Denosumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 28, 2023.

Applies to denosumab: subcutaneous solution.

Precautions

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Prolia® contains denosumab which can also be found in Xgeva®. Patients receiving Prolia® should not receive Xgeva®.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 5 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.

This medicine may cause hypocalcemia (low calcium in the blood). A low blood calcium must be treated before you receive this medicine. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.

Prolia® may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are receiving this medicine. Check with your doctor right away if you have a fever or chills, red, swollen skin, severe abdominal or stomach pain, or burning or painful urination