Breo ellipta and Bipolar disorder - a phase IV clinical study of FDA data

Summary:

Bipolar disorder is reported as a side effect among people who take Breo ellipta (fluticasone furoate; vilanterol trifenatate), especially for people who are female, 40-49 old, also take Xyrem, and have Narcolepsy.

The phase IV clinical study analyzes which people have Bipolar disorder 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 Bipolar disorder?

Bipolar disorder (mood disorder) is found to be associated with 907 drugs and 1,231 conditions by eHealthMe. Check the latest studies of Bipolar disorder.

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, 31, 2026

37,063 people reported to have side effects when taking Breo ellipta.
Among them, 26 people (0.07%) have Bipolar disorder.

Could Breo ellipta cause Bipolar disorder?

Among these 26 people:

What is the gender of people who have Bipolar disorder when taking Breo ellipta? *

female: 76.92 %
male: 23.08 %

What is the age of people who have Bipolar disorder when taking Breo ellipta? *

What are other drugs people take besides Breo ellipta? *

What are other side effects people have besides Bipolar disorder? *

High Blood Pressure: 5 people, 19.23%
Dyspnea (difficult or laboured breathing): 5 people, 19.23%
Skin - Clammy: 4 people, 15.38%
Upper-Airway Cough Syndrome: 4 people, 15.38%
Bronchitis (inflammation of the mucous membrane in the bronchial tubes): 4 people, 15.38%
Drowsiness: 4 people, 15.38%
Otitis (ear infection): 4 people, 15.38%
Dehydration (dryness resulting from the removal of water): 4 people, 15.38%
Stress And Anxiety: 3 people, 11.54%
Drug Ineffective: 3 people, 11.54%

What are the existing conditions these people have? *

Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 13 people, 50.00%
Cataplexy (loss of muscle tone accompanied by full conscious awareness): 12 people, 46.15%
Drowsiness: 5 people, 19.23%
Immunodeficiency Common Variable: 4 people, 15.38%
Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 1 person, 3.85%
High Blood Cholesterol: 1 person, 3.85%

* Approximation only. Some reports may have incomplete information.

Do you take Breo ellipta and have Bipolar disorder?

- Check whether Bipolar disorder 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)

Bipolar disorder treatments and more:

Bipolar disorder (109,431 reports)

How severe was Bipolar disorder and when was it recovered:

Bipolar disorder in Breo ellipta

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

Bipolar disorder and drugs with ingredients of fluticasone furoate; vilanterol trifenatate (16 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 Bipolar disorder:

Bipolar disorder (907 drugs)

Browse all the conditions that are associated with Bipolar disorder:

Bipolar disorder (1,231 conditions)

Related publications that referenced our studies

Ayano G, "Bipolar Disorders and Valproate: Pharmacokinetics, Pharmacodynamics and Therapeutic Effects and Indications of Valproate: Review of Articles", Bipolar Disord, 2017 Jan .
Ayano G, "Bipolar Disorders and Valproate: Pharmacokinetics, Pharmacodynamics and Therapeutic Effects and Indications of Valproate: Review of Articles", Bipolar Disord, 2017 Jan .

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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