85/100 · Critical
Manufactured by Janssen Biotech, Inc.
High Serious Adverse Events with Daratumumab
59,976 FDA adverse event reports analyzed
Last updated: 2026-05-12
DARATUMUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Biotech, Inc.. Based on analysis of 59,976 FDA adverse event reports, DARATUMUMAB has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DARATUMUMAB include PLASMA CELL MYELOMA, OFF LABEL USE, INFUSION RELATED REACTION, PNEUMONIA, NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DARATUMUMAB.
Daratumumab has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 59,976 adverse event reports for this medication, which is primarily manufactured by Janssen Biotech, Inc..
The most commonly reported adverse events include Plasma Cell Myeloma, Off Label Use, Infusion Related Reaction. Of classified reports, 84.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious reactions such as death, pneumonia, and sepsis.
Frequent infusion-related reactions and infections. Neutropenia and thrombocytopenia are common hematological adverse events.
Patients taking Daratumumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Daratumumab requires careful monitoring for infusion-related reactions and infections. Patients should be warned about the potential for severe hematological adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Daratumumab received a safety concern score of 85/100 (high concern). This is based on a 84.3% serious event ratio across 37,410 classified reports. The score accounts for 59,976 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 17,327, Female: 13,953, Unknown: 1. The most frequently reported age groups are age 69 (960 reports), age 70 (940 reports), age 72 (935 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 37,410 classified reports for DARATUMUMAB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Daratumumab requires careful monitoring for infusion-related reactions and infections. Patients should be warned about the potential for severe hematological adverse events.
If you are taking Daratumumab, here are important things to know. The most commonly reported side effects include plasma cell myeloma, off label use, infusion related reaction, pneumonia, neutropenia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any signs of infection or severe reactions to their healthcare provider immediately. Follow all dosing instructions and do not alter the regimen without medical advice. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety profile of Daratumumab and may require additional studies or labeling changes based on ongoing data.
The FDA has received approximately 59,976 adverse event reports associated with Daratumumab. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Daratumumab include Plasma Cell Myeloma, Off Label Use, Infusion Related Reaction, Pneumonia, Neutropenia. By volume, the top reported reactions are: Plasma Cell Myeloma (3,705 reports), Off Label Use (3,306 reports), Infusion Related Reaction (2,597 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Daratumumab.
Out of 37,410 classified reports, 31,537 (84.3%) were classified as serious and 5,873 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Daratumumab break down by patient sex as follows: Male: 17,327, Female: 13,953, Unknown: 1. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Daratumumab adverse events are: age 69: 960 reports, age 70: 940 reports, age 72: 935 reports, age 73: 921 reports, age 74: 921 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Daratumumab adverse event reports is Janssen Biotech, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Daratumumab include: Fatigue, Diarrhoea, Drug Ineffective, Death, Neuropathy Peripheral. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Daratumumab to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Daratumumab has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High incidence of serious reactions such as death, pneumonia, and sepsis.
Key safety signals identified in Daratumumab's adverse event data include: High rate of serious adverse events (84.3%). Multiple hematological adverse events including neutropenia and thrombocytopenia. Frequent infusion-related reactions. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Daratumumab requires careful monitoring for infusion-related reactions and infections. Patients should be warned about the potential for severe hematological adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Daratumumab.
Patients should report any signs of infection or severe reactions to their healthcare provider immediately. Follow all dosing instructions and do not alter the regimen without medical advice.
Daratumumab has 59,976 adverse event reports on file with the FDA. Frequent infusion-related reactions and infections. The volume of reports for Daratumumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of Daratumumab and may require additional studies or labeling changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Janssen Biotech, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DARATUMUMAB:
Drugs related to DARATUMUMAB based on therapeutic use, drug class, or shared indications: