Hyrimoz: adverse event reports filed with FDA

8,482

reports as suspect product

0% of all reports · about 766 a year

1,970

reports, 12 months to June 2026

2,034 in the 12 months before

83.9%

marked serious by the reporter

56.2% across the class

20%

record death among outcomes, as reported

1,693 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 Hyrimoz reports recording the termmedian drug in tumor necrosis factor blocker

1. Off label useused for a purpose or in a way not on the label15.5%1,312
2. Drug ineffectivethe medicine did not work as expected15.2%1,290
3. Fatiguetiredness13.3%1,124
4. Arthralgiajoint pain13.1%1,109
5. Painpain, site not specified12.7%1,077
6. Diarrhoealoose or frequent stools11.1%939
7. General physical health deteriorationgeneral decline in health10.7%904
8. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease10.1%853
9. Malaisegeneral feeling of being unwell9.7%820
10. Rashskin rash9%767
11. Psoriatic arthropathy8.5%725
12. Nauseafeeling sick8.5%723
13. Condition aggravatedthe condition being treated got worse8.1%690
14. Headachehead pain8%675
15. Abdominal painstomach or belly pain7.4%628
16. Pemphigus7.4%626
17. Vomitingbeing sick7.4%626
18. Wound7.3%618
19. Maternal exposure during pregnancythe mother took the medicine during pregnancy7.2%613
20. Systemic lupus erythematosuslupus, an autoimmune disease7.2%610
21. Product dose omission issuea dose was missed7.2%609
22. Pain in extremitypain in an arm or leg7.1%605
23. Joint swellinga swollen joint7.1%604
24. Nasopharyngitisa cold7%596
25. Glossodynia7%594
26. Hypoaesthesianumbness7%593
27. Peripheral swellingswelling of the arms or legs7%592
28. Dizzinesslight-headedness or unsteadiness7%591
29. Alopeciahair loss7%590
30. Abdominal discomfortstomach discomfort6.9%586

Top 30 of 1,396 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 17 drugs in the tumor necrosis factor blocker 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 1,064,042 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. 18.1% 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 8,482 reports.

Drugs most often listed in the same reports

Other products listed in reports where Hyrimoz 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 tumor necrosis factor blocker 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 Hyrimoz as a suspect or interacting product; reports listing it only as a concomitant medication (858) 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.