🇺🇸 Denosumab (Prolia) in United States

10 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 10

Most-reported reactions

1. Acute Kidney Injury — 1 report (10%)
2. Antineutrophil Cytoplasmic Antibody Positive — 1 report (10%)
3. Asthenia — 1 report (10%)
4. Cat Scratch Disease — 1 report (10%)
5. Decreased Appetite — 1 report (10%)
6. Dehydration — 1 report (10%)
7. Dementia — 1 report (10%)
8. Dyspnoea — 1 report (10%)
9. Dyspnoea Exertional — 1 report (10%)
10. Endocarditis — 1 report (10%)

Source database →

Frequently asked questions

Is Denosumab (Prolia) approved in United States?

Denosumab (Prolia) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Denosumab (Prolia) in United States?

Prince of Wales Hospital, Shatin, Hong Kong is the originator. The local marketing authorisation holder may differ — check the official source linked above.