Tracleer and Localised oedema - a phase IV clinical study of FDA data

Summary:

Localised oedema is reported as a side effect among people who take Tracleer (bosentan), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Coumadin, and have Pulmonary hypertension.

The phase IV clinical study analyzes which people have Localised oedema when taking Tracleer. It is created by eHealthMe based on reports of 55,065 people who have side effects when taking Tracleer from the FDA, and is updated regularly.

What is Tracleer?

Tracleer has active ingredients of bosentan. It is often used in primary pulmonary hypertension. eHealthMe is studying from 55,125 Tracleer users. Check the latest studies of Tracleer.

What is Localised oedema?

Localised oedema (fluid retention in a particular part of the body) is found to be associated with 546 drugs and 707 conditions by eHealthMe. Check the latest studies of Localised oedema.

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, 26, 2026

55,065 people reported to have side effects when taking Tracleer.
Among them, 89 people (0.16%) have Localised oedema.

Among these 89 people:

How long have people been on Tracleer when they have Localised oedema? *

What is the gender of people who have Localised oedema when taking Tracleer? *

female: 55.7 %
male: 44.3 %

What is the age of people who have Localised oedema when taking Tracleer? *

What are other drugs people take besides Tracleer? *

What are other side effects people have besides Localised oedema? *

Oedema Peripheral (superficial swelling): 42 people, 47.19%
Dyspnea (difficult or laboured breathing): 40 people, 44.94%
Fluid Retention (an abnormal accumulation of fluid in the blood): 23 people, 25.84%
Weight Increased: 22 people, 24.72%
Pulmonary Oedema (fluid accumulation in the lungs): 15 people, 16.85%
Fatigue (feeling of tiredness): 13 people, 14.61%
Headache (pain in head): 13 people, 14.61%
Oedema (fluid collection in tissue): 12 people, 13.48%
Pain In Extremity: 12 people, 13.48%
Nausea (feeling of having an urge to vomit): 11 people, 12.36%

What are the existing conditions these people have? *

Pulmonary Hypertension (increase in blood pressure in the lung artery): 22 people, 24.72%
Systemic Sclerosis (Scleroderma) (an autoimmune or connective tissue disease. it is characterized by thickening of the skin): 5 people, 5.62%
Cor Pulmonale Chronic (long lasting enlargement of the right ventricle of the heart): 4 people, 4.49%
Pulmonary Hypertension Secondary (increase in blood pressure in the lung artery): 3 people, 3.37%
Arthritis Bacterial (form of joint disorder that involves inflammation of one or more joints due to bacterial infection): 2 people, 2.25%
Gallbladder Disorder: 2 people, 2.25%
Cardiac Failure Congestive: 1 person, 1.12%
Connective Tissue Disorder (any disease that has the connective tissues of the body): 1 person, 1.12%
Cor Pulmonale (enlargement of the right ventricle of the heart): 1 person, 1.12%
Fatigue (feeling of tiredness): 1 person, 1.12%

* Approximation only. Some reports may have incomplete information.

Do you take Tracleer and have Localised oedema?

- Check whether Localised oedema 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 Tracleer:

Tracleer (55,125 reports)

Browse all side effects of Tracleer:

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 Localised oedema:

Localised oedema (546 drugs)

Browse all the conditions that are associated with Localised oedema:

Localised oedema (707 conditions)

How the study uses the data?

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