Ofatumumab: adverse event reports filed with FDA

2,942

reports as suspect product

0% of all reports · about 172 a year

97

reports, 12 months to June 2026

166 in the 12 months before

97.9%

marked serious by the reporter

77% across the class

13.5%

record death among outcomes, as reported

397 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 Ofatumumab reports recording the termmedian drug in cd20-directed cytolytic antibody

1. Febrile neutropeniafever with low white blood cells16.5%485
2. Neutropenialow neutrophils, a type of white blood cell11.9%349
3. Anaemialow red blood cells10.5%309
4. Thrombocytopenialow platelets10.3%302
5. Infectionan infection, type not specified10.2%300
6. Atrial fibrillationan irregular heart rhythm9.8%287
7. Haemorrhagebleeding8.9%263
8. Cytopenia8.7%257
9. Aspergillus infection8.7%256
10. Pyrexiafever7.7%226
11. Disease progressionthe disease advanced6.5%191
12. Pneumonialung infection6.1%178
13. Fatiguetiredness3.6%105
14. Off label useused for a purpose or in a way not on the label3.1%90
15. Headachehead pain2.7%80
16. Vomitingbeing sick2.6%76
17. Sepsisa severe body-wide response to infection2.5%74
18. Nauseafeeling sick2.2%65
19. Dyspnoeashortness of breath2.1%61
20. Astheniaweakness or lack of energy1.9%57
21. Lung infection1.9%56
22. Neutropenic sepsis1.9%55
23. Diarrhoealoose or frequent stools1.8%54
24. Infusion related reactiona reaction during or soon after an infusion1.8%54
25. Drug ineffectivethe medicine did not work as expected1.8%52
26. Rashskin rash1.8%52
27. Dizzinesslight-headedness or unsteadiness1.6%48
28. Malaisegeneral feeling of being unwell1.6%47
29. Product use in unapproved indicationused for a purpose not on the label1.6%47
30. Hypogammaglobulinaemia1.5%44

Top 30 of 510 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. 20.6% 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 2,942 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ofatumumab 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 Ofatumumab as a suspect or interacting product; reports listing it only as a concomitant medication (276) 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.