Tracleer and Myositis - a phase IV clinical study of FDA data

Summary:

Myositis 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 - 6 months also take Ramipril, and have Pulmonary hypertension.

The phase IV clinical study analyzes which people have Myositis 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 Myositis?

Myositis (inflammation of the muscles) is found to be associated with 828 drugs and 1,134 conditions by eHealthMe. Check the latest studies of Myositis.

On Jul, 11, 2026

55,065 people reported to have side effects when taking Tracleer.
Among them, 12 people (0.02%) have Myositis.

Among these 12 people:

How long have people been on Tracleer when they have Myositis? *

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

female: 100 %
male: 0.0 %

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

What are other drugs people take besides Tracleer? *

Pantoprazole Sodium: 2 people, 16.67%
Synthroid: 2 people, 16.67%
Ramipril: 2 people, 16.67%
Warfarin Sodium: 1 person, 8.33%
Hydroxychloroquine Sulfate: 1 person, 8.33%
Hydrochlorothiazide: 1 person, 8.33%
Folic Acid: 1 person, 8.33%
Fluoxetine: 1 person, 8.33%
Enoxaparin Sodium: 1 person, 8.33%
Dipyridamole: 1 person, 8.33%

What are other side effects people have besides Myositis? *

Alanine Aminotransferase Increased: 5 people, 41.67%
Aspartate Aminotransferase Increased: 5 people, 41.67%
Pain In Extremity: 3 people, 25.00%
Blood Alkaline Phosphatase Increased: 3 people, 25.00%
Oedema Peripheral (superficial swelling): 3 people, 25.00%
Drug Ineffective: 3 people, 25.00%
Gastrointestinal Haemorrhage (bleeding gastrointestinal tract): 2 people, 16.67%
Oropharyngeal Pain: 2 people, 16.67%
Liver Function Test Abnormal: 2 people, 16.67%
Liver Disorder (liver diseases): 2 people, 16.67%

What are the existing conditions these people have? *

Pulmonary Hypertension (increase in blood pressure in the lung artery): 6 people, 50.00%
Skin Ulcer: 2 people, 16.67%
Insomnia (sleeplessness): 1 person, 8.33%
Extremity Necrosis (death of body tissue of arms and legs): 1 person, 8.33%
Discomfort: 1 person, 8.33%

* Approximation only. Some reports may have incomplete information.

Do you take Tracleer and have Myositis?

- Check whether Myositis 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)

Myositis treatments and more:

Myositis (13,181 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 Myositis:

Myositis (828 drugs)

Browse all the conditions that are associated with Myositis:

Myositis (1,134 conditions)

Related publications that referenced our studies

Proti? D, Balti? S, Stupar N, Pavlov-Dolijanovi? S, Mugo?a S, Todorovi? Z, "A case of myositis with immunological background associated with statin use", Open Medicine, 2014 Oct .
Proti? D, Balti? S, Stupar N, Pavlov-Dolijanovi? S, Mugo?a S, Todorovi? Z, "A case of myositis with immunological background associated with statin use", Open Medicine, 2014 Oct .

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.