82/100 · Critical
Manufactured by Janssen Pharmaceuticals, Inc.
Risperidone Adverse Events: High Seriousness and Weight-Related Concerns
254,329 FDA adverse event reports analyzed
Last updated: 2026-05-12
RISPERIDONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. Based on analysis of 254,329 FDA adverse event reports, RISPERIDONE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for RISPERIDONE include GYNAECOMASTIA, OFF LABEL USE, ABNORMAL WEIGHT GAIN, WEIGHT INCREASED, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RISPERIDONE.
Risperidone has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 254,329 adverse event reports for this medication, which is primarily manufactured by Janssen Pharmaceuticals, Inc..
The most commonly reported adverse events include Gynaecomastia, Off Label Use, Abnormal Weight Gain. Of classified reports, 66.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious adverse events (66.3%) and weight gain issues.
Gynaecomastia and obesity are among the most reported side effects. Psychiatric and neurological disorders are frequently reported, including suicidal ideation and extrapyramidal disorders.
Patients taking Risperidone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Risperidone can cause drug interactions, particularly with other antipsychotics and sedatives, and should be used with caution. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Risperidone received a safety concern score of 82/100 (high concern). This is based on a 66.3% serious event ratio across 129,886 classified reports. The score accounts for 254,329 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 74,270, Female: 41,455, Unknown: 541. The most frequently reported age groups are age 17 (1,304 reports), age 15 (1,258 reports), age 16 (1,220 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 129,886 classified reports for RISPERIDONE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Risperidone can cause drug interactions, particularly with other antipsychotics and sedatives, and should be used with caution.
If you are taking Risperidone, here are important things to know. The most commonly reported side effects include gynaecomastia, off label use, abnormal weight gain, weight increased, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor weight and blood glucose levels regularly, especially in patients with pre-existing conditions. Be aware of potential drug interactions and inform healthcare providers of all medications being taken. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with regular updates on safety profiles and warnings issued.
The FDA has received approximately 254,329 adverse event reports associated with Risperidone. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Risperidone include Gynaecomastia, Off Label Use, Abnormal Weight Gain, Weight Increased, Drug Ineffective. By volume, the top reported reactions are: Gynaecomastia (24,608 reports), Off Label Use (12,324 reports), Abnormal Weight Gain (9,446 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Risperidone.
Out of 129,886 classified reports, 86,063 (66.3%) were classified as serious and 43,823 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Risperidone break down by patient sex as follows: Male: 74,270, Female: 41,455, Unknown: 541. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Risperidone adverse events are: age 17: 1,304 reports, age 15: 1,258 reports, age 16: 1,220 reports, age 52: 1,207 reports, age 14: 1,165 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Risperidone adverse event reports is Janssen Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Risperidone include: Emotional Disorder, Product Use In Unapproved Indication, Injury, Drug Interaction, Hyperprolactinaemia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Risperidone to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Risperidone has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High incidence of serious adverse events (66.3%) and weight gain issues.
Key safety signals identified in Risperidone's adverse event data include: Gynaecomastia and obesity are key safety signals, with high report counts.. Suicidal ideation and attempts are significant safety concerns.. Extrapyramidal disorders and weight gain are critical safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Risperidone can cause drug interactions, particularly with other antipsychotics and sedatives, and should be used with caution. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Risperidone.
Monitor weight and blood glucose levels regularly, especially in patients with pre-existing conditions. Be aware of potential drug interactions and inform healthcare providers of all medications being taken.
Risperidone has 254,329 adverse event reports on file with the FDA. Gynaecomastia and obesity are among the most reported side effects. The volume of reports for Risperidone reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with regular updates on safety profiles and warnings issued. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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