Invega Hafyera: adverse event reports filed with FDA

650

reports as suspect product

0% of all reports · about 128 a year

80

reports, 12 months to June 2026

139 in the 12 months before

29.1%

marked serious by the reporter

70.7% across the class

0.3%

record death among outcomes, as reported

2 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 Hafyera reports recording the termmedian drug in atypical antipsychotic

1. Drug ineffectivethe medicine did not work as expected12.3%80
2. Product dose omission issuea dose was missed9.2%60
3. Condition aggravatedthe condition being treated got worse8.2%53
4. Schizophreniaschizophrenia7.2%47
5. Underdoseless than the intended dose7.2%47
6. Off label useused for a purpose or in a way not on the label7.1%46
7. Therapeutic response decreasedthe medicine worked less well7.1%46
8. Product administered at inappropriate site4.5%29
9. Syringe issue3.7%24
10. Needle issuea problem with the needle3.5%23
11. Psychotic disordera loss of contact with reality3.5%23
12. Hallucination, auditory3.1%20
13. Therapeutic product effect decreased3.1%20
14. Hospitalisationadmission to hospital2.9%19
15. Inappropriate schedule of product administrationthe product was taken at the wrong times2.3%15
16. Blood prolactin increased2%13
17. Injection site painpain where the injection was given2%13
18. Wrong technique in product usage processthe product was used in the wrong way1.8%12
19. Anxietyanxiety1.5%10
20. Device issuea problem with the device1.4%9
21. Paranoiaparanoia1.4%9
22. Weight increasedweight gain1.4%9
23. Adverse eventan unwanted medical event, type not specified1.2%8
24. Device occlusionthe device blocked1.2%8
25. Treatment noncompliancethe treatment was not taken as directed1.2%8
26. Tremorshaking1.2%8
27. Aggressionaggressive behaviour1.1%7
28. Akathisiainner restlessness and an urge to move1.1%7
29. Injection site nodule1.1%7
30. Product storage errorthe product was stored wrongly1.1%7

Top 30 of 95 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. 96.6% 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 650 reports.

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 Hafyera as a suspect or interacting product; reports listing it only as a concomitant medication (6) 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.