Prolia and Fracture pain - a phase IV clinical study of FDA data
Summary:
Fracture pain 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 6 - 12 months also take Calcium, and have Bone loss.
The phase IV clinical study analyzes which people have Fracture pain 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 Fracture pain?
Fracture pain is found to be associated with 102 drugs and 160 conditions by eHealthMe. Check the latest studies of Fracture pain.
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 >>>.
150,727 people reported to have side effects when taking Prolia.
Among them, 33 people (0.02%) have Fracture pain.

Among these 33 people:
How long have people been on Prolia when they have Fracture pain? *
- < 1 month: 0.0 %
- 1 - 6 months: 12.5 %
- 6 - 12 months: 25.0 %
- 1 - 2 years: 25.0 %
- 2 - 5 years: 25.0 %
- 5 - 10 years: 12.5 %
- 10+ years: 0.0 %
What is the gender of people who have Fracture pain when taking Prolia? *
- female: 100 %
- male: 0.0 %
What is the age of people who have Fracture pain when taking Prolia? *
- 0-1: 0.0 %
- 2-9: 0.0 %
- 10-19: 0.0 %
- 20-29: 0.0 %
- 30-39: 0.0 %
- 40-49: 0.0 %
- 50-59: 13.04 %
- 60+: 86.96 %
What are other drugs people take besides Prolia? *
- Calcium: 3 people, 9.09%
- Boniva: 2 people, 6.06%
- Evenity: 2 people, 6.06%
- Reclast: 2 people, 6.06%
- Forteo: 2 people, 6.06%
- Phenergan: 2 people, 6.06%
- Fosamax: 2 people, 6.06%
- Vitamin D3: 1 person, 3.03%
- Lipitor: 1 person, 3.03%
- Benicar Hct: 1 person, 3.03%
What are other side effects people have besides Fracture pain? *
- Back Pain: 7 people, 21.21%
- Joint Pain: 6 people, 18.18%
- Bone Pain: 6 people, 18.18%
- Muscle Aches (muscle pain): 5 people, 15.15%
- Hypoaesthesia (reduced sense of touch or sensation): 5 people, 15.15%
- Pain: 4 people, 12.12%
- Mobility Decreased (ability to move is reduced): 4 people, 12.12%
- Hip Fracture: 4 people, 12.12%
- Foot Fracture: 4 people, 12.12%
- Urticaria (rash of round, red welts on the skin that itch intensely): 4 people, 12.12%
What are the existing conditions these people have? *
- Osteopenia (a condition where bone mineral density is lower than normal): 2 people, 6.06%
- Bone Loss: 2 people, 6.06%
- Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 1 person, 3.03%
- Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 1 person, 3.03%
- Hyperlipidaemia (presence of excess lipids in the blood): 1 person, 3.03%
- High Blood Pressure: 1 person, 3.03%
- High Blood Cholesterol: 1 person, 3.03%
- Broken Bone: 1 person, 3.03%
- Blood Pressure Abnormal: 1 person, 3.03%
- Atrophic Vulvovaginitis (inflammation of the vulva): 1 person, 3.03%
* Approximation only. Some reports may have incomplete information.
Do you take Prolia and have Fracture pain?
- Check whether Fracture pain 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)
Fracture pain treatments and more:
- Fracture pain (1,113 reports)
How severe was Fracture pain and when was it recovered:
Expand to all the drugs that have ingredients of denosumab:
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 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 zBrowse all the drugs that are associated with Fracture pain:
- Fracture pain (102 drugs)
Browse all the conditions that are associated with Fracture pain:
- Fracture pain (160 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.
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