Aristada: adverse event reports filed with FDA

4,352

reports as suspect product

0% of all reports · about 408 a year

274

reports, 12 months to June 2026

199 in the 12 months before

16.2%

marked serious by the reporter

70.7% across the class

1.8%

record death among outcomes, as reported

77 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 Aristada reports recording the termmedian drug in atypical antipsychotic

1. Off label useused for a purpose or in a way not on the label25.3%1,100
2. Needle issuea problem with the needle14.6%636
3. Injection site painpain where the injection was given9.9%431
4. Drug ineffectivethe medicine did not work as expected6%259
5. Product administered at inappropriate site4.8%209
6. Weight increasedweight gain4.8%207
7. Incorrect dose administeredthe wrong dose was given4.3%186
8. Therapeutic response shortened4.1%179
9. Hallucination, auditory4%174
10. Underdoseless than the intended dose3.9%168
11. Syringe issue3.8%166
12. Anxietyanxiety3.4%148
13. Injection site mass3.3%144
14. Fatiguetiredness3.3%142
15. Hospitalisationadmission to hospital3.1%136
16. Wrong technique in device usage process3%131
17. Agitationrestlessness2.8%120
18. Depressionlow mood2.5%109
19. Psychotic disordera loss of contact with reality2.5%109
20. Malaisegeneral feeling of being unwell2.4%105
21. Wrong technique in product usage processthe product was used in the wrong way2.4%104
22. Feeling abnormalfeeling odd or not right2.3%101
23. Schizophreniaschizophrenia2.3%99
24. Hallucinationseeing or hearing things that are not there2.2%97
25. Insomniadifficulty sleeping2.2%96
26. Tremorshaking2.2%96
27. Inappropriate schedule of product administrationthe product was taken at the wrong times2.1%90
28. Somnolencedrowsiness2%89
29. Paranoiaparanoia2%88
30. Restlessnessrestlessness2%85

Top 30 of 474 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. 100% 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 4,352 reports.

Drugs most often listed in the same reports

Other products listed in reports where Aristada 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 Aristada as a suspect or interacting product; reports listing it only as a concomitant medication (96) 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.