asenapine Side Effects
Also known as: Saphris
Analysis of 863 adverse event reports submitted to the FDA from 2010 to 2025.
Total Reports
863
Death-Related
125
14.5% of reports
Hospitalizations
316
36.6% 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 125 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 61 |
| TOXICITY TO VARIOUS AGENTS | 46 |
| DEATH | 17 |
| CARDIAC ARREST | 12 |
| ASPIRATION | 8 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 8 |
| EMBOLIC STROKE | 8 |
| RESPIRATION ABNORMAL | 8 |
| SEIZURE | 8 |
| PULMONARY OEDEMA | 7 |
| CARDIO-RESPIRATORY ARREST | 6 |
| HYPONATRAEMIA | 6 |
| INTENTIONAL OVERDOSE | 6 |
| PULMONARY CONGESTION | 6 |
| ACCIDENTAL OVERDOSE | 5 |
| ASPHYXIA | 5 |
| CEREBROVASCULAR ACCIDENT | 5 |
| POLYDIPSIA | 5 |
| UNRESPONSIVE TO STIMULI | 5 |
| OVERDOSE | 4 |
Reactions in Hospitalization Reports
Top reactions in 316 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 46 |
| DRUG INEFFECTIVE | 37 |
| OFF LABEL USE | 28 |
| MYOCARDITIS | 27 |
| TOXICITY TO VARIOUS AGENTS | 25 |
| DEPRESSION | 22 |
| SEDATION | 20 |
| SOMNOLENCE | 19 |
| HYPOTENSION | 18 |
| SEROTONIN SYNDROME | 18 |
| ACUTE KIDNEY INJURY | 17 |
| SUICIDAL IDEATION | 17 |
| DEPRESSED MOOD | 16 |
| VOMITING | 16 |
| EXTRAPYRAMIDAL DISORDER | 15 |
| HALLUCINATION, AUDITORY | 15 |
| WEIGHT DECREASED | 15 |
| DECREASED APPETITE | 14 |
| NEUROLEPTIC MALIGNANT SYNDROME | 14 |
| PSYCHOTIC DISORDER | 14 |
Nearby — Related Medications
What the FAERS Data Reveals About asenapine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 863 voluntary reports linked to asenapine and its brand equivalents (Saphris), spanning 2010 through 2025. Of those, 125 (14.5%) listed death as an outcome and 316 (36.6%) 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, 53% were female and 47% male; age distribution skews toward 18-44, with 295 reports in that bracket. The single most reported reaction is drug ineffective with 110 submissions, followed by drug interaction 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.