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Risperidone Side Effects

The most commonly reported side effects of risperidone include gynaecomastia, off label use, and abnormal weight gain, based on 132,418 FDA adverse event reports from 2004 to 2025. 5.1% of reports found the drug to be ineffective.

#1 Reported: GynaecomastiaAll side effects ↓Top Co-Medication: PaliperidoneDrug interactions ↓60% of Reports Are AdultDemographics ↓

Risperidone side effects

Percentages show how often each reaction appears relative to total reports for risperidone.

1
Gynaecomastia18.5%24,555
2
Off Label Use9.2%12,121
3
Abnormal Weight Gain7.1%9,434
4
Weight Increased5.9%7,797
5
Drug Ineffective5.1%6,713
6
Product Use In Unapproved Indication4.5%5,974
7
Emotional Disorder4.4%5,868
8
Injury3.4%4,502
9
Hyperprolactinaemia3.2%4,229
10
Galactorrhoea2.7%3,594
11
Drug Interaction2.7%3,534
12
Emotional Distress2.6%3,432
13
Somnolence2.6%3,401
14
Obesity2.4%3,195
15
Extrapyramidal Disorder2.2%2,963

These are voluntary reports and do not establish that risperidone caused these reactions.

Report severity

66.7%Serious88,367 reports
30.5%Hospitalizations40,356 reports
7.7%Fatal10,197 reports

Seriousness is determined by the reporter, not by OpenClaim.

Risperidone drug interactions

Other drugs that appear in adverse event reports alongside risperidone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Paliperidone8.9%11,765
2
Quetiapine-fumarate8.6%11,353
3
Olanzapine7.0%9,307
4
Aripiprazole5.6%7,430
5
Clozapine3.9%5,174
6
Haloperidol3.3%4,388
7
Sertraline-hydrochloride2.4%3,192
8
Lorazepam2.0%2,699
9
Lithium1.6%2,184
10
Lamotrigine1.6%2,160
11
Diazepam1.6%2,147
12
Clonazepam1.5%2,015
13
Mirtazapine1.5%1,981
14
Venlafaxine1.5%1,980
15
Fluoxetine-hydrochloride1.4%1,838

Taken alongside

1
Lorazepam3.8%5,019
2
Acetaminophen3.7%4,926
3
Clonazepam3.1%4,162
4
Aspirin2.9%3,864
5
Sertraline-hydrochloride2.9%3,864
6
Levothyroxine-sodium2.8%3,759
7
Quetiapine-fumarate2.7%3,577
8
Trazodone-hydrochloride2.6%3,501
9
Olanzapine2.6%3,397
10
Divalproex-sodium2.5%3,301
11
Metformin2.4%3,227
12
Omeprazole2.4%3,164
13
Aripiprazole2.3%3,101
14
Atorvastatin-calcium2.2%2,966
15
Furosemide2.2%2,927

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports risperidone side effects

32.1% of risperidone adverse event reports involve female patients and 57.0% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female32.1%
Male57.0%
Unknown10.9%

Age group

< 20.6%
2–1112.4%
12–179.8%
18–6459.5%
65+17.7%

What is risperidone used for

Conditions and purposes for which patients were taking risperidone when the adverse event was reported.

22q11.2 Deletion SyndromeAbnormal BehaviourAbnormal Weight GainAbortion SpontaneousAbuliaAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental Needle StickAcute EndocarditisAcute Myocardial InfarctionAcute PsychosisAcute Stress DisorderAdhd

Showing 15 of 1,248 indications

Risperidone brand names and reporting trend

Risperidone is sold under the brand name Risperdal Consta.

Brand names

Risperdal Consta90,542

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking risperidone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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