Invega Sustenna: adverse event reports filed with FDA

23,648

reports as suspect product

0.1% of all reports · about 1,412 a year

1,513

reports, 12 months to June 2026

1,249 in the 12 months before

35.8%

marked serious by the reporter

70.7% across the class

2.5%

record death among outcomes, as reported

584 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 Invega Sustenna reports recording the termmedian drug in atypical antipsychotic

1. Off label useused for a purpose or in a way not on the label10.9%2,566
2. Drug ineffectivethe medicine did not work as expected6%1,412
3. Weight increasedweight gain5.9%1,403
4. Drug dose omissiona dose was missed5.6%1,326
5. Hospitalisationadmission to hospital5.1%1,202
6. Gynaecomastiabreast enlargement in men4.4%1,039
7. Product dose omission issuea dose was missed4.3%1,027
8. Blood prolactin increased3.4%809
9. Incorrect dose administeredthe wrong dose was given3.2%766
10. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.1%730
11. Treatment noncompliancethe treatment was not taken as directed3.1%723
12. Galactorrhoea2.7%634
13. Injection site painpain where the injection was given2.5%600
14. Schizophreniaschizophrenia2.5%597
15. Psychotic disordera loss of contact with reality2.5%594
16. Condition aggravatedthe condition being treated got worse2.2%518
17. Inappropriate schedule of product administrationthe product was taken at the wrong times2.2%515
18. Injection site nodule2%469
19. Insomniadifficulty sleeping2%469
20. Depressionlow mood1.9%461
21. Hallucination, auditory1.9%458
22. Therapeutic response decreasedthe medicine worked less well1.9%452
23. Adverse eventan unwanted medical event, type not specified1.9%448
24. Product use in unapproved indicationused for a purpose not on the label1.9%440
25. Anxietyanxiety1.8%426
26. Feeling abnormalfeeling odd or not right1.7%403
27. Akathisiainner restlessness and an urge to move1.7%402
28. Fatiguetiredness1.7%402
29. Tremorshaking1.7%400
30. Product use issuea problem in how the product was used1.7%397

Top 30 of 972 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. 89.1% 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 23,648 reports.

Drugs most often listed in the same reports

Other products listed in reports where Invega Sustenna 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 Invega Sustenna as a suspect or interacting product; reports listing it only as a concomitant medication (597) 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.