Public record
Romosozumab: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Label
FDA label facts for romosozumab
The FDA label read for romosozumab (Evenity, application BLA761062) was last revised on 2026-07-16. It carries a boxed warning headed "WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-07-16 | |
| Label read | Evenity | BLA761062, brand-name application |
| Boxed warning | Yes | heading as printed: "WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY" |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
How this was calculated
Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.
One label: the newest prescription label for single-ingredient romosozumab from an original manufacturer
Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.
Medicaid
Medicaid prescriptions for romosozumab by state
State Medicaid programmes paid for 16,549 romosozumab prescriptions in 2025, with $33.0M reimbursed before rebates. California reported the most (3,009), followed by New York (1,453) and Arizona (1,171); 48 states and territories reported any.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 16,549 | |
| Total reimbursed before rebates, 2025 | $33.0M | |
| States and territories reporting | 48 | with at least one count CMS did not suppress |
| California | 3,009 prescriptions | $6.2M reimbursed |
| New York | 1,453 prescriptions | $2.6M reimbursed |
| Arizona | 1,171 prescriptions | $1.3M reimbursed |
| Illinois | 1,004 prescriptions | $2.1M reimbursed |
| Minnesota | 722 prescriptions | $1.6M reimbursed |
How this was calculated
Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.
All single-ingredient romosozumab products in the FDA NDC Directory, fee-for-service and managed care, 2025
Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.
Adverse event reports
Most reported events in FDA adverse event reports for romosozumab
Through 2026-10-28, FDA had received 709 adverse event reports for romosozumab, 656 of them marked serious by the reporter. The symptom terms named most often were spinal fracture (60), fall (46) and pathological fracture (41).
| Measure | Value | Note |
|---|---|---|
| All reports received | 709 | |
| Reports the reporter marked serious | 656 | death, hospitalisation, disability or similar outcome |
| Spinal fracture | 60 reports | |
| Fall | 46 reports | |
| Pathological fracture | 41 reports | |
| Osteoporotic fracture | 35 reports | |
| Fracture | 33 reports |
How this was calculated
Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example death) were left out of the list.
Reports where FDA recorded romosozumab as a single-ingredient active substance (any brand), all years to 2026-10-28
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Clinical studies
Registered clinical studies of romosozumab
ClinicalTrials.gov lists 50 registered studies that name romosozumab as an intervention as of 2026-11-11. Of these, 11 are recruiting, 25 are completed and 12 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 50 |
| Recruiting now | 11 |
| Not yet recruiting | 4 |
| Completed | 25 |
| Terminated, withdrawn or suspended | 1 |
| Phase 3 (including phase 2/3) | 12 |
| Phase 2 (including phase 1/2) | 9 |
| Phase 1 | 10 |
How this was calculated
Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.
Studies whose intervention field matches romosozumab, any condition, any country, all statuses
A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.
Articles on Romosozumab
- Evenity (Romosozumab) Cancer Risk Signal Review
- Evenity (Romosozumab) Cardiovascular Impact: Long-Term Evidence and Clinical Guidance
- Evenity (Romosozumab) Safety in Adults 65 and Older
- Evenity (Romosozumab) Hair and Skin Changes: What Patients and Clinicians Need to Know
- Evenity (Romosozumab) Missed-Dose Protocol: What to Do and Why Timing Matters
- Evenity (Romosozumab) Self-Injection Technique: What Patients Need to Know