Breo ellipta and Sinus headache - a phase IV clinical study of FDA data

Summary:

Sinus headache is reported as a side effect among people who take Breo ellipta (fluticasone furoate; vilanterol trifenatate), especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months also take Vitamin D3, and have Relapsing-remitting multiple sclerosis.

The phase IV clinical study analyzes which people have Sinus headache 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 Sinus headache?

Sinus headache (headache caused by sinus infections) is found to be associated with 690 drugs and 791 conditions by eHealthMe. Check the latest studies of Sinus headache.

On Jul, 07, 2026

37,063 people reported to have side effects when taking Breo ellipta.
Among them, 24 people (0.06%) have Sinus headache.

Could Breo ellipta cause Sinus headache?

Among these 24 people:

How long have people been on Breo ellipta when they have Sinus headache? *

What is the gender of people who have Sinus headache when taking Breo ellipta? *

female: 91.3 %
male: 8.7 %

What is the age of people who have Sinus headache when taking Breo ellipta? *

What are other drugs people take besides Breo ellipta? *

What are other side effects people have besides Sinus headache? *

Cough: 8 people, 33.33%
Bronchitis (inflammation of the mucous membrane in the bronchial tubes): 7 people, 29.17%
Chest Pain: 6 people, 25.00%
Nasopharyngitis (inflammation of the nasopharynx): 6 people, 25.00%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 6 people, 25.00%
Dyspnea (difficult or laboured breathing): 6 people, 25.00%
Pneumonia: 6 people, 25.00%
Headache (pain in head): 6 people, 25.00%
Insomnia (sleeplessness): 5 people, 20.83%
Productive Cough: 5 people, 20.83%

What are the existing conditions these people have? *

Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 3 people, 12.50%
Cataplexy (loss of muscle tone accompanied by full conscious awareness): 3 people, 12.50%
Depression: 3 people, 12.50%
Immunodeficiency Common Variable: 3 people, 12.50%
Relapsing-Remitting Multiple Sclerosis (reoccurrence of an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 3 people, 12.50%
Cough: 2 people, 8.33%
Sinus Disorder (disease of sinus): 1 person, 4.17%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 1 person, 4.17%
Bronchitis Chronic (inflammation of the mucous membrane in the bronchial tubes- chronic): 1 person, 4.17%
Drowsiness: 1 person, 4.17%

* Approximation only. Some reports may have incomplete information.

Do you take Breo ellipta and have Sinus headache?

- Check whether Sinus headache 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)

Sinus headache treatments and more:

Sinus headache (9,129 reports)

How severe was Sinus headache and when was it recovered:

Sinus headache in Breo ellipta

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

Sinus headache and drugs with ingredients of fluticasone furoate; vilanterol trifenatate (4 reports)

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 Sinus headache:

Sinus headache (690 drugs)

Browse all the conditions that are associated with Sinus headache:

Sinus headache (791 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.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.