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romosozumab

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Brand names: Evenity

Sclerostin Inhibitor Rx

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.

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.

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.

How to Take It

Evenity is given as two separate shots under the skin (subcutaneously) by a healthcare provider. You will receive a 210 mg dose once a month for 12 months. The shots are given in your stomach area, thigh, or upper arm. Make sure you also take enough calcium and vitamin D during your treatment.

Pregnancy & Breastfeeding

Evenity is not for women who could become pregnant. Animal studies showed harm to the baby when Evenity was given to pregnant animals. It is also unknown if Evenity passes into breast milk.

Missed Dose

If you miss a dose of Evenity, get the shot as soon as you can reschedule. Then, you can get Evenity every month from the date of your last dose.

Storage

Keep Evenity in the refrigerator between 36°F and 46°F (2°C to 8°C) in its original carton to protect it from light. Do not freeze or shake it.

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 most commonly reported side effects of romosozumab include Joint pain, Headache. Always consult your healthcare provider about potential side effects.
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.
Is romosozumab safe during pregnancy?
Evenity is not for women who could become pregnant. Animal studies showed harm to the baby when Evenity was given to pregnant animals. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
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

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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: January 8, 2026

All federal data sources used on this page