Drugs › CD38-directed cytolytic antibody
Generic name
Daratumumab: adverse event reports filed with FDA
13,511 reports list it as a suspect or interacting product, 2014–2026. Class: CD38-directed cytolytic antibody.
- 13,511
- reports as suspect product
- 0.1% of all reports · about 1,167 a year
- 1,475
- reports, 12 months to June 2026
- 1,903 in the 12 months before
- 97%
- marked serious by the reporter
- 89.1% across the class
- 15.4%
- record death among outcomes, as reported
- 2,078 reports · not verified by FDA
13,511 adverse event reports received by FDA list daratumumab, a generic name as a suspect or interacting product, from December 2014 to June 2026. A further 3,352 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 1,475 reports listed it, down 22% from 1,903 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,167 reports a year and 0.1% of the 20,646,523 reports in the database, and 36.3% of the reports for the CD38-directed cytolytic antibody class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are plasma cell myeloma (9.9%), off label use (9.3%) and pneumonia (7.1%). A report can list several reactions, so shares add to more than 100%; 1,389 different terms appear across these reports. Plasma cell myeloma is recorded in 9.9% of these reports, a larger share than in the median CD38-directed cytolytic antibody drug (6.6%).
97% of the reports are marked serious by the reporter (89.1% across the class); 15.4% record death among the outcomes and 47.5% record hospitalisation, as reported. 56.9% of the reports came from physicians, and the largest patient age group is 65 to 74 (28.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Daratumumab reports recording the termmedian drug in cd38-directed cytolytic antibody
- Plasma cell myeloma9.9%1,339
- Off label useused for a purpose or in a way not on the label9.3%1,256
- Pneumonialung infection7.1%955
- Neutropenialow neutrophils, a type of white blood cell6.9%927
- Drug ineffectivethe medicine did not work as expected5.4%725
- Thrombocytopenialow platelets4.7%635
- Pyrexiafever4%542
- Anaemialow red blood cells3.9%521
- Diarrhoealoose or frequent stools3.8%507
- Infusion related reactiona reaction during or soon after an infusion3.7%495
- Febrile neutropeniafever with low white blood cells3.5%479
- Neuropathy peripheralnerve damage in hands or feet3.5%475
- Fatiguetiredness3.3%443
- Infectionan infection, type not specified3.1%419
- Covid-19COVID-19 infection2.9%396
- Deaththe patient died; cause not stated by this term2.9%395
- Disease progressionthe disease advanced2.7%370
- Dyspnoeashortness of breath2.6%352
- Sepsisa severe body-wide response to infection2.6%352
- Plasma cell myeloma refractory2.6%351
- Nauseafeeling sick2.6%349
- Acute kidney injurysudden loss of kidney function2.2%301
- Atrial fibrillationan irregular heart rhythm1.9%254
- Cardiac failureheart failure1.7%233
- Myelosuppression1.7%233
- Pancytopenialow counts of all blood cells1.7%224
- Product use in unapproved indicationused for a purpose not on the label1.6%221
- Astheniaweakness or lack of energy1.6%217
- Rashskin rash1.6%215
- Cytokine release syndrome1.5%206
Top 30 of 1,389 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 5 drugs in the cd38-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 37,241 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 24.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Plasma cell myeloma | 9,463 | 70% |
| Plasma cell myeloma refractory | 533 | 3.9% |
| Primary amyloidosis | 353 | 2.6% |
| Amyloidosis | 150 | 1.1% |
| Plasma cell leukaemia | 75 | 0.6% |
| Nephrotic syndrome | 56 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 13,511 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Daratumumab reports |
|---|---|---|
| Dexamethasone | 9,004 | 66.6% |
| Lenalidomide | 4,532 | 33.5% |
| Bortezomib | 4,027 | 29.8% |
| Cyclophosphamide | 2,254 | 16.7% |
| Velcade | 1,908 | 14.1% |
| Pomalidomide | 1,839 | 13.6% |
| Carfilzomib | 1,750 | 13% |
| Revlimid | 1,583 | 11.7% |
| Acyclovir | 1,204 | 8.9% |
| Melphalan | 1,059 | 7.8% |
Other products listed in reports where Daratumumab 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
| Measure | Daratumumab | CD38-directed cytolytic antibody | All reports |
|---|---|---|---|
| Reports as suspect product | 13,511 | 37,241 | 20,646,523 |
| Share of that pool | — | 36.3% | 0.1% |
| Reports, latest 12 months | 1,475 | — | 1,332,454 |
| Marked serious | 97% | 89.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 154 | 132 | 91 |
| Hospitalisation recorded, per 1,000 reports | 475 | 378 | 213 |
| Consumer-filed share | 6.1% | 9.7% | 45.8% |
| Top term, share of reports | Plasma cell myeloma 9.9% | median 6.6% | 0.2% |
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 cd38-directed cytolytic antibody class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Darzalex | brand | 16,606 | 1,623 | 87.1% |
| Isatuximab | generic | 4,311 | 545 | 97.8% |
| Darzalex Faspro | brand | 2,076 | 365 | 42.8% |
| Sarclisa | brand | 737 | 144 | 69.2% |
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.
Questions about Daratumumab reports
How many adverse event reports has FDA received for Daratumumab?
13,511 reports list Daratumumab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,475 of them arrived in the latest 12 months. Another 3,352 list it only as a concomitant medication.
What reactions are recorded in Daratumumab reports?
plasma cell myeloma (9.9%), off label use (9.3%), pneumonia (7.1%), neutropenia (6.9%) and drug ineffective (5.4%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Daratumumab was responsible.
How serious are the reports?
97% are marked serious by the reporter. Among the outcomes recorded, 15.4% of reports include death and 47.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (56.9%), other health professional (31.6%) and consumer or non-health professional (6.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Daratumumab rising?
1,475 reports in the 12 months to June 2026, down 22% from 1,903 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Daratumumab was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Daratumumab?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Daratumumab as a suspect or interacting product; reports listing it only as a concomitant medication (3,352) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.