quetiapine Side Effects
Also known as: Seroquel
Analysis of 185,533 adverse event reports submitted to the FDA from 2001 to 2025.
Total Reports
185,533
Death-Related
26,984
14.5% of reports
Hospitalizations
67,436
36.3% 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 26,984 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 7,059 |
| DEATH | 5,619 |
| TOXICITY TO VARIOUS AGENTS | 5,237 |
| OFF LABEL USE | 1,503 |
| CARDIO-RESPIRATORY ARREST | 1,450 |
| CARDIAC ARREST | 1,410 |
| PNEUMONIA | 1,406 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,384 |
| OVERDOSE | 1,354 |
| VOMITING | 1,346 |
| FATIGUE | 1,319 |
| PAIN | 1,295 |
| HYPERTENSION | 1,254 |
| CONFUSIONAL STATE | 1,249 |
| TYPE 2 DIABETES MELLITUS | 1,244 |
| CONDITION AGGRAVATED | 1,226 |
| RASH | 1,219 |
| PYREXIA | 1,202 |
| DIARRHOEA | 1,182 |
| DRUG ABUSE | 1,149 |
Reactions in Hospitalization Reports
Top reactions in 67,436 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 4,770 |
| TOXICITY TO VARIOUS AGENTS | 4,546 |
| DRUG INEFFECTIVE | 4,335 |
| DRUG INTERACTION | 4,109 |
| VOMITING | 3,801 |
| NAUSEA | 3,715 |
| CONFUSIONAL STATE | 3,650 |
| SUICIDE ATTEMPT | 3,471 |
| FALL | 3,449 |
| INTENTIONAL OVERDOSE | 3,445 |
| ANXIETY | 3,408 |
| DEPRESSION | 3,400 |
| FATIGUE | 3,375 |
| OVERDOSE | 3,263 |
| SOMNOLENCE | 3,208 |
| PNEUMONIA | 3,168 |
| DIZZINESS | 3,064 |
| DYSPNOEA | 3,041 |
| CONDITION AGGRAVATED | 3,009 |
| PYREXIA | 2,979 |
Nearby — Related Medications
What the FAERS Data Reveals About quetiapine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 185,533 voluntary reports linked to quetiapine and its brand equivalents (Seroquel), spanning 2001 through 2025. Of those, 26,984 (14.5%) listed death as an outcome and 67,436 (36.3%) 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, 59% were female and 40% male; age distribution skews toward 18-44, with 46,912 reports in that bracket. The single most reported reaction is drug ineffective with 12,343 submissions, followed by off label use and toxicity to various agents.
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.