safinamide Side Effects
Also known as: Xadago
Analysis of 1,205 adverse event reports submitted to the FDA from 2016 to 2025.
Total Reports
1,205
Death-Related
151
12.5% of reports
Hospitalizations
496
41.2% of reports
Top Indication
Parkinson^S Disease
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 151 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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
Top reactions in 496 reports where hospitalization was an outcome.
| 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 |
| DRUG INEFFECTIVE | 24 |
| DEVICE DISLOCATION | 23 |
| TREMOR | 23 |
| URINARY TRACT INFECTION | 22 |
Nearby — Related Medications
What the FAERS Data Reveals About safinamide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,205 voluntary reports linked to safinamide and its brand equivalents (Xadago), spanning 2016 through 2025. Of those, 151 (12.5%) listed death as an outcome and 496 (41.2%) involved hospitalization. The most common indication reported alongside adverse events was Parkinson^S Disease.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 41% were female and 59% male; age distribution skews toward 65-74, with 330 reports in that bracket. The single most reported reaction is fall with 154 submissions, followed by hallucination and dyskinesia.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.