Risperdal Constarisperidone
According to the FDA label: RISPERDAL CONSTA is an atypical antipsychotic indicated: for the treatment of schizophrenia. ( 1.1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. ( 1.2 ) 1.1 Schizophrenia RISPERDAL CONSTA (risperidone) is indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ].
73,338 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Risperdal Consta 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 10,043 reports
Off Label Use 6,066 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 5,595 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 4,800 reports
Drug Interaction 3,270 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →- Abnormal Weight Gain 3,120 reports
- Emotional Disorder 3,001 reports
Product Use in Unapproved Indication 2,982 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 →Condition Aggravated 2,466 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 →Somnolence 2,349 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Toxicity to Various Agents 2,240 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Extrapyramidal Disorder 2,217 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 2,030 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 →Anxiety 2,022 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Psychotic Disorder 2,004 reports
A mental health condition involving a loss of contact with reality, which can include hallucinations or delusions. The term records what was reported and does not establish that a medication was the cause.
Full definition in the glossary →
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 | 39,603 |
| Female | 24,994 |
| Unknown | 321 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 8,558 |
| 18-34 | 11,402 |
| 35-49 | 9,086 |
| 50-64 | 9,000 |
| 65-74 | 4,318 |
| 75+ | 4,845 |
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 Risperdal Consta. 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 | 34,497 |
| Hospitalization | 25,633 |
| Non-Serious | 19,505 |
| Death | 6,557 |
| Life-Threatening | 3,894 |
| Disability | 2,019 |
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 Risperdal Consta. 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 | 541 |
| 2005 | 678 |
| 2006 | 935 |
| 2007 | 851 |
| 2008 | 1,012 |
| 2009 | 1,661 |
| 2010 | 1,654 |
| 2011 | 2,063 |
| 2012 | 2,324 |
| 2013 | 1,886 |
| 2014 | 2,263 |
| 2015 | 7,745 |
| 2016 | 6,152 |
| 2017 | 7,820 |
| 2018 | 5,095 |
| 2019 | 5,327 |
| 2020 | 4,531 |
| 2021 | 4,077 |
| 2022 | 4,181 |
| 2023 | 3,895 |
| 2024 | 3,915 |
| 2025 | 3,848 |
| 2026 (partial) | 883 |
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 Risperdal Consta
In FDA adverse event reports that mention Risperdal Consta, these medications appeared most often in the same report.
- Quetiapine (8,920 reports)
- Olanzapine (8,616 reports)
- Aripiprazole (6,814 reports)
- Lorazepam (5,160 reports)
- Clozapine (4,988 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