Public record

Romosozumab: the public record

4 tables from US federal sources. Latest data date: Nov 11, 2026.

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.

FDA label facts for romosozumab: the figures
MeasureValueNote
Label revision date2026-07-16
Label readEvenityBLA761062, brand-name application
Boxed warningYesheading as printed: "WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY"
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

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.

Scope: 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.

Download the data (CSV)

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.

Medicaid prescriptions for romosozumab by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 202516,549
Total reimbursed before rebates, 2025$33.0M
States and territories reporting48with at least one count CMS did not suppress
California3,009 prescriptions$6.2M reimbursed
New York1,453 prescriptions$2.6M reimbursed
Arizona1,171 prescriptions$1.3M reimbursed
Illinois1,004 prescriptions$2.1M reimbursed
Minnesota722 prescriptions$1.6M reimbursed

Source: CMS, Medicaid State Drug Utilization Data 2025, data as of 2025

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.

Scope: 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.

Download the data (CSV)

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).

Most reported events in FDA adverse event reports for romosozumab: the figures
MeasureValueNote
All reports received709
Reports the reporter marked serious656death, hospitalisation, disability or similar outcome
Spinal fracture60 reports
Fall46 reports
Pathological fracture41 reports
Osteoporotic fracture35 reports
Fracture33 reports

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

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.

Scope: 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.

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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.

Registered clinical studies of romosozumab: the figures
MeasureValue
Registered studies50
Recruiting now11
Not yet recruiting4
Completed25
Terminated, withdrawn or suspended1
Phase 3 (including phase 2/3)12
Phase 2 (including phase 1/2)9
Phase 110

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

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.

Scope: 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.

Download the data (CSV)

Articles on Romosozumab