olanzapine Side Effects
Also known as: Zyprexa
Analysis of 103,356 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
103,356
Death-Related
12,783
12.4% of reports
Hospitalizations
45,342
43.9% 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 12,783 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 2,633 |
| COMPLETED SUICIDE | 2,318 |
| TOXICITY TO VARIOUS AGENTS | 1,837 |
| CARDIAC ARREST | 735 |
| CARDIO-RESPIRATORY ARREST | 685 |
| OVERDOSE | 662 |
| OFF LABEL USE | 512 |
| PNEUMONIA | 500 |
| DRUG INTERACTION | 466 |
| DRUG ABUSE | 435 |
| DIABETES MELLITUS | 419 |
| RESPIRATORY ARREST | 400 |
| PULMONARY EMBOLISM | 356 |
| FALL | 345 |
| NAUSEA | 328 |
| SOMNOLENCE | 301 |
| SUDDEN DEATH | 298 |
| VOMITING | 297 |
| FATIGUE | 291 |
| NEUROLEPTIC MALIGNANT SYNDROME | 288 |
Reactions in Hospitalization Reports
Top reactions in 45,342 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 3,222 |
| OFF LABEL USE | 2,733 |
| DIABETES MELLITUS | 2,518 |
| WEIGHT INCREASED | 2,454 |
| DRUG INTERACTION | 2,087 |
| OVERDOSE | 2,022 |
| TOXICITY TO VARIOUS AGENTS | 1,949 |
| VOMITING | 1,903 |
| SOMNOLENCE | 1,881 |
| NAUSEA | 1,864 |
| NEUROLEPTIC MALIGNANT SYNDROME | 1,864 |
| CONFUSIONAL STATE | 1,850 |
| SUICIDE ATTEMPT | 1,809 |
| PNEUMONIA | 1,730 |
| INTENTIONAL OVERDOSE | 1,721 |
| PSYCHOTIC DISORDER | 1,684 |
| FALL | 1,682 |
| PYREXIA | 1,666 |
| AGITATION | 1,604 |
| ANXIETY | 1,533 |
Nearby — Related Medications
What the FAERS Data Reveals About olanzapine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 103,356 voluntary reports linked to olanzapine and its brand equivalents (Zyprexa), spanning 2003 through 2025. Of those, 12,783 (12.4%) listed death as an outcome and 45,342 (43.9%) 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, 49% were female and 50% male; age distribution skews toward 18-44, with 29,265 reports in that bracket. The single most reported reaction is drug ineffective with 7,118 submissions, followed by weight increased and off label use.
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.