Prolia and Bruxism - a phase IV clinical study of FDA data

Summary:

Bruxism 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 Calcium, and have High blood cholesterol.

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

Bruxism (habitual grinding of the teeth, typically during sleep) is found to be associated with 590 drugs and 983 conditions by eHealthMe. Check the latest studies of Bruxism.

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, 26, 2026

150,727 people reported to have side effects when taking Prolia.
Among them, 58 people (0.04%) have Bruxism.

Among these 58 people:

How long have people been on Prolia when they have Bruxism? *

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

female: 96.55 %
male: 3.45 %

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

What are other drugs people take besides Prolia? *

What are other side effects people have besides Bruxism? *

Pain In Jaw: 18 people, 31.03%
Tooth Fracture: 10 people, 17.24%
Tooth Disorder (tooth disease): 9 people, 15.52%
Joint Pain: 8 people, 13.79%
Stress And Anxiety: 8 people, 13.79%
Fatigue (feeling of tiredness): 8 people, 13.79%
Toothaches (tooth pain): 8 people, 13.79%
Pain: 7 people, 12.07%
Temporomandibular Joint Syndrome (pain at the temporomandibular joint due to various causes of increased muscle tension and spasm. it is believed that syndrome is a physical manifestation of psychological stress): 6 people, 10.34%
Headache (pain in head): 6 people, 10.34%

What are the existing conditions these people have? *

High Blood Cholesterol: 3 people, 5.17%
Seizures (abnormal excessive or synchronous neuronal activity in the brain): 2 people, 3.45%
Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 2 people, 3.45%
Pain: 2 people, 3.45%
Asthma: 2 people, 3.45%
Osteopenia (a condition where bone mineral density is lower than normal): 2 people, 3.45%
Thyroid Diseases: 2 people, 3.45%
Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 1 person, 1.72%
Diabetes: 1 person, 1.72%
Antiphospholipid Syndrome (disorder that manifests clinically as recurrent venous or arterial thrombosis and/or fetal loss): 1 person, 1.72%

* Approximation only. Some reports may have incomplete information.

Do you take Prolia and have Bruxism?

- Check whether Bruxism 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)

Bruxism treatments and more:

Bruxism (7,187 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 Bruxism:

Bruxism (590 drugs)

Browse all the conditions that are associated with Bruxism:

Bruxism (983 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.