Short answer: In the label's placebo-controlled trial of 7,180 postmenopausal women, the most common Evenity side effects were joint pain (13.1% vs 12.1% on placebo) and headache (6.6% vs 5.8%), followed by muscle spasms and leg swelling. Evenity has a boxed warning: it may raise the risk of heart attack, stroke and cardiovascular death, and is not started within a year of either.
What Evenity is approved for: Evenity is a sclerostin inhibitor approved to treat osteoporosis in postmenopausal women at high risk for fracture: a past osteoporotic fracture, several risk factors, or other osteoporosis treatments that failed or were not tolerated (section 1.1). Because its bone-building effect wanes, use is limited to 12 monthly doses, after which an anti-resorptive medicine may be considered (section 1.2).
Source
EVENITY (romosozumab-aqqg) injection, for subcutaneous use, prescribing information and Medication Guide. Amgen. DailyMed, version published August 3, 2026. DailyMed setid 471baba2-7154-4488-9891-0db2f46791e7
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH
Evenity may increase the risk of heart attack (myocardial infarction), stroke and cardiovascular death. It should not be started in people who have had a heart attack or stroke within the past year. In people with other cardiovascular risk factors, whether the benefits outweigh the risks is considered. If a heart attack or stroke happens during treatment, Evenity should be stopped.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Evenity.
| Preferred Term | Study 1 Placebo (N = 3576) n (%) | Study 1 EVENITY (N = 3581) n (%) | Study 2 Alendronate (N = 2014) n (%) | Study 2 EVENITY (N = 2040) n (%) |
|---|---|---|---|---|
| Arthralgia | 434 (12.1) | 468 (13.1) | 194 (9.6) | 166 (8.1) |
| Headache | 208 (5.8) | 235 (6.6) | 110 (5.5) | 106 (5.2) |
| Muscle spasms | 140 (3.9) | 163 (4.6) | 81 (4.0) | 70 (3.4) |
| Edema peripheral | 67 (1.9) | 86 (2.4) | 38 (1.9) | 34 (1.7) |
| Asthenia | 79 (2.2) | 84 (2.3) | 53 (2.6) | 50 (2.5) |
| Neck pain | 54 (1.5) | 80 (2.2) | 42 (2.1) | 34 (1.7) |
| Insomnia | 68 (1.9) | 72 (2.0) | 36 (1.8) | 34 (1.7) |
| Paresthesia | 62 (1.7) | 72 (2.0) | 34 (1.7) | 29 (1.4) |
Study 1: 12 months, Evenity vs placebo, 7,180 postmenopausal women aged 55 to 90. Study 2: 12 months, Evenity vs alendronate, 4,093 women at high fracture risk. Stopping because of side effects was 1.1% vs 1.1% in Study 1 and 1.2% vs 1.2% in Study 2.
Major heart events (cardiovascular death, heart attack, stroke) vs alendronate in Study 2: 41 (2.0%) on Evenity vs 22 (1.1%), hazard ratio 1.87 (95% CI 1.11, 3.14). Heart attack 0.8% vs 0.2%; stroke 0.6% vs 0.3%; cardiovascular death 0.8% vs 0.6%.
Major heart events vs placebo in Study 1: 30 (0.8%) on Evenity vs 29 (0.8%), hazard ratio 1.03 (95% CI 0.62, 1.72).
Injection site reactions across both trials: 4.9% on Evenity vs 2.8% on control; mostly pain (1.7% vs 1.3%) and redness (1.4% vs 0.3%). 0.1% stopped because of them.
Allergic reactions across both trials: 6.5% in each group, including rash 1.1% vs 0.9%. Some cases of angioedema, dermatitis and hives were judged related to Evenity.
Calcium below 8.3 mg/dL: 0.2% in each group, and no one on Evenity fell below 7.5 mg/dL. Jaw osteonecrosis and an atypical thigh fracture each occurred in one person on Evenity.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Heart attack, stroke and cardiovascular death. In a trial against alendronate, major heart events were more common on Evenity. It is not started within a year of a heart attack or stroke, and it is stopped if one occurs during treatment. Signs of heart attack and stroke need prompt medical attention.
Allergic reactions. Angioedema, erythema multiforme, dermatitis, rash and hives have occurred. Evenity is stopped after a clinically significant allergic reaction.
Low blood calcium. Low calcium is corrected before starting, and calcium and vitamin D are taken during treatment. People with severe kidney impairment (eGFR 15 to 29) or on dialysis are at greater risk and have calcium monitored.
Osteonecrosis of the jaw. Jaw bone death has been reported, usually with tooth extraction or infection with slow healing. An oral exam comes before starting. Chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors and steroids may raise the risk.
Unusual thigh bone fractures. Atypical low-trauma fractures of the thigh bone have been reported, often after weeks to months of dull thigh pain. New thigh, hip or groin pain is checked for a fracture.
Who should not use it. People with low blood calcium, or with a past whole-body allergic reaction to romosozumab-aqqg or any ingredient.
From the Medication Guide that comes with Evenity:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.