pramipexole Side Effects
Also known as: Mirapex
Analysis of 14,399 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
14,399
Death-Related
1,206
8.4% of reports
Hospitalizations
5,034
35.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,206 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 565 |
| COMPLETED SUICIDE | 80 |
| PARKINSON^S DISEASE | 61 |
| PNEUMONIA | 60 |
| OFF LABEL USE | 54 |
| HALLUCINATION | 52 |
| DYSPNOEA | 51 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 50 |
| FALL | 48 |
| FATIGUE | 47 |
| ASTHENIA | 41 |
| SEPSIS | 41 |
| CARDIAC ARREST | 40 |
| PAIN | 40 |
| RENAL FAILURE | 37 |
| URINARY TRACT INFECTION | 36 |
| ACUTE KIDNEY INJURY | 34 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 34 |
| SOMNOLENCE | 34 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 33 |
Reactions in Hospitalization Reports
Top reactions in 5,034 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 516 |
| DRUG INEFFECTIVE | 431 |
| FATIGUE | 426 |
| DYSPNOEA | 423 |
| PNEUMONIA | 409 |
| PAIN | 385 |
| CONDITION AGGRAVATED | 351 |
| OFF LABEL USE | 325 |
| NAUSEA | 303 |
| ASTHENIA | 299 |
| DYSKINESIA | 278 |
| HEADACHE | 258 |
| HALLUCINATION | 249 |
| ARTHRALGIA | 247 |
| TREMOR | 242 |
| CONSTIPATION | 241 |
| VOMITING | 238 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 232 |
| DIARRHOEA | 227 |
| ABDOMINAL PAIN | 222 |
Nearby — Related Medications
What the FAERS Data Reveals About pramipexole Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 14,399 voluntary reports linked to pramipexole and its brand equivalents (Mirapex), spanning 2004 through 2025. Of those, 1,206 (8.4%) listed death as an outcome and 5,034 (35.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 61% were female and 39% male; age distribution skews toward 65-74, with 3,174 reports in that bracket. The single most reported reaction is drug ineffective with 1,349 submissions, followed by fall and fatigue.
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.