pregabalin Side Effects
Also known as: Lyrica
Analysis of 264,092 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
264,092
Death-Related
21,160
8.0% of reports
Hospitalizations
74,751
28.3% 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 21,160 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 5,335 |
| TOXICITY TO VARIOUS AGENTS | 2,847 |
| FATIGUE | 1,626 |
| COMPLETED SUICIDE | 1,529 |
| PYREXIA | 1,528 |
| PNEUMONIA | 1,526 |
| OFF LABEL USE | 1,523 |
| VOMITING | 1,520 |
| DYSPNOEA | 1,425 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,359 |
| DIARRHOEA | 1,315 |
| NAUSEA | 1,285 |
| MALAISE | 1,257 |
| PAIN | 1,242 |
| DECREASED APPETITE | 1,166 |
| HYPERTENSION | 1,166 |
| HEADACHE | 1,134 |
| OVERDOSE | 1,123 |
| ASTHENIA | 1,107 |
| PRURITUS | 1,080 |
Reactions in Hospitalization Reports
Top reactions in 74,751 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PAIN | 6,244 |
| FALL | 5,541 |
| NAUSEA | 5,260 |
| FATIGUE | 5,252 |
| PNEUMONIA | 5,032 |
| DYSPNOEA | 4,892 |
| DRUG INEFFECTIVE | 4,596 |
| VOMITING | 4,584 |
| MALAISE | 4,466 |
| OFF LABEL USE | 4,380 |
| HEADACHE | 4,313 |
| PYREXIA | 4,245 |
| DIARRHOEA | 4,221 |
| DIZZINESS | 3,996 |
| ASTHENIA | 3,859 |
| CONFUSIONAL STATE | 3,493 |
| ARTHRALGIA | 3,141 |
| PAIN IN EXTREMITY | 3,132 |
| CONDITION AGGRAVATED | 3,004 |
| SOMNOLENCE | 2,988 |
Nearby — Related Medications
What the FAERS Data Reveals About pregabalin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 264,092 voluntary reports linked to pregabalin and its brand equivalents (Lyrica), spanning 2004 through 2025. Of those, 21,160 (8.0%) listed death as an outcome and 74,751 (28.3%) 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, 65% were female and 34% male; age distribution skews toward 45-64, with 71,463 reports in that bracket. The single most reported reaction is drug ineffective with 26,491 submissions, followed by pain 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.