Risperdal: adverse event reports filed with FDA

54,454

reports as suspect product

0.3% of all reports · about 2,421 a year

882

reports, 12 months to June 2026

1,523 in the 12 months before

48.4%

marked serious by the reporter

70.7% across the class

4.3%

record death among outcomes, as reported

2,353 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Risperdal reports recording the termmedian drug in atypical antipsychotic

1. Gynaecomastiabreast enlargement in men43.3%23,582
2. Abnormal weight gain16.9%9,218
3. Off label useused for a purpose or in a way not on the label15.6%8,485
4. Weight increasedweight gain10.5%5,710
5. Emotional disorder10.1%5,494
6. Product use in unapproved indicationused for a purpose not on the label8.4%4,591
7. Injurya physical injury8%4,380
8. Hyperprolactinaemia6.6%3,569
9. Galactorrhoea6.1%3,315
10. Emotional distressemotional distress5.4%2,916
11. Obesity5.2%2,856
12. Product use issuea problem in how the product was used4%2,175
13. Drug ineffectivethe medicine did not work as expected3.7%1,988
14. Somnolencedrowsiness3.3%1,778
15. Extrapyramidal disordermovement problems such as stiffness or tremor3%1,615
16. Treatment noncompliancethe treatment was not taken as directed2.4%1,300
17. Adverse eventan unwanted medical event, type not specified2.1%1,129
18. Drug interactionan interaction between medicines2%1,080
19. Suicide attempta suicide attempt1.8%991
20. Blood prolactin increased1.7%930
21. Fatiguetiredness1.6%878
22. Sedationdrowsiness from a medicine1.6%853
23. Insomniadifficulty sleeping1.5%798
24. Depressionlow mood1.5%792
25. Diabetes mellitusdiabetes1.5%791
26. Intentional overdosea deliberate overdose1.4%773
27. Falla fall1.4%754
28. Tardive dyskinesiainvoluntary repetitive movements1.3%728
29. Anxietyanxiety1.3%717
30. Suicidal ideationthoughts of suicide1.3%714

Top 30 of 1,915 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 37 drugs in the atypical antipsychotic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 683,680 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 69.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 54,454 reports.

Drugs most often listed in the same reports

Other products listed in reports where Risperdal is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the atypical antipsychotic class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Risperdal as a suspect or interacting product; reports listing it only as a concomitant medication (14,466) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.