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

Summary:

Anaphylaxis 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 Revatio, and have Pulmonary hypertension.

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

Anaphylaxis (serious allergic reaction that is rapid in onset and may cause death) is found to be associated with 1,945 drugs and 2,855 conditions by eHealthMe. Check the latest studies of Anaphylaxis.

On Jul, 05, 2026

55,065 people reported to have side effects when taking Tracleer.
Among them, 31 people (0.06%) have Anaphylaxis.

Among these 31 people:

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

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

female: 76.67 %
male: 23.33 %

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

What are other drugs people take besides Tracleer? *

What are other side effects people have besides Anaphylaxis? *

Dyspnea (difficult or laboured breathing): 7 people, 22.58%
Hypersensitivity: 4 people, 12.90%
Nausea (feeling of having an urge to vomit): 4 people, 12.90%
Asthma: 4 people, 12.90%
Drug Hypersensitivity: 4 people, 12.90%
Hyperhidrosis (abnormally increased sweating): 3 people, 9.68%
Diarrhea: 3 people, 9.68%
Oedema Peripheral (superficial swelling): 3 people, 9.68%
Fever: 3 people, 9.68%
Pain In Jaw: 3 people, 9.68%

What are the existing conditions these people have? *

Pulmonary Hypertension (increase in blood pressure in the lung artery): 9 people, 29.03%
Pulmonary Hypertension Primary (increase in blood pressure in the lung artery with no cause): 3 people, 9.68%
Asthma: 3 people, 9.68%
Pneumonia: 3 people, 9.68%
Osteoporosis (bones weak and more likely to break): 3 people, 9.68%
Bronchiectasis (abnormal widening of the bronchi or their branches, causing a risk of infection): 3 people, 9.68%
Hypokalemia (low potassium): 3 people, 9.68%
Systemic Sclerosis (an autoimmune or connective tissue disease. it is characterized by thickening of the skin): 2 people, 6.45%
Idiopathic Pulmonary Fibrosis (chronic lung disease): 1 person, 3.23%
Arterial Disorder: 1 person, 3.23%

* Approximation only. Some reports may have incomplete information.

Do you take Tracleer and have Anaphylaxis?

- Check whether Anaphylaxis 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)

Anaphylaxis treatments and more:

Anaphylaxis (91,195 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 Anaphylaxis:

Anaphylaxis (1,945 drugs)

Browse all the conditions that are associated with Anaphylaxis:

Anaphylaxis (2,855 conditions)

Related publications that referenced our studies

An?eli? N, Erdeljan S, Popovi? R, Bo?i? T, "Anaphylaxis on graft reperfusion during orthotopic liver transplantation: A case study", Srpski arhiv za celokupno lekarstvo, 2016 Jan .
Thangakunam B, Christopher DJ, Mathews V, Srivastava A, "Mesenchymal stromal stem cell therapy in advanced interstitial lung disease-Anaphylaxis and short-term follow-up", Lung India: official organ of Indian Chest Society, 2015 Jan .
Guensley Delva, M. D., & Muse, I, "Rare case of laryngeal edema and anaphylaxis to Ofirmev (IV Acetaminophen): Case Report", , 2012 Jan .
Azkur D, Yoldas T, Toyran M, Kocabas CN, "A pediatric case of anaphylaxis due to octreotide", Asian Pacific journal of allergy and immunology, 2011 Dec .
An?eli? N, Erdeljan S, Popovi? R, Bo?i? T, "Anaphylaxis on graft reperfusion during orthotopic liver transplantation: A case study", Srpski arhiv za celokupno lekarstvo, 2016 Jan .
Thangakunam B, Christopher DJ, Mathews V, Srivastava A, "Mesenchymal stromal stem cell therapy in advanced interstitial lung disease-Anaphylaxis and short-term follow-up", Lung India: official organ of Indian Chest Society, 2015 Jan .
Guensley Delva, M. D., & Muse, I, "Rare case of laryngeal edema and anaphylaxis to Ofirmev (IV Acetaminophen): Case Report", , 2012 Jan .
Azkur D, Yoldas T, Toyran M, Kocabas CN, "A pediatric case of anaphylaxis due to octreotide", Asian Pacific journal of allergy and immunology, 2011 Dec .

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.