Ocaliva and Hyperbilirubinaemia - a phase IV clinical study of FDA data

Summary:

Hyperbilirubinaemia is reported as a side effect among people who take Ocaliva (obeticholic acid), especially for people who are female, 40-49 old, have been taking the drug for 1 - 6 months also take Aleve, and have Biliary cirrhosis primary.

The phase IV clinical study analyzes which people have Hyperbilirubinaemia when taking Ocaliva. It is created by eHealthMe based on reports of 6,917 people who have side effects when taking Ocaliva from the FDA, and is updated regularly.

What is Ocaliva?

Ocaliva has active ingredients of obeticholic acid. eHealthMe is studying from 6,919 Ocaliva users. Check the latest studies of Ocaliva.

What is Hyperbilirubinaemia?

Hyperbilirubinaemia (excess of bilirubin in the blood) is found to be associated with 904 drugs and 1,074 conditions by eHealthMe. Check the latest studies of Hyperbilirubinaemia.

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, 28, 2026

6,917 people reported to have side effects when taking Ocaliva.
Among them, 20 people (0.29%) have Hyperbilirubinaemia.

Could Ocaliva cause Hyperbilirubinaemia?

Among these 20 people:

How long have people been on Ocaliva when they have Hyperbilirubinaemia? *

What is the gender of people who have Hyperbilirubinaemia when taking Ocaliva? *

female: 100 %
male: 0.0 %

What is the age of people who have Hyperbilirubinaemia when taking Ocaliva? *

What are other drugs people take besides Ocaliva? *

What are other side effects people have besides Hyperbilirubinaemia? *

Itching: 9 people, 45.00%
Jaundice - Yellow Skin (a yellowish pigmentation of the skin): 8 people, 40.00%
Ascites (accumulation of fluid in the abdominal cavity): 7 people, 35.00%
Hepatic Failure (liver failure): 7 people, 35.00%
Fatigue (feeling of tiredness): 5 people, 25.00%
Melaena (the passage of black, tarry stools): 4 people, 20.00%
Choledocholithiasis (stones in the common bile duct): 3 people, 15.00%
Hypersensitivity: 3 people, 15.00%
Abdominal Distension: 3 people, 15.00%
Carbohydrate Antigen 19-9 Increased: 3 people, 15.00%

What are the existing conditions these people have? *

Biliary Cirrhosis Primary (primary biliary cirrhosis (pbc) is a long-term liver disease that damages the small bile ducts in the liver. the build-up of bile damages the liver): 12 people, 60.00%
Itching: 3 people, 15.00%
Urinary Tract Infection: 1 person, 5.00%
Pain: 1 person, 5.00%

* Approximation only. Some reports may have incomplete information.

Do you take Ocaliva and have Hyperbilirubinaemia?

- Check whether Hyperbilirubinaemia 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 Ocaliva:

Ocaliva (6,919 reports)

Browse all side effects of Ocaliva:

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 Hyperbilirubinaemia:

Hyperbilirubinaemia (904 drugs)

Browse all the conditions that are associated with Hyperbilirubinaemia:

Hyperbilirubinaemia (1,074 conditions)

How the study uses the data?

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