Paliperidone: adverse event reports filed with FDA

3,670

reports as suspect product

0% of all reports · about 189 a year

402

reports, 12 months to June 2026

375 in the 12 months before

93.2%

marked serious by the reporter

70.7% across the class

8.5%

record death among outcomes, as reported

312 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 Paliperidone reports recording the termmedian drug in atypical antipsychotic

1. Drug ineffectivethe medicine did not work as expected21.5%790
2. Sedationdrowsiness from a medicine11.4%419
3. Dystoniainvoluntary muscle contractions11%405
4. Dyskinesiainvoluntary movements10.9%401
5. Suicide attempta suicide attempt10.3%378
6. Schizophreniaschizophrenia9.4%346
7. Sexual dysfunctiona sexual problem8.9%326
8. Blood prolactin abnormal8.3%303
9. Blood glucose increasedraised blood sugar reading8.1%296
10. Metabolic disorder8%294
11. Anosognosia8%293
12. Disturbance in social behaviour7.8%287
13. Condition aggravatedthe condition being treated got worse7.4%271
14. Personality change7.2%265
15. Drug interactionan interaction between medicines5.2%192
16. Tremorshaking4.6%167
17. Weight increasedweight gain4.4%162
18. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity4.2%154
19. Off label useused for a purpose or in a way not on the label4.2%154
20. Psychotic disordera loss of contact with reality4.2%154
21. Akathisiainner restlessness and an urge to move3.8%140
22. Extrapyramidal disordermovement problems such as stiffness or tremor3.7%137
23. Toxicity to various agentspoisoning or toxic effect of one or more substances3.7%135
24. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine3.5%128
25. Somnolencedrowsiness3.4%124
26. Treatment noncompliancethe treatment was not taken as directed3.4%124
27. Anxietyanxiety3.3%121
28. Completed suicidedeath by suicide3.2%116
29. Tachycardiafast heart rate2.9%107
30. Confusional stateconfusion2.9%106

Top 30 of 697 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. 22.5% 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 3,670 reports.

Drugs most often listed in the same reports

Other products listed in reports where Paliperidone 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 Paliperidone as a suspect or interacting product; reports listing it only as a concomitant medication (1,516) 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.