Ursodiol and Splenomegaly - a phase IV clinical study of FDA data

Summary:

Splenomegaly is reported as a side effect among people who take Ursodiol (ursodiol), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Calcium, and have Pain.

The phase IV clinical study analyzes which people have Splenomegaly when taking Ursodiol. It is created by eHealthMe based on reports of 18,820 people who have side effects when taking Ursodiol from the FDA, and is updated regularly.

What is Ursodiol?

Ursodiol has active ingredients of ursodiol. It is often used in primary biliary cirrhosis. eHealthMe is studying from 19,061 Ursodiol users. Check the latest studies of Ursodiol.

What is Splenomegaly?

Splenomegaly (enlargement of spleen) is found to be associated with 1,107 drugs and 1,478 conditions by eHealthMe. Check the latest studies of Splenomegaly.

On Aug, 05, 2026

18,820 people reported to have side effects when taking Ursodiol.
Among them, 88 people (0.47%) have Splenomegaly.

Among these 88 people:

How long have people been on Ursodiol when they have Splenomegaly? *

What is the gender of people who have Splenomegaly when taking Ursodiol? *

female: 57.53 %
male: 42.47 %

What is the age of people who have Splenomegaly when taking Ursodiol? *

What are other drugs people take besides Ursodiol? *

What are other side effects people have besides Splenomegaly? *

Thrombocytopenia (decrease of platelets in blood): 39 people, 44.32%
Fatigue (feeling of tiredness): 29 people, 32.95%
Ascites (accumulation of fluid in the abdominal cavity): 29 people, 32.95%
Diarrhea: 24 people, 27.27%
Fever: 22 people, 25.00%
Haemoglobin Decreased: 20 people, 22.73%
Hepatomegaly (abnormal enlargement of the liver): 20 people, 22.73%
Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 19 people, 21.59%
Portal Hypertension (increase in the blood pressure within a system of veins called the portal venous system): 19 people, 21.59%
Nausea (feeling of having an urge to vomit): 17 people, 19.32%

What are the existing conditions these people have? *

Pain: 11 people, 12.50%
Primary Myelofibrosis (primary disorder of the bone marrow): 8 people, 9.09%
Short-Bowel Syndrome (a condition in which the body cannot absorb enough fluids and nutrients because part of the small intestine is missing): 8 people, 9.09%
Cystic Fibrosis (disease of the secretary glands): 7 people, 7.95%
Abdominal Pain Upper: 6 people, 6.82%
Acute Lymphocytic Leukemia (All) (cancer of the white blood cells characterized by excess lymphoblasts): 6 people, 6.82%
Stress And Anxiety: 6 people, 6.82%
Polycythaemia Vera (blood disorder in which the bone marrow makes too many red blood cells): 6 people, 6.82%
Diarrhea: 6 people, 6.82%
Gastrointestinal Disorder (functional problems of gastrointestinal tract): 5 people, 5.68%

* Approximation only. Some reports may have incomplete information.

Do you take Ursodiol and have Splenomegaly?

- Check whether Splenomegaly 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 Ursodiol:

Ursodiol (19,061 reports)

Splenomegaly treatments and more:

Splenomegaly (17,257 reports)

Browse all side effects of Ursodiol:

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 Splenomegaly:

Splenomegaly (1,107 drugs)

Browse all the conditions that are associated with Splenomegaly:

Splenomegaly (1,478 conditions)

How the study uses the data?

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