paroxetine Side Effects
Also known as: Paxil
Analysis of 32,666 adverse event reports submitted to the FDA from 1995 to 2025.
Total Reports
32,666
Death-Related
4,275
13.1% of reports
Hospitalizations
12,918
39.5% 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 4,275 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 944 |
| DEATH | 911 |
| TOXICITY TO VARIOUS AGENTS | 839 |
| DRUG ABUSE | 345 |
| CARDIO-RESPIRATORY ARREST | 225 |
| CARDIAC ARREST | 201 |
| OVERDOSE | 176 |
| DRUG INTERACTION | 162 |
| DYSPNOEA | 126 |
| OFF LABEL USE | 124 |
| FALL | 123 |
| INTENTIONAL OVERDOSE | 109 |
| RESPIRATORY ARREST | 107 |
| ACUTE KIDNEY INJURY | 106 |
| CONFUSIONAL STATE | 105 |
| PNEUMONIA | 102 |
| HYPOTENSION | 101 |
| RENAL FAILURE | 99 |
| ASTHENIA | 98 |
| DRUG INEFFECTIVE | 95 |
Reactions in Hospitalization Reports
Top reactions in 12,918 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 1,045 |
| FALL | 820 |
| CONFUSIONAL STATE | 751 |
| TOXICITY TO VARIOUS AGENTS | 700 |
| SOMNOLENCE | 647 |
| SEROTONIN SYNDROME | 620 |
| DYSPNOEA | 593 |
| VOMITING | 590 |
| DRUG ABUSE | 572 |
| FATIGUE | 571 |
| NAUSEA | 570 |
| DRUG INEFFECTIVE | 545 |
| DIARRHOEA | 525 |
| ASTHENIA | 522 |
| OFF LABEL USE | 517 |
| ANXIETY | 489 |
| PNEUMONIA | 477 |
| HYPONATRAEMIA | 476 |
| SUICIDE ATTEMPT | 469 |
| HEADACHE | 452 |
Nearby — Related Medications
What the FAERS Data Reveals About paroxetine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 32,666 voluntary reports linked to paroxetine and its brand equivalents (Paxil), spanning 1995 through 2025. Of those, 4,275 (13.1%) listed death as an outcome and 12,918 (39.5%) 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 35% male; age distribution skews toward 45-64, with 8,712 reports in that bracket. The single most reported reaction is drug ineffective with 2,032 submissions, followed by drug interaction 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.