Prolia and Extrapyramidal disorder - a phase IV clinical study of FDA data

Summary:

Extrapyramidal disorder 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 Haldol, and have Back pain.

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

Extrapyramidal disorder (involuntary muscle spasms in the face and neck) is found to be associated with 813 drugs and 960 conditions by eHealthMe. Check the latest studies of Extrapyramidal 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, 25, 2026

150,727 people reported to have side effects when taking Prolia.
Among them, 13 people (0.01%) have Extrapyramidal disorder.

Could Prolia cause Extrapyramidal disorder?

Among these 13 people:

How long have people been on Prolia when they have Extrapyramidal disorder? *

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

female: 100 %
male: 0.0 %

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

What are other drugs people take besides Prolia? *

Haldol: 3 people, 23.08%
Vitamin D: 1 person, 7.69%
Vimovo: 1 person, 7.69%

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

Fall: 12 people, 92.31%
Weakness: 9 people, 69.23%
Balance Disorder: 9 people, 69.23%
Dyskinesia (abnormality or impairment of voluntary movement): 9 people, 69.23%
Speech Impairment (Adult) (inability to speak (adult)): 9 people, 69.23%
Wrist Fracture: 6 people, 46.15%
Facial Bones Fracture (bone fracture of face): 5 people, 38.46%
Amyotrophic Lateral Sclerosis (nervous system disease that attacks nerve cells called neurons in your brain and spinal cord): 5 people, 38.46%
Muscle Rigidity (muscle stiffness): 5 people, 38.46%
Upper Motor Neurone Lesion (lesion of the neural pathway above the anterior horn cell of the spinal cord or motor nuclei of the cranial nerves): 4 people, 30.77%

What are the existing conditions these people have? *

Back Pain: 9 people, 69.23%
Osteoporotic Fracture (fracture due to weak bone): 6 people, 46.15%
Insomnia (sleeplessness): 3 people, 23.08%
Agitation (state of anxiety or nervous excitement): 3 people, 23.08%

* Approximation only. Some reports may have incomplete information.

Do you take Prolia and have Extrapyramidal disorder?

- Check whether Extrapyramidal 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 Prolia:

Prolia (151,388 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 Extrapyramidal disorder:

Extrapyramidal disorder (813 drugs)

Browse all the conditions that are associated with Extrapyramidal disorder:

Extrapyramidal disorder (960 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.