Prescription medicine
Romosozumab Brand names: Evenity
Romosozumab (Evenity) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the romosozumab FDA label on DailyMed (effective July 16, 2026); every romosozumab label on DailyMed.
Highlights of the record
FDA label of July 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH.
EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ]. EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. ( 5.1 ) EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. ( 5.1 ) If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.
Used for
From the label: indications and usageEVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture;
Forms and strengths
- 105 mg/1.17ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest April 21, 2025
- FAERS reports
- 13,496 through July 30, 2026
What is romosozumab used for?
From the label: indications and usageEVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. […]
Source: FDA drug label (Evenity), Amgen, Inc, effective July 16, 2026 (SPL set 471baba2-7154-4488-9891-0db2f46791e7), via openFDA; the full label on DailyMed
What does the patient leaflet for romosozumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EVENITY ?EVENITY can cause serious side effects, including: increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem. Call your healthcare provider or get emergency help right away if you have any of the symptoms listed below. Symptoms of heart attack may include: chest pain or pressure shortness of breath feeling light-headed or dizzy Symptoms of stroke may include: headache numbness or weakness in face, arm, or legs difficulty talking changes in vision or loss of balance Before you receive EVENITY, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year. See “What are the possible side effects of EVENITY ?” below for other side effects of EVENITY.
From the patient leaflet: How should I store EVENITY if I need to pick it up from a pharmacy?Keep EVENITY in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect it from light. Do not freeze EVENITY. Do not shake EVENITY. When you remove EVENITY from the refrigerator, EVENITY must be kept at room temperature up to 77°F (25°C) in the original carton and must be used within 30 days. EVENITY should be thrown away if taken out of the refrigerator and not used within 30 days. Do not keep EVENITY at temperatures above 77°F (25°C). Warm temperatures will affect how EVENITY works. Keep EVENITY and all medicines out of the reach of children.
Source: FDA drug label (Evenity), Amgen, Inc, effective July 16, 2026 (SPL set 471baba2-7154-4488-9891-0db2f46791e7), via openFDA; the full label on DailyMed
Is there a generic for romosozumab (Evenity)?
No generic romosozumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has romosozumab been recalled?
The FDA's Enforcement Report lists 1 recall naming romosozumab since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 21, 2025 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | CGMP Deviations; potential temperature excursions due to transit delays |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the romosozumab label say about other medicines?
The romosozumab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alendronate | warnings and precautions | … myocardial infarction and nonfatal stroke, in patients treated with EVENITY compared to those treated with alendronate [see Boxed Warning and Adverse Reactions (6.1) ]. |
| Denosumab | warnings and precautions | Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. |
Source: FDA drug label (Evenity), Amgen, Inc, effective July 16, 2026 (SPL set 471baba2-7154-4488-9891-0db2f46791e7), via openFDA; the full label on DailyMed
What do FAERS reports show for romosozumab?
The FDA Adverse Event Reporting System holds 13,496 reports that list romosozumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 724 are coded as a death and 3,264 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Romosozumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other