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Daratumumab Side Effects

The most commonly reported side effects of daratumumab include plasma cell myeloma, off label use, and infusion related reaction, based on 40,103 FDA adverse event reports from 2014 to 2025. 3.7% of reports found the drug to be ineffective.

Daratumumab side effects

Percentages show how often each reaction appears relative to total reports for daratumumab.

1
Plasma Cell Myeloma9.4%3,781
2
Off Label Use8.7%3,486
3
Infusion Related Reaction6.6%2,647
4
Pneumonia5.0%1,990
5
Neutropenia4.8%1,924
6
Fatigue4.7%1,872
7
Diarrhoea4.4%1,767
8
Drug Ineffective3.7%1,502
9
Death3.7%1,492
10
Neuropathy Peripheral3.7%1,484
11
Dyspnoea3.4%1,367
12
Thrombocytopenia3.4%1,353
13
Pyrexia3.3%1,310
14
Anaemia2.9%1,169
15
Nausea2.9%1,163

These are voluntary reports and do not establish that daratumumab caused these reactions.

Report severity

81.6%Serious32,729 reports
33.6%Hospitalizations13,457 reports
12.2%Fatal4,896 reports

Seriousness is determined by the reporter, not by OpenClaim.

Daratumumab drug interactions

Other drugs that appear in adverse event reports alongside daratumumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dexamethasone39.0%15,653
2
Lenalidomide36.7%14,721
3
Bortezomib28.6%11,478
4
Pomalidomide16.7%6,686
5
Carfilzomib8.3%3,343
6
Cyclophosphamide7.9%3,163
7
Thalidomide4.5%1,806
8
Melphalan3.9%1,570
9
Ixazomib-citrate2.9%1,143
10
Doxorubicin-hydrochloride2.3%909
11
Prednisone2.1%823
12
Etoposide1.7%693
13
Cisplatin1.2%471
14
Acyclovir1.1%460
15
Prednisolone1.0%404

Taken alongside

1
Dexamethasone22.0%8,810
2
Acyclovir17.9%7,167
3
Aspirin11.8%4,718
4
Acetaminophen9.6%3,862
5
Bortezomib6.4%2,577
6
Omeprazole5.3%2,137
7
Ergocalciferol5.3%2,118
8
Ondansetron5.1%2,044
9
Pantoprazole-sodium4.8%1,905
10
Sulfamethoxazole4.7%1,904
11
Zoledronic-acid4.6%1,831
12
Trimethoprim4.4%1,770
13
Montelukast-sodium4.3%1,715
14
Furosemide4.3%1,714
15
Lenalidomide4.1%1,647

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports daratumumab side effects

37.2% of daratumumab adverse event reports involve female patients and 45.8% involve male patients. The largest age group is elderly at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female37.2%
Male45.8%
Unknown17.1%

Age group

< 2<0.1%
2–110.5%
12–170.3%
18–6437.1%
65+62.0%

What is daratumumab used for

Conditions and purposes for which patients were taking daratumumab when the adverse event was reported.

Accidental Exposure To ProductAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAdenocarcinoma PancreasAdjuvant TherapyAdrenal AdenomaAgranulocytosisAllogenic Stem Cell TransplantationAmyloidosisAnaemiaAngiocentric LymphomaAntiviral ProphylaxisAnxiety

Showing 15 of 397 indications

Daratumumab brand names and reporting trend

Daratumumab is sold under brand names including Darzalex, Darzalex Faspro.

Brand names

Darzalex22,227
Darzalex Faspro10

Quarterly reports (20142025)

20142016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking daratumumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.