUME FAERS extract #483 of 524 by FAERS report count. Still opens on HOSP-HEAVY: 41.2% mention hospitalization (496 reports).
Data updated 2026-05-15
- 1,205
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
safinamide: 41.2% mention hospitalization (496 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #483 of 524 by FAERS report count.
Thinner FAERS extract for safinamide (Xadago) (1,205 reports #483 of 524 by FAERS report count). 41.2% mention hospitalization (496 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2016–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
FALL leads 154 of 1,205 reports
Who reports · age peak 65-74 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 65-74 (330 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (151 reports, 12.5%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 90 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 16 |
| PARKINSON^S DISEASE | 12 |
| FALL | 11 |
| VOMITING | 9 |
| DYSKINESIA | 8 |
| EPILEPSY | 7 |
| MYOCARDIAL INFARCTION | 7 |
| DYSPHAGIA | 6 |
| HALLUCINATION | 6 |
| HEAD INJURY | 6 |
| DIZZINESS | 5 |
| LOSS OF CONSCIOUSNESS | 5 |
| ON AND OFF PHENOMENON | 5 |
| PNEUMONIA | 5 |
| RESTLESSNESS | 5 |
| TREMOR | 5 |
| UNRESPONSIVE TO STIMULI | 5 |
| DEVICE DISLOCATION | 4 |
| FATIGUE | 4 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (496, 41.2% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FALL | 107 |
| HALLUCINATION | 69 |
| DYSKINESIA | 61 |
| PARKINSON^S DISEASE | 39 |
| ON AND OFF PHENOMENON | 38 |
| GAIT DISTURBANCE | 37 |
| HYPERKINESIA | 33 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 31 |
| WEIGHT DECREASED | 31 |
| MOBILITY DECREASED | 30 |
| SOMNOLENCE | 29 |
| CONFUSIONAL STATE | 28 |
| FREEZING PHENOMENON | 27 |
| ASTHENIA | 26 |
| DEVICE ISSUE | 25 |
| HYPOKINESIA | 25 |
| DEVICE DISLOCATION | 23 |
| TREMOR | 23 |
| URINARY TRACT INFECTION | 22 |
How to read safinamide FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 1,205 voluntary reports linked to safinamide (Xadago), 2016-2025. Death is listed on 151 (12.5%). Hospitalization appears on 496 (41.2%). Top co-reported indication: Parkinson^S Disease.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with safinamide
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 1,191 FAERS cases (Δ 14 lighter vs safinamide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 1,220 FAERS cases (Δ 15 heavier vs safinamide); DEATH-MARKED · HOSP-HEAVY · FEMALE-LED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 1,256 FAERS cases (Δ 51 heavier vs safinamide); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 1,152 FAERS cases (Δ 53 lighter vs safinamide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 49.6 pp vs safinamide's DEATH-HEAVY): CASELOAD · HOSP-MID.
safinamide stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.