Paliperidone palmitate: adverse event reports filed with FDA

2,899

reports as suspect product

0% of all reports · about 144 a year

307

reports, 12 months to June 2026

362 in the 12 months before

95.6%

marked serious by the reporter

70.7% across the class

15.5%

record death among outcomes, as reported

449 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 palmitate reports recording the termmedian drug in atypical antipsychotic

1. Hospitalisationadmission to hospital13.8%400
2. Drug ineffectivethe medicine did not work as expected9.9%288
3. Schizophreniaschizophrenia8.5%247
4. Deaththe patient died; cause not stated by this term8.1%235
5. Suicide attempta suicide attempt7.9%228
6. Dyskinesiainvoluntary movements7.8%225
7. Off label useused for a purpose or in a way not on the label7.5%216
8. Sedationdrowsiness from a medicine7.2%210
9. Sexual dysfunctiona sexual problem7%204
10. Dystoniainvoluntary muscle contractions6.7%195
11. Disturbance in social behaviour6.5%188
12. Metabolic disorder6.5%188
13. Blood glucose increasedraised blood sugar reading6.4%186
14. Anosognosia6.3%184
15. Blood prolactin abnormal6.3%184
16. Personality change6.2%181
17. Condition aggravatedthe condition being treated got worse6.1%178
18. Weight increasedweight gain4.3%125
19. Psychotic disordera loss of contact with reality3.4%98
20. Suicidal ideationthoughts of suicide3.2%93
21. Treatment noncompliancethe treatment was not taken as directed3.1%90
22. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine2.9%84
23. Insomniadifficulty sleeping2.9%83
24. Depressionlow mood2.5%73
25. Inappropriate schedule of product administrationthe product was taken at the wrong times2.4%70
26. Hallucination, auditory2.4%69
27. Somnolencedrowsiness2.3%68
28. Anxietyanxiety2.3%66
29. Fatiguetiredness2.2%63
30. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity2%57

Top 30 of 562 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. 6.2% 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 2,899 reports.

Drugs most often listed in the same reports

Other products listed in reports where Paliperidone palmitate 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 palmitate as a suspect or interacting product; reports listing it only as a concomitant medication (389) 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.