Drug side effects
asenapine Side Effects
The reactions most often reported to the FDA for asenapine (also sold as Saphris), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 863
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2010 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of asenapine come from 863 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 863 reports to the FDA Adverse Event Reporting System (FAERS) for asenapine (Saphris): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
863
Reports Mentioning Death
125
14.5% of reports — not proof the medicine caused the death
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 |
| 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 interaction with 78 submissions, followed by toxicity to various agents and completed suicide.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to asenapine's 863.
Read our methodology - how this data is sourced, computed, and verified.