Breo ellipta and Systemic sclerosis (scleroderma) - a phase IV clinical study of FDA data

Summary:

Systemic sclerosis (scleroderma) is reported as a side effect among people who take Breo ellipta (fluticasone furoate; vilanterol trifenatate), especially for people who are female, 60+ old, also take Pantoprazole, and have Primary pulmonary hypertension.

The phase IV clinical study analyzes which people have Systemic sclerosis (scleroderma) when taking Breo ellipta. It is created by eHealthMe based on reports of 37,063 people who have side effects when taking Breo ellipta from the FDA, and is updated regularly.

What is Breo ellipta?

Breo ellipta has active ingredients of fluticasone furoate; vilanterol trifenatate. It is often used in asthma. eHealthMe is studying from 37,362 Breo ellipta users. Check the latest studies of Breo ellipta.

What is Systemic sclerosis (scleroderma)?

Systemic sclerosis (scleroderma) (an autoimmune or connective tissue disease. it is characterized by thickening of the skin) is found to be associated with 493 drugs and 857 conditions by eHealthMe. Check the latest studies of Systemic sclerosis (scleroderma).

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, 06, 2026

37,063 people reported to have side effects when taking Breo ellipta.
Among them, 13 people (0.04%) have Systemic sclerosis (scleroderma).

Could Breo ellipta cause Systemic sclerosis (scleroderma)?

Among these 13 people:

What is the gender of people who have Systemic sclerosis (scleroderma) when taking Breo ellipta? *

female: 84.62 %
male: 15.38 %

What is the age of people who have Systemic sclerosis (scleroderma) when taking Breo ellipta? *

What are other drugs people take besides Breo ellipta? *

What are other side effects people have besides Systemic sclerosis (scleroderma)? *

Weakness: 6 people, 46.15%
Cough: 6 people, 46.15%
Dyspnea (difficult or laboured breathing): 6 people, 46.15%
Fatigue (feeling of tiredness): 5 people, 38.46%
Abdominal Distension: 4 people, 30.77%
Anaemia (lack of blood): 4 people, 30.77%
Pulmonary Hypertension (increase in blood pressure in the lung artery): 4 people, 30.77%
Chronic Kidney Disease: 4 people, 30.77%
Pain: 4 people, 30.77%
Sleep Disorder: 4 people, 30.77%

What are the existing conditions these people have? *

Primary Pulmonary Hypertension (primary high blood pressure that affects the arteries in the lungs and the right side of your heart): 6 people, 46.15%
Pulmonary Hypertension (increase in blood pressure in the lung artery): 3 people, 23.08%
Pain: 3 people, 23.08%
Flatulence (flatus expelled through the anus): 3 people, 23.08%
Constipation: 3 people, 23.08%
Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 2 people, 15.38%
Pyoderma (any skin disease that is pyogenic): 2 people, 15.38%
Nausea (feeling of having an urge to vomit): 2 people, 15.38%
Interstitial Lung Disease: 2 people, 15.38%
Osteoporosis (bones weak and more likely to break): 1 person, 7.69%

* Approximation only. Some reports may have incomplete information.

Do you take Breo ellipta and have Systemic sclerosis (scleroderma)?

- Check whether Systemic sclerosis (scleroderma) 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 Breo ellipta:

Breo ellipta (37,362 reports)

Systemic sclerosis (scleroderma) treatments and more:

Systemic sclerosis (scleroderma) (10,958 reports)

How severe was Systemic sclerosis (scleroderma) and when was it recovered:

Systemic sclerosis (scleroderma) in Breo ellipta

Expand to all the drugs that have ingredients of fluticasone furoate; vilanterol trifenatate:

Systemic sclerosis (scleroderma) and drugs with ingredients of fluticasone furoate; vilanterol trifenatate

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Breo ellipta:

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 Systemic sclerosis (scleroderma):

Systemic sclerosis (scleroderma) (493 drugs)

Browse all the conditions that are associated with Systemic sclerosis (scleroderma):

Systemic sclerosis (scleroderma) (857 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on fluticasone furoate; vilanterol trifenatate (the active ingredients of Breo ellipta) and Breo ellipta (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.

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