Ursodeoxycholic acid and Haemolysis - a phase IV clinical study of FDA data

Summary:

Haemolysis is reported as a side effect among people who take Ursodeoxycholic acid (ursodiol), especially for people who are male, 10-19 old, have been taking the drug for 1 - 6 months also take Soliris, and have Autoimmune hepatitis.

The phase IV clinical study analyzes which people have Haemolysis when taking Ursodeoxycholic acid. It is created by eHealthMe based on reports of 7,467 people who have side effects when taking Ursodeoxycholic acid from the FDA, and is updated regularly.

What is Ursodeoxycholic acid?

Ursodeoxycholic acid has active ingredients of ursodiol. It is often used in biliary cirrhosis primary. eHealthMe is studying from 7,528 Ursodeoxycholic acid users. Check the latest studies of Ursodeoxycholic acid.

What is Haemolysis?

Haemolysis (breaking open of red blood cells and the release of haemoglobin into the surrounding fluid) is found to be associated with 611 drugs and 838 conditions by eHealthMe. Check the latest studies of Haemolysis.

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, 16, 2026

7,467 people reported to have side effects when taking Ursodeoxycholic acid.
Among them, 17 people (0.23%) have Haemolysis.

Could Ursodeoxycholic acid cause Haemolysis?

Among these 17 people:

How long have people been on Ursodeoxycholic acid when they have Haemolysis? *

What is the gender of people who have Haemolysis when taking Ursodeoxycholic acid? *

female: 42.86 %
male: 57.14 %

What is the age of people who have Haemolysis when taking Ursodeoxycholic acid? *

What are other drugs people take besides Ursodeoxycholic acid? *

What are other side effects people have besides Haemolysis? *

Fever: 8 people, 47.06%
Thrombocytopenia (decrease of platelets in blood): 6 people, 35.29%
Jaundice - Yellow Skin (a yellowish pigmentation of the skin): 5 people, 29.41%
Lymphopenia (an abnormally low level of lymphocytes in the blood): 4 people, 23.53%
Haemoglobinuria (the presence of free haemoglobin in the urine): 4 people, 23.53%
Polychromasia (abnormally high number of red blood cells found in the bloodstream): 4 people, 23.53%
Acute Kidney Failure: 3 people, 17.65%
Respiratory Acidosis (respiratory failure or ventilatory failure, causes the ph of blood and other bodily fluids to decrease): 2 people, 11.76%
Blood Lactate Dehydrogenase Increased: 2 people, 11.76%
High Blood Pressure: 2 people, 11.76%

What are the existing conditions these people have? *

Autoimmune Hepatitis: 4 people, 23.53%
Paroxysmal Nocturnal Haemoglobinuria (haemoglobin in the urine): 3 people, 17.65%
Bone Marrow Conditioning Regimen: 3 people, 17.65%
Lung Cancer - Non-Small Cell (lung cancer): 2 people, 11.76%
Constipation: 2 people, 11.76%
Pancreatic Carcinoma Recurrent (pancreatic cancer - recurrent): 1 person, 5.88%
Pancreatic Carcinoma (pancreatic cancer): 1 person, 5.88%
Lung Adenocarcinoma (a form of non-small cell lung cancer): 1 person, 5.88%
Gout (uric acid crystals building up in the body): 1 person, 5.88%
Cholestasis (a condition where bile cannot flow from the liver to the duodenum): 1 person, 5.88%

* Approximation only. Some reports may have incomplete information.

Do you take Ursodeoxycholic acid and have Haemolysis?

- Check whether Haemolysis 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 Ursodeoxycholic acid:

Ursodeoxycholic acid (7,528 reports)

Haemolysis treatments and more:

Haemolysis (9,155 reports)

Browse all side effects of Ursodeoxycholic acid:

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 Haemolysis:

Haemolysis (611 drugs)

Browse all the conditions that are associated with Haemolysis:

Haemolysis (838 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on ursodiol (the active ingredients of Ursodeoxycholic acid) and Ursodeoxycholic acid (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.