Darzalex and Sepsis - a phase IV clinical study of FDA data

Summary:

Sepsis is reported as a side effect among people who take Darzalex (daratumumab), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Dexamethasone, and have Multiple myeloma.

The phase IV clinical study analyzes which people have Sepsis when taking Darzalex. It is created by eHealthMe based on reports of 20,191 people who have side effects when taking Darzalex from the FDA, and is updated regularly.

What is Darzalex?

Darzalex has active ingredients of daratumumab. eHealthMe is studying from 20,206 Darzalex users. Check the latest studies of Darzalex.

What is Sepsis?

Sepsis (a severe blood infection that can lead to organ failure and death) is found to be associated with 2,525 drugs and 3,260 conditions by eHealthMe. Check the latest studies of Sepsis.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.

On Aug, 20, 2026

20,191 people reported to have side effects when taking Darzalex.
Among them, 308 people (1.53%) have Sepsis.

Among these 308 people:

* Approximation only. Some reports may have incomplete information.

Do you take Darzalex and have Sepsis?

- Check whether Sepsis is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously

Related studies:

Effectiveness of, long term effects of, and alternative drugs to Darzalex:

Darzalex (20,206 reports)

Sepsis treatments and more:

Sepsis (140,102 reports)

How severe was Sepsis and when was it recovered:

Sepsis in Darzalex

Expand to all the drugs that have ingredients of daratumumab:

Sepsis and drugs with ingredients of daratumumab (85 reports)

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Darzalex:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Sepsis:

Sepsis (2,525 drugs)

Browse all the conditions that are associated with Sepsis:

Sepsis (3,260 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on daratumumab (the active ingredients of Darzalex) and Darzalex (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.