Proliadenosumab
According to the FDA label: Conexxence is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer ( 1.4 ) to increase bone mass in women at high risk…
163,378 adverse event reports submitted to the FDA (2008–2026)
Top Reported Adverse Events
The most frequently reported events in association with Prolia in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Off Label Use 34,664 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Death 15,889 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Arthralgia 7,788 reports
Pain in Extremity 6,232 reports
Pain in an arm or leg.
Full definition in the glossary →Back Pain 5,985 reports
Pain 5,697 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Osteonecrosis Of Jaw 4,631 reports
Fall 4,540 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Fatigue 4,447 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Myalgia 3,807 reports
Nausea 3,506 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Rash 3,478 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Product Storage Error 3,287 reports
A report that a medication was stored incorrectly, for example at the wrong temperature. This is a handling category, not a sign of a problem with the drug.
Full definition in the glossary →Bone Pain 3,259 reports
Pain felt in or coming from the bones.
Full definition in the glossary →Diarrhoea 3,233 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 129,906 |
| Male | 14,806 |
| Unknown | 462 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 422 |
| 18-34 | 557 |
| 35-49 | 2,665 |
| 50-64 | 20,453 |
| 65-74 | 30,823 |
| 75+ | 42,832 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Prolia. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 82,539 |
| Other Serious | 62,092 |
| Hospitalization | 21,626 |
| Death | 19,385 |
| Disability | 2,663 |
| Life-Threatening | 1,718 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Prolia. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 145 |
| 2011 | 1,453 |
| 2012 | 4,592 |
| 2013 | 5,988 |
| 2014 | 8,683 |
| 2015 | 9,498 |
| 2016 | 16,779 |
| 2017 | 30,325 |
| 2018 | 30,236 |
| 2019 | 8,933 |
| 2020 | 7,984 |
| 2021 | 7,764 |
| 2022 | 7,682 |
| 2023 | 8,491 |
| 2024 | 7,304 |
| 2025 | 6,245 |
| 2026 (partial) | 1,273 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Prolia
In FDA adverse event reports that mention Prolia, these medications appeared most often in the same report.
- Ergocalciferol (11,123 reports)
- Acetaminophen (4,400 reports)
- Prednisone (4,208 reports)
- Aspirin (4,084 reports)
- Levothyroxine (3,818 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026