Daratumumab

Common brands: Darzalex, Ozurdex, Hemady, Maxidex, Dexamethasone

Top reporter: Janssen Biotech, Inc.

CD38-directed Cytolytic Antibody [EPC]Corticosteroid [EPC]Thalidomide Analog [EPC]Proteasome Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
38,558
Total Reports
23,738
Serious Reports
4,930
Death Reports
30
Reported Reactions
Death Report Ratio: High (12.79%)

Patient Demographics

Male
17,827
Female
14,416

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Daratumumab.

# Reaction Reports % of Total
1 PLASMA CELL MYELOMA 3,780
9.7%
2 OFF LABEL USE 3,426
8.8%
3 INFUSION RELATED REACTION 2,619
6.7%
4 PNEUMONIA 1,982
5.1%
5 NEUTROPENIA 1,926
4.9%
6 FATIGUE 1,733
4.5%
7 DIARRHOEA 1,680
4.3%
8 DRUG INEFFECTIVE 1,537
3.9%
9 DEATH 1,445
3.7%
10 NEUROPATHY PERIPHERAL 1,431
3.7%
11 THROMBOCYTOPENIA 1,377
3.5%
12 DYSPNOEA 1,293
3.3%
13 PYREXIA 1,277
3.3%
14 ANAEMIA 1,187
3.0%
15 NAUSEA 1,090
2.8%
16 COVID-19 918
2.4%
17 WHITE BLOOD CELL COUNT DECREASED 874
2.2%
18 INTENTIONAL PRODUCT USE ISSUE 861
2.2%
19 RASH 857
2.2%
20 INFECTION 812
2.1%
21 PLATELET COUNT DECREASED 797
2.0%
22 FEBRILE NEUTROPENIA 774
2.0%
23 DISEASE PROGRESSION 755
1.9%
24 ASTHENIA 720
1.8%
25 SEPSIS 697
1.8%
26 CONSTIPATION 659
1.7%
27 VOMITING 626
1.6%
28 COUGH 622
1.6%
29 CHILLS 585
1.5%
30 ACUTE KIDNEY INJURY 581
1.5%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.