Evenity Side Effects: Risks, Management & Comparison

A close-up of a senior woman with grey hair and a worried expression, carefully examining a plain white medicine box she holds in her hands. She appears to be concentrating deeply on the information on the box, suggesting she is weighing decisions about medication.

Evenity Side Effects: Risks, Management & Comparison

If you’re weighing Evenity (romosozumab) for osteoporosis, you want clear, trustworthy info on Evenity side effects. This guide summarizes what’s common vs. serious, who should be cautious, how to manage symptoms, and how Evenity’s safety compares to Prolia.

Quick answer: The most common side effects are joint pain and headache. Rare but serious risks include heart attack or stroke (FDA boxed warning). In the U.S., do not start Evenity if you’ve had a heart attack or stroke in the past year; stop treatment if either occurs. Call 911 for chest pain, one-sided weakness, or trouble speaking. Typical course is 12 monthly doses, then switch to another medicine to maintain gains (FDA prescribing information).

Note: Educational only—not medical advice. Always speak with your clinician about your situation.

Key takeaways (at a glance)

  • Boxed warning (heart and brain): Evenity may raise the risk of heart attack, stroke, and cardiovascular death. Don’t start it if you’ve had a heart attack or stroke in the last year (U.S. label) (FDA prescribing information), and stop treatment if either occurs. Note: requirements differ by country; Australia applies stricter contraindications (TGA update).
  • Most common side effects: joint pain and headache. According to guidance from the American College of Rheumatology (ACR), joint pain occurs in about 8–13%, headache in ~5–7%, and injection-site irritation in ~5% (ACR patient guidance).
  • Less common but important: low blood calcium, severe jaw problems (osteonecrosis), atypical femur fractures, and severe allergic reactions (FDA prescribing information).
  • Treatment plan: Usually 12 monthly doses (two back-to-back shots each month), then transition to an antiresorptive to keep the bone gains you made (StatPearls).

What is Evenity—and why consider it?

Evenity is a lab-made antibody that blocks sclerostin, a signal that puts the brakes on bone building. Blocking it helps you build bone faster (and also slows breakdown a bit). Dosing is 210 mg once monthly—given as two injections back-to-back—for up to 12 months, typically with daily calcium and vitamin D (FDA prescribing information).

In a large study of 7,180 postmenopausal women (FRAME), Evenity reduced new spine fractures by 73% at 12 months vs placebo, and the benefit persisted after both groups moved to denosumab in year two (NEJM FRAME trial).

Boxed warning: cardiovascular risks

A red warning sign with a white background containing a black exclamation mark above a red heart and a green brain, symbolizing potential risks to the heart and brain.
  • The U.S. label warns of possible heart attack, stroke, and cardiovascular death. Do not start if you’ve had a heart attack or stroke within the past year, and stop if either happens during treatment (FDA prescribing information).
  • Country differences: Australia’s TGA notes any prior heart attack or stroke is a contraindication (TGA safety update).
  • Call 911 for chest pain, shortness of breath, sudden weakness or numbness on one side, trouble speaking, or vision changes (Evenity safety info).

Common side effects (and how often)

  • Joint pain (arthralgia): ~8–13%
  • Headache: ~5–7%
  • Injection-site pain/irritation: ~5%

Sources: ACR patient guidance; Evenity safety info.

An older woman with curly blonde hair and a light blue sweater sits on a couch, intently massaging her knee with both hands, her eyes closed and face showing discomfort, illustrating common joint pain.

Other mild reactions can include muscle spasms and swelling of hands/feet; check in with your clinician if these persist or worsen (Cleveland Clinic overview).

Serious but uncommon risks

  • Low blood calcium (hypocalcemia): risk is higher with severe kidney disease or dialysis. Correct low calcium/Vitamin D before starting and monitor during treatment (FDA prescribing information).
  • Osteonecrosis of the jaw (ONJ): get a dental exam before therapy, report jaw pain or poor healing, and avoid elective invasive dental work during treatment when possible (FDA prescribing information; Cleveland Clinic overview).
  • Atypical femur fractures: report new or unusual dull aching in the thigh, hip, or groin right away (FDA prescribing information).
  • Severe allergic reactions (anaphylaxis/angioedema): get emergency care for swelling of the face/lips/tongue/throat, trouble breathing, or hives (Mayo Clinic monograph).
Illustration of a human femur bone with a crack in the middle and a red alert symbol with an exclamation mark over the cracked part, suggesting a fracture warning or risk.

Who should avoid or use caution with Evenity?

