Ruxience: adverse event reports filed with FDA

4,723

reports as suspect product

0% of all reports · about 515 a year

807

reports, 12 months to June 2026

1,116 in the 12 months before

91.1%

marked serious by the reporter

77% across the class

9.5%

record death among outcomes, as reported

448 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 Ruxience reports recording the termmedian drug in cd20-directed cytolytic antibody

1. Off label useused for a purpose or in a way not on the label45.2%2,136
2. Intentional product use issuedeliberate use not as intended13.5%637
3. Condition aggravatedthe condition being treated got worse12.5%590
4. Fatiguetiredness7.9%371
5. Deaththe patient died; cause not stated by this term7.7%362
6. Dyspnoeashortness of breath7.2%341
7. Covid-19COVID-19 infection7.2%339
8. Inappropriate schedule of product administrationthe product was taken at the wrong times7.2%339
9. Nauseafeeling sick6.8%321
10. Headachehead pain6.8%320
11. Pruritusitching6.7%317
12. Throat irritationan irritated throat6.5%309
13. Malaisegeneral feeling of being unwell6.2%292
14. Painpain, site not specified6%283
15. Coughcough5.8%275
16. Blood pressure fluctuation5.3%252
17. Pneumonialung infection5.2%245
18. Blood pressure increaseda raised blood pressure reading4.9%233
19. Product use issuea problem in how the product was used4.9%231
20. Drug ineffectivethe medicine did not work as expected4.8%227
21. Hypertensionhigh blood pressure4.7%223
22. Dizzinesslight-headedness or unsteadiness4.6%217
23. Arthralgiajoint pain4.3%203
24. Astheniaweakness or lack of energy4.1%194
25. Pyrexiafever3.6%171
26. Rashskin rash3.6%170
27. Erythemaskin redness3.6%168
28. Nasopharyngitisa cold3.5%166
29. Falla fall3.3%154
30. Heart rate increaseda fast heart rate reading3.3%154

Top 30 of 1,001 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 12 drugs in the cd20-directed cytolytic antibody 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 316,120 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. 14.2% 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 4,723 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ruxience 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 cd20-directed cytolytic antibody 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 Ruxience as a suspect or interacting product; reports listing it only as a concomitant medication (257) 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.