Samsca and Death - a phase IV clinical study of FDA data

Summary:

Death is reported as a side effect among people who take Samsca (tolvaptan), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Spironolactone, and have Hyponatremia.

The study is created by eHealthMe based on reports of 8,134 people who have side effects when taking Samsca from the FDA, and is updated regularly.

What is Samsca?

Samsca has active ingredients of tolvaptan. eHealthMe is studying from 8,139 Samsca users. Check the latest studies of Samsca.

On May, 10, 2026

8,134 people reported to have side effects when taking Samsca.
Among them, 562 people (6.91%) died.

Among these 562 people:

* Approximation only. Some reports may have incomplete information.

Related studies:

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

Samsca (8,139 reports)

Expand to all the drugs that have ingredients of tolvaptan:

Death and drugs with ingredients of tolvaptan (921 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 Samsca:

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 Death:

Death (3,155 drugs)

Browse all the conditions that are associated with Death:

Death (3,686 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on tolvaptan (the active ingredients of Samsca) and Samsca (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.

Samsca and Death - a phase IV clinical study of FDA data

Summary:

What is Samsca?

Among these 562 people:

How long have people been on Samsca when they died? *

What is the gender of people who died when taking Samsca? *

What is the age of people who died when taking Samsca? *

What are other drugs people take besides Samsca? *

What are other side effects people have before they died? *

What are the existing conditions these people have? *