Truxima: adverse event reports filed with FDA

4,630

reports as suspect product

0% of all reports · about 520 a year

400

reports, 12 months to June 2026

536 in the 12 months before

72.3%

marked serious by the reporter

77% across the class

10.3%

record death among outcomes, as reported

475 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 Truxima reports recording the termmedian drug in cd20-directed cytolytic antibody

1. Off label useused for a purpose or in a way not on the label48.5%2,247
2. Intentional product use issuedeliberate use not as intended6.9%321
3. Hypertensionhigh blood pressure5.4%252
4. Intentional dose omission4.8%223
5. Painpain, site not specified4.8%221
6. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease4.8%221
7. Dyspnoeashortness of breath4.7%216
8. Fatiguetiredness4.7%216
9. Drug ineffectivethe medicine did not work as expected4.4%206
10. Infusion related reactiona reaction during or soon after an infusion4.4%206
11. Pyrexiafever4.4%204
12. Rashskin rash4.4%203
13. Headachehead pain4.1%188
14. Nauseafeeling sick3.8%178
15. Deaththe patient died; cause not stated by this term3.8%176
16. Arthralgiajoint pain3.8%175
17. Underdoseless than the intended dose3.7%171
18. Hypersensitivityan allergic-type reaction3.6%165
19. Condition aggravatedthe condition being treated got worse3.5%160
20. Pruritusitching3.5%160
21. Malaisegeneral feeling of being unwell3.2%150
22. Pneumonialung infection3.2%148
23. Systemic lupus erythematosuslupus, an autoimmune disease3%140
24. Diarrhoealoose or frequent stools3%137
25. Product use in unapproved indicationused for a purpose not on the label2.8%131
26. Product use issuea problem in how the product was used2.8%129
27. Joint swellinga swollen joint2.8%128
28. Astheniaweakness or lack of energy2.7%126
29. Alopeciahair loss2.7%124
30. Hepatic enzyme increasedraised liver enzymes2.6%120

Top 30 of 872 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. 42.4% 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 4,630 reports.

Drugs most often listed in the same reports

Other products listed in reports where Truxima 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 Truxima as a suspect or interacting product; reports listing it only as a concomitant medication (218) 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.