Romosozumab Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 3, 2024.

Applies to romosozumab: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Subcutaneous route (injectable)

Warning: Potential Risk of Myocardial Infarction, Stroke and Cardiovascular Death. Romosozumab-aqqg may increase the risk of myocardial infarction, stroke, and cardiovascular death.Romosozumab-aqqg should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year.

Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors.If a patient experiences a myocardial infarction or stroke during therapy, romosozumab-aqqg should be discontinued.

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:

More common side effects

• fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Less common side effects

• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Rare side effects

• chest pain or discomfort
• confusion
• difficulty in breathing
• difficulty in speaking
• double vision
• headache
• heavy jaw feeling
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular heartbeat
• limp
• loosening of a tooth
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea
• numbness and tingling around the mouth, fingertips, or feet
• pain or discomfort in the arms, jaw, back, or neck
• pain, swelling, or numbness in the mouth or jaw
• pain, swelling, tenderness, and bruising in your thigh
• seizures
• slow speech
• stomach cramps
• sweating
• tremor
• vomiting

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:

More common side effects

• difficulty in moving
• muscle pain or stiffness

Less common side effects

• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• lack or loss of strength
• trouble sleeping

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.

Frequently asked questions

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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.

Some side effects may not be reported. You may report them to the FDA.

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