Risperidone
According to the FDA label: Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia.
60,817 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Risperidone 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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- Gynaecomastia 9,322 reports
Off Label Use 5,518 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 5,072 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 →Weight Increased 4,305 reports
Drug Interaction 3,160 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Product Use in Unapproved Indication 2,898 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →- Emotional Disorder 2,871 reports
- Abnormal Weight Gain 2,855 reports
Condition Aggravated 2,253 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Toxicity to Various Agents 2,220 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Somnolence 2,202 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Extrapyramidal Disorder 2,049 reports
A group of movement problems, such as stiffness, tremor, or restlessness, that can be associated with certain medications.
Full definition in the glossary →Emotional Distress 1,950 reports
A report of emotional suffering such as upset, worry, or anguish. If you are 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 →Suicide Attempt 1,815 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 →- Hyperprolactinaemia 1,791 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 |
|---|---|
| Male | 33,427 |
| Female | 21,040 |
| Unknown | 270 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 8,156 |
| 18-34 | 9,711 |
| 35-49 | 7,496 |
| 50-64 | 7,515 |
| 65-74 | 3,907 |
| 75+ | 4,655 |
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 Risperidone. 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 |
|---|---|
| Other Serious | 31,086 |
| Hospitalization | 22,749 |
| Non-Serious | 13,388 |
| Death | 5,735 |
| Life-Threatening | 3,600 |
| Disability | 1,826 |
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 Risperidone. 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 |
|---|---|
| 2003 | 1 |
| 2004 | 400 |
| 2005 | 504 |
| 2006 | 592 |
| 2007 | 580 |
| 2008 | 698 |
| 2009 | 1,199 |
| 2010 | 1,157 |
| 2011 | 1,586 |
| 2012 | 1,882 |
| 2013 | 1,528 |
| 2014 | 1,922 |
| 2015 | 4,814 |
| 2016 | 4,930 |
| 2017 | 6,885 |
| 2018 | 4,494 |
| 2019 | 4,735 |
| 2020 | 4,059 |
| 2021 | 3,693 |
| 2022 | 3,744 |
| 2023 | 3,469 |
| 2024 | 3,565 |
| 2025 | 3,569 |
| 2026 (partial) | 811 |
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 Risperidone
In FDA adverse event reports that mention Risperidone, these medications appeared most often in the same report.
- Quetiapine (8,483 reports)
- Olanzapine (8,126 reports)
- Aripiprazole (6,439 reports)
- Lorazepam (4,926 reports)
- Clozapine (4,678 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