Prolia: adverse event reports filed with FDA

137,683

reports as suspect product

0.7% of all reports · about 8,475 a year

3,532

reports, 12 months to June 2026

3,707 in the 12 months before

43.6%

marked serious by the reporter

51.1% across the class

12.4%

record death among outcomes, as reported

17,050 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Prolia reports recording the termmedian drug in rank ligand inhibitor

1. Off label useused for a purpose or in a way not on the label24%33,041
2. Deaththe patient died; cause not stated by this term11%15,175
3. Arthralgiajoint pain4.8%6,575
4. Pain in extremitypain in an arm or leg3.9%5,413
5. Back painback pain3.7%5,147
6. Painpain, site not specified3.3%4,479
7. Falla fall2.5%3,482
8. Myalgiamuscle pain2.5%3,451
9. Product storage errorthe product was stored wrongly2.4%3,249
10. Osteonecrosis of jawdeath of jaw bone tissue2.3%3,183
11. Bone painbone pain2.2%2,993
12. Rashskin rash2%2,712
13. Tooth disordera dental problem1.9%2,616
14. Spinal fracturea broken bone in the spine1.9%2,575
15. Fatiguetiredness1.6%2,262
16. Malaisegeneral feeling of being unwell1.6%2,157
17. Pain in jaw1.5%2,117
18. Pruritusitching1.4%1,928
19. Muscle spasmsmuscle cramps1.3%1,851
20. Circumstance or information capable of leading to medication errora situation that could lead to a medication error1.3%1,831
21. Astheniaweakness or lack of energy1.3%1,809
22. Headachehead pain1.3%1,797
23. Nauseafeeling sick1.2%1,680
24. Gait disturbancedifficulty walking1.2%1,670
25. Hospitalisationadmission to hospital1.1%1,517
26. Hypocalcaemialow blood calcium1.1%1,478
27. Urinary tract infectionbladder or urinary infection1.1%1,478
28. Musculoskeletal painpain in muscles or bones1%1,429
29. Mobility decreasedreduced ability to move about1%1,412
30. Dizzinesslight-headedness or unsteadiness1%1,408

Top 30 of 2,814 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the rank ligand inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 168,671 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 79.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 137,683 reports.

Drugs most often listed in the same reports

Other products listed in reports where Prolia is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the rank ligand inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Prolia as a suspect or interacting product; reports listing it only as a concomitant medication (12,804) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.