Prolia and Otitis media - a phase IV clinical study of FDA data

Summary:

Otitis media is reported as a side effect among people who take Prolia (denosumab), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Pantoprazole, and have Hypothyroidism.

The phase IV clinical study analyzes which people have Otitis media when taking Prolia. It is created by eHealthMe based on reports of 150,727 people who have side effects when taking Prolia from the FDA, and is updated regularly.

What is Prolia?

Prolia has active ingredients of denosumab. It is often used in osteoporosis. eHealthMe is studying from 151,388 Prolia users. Check the latest studies of Prolia.

What is Otitis media?

Otitis media (inflammation of the middle ear) is found to be associated with 694 drugs and 662 conditions by eHealthMe. Check the latest studies of Otitis media.

On Jul, 10, 2026

150,727 people reported to have side effects when taking Prolia.
Among them, 28 people (0.02%) have Otitis media.

Among these 28 people:

How long have people been on Prolia when they have Otitis media? *

What is the gender of people who have Otitis media when taking Prolia? *

female: 96.15 %
male: 3.85 %

What is the age of people who have Otitis media when taking Prolia? *

What are other drugs people take besides Prolia? *

What are other side effects people have besides Otitis media? *

Ear Pain: 5 people, 17.86%
Urinary Tract Infection: 5 people, 17.86%
Ruptured Eardrum (tear in eardrum): 5 people, 17.86%
Hypoacusis (loss of hearing): 3 people, 10.71%
Gastroenteritis (inflammation of stomach and intestine): 3 people, 10.71%
Otitis Externa (external ear infection): 3 people, 10.71%
Sepsis (a severe blood infection that can lead to organ failure and death): 3 people, 10.71%
Immunodeficiency Disorders: 2 people, 7.14%
Infection: 2 people, 7.14%
Pain In Jaw: 2 people, 7.14%

What are the existing conditions these people have? *

Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 2 people, 7.14%
Pain: 2 people, 7.14%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 2 people, 7.14%
Vitamin D Increased: 1 person, 3.57%
Osteopenia (a condition where bone mineral density is lower than normal): 1 person, 3.57%
Local Swelling (swelling at the site of some application of substance or injury): 1 person, 3.57%
Lipids Increased (excess lipid in body): 1 person, 3.57%
Joint Pain: 1 person, 3.57%
Irritable Bowel Syndrome: 1 person, 3.57%
Hypersensitivity: 1 person, 3.57%

* Approximation only. Some reports may have incomplete information.

Do you take Prolia and have Otitis media?

- Check whether Otitis media 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 Prolia:

Prolia (151,388 reports)

Otitis media treatments and more:

Otitis media (6,471 reports)

Browse all side effects of Prolia:

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 Otitis media:

Otitis media (694 drugs)

Browse all the conditions that are associated with Otitis media:

Otitis media (662 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on denosumab (the active ingredients of Prolia) and Prolia (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.