Saphrisasenapine
According to the FDA label: 1 INDICATIONS AN D USAGE SAPHRIS is indicated for: Schizophrenia in adults [see Clinical Studies ( 14.1 )] Bipolar I disorder [see Clinical Studies ( 14.2 )] • Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults • Maintenance monotherapy treatment in adults SAPHRIS is an atypical antipsychotic indicated for ( 1 ): Schizophrenia in adults Bipolar I disorder ○ Acute monotherapy treatment of…
7,767 adverse event reports submitted to the FDA (2009–2026)
Top Reported Adverse Events
The most frequently reported events in association with Saphris in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 802 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Sedation 664 reports
A state of calm, drowsiness, or reduced alertness.
Full definition in the glossary →Suicide Attempt 648 reports
A report that a person attempted suicide. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Inappropriate Schedule of Drug Administration 557 reports
A report that a medication was taken on the wrong schedule, such as too often or at the wrong time. This is a usage category, the same idea as inappropriate schedule of product administration.
Full definition in the glossary →Weight Increased 534 reports
Dyskinesia 516 reports
Involuntary, uncontrolled movements of the body.
Full definition in the glossary →Dystonia 494 reports
Involuntary muscle contractions that cause twisting movements or abnormal postures.
Full definition in the glossary →Blood Glucose Increased 474 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →- Sexual Dysfunction 424 reports
- Anosognosia 420 reports
- Blood Prolactin Abnormal 410 reports
- Metabolic Disorder 410 reports
- Disturbance In Social Behaviour 407 reports
Akathisia 395 reports
A feeling of inner restlessness and an inability to stay still, sometimes associated with certain medications.
Full definition in the glossary →- Personality Change 382 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 4,212 |
| Male | 2,375 |
| Unknown | 269 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 193 |
| 18-34 | 1,402 |
| 35-49 | 1,156 |
| 50-64 | 897 |
| 65-74 | 143 |
| 75+ | 66 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Saphris. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 4,343 |
| Other Serious | 2,499 |
| Hospitalization | 1,134 |
| Death | 278 |
| Life-Threatening | 226 |
| Disability | 191 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Saphris. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2009 | 17 |
| 2010 | 1,716 |
| 2011 | 1,017 |
| 2012 | 1,003 |
| 2013 | 1,397 |
| 2014 | 197 |
| 2015 | 152 |
| 2016 | 279 |
| 2017 | 215 |
| 2018 | 206 |
| 2019 | 306 |
| 2020 | 241 |
| 2021 | 265 |
| 2022 | 288 |
| 2023 | 232 |
| 2024 | 110 |
| 2025 | 109 |
| 2026 (partial) | 17 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Saphris
In FDA adverse event reports that mention Saphris, these medications appeared most often in the same report.
- Quetiapine (1,074 reports)
- Aripiprazole (966 reports)
- Olanzapine (897 reports)
- Risperidone (870 reports)
- Clozapine (637 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026