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

Summary:

Death is reported as a side effect among people who take Cholbam (cholic acid), especially for people who are male, 0-1 old, have been taking the drug for < 1 month also take Keppra, and have Cerebrohepatorenal syndrome.

The study is created by eHealthMe based on reports of 264 people who have side effects when taking Cholbam from the FDA, and is updated regularly.

What is Cholbam?

Cholbam has active ingredients of cholic acid. eHealthMe is studying from 264 Cholbam users. Check the latest studies of Cholbam.

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, 27, 2026

264 people reported to have side effects when taking Cholbam.
Among them, 24 people (9.09%) died.

Among these 24 people:

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

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

female: 36.36 %
male: 63.64 %

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

What are other drugs people take besides Cholbam? *

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

Hospitalisation: 2 people, 8.33%
Venoocclusive Liver Disease (small veins in the liver are obstructed): 1 person, 4.17%
Alanine Aminotransferase Increased: 1 person, 4.17%
Aspartate Aminotransferase Increased: 1 person, 4.17%
Diarrhea: 1 person, 4.17%
Fever: 1 person, 4.17%
Gastrointestinal Disorder (functional problems of gastrointestinal tract): 1 person, 4.17%
Gravitational Oedema (abnormally large fluid volume in the circulatory system makes obese): 1 person, 4.17%
Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 1 person, 4.17%
Infection: 1 person, 4.17%

What are the existing conditions these people have? *

Cerebrohepatorenal Syndrome (absence of functional organelles in brain cells (by birth disorder )): 15 people, 62.50%
Metabolic Disorder (an abnormal function and pattern of body fat. insulin resistance refers to the diminished ability of cells to respond to the action of insulin in promoting the transport of the sugar glucose, from blood into muscles and other tissues): 2 people, 8.33%
Liver Disorder (liver diseases): 1 person, 4.17%

* Approximation only. Some reports may have incomplete information.

Related studies:

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

Cholbam (264 reports)

Expand to all the drugs that have ingredients of cholic acid:

Death and drugs with ingredients of cholic acid (39 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 Cholbam:

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 (3,113 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 cholic acid (the active ingredients of Cholbam) and Cholbam (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.