Evenity Side Effects: What to Expect and When to Call Your Doctor

Evenity (romosozumab) is one of the most effective osteoporosis treatments available, but it comes with an important safety profile that every patient should understand. This guide covers Evenity's common side effects, its FDA boxed warning, and specific symptoms that require immediate medical attention.

The FDA Boxed Warning: Cardiovascular Risk

Evenity carries the FDA's most serious safety warning — a boxed warning — for increased risk of heart attack (myocardial infarction), stroke, and cardiovascular death. This risk was identified in the ARCH clinical trial, where patients treated with Evenity had a higher rate of major adverse cardiac events (MACE) compared to those treated with alendronate.

Key points about the cardiovascular boxed warning:

Do not use Evenity if you have had a heart attack or stroke in the past 12 months.

Tell your doctor about any history of heart disease, angina, heart failure, or other cardiovascular conditions.

If you have a heart attack or stroke while receiving Evenity, stop the medication immediately.

Call 911 or go to the nearest emergency room immediately if you experience: chest pain or pressure, shortness of breath, sudden numbness or weakness on one side of the body, sudden trouble speaking or understanding speech, sudden vision changes, or severe dizziness.

Common Side Effects of Evenity

Based on clinical trial data from over 5,000 women treated with Evenity, the most commonly reported side effects were:

Joint pain (arthralgia): Reported in 8–13% of participants. Generally mild to moderate.

Headache: Reported in approximately 5–7% of participants.

Injection site reactions: Pain, redness, or swelling at the injection site occurred in approximately 5% of patients. These generally did not recur with subsequent injections.

Nasopharyngitis: Common cold-like symptoms (runny nose, sore throat).

Back pain: Reported in some patients during the trial period.

Serious Side Effects to Know About

Low Calcium Levels (Hypocalcemia)

Evenity can lower calcium levels in your blood. Symptoms include muscle spasms, twitches, or cramps; numbness or tingling in your fingers, toes, or around your mouth. Hypocalcemia must be corrected before starting Evenity. Tell your doctor if you develop these symptoms during treatment.

Osteonecrosis of the Jaw (ONJ)

ONJ is a rare but serious condition where jawbone tissue dies due to reduced blood supply. Symptoms include jaw pain, swelling, numbness, loose teeth, exposed bone in the mouth, or non-healing sores after dental procedures. Before starting Evenity, your doctor should conduct a dental exam. Tell your dentist you are on Evenity before any dental work.

Atypical Femoral Fractures

There have been rare reports of atypical (unusual) fractures of the thigh bone (femur) in patients on Evenity. These may present as a dull, aching pain in the thigh, hip, or groin area before a fracture occurs. Call your doctor promptly if you notice this type of pain.

Serious Allergic Reactions

Rare but serious allergic reactions have been reported, including angioedema (swelling of the face, lips, mouth, or throat) and erythema multiforme (a skin reaction). Seek emergency care immediately if you develop difficulty breathing, swallowing, or severe rash after an injection.

When to Call Your Doctor vs. When to Call 911

Call 911 or go to the ER immediately for: chest pain, shortness of breath, sudden weakness on one side, sudden speech problems, sudden vision changes, severe facial or throat swelling, or difficulty breathing.

Call your doctor promptly (same day) for: muscle spasms or numbness suggesting low calcium, jaw pain or swelling, dull thigh pain, significant injection site reactions, or new rash.

Managing Side Effects During Treatment

Most patients tolerate Evenity well over the 12-month course. Take calcium and vitamin D supplements as directed. Maintain good dental hygiene and inform your dentist you are on Evenity. Report any unusual symptoms to your healthcare provider promptly. See our related guide on Evenity drug interactions to understand what medications may increase your risk of side effects.