Columvi: adverse event reports filed with FDA

758

reports as suspect product

0% of all reports · about 246 a year

325

reports, 12 months to June 2026

268 in the 12 months before

81.1%

marked serious by the reporter

91.8% across the class

32.7%

record death among outcomes, as reported

248 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 Columvi reports recording the termmedian drug in bispecific cd20-directed cd3 t cell engager

1. Cytokine release syndrome22%167
2. Disease progressionthe disease advanced15.7%119
3. Deaththe patient died; cause not stated by this term13.7%104
4. Off label useused for a purpose or in a way not on the label12.1%92
5. Pyrexiafever8.6%65
6. Immune effector cell-associated neurotoxicity syndrome5.9%45
7. No adverse eventno adverse event was reported4.6%35
8. Infectionan infection, type not specified3.3%25
9. Pneumonialung infection2.6%20
10. Drug ineffectivethe medicine did not work as expected2.5%19
11. Sepsisa severe body-wide response to infection2.2%17
12. Diffuse large B-cell lymphoma recurrent2.1%16
13. Platelet count decreasedlow platelet count2.1%16
14. Anaemialow red blood cells2%15
15. Hyperpyrexia2%15
16. Hypotensionlow blood pressure2%15
17. Myelosuppression2%15
18. Diffuse large B-cell lymphoma1.8%14
19. Malignant neoplasm progression1.7%13
20. Condition aggravatedthe condition being treated got worse1.6%12
21. Covid-19COVID-19 infection1.6%12
22. Febrile neutropeniafever with low white blood cells1.6%12
23. Neutropenialow neutrophils, a type of white blood cell1.5%11
24. Pancytopenialow counts of all blood cells1.5%11
25. Astheniaweakness or lack of energy1.3%10
26. Mantle cell lymphoma1.3%10
27. Dyspnoeashortness of breath1.2%9
28. Respiratory failurethe lungs could not supply enough oxygen1.2%9
29. Thrombocytopenialow platelets1.2%9
30. Vomitingbeing sick1.2%9

Top 30 of 150 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 3 drugs in the bispecific cd20-directed cd3 t cell engager 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 3,559 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. 19% 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 758 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 bispecific cd20-directed cd3 t cell engager 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 Columvi as a suspect or interacting product; reports listing it only as a concomitant medication (11) 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.