  • Don’t start if you’ve had a heart attack or stroke in the past year (U.S. label) (FDA prescribing information). In Australia, any prior heart attack or stroke is a contraindication. In an alendronate-controlled trial, major adverse cardiac events were 2.0% with romosozumab vs 1.1% with alendronate; during the 12-month romosozumab phase, heart attack occurred in 0.8% vs 0.2% and stroke in 0.6% vs 0.3% (TGA safety update).
  • Correct low calcium first; ensure adequate calcium and vitamin D intake (FDA prescribing information).
  • Severe kidney disease/dialysis: higher hypocalcemia risk—monitor closely (FDA prescribing information).
  • Known allergy to romosozumab or its ingredients (FDA prescribing information).
  • Pregnancy/breastfeeding: not recommended; discuss risks with your clinician (FDA prescribing information).
  • Men: In the U.S., Evenity is not approved for men; some regulators (e.g., Australia’s TGA) do approve it for men at high fracture risk—confirm local indications with your clinician (StatPearls; TGA safety update).

Symptom Management: When to Seek Medical Help

  • Mild symptoms (e.g., headache, small injection-site redness): track for 24–48 hours; try hydration and rest. Call your clinician if persistent or bothersome (ACR patient guidance).
  • Possible low-calcium signs (numbness/tingling around lips or fingertips, muscle cramps): call your clinician promptly for a calcium check (FDA prescribing information).
  • Dental/jaw symptoms or dull aching in thigh/hip/groin: pause high-impact activity and contact your clinician or dentist; you may need imaging or dental evaluation (FDA prescribing information).
  • Emergency signs—call 911: chest pain, shortness of breath, one-sided weakness/numbness, trouble speaking, facial droop, or severe allergic reaction (Evenity safety info; Mayo Clinic monograph).

Evenity vs. Prolia: Side Effect Comparison

An illustration of a balance scale with two medicine bottles. The bottle on the left has an 'E' for Evenity, and the bottle on the right has a 'P' for Prolia. The scale is balanced.
FeatureEvenity (romosozumab)Prolia (denosumab)
MechanismSclerostin inhibitor; increases bone formationRANKL inhibitor; decreases bone resorption
CourseMonthly for 12 months max; then switch to antiresorptiveEvery 6 months; ongoing long-term therapy
Boxed warning / key warningsCardiovascular risk; avoid starting if MI/stroke in past year (U.S.)Severe hypocalcemia risk, especially with advanced CKD
Common side effectsJoint pain, headacheBack/joint/limb pain, high cholesterol, bladder infection (per prescribing information)
HypocalcemiaCan occur; higher risk in severe CKD/dialysisCan be severe/life-threatening; monitor calcium closely
ONJ & atypical femur fractureRare but reported; dental exam before therapyReported; dental check recommended
Cardiovascular riskBoxed warning; Australia lists prior MI/stroke as contraindicationNo CV boxed warning
After stopping12-month cap; follow with an antiresorptive to preserve gainsRebound vertebral fracture risk if stopped or delayed—plan transition

Practical ways to lower risk while on Evenity

FAQs

An infographic showing a circular chart representing a year-long treatment course, divided into 12 segments. A checkered flag marks the end of the 12th segment. An arrow curves around the chart, indicating progression, and points to the text 'NEXT PHASE', suggesting a transition after the completion of the year-long course.
  • How long can I take Evenity? The approved course is 12 monthly doses. After that, most patients transition to an antiresorptive medication to maintain gains (FDA prescribing information; StatPearls).
  • Is Evenity used in men? In the U.S., Evenity is not approved for men. Outside the U.S., some regulators approve romosozumab for men—confirm local indications with your clinician (e.g., Australia’s TGA) (StatPearls; TGA safety update).
  • I have kidney disease—can I still use Evenity? Evenity can cause or worsen hypocalcemia, especially with severe kidney impairment or dialysis; you’ll need careful calcium/vitamin D management and monitoring (FDA prescribing information).
  • What dental steps should I take? Have a dental exam before starting, prioritize routine care, avoid elective invasive dental procedures during therapy when possible, and alert your dentist you’re on Evenity (FDA prescribing information).

The bottom line

Evenity can build bone quickly and reduce fracture risk, but it carries important safety considerations—especially cardiovascular risk. With the right screening, monitoring, and follow-up plan, many people can use it safely and effectively.

If you’re evaluating therapy, one smart next step: track your bone density and body composition changes over time with a BodySpec DEXA scan (Book a BodySpec DEXA scan).

Recommended articles
A couple running on a snowy sidewalk, smiling and looking at each other. The woman is wearing a yellow puffer jacket and the man is wearing a gray hooded jacket.
27 Dec
3 mins read
Impact of Clothing on DEXA Scans
Diagram showing the layers of fat and muscle in the abdomen: Abdomen Muscles, Subcutaneous Fat, and Visceral Fat.
10 Nov
5 mins read
5 Ways to Impact Visceral Fat
Feet in gray socks stand on a weight scale with the needle pointing towards 60 kg.
03 Feb
2 mins read
"But I don't need to scan every month. Is a membership still right for me?"