Prescription medication · Sclerostin Inhibitor

romosozumab

Also sold as Evenity. Evenity treats osteoporosis in women after menopause.

Data updated 2026-05-15

1
Recall record

romosozumab (Evenity) is a prescription Sclerostin Inhibitor. Evenity treats osteoporosis in women after menopause.

Evenity is a medicine to treat osteoporosis in women after menopause who are at high risk for bone fracture. It can help make your bones stronger.

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What it does

Evenity treats osteoporosis in women after menopause.

Common side effects

Joint pain, Headache

Key warnings

Evenity may increase your risk of heart attack, stroke, and death from heart problems.

The sections below are summarized in plain English from romosozumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Evenity works by blocking a protein called sclerostin. Sclerostin slows down new bone formation. By blocking sclerostin, Evenity helps your body build new bone and increase bone strength.

Serious Warnings

Evenity may increase your risk of heart attack, stroke, and death from heart problems. You should not start Evenity if you have had a heart attack or stroke in the past year. Your doctor will consider if the benefits of Evenity outweigh these risks if you have other heart risk factors. If you have a heart attack or stroke while taking Evenity, stop taking it.

Common Questions

Who should not take Evenity?
You should not take Evenity if you have low blood calcium or have had a severe allergic reaction to Evenity.
How long can I take Evenity?
You should only use Evenity for 12 monthly doses.
What should I do if I have symptoms of a heart attack or stroke?
Seek medical attention right away if you have chest pain, shortness of breath, sudden numbness or weakness, trouble speaking, or severe headache.
Can Evenity cause allergic reactions?
Yes, some people have had allergic reactions like rash, hives, and swelling with Evenity.
Will I need to take calcium and vitamin D while using Evenity?
Yes, it is important to take enough calcium and vitamin D during Evenity treatment.
What are the signs of low calcium?
Symptoms of low calcium can include muscle spasms, numbness, and tingling.
Can Evenity cause jaw problems?
In rare cases, Evenity has been linked to osteonecrosis of the jaw (ONJ). Tell your doctor if you have jaw pain, swelling, or numbness.
What are the symptoms of an unusual thigh pain?
Tell your doctor right away if you develop new or unusual pain in your thigh, hip, or groin.
How is Evenity supplied?
Evenity comes in a box with two prefilled syringes. Each syringe contains 105 mg of Evenity.
What if Evenity is left out of the refrigerator?
If Evenity is left out of the refrigerator, it can be kept at room temperature for up to 30 days as long as it is in its original carton.
What are the common side effects of romosozumab?
The registry lists Joint pain, Headache among the most-reported FAERS reaction terms for romosozumab. These counts are not an individual symptom assessment.
What drug class is romosozumab?
romosozumab belongs to the Sclerostin Inhibitor drug class. It requires a prescription (Rx). Evenity treats osteoporosis in women after menopause.
What pregnancy or breastfeeding source fields are listed for romosozumab?
The FDA label for romosozumab contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has romosozumab been recalled?
There is 1 recall associated with romosozumab products. CGMP Deviations; potential temperature excursions due to transit delays. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 21, 2025

CGMP Deviations; potential temperature excursions due to transit delays

Mckesson Medical-Surgical Inc. Corporate Office

Related Medications in Sclerostin Inhibitor

Other drugs grouped near romosozumab - same-class peers and common alternatives.

abaloparatide

Tymlos

Tymlos is a medicine to treat osteoporosis.

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alendronate

Fosamax

Binosto is a medicine that helps make your bones stronger.

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calcitonin

Miacalcin, Fortical

Calcitonin is a medicine that helps manage calcium levels in your body.

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denosumab

Prolia, Xgeva

Stoboclo is a medicine that helps to treat osteoporosis and increase bone mass.

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ibandronate

Boniva

Ibandronate (Boniva) is a medicine that helps treat and prevent bone loss in women after menopause.

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Compare romosozumab vs abaloparatide side-by-side →

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What the FDA Data Shows for romosozumab

The FDA label for romosozumab (sold under brand names such as Evenity) classifies it as a prescription-only medication in the Sclerostin Inhibitor class. Evenity treats osteoporosis in women after menopause. Official labeling lists 2 commonly reported side effects, including Joint pain, Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: January 8, 2026

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page