Romosozumab Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 21, 2024.

Applies to romosozumab: subcutaneous solution.

Serious side effects of romosozumab

Along with its needed effects, romosozumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking romosozumab:

Other side effects of romosozumab

Some side effects of romosozumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to romosozumab: subcutaneous solution.

General adverse events

The most commonly reported adverse reactions have included arthralgia and headache.^[Ref]

Cardiovascular

• Common (1% to 10%): Peripheral edema
• Uncommon (0.1% to 1%): Myocardial infarction, myocardial death

During clinical trials, this drug increased the risk of cardiovascular death, heart attack and stroke in the compared with alendronate, but not compared with placebo; myocardial infarction occurred in 16 (0.8%) women receiving this drug compared to 5 (0.2%) receiving alendronate and stroke in 13 (0.5%) and 7 (0.3%) patients receiving this drug and alendronate, respectively. These events occurred in women with and without a history of MI or stroke. Cardiovascular death occurred in 17 (0.8%) and 12 (0.6%) of patients receiving this drug and alendronate, respectively. Positively adjudicated MACE (major adverse cardiac events; composite endpoint of cardiovascular death, nonfatal MI and nonfatal stroke) was significantly different at 41 (2%) and 22 (1.1%) in patients receiving this drug and alendronate respectively.

In the placebo-controlled trial, the number of women with positively adjudicated MACE was not significantly different with both groups reporting 0.8%.

Nervous system

• Common (1% to 10%): Headache, paresthesia
• Uncommon (0.1% to 1%): Stroke

During clinical trials, this drug increased the risk of cardiovascular death, heart attack and stroke in the alendronate trial, but not in the placebo trial; myocardial infarction occurred in 16 (0.8%) women receiving this drug compared to 5 (0.2%) receiving alendronate and stroke in 13 (0.5%) and 7 (0.3%) of patients receiving this drug and alendronate, respectively. These events occurred in women both with and without a history of MI or stroke. Positively adjudicated MACE (major adverse cardiac events; composite endpoint of cardiovascular death, nonfatal MI and nonfatal stroke) was significantly different at 41 (2%) and 22 (1.1%) in patients receiving this drug and alendronate respectively.

In the placebo-controlled trial, the number of women with positively adjudicated MACE was not significantly different with both groups reporting 0.8%.

Nervous system

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reactions (angioedema, erythema multiforme, dermatitis, rash, urticaria)

Hypersensitivity reactions were reported in 6.5% of women in clinical trials; reactions included angioedema and erythema multiforme in less than 0.1%, dermatitis (0.6%), rash (1.1%), and urticaria (0.4%).

Local

• Common (1% to 10%): Injection site reactions

Injection site reactions occurred in 278 (4.9%) of patients and included injection site pain (1.7%) and erythema (1.4%).

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 13.1%)
• Common (1% to 10%): Muscle spasms, neck pain
• Very rare (less than 0.01%): Osteonecrosis of the jaw, atypical femoral fracture

Osteonecrosis of the jaw occurred in 1 patient receiving this drug during clinical trials. Atypical femoral fracture also occurred in 1 patient.

Other

• Common (1% to 10%): Asthenia

Psychiatric

• Common (1% to 10%): Insomnia

Immunologic

• Very common (10% or more): Anti-drug antibodies (18.1%)

During clinical trials, 18.1% of the 5914 postmenopausal women receiving this drug developed antibodies; 4.7% had antibodies classified as neutralizing. Development of antibodies was associated with lower serum drug concentrations, however, was not associated with changes in safety and efficacy.

Metabolic

• Uncommon (0.1% to 1%): Hypocalcemia

In clinical trials, 2 women receiving this drug experienced hypocalcemia. Decreases in albumin adjusted serum calcium to less than 8.3 mg/dL were reported in 14 (0.2%) women; there were no reports of adjusted serum calcium less than 7.5 mg/dL. The nadir in albumin-adjusted serum calcium occurred by month 1 in patients with normal renal function.

See also:

Frequently asked questions

• How does Evenity work?

Further information

Romosozumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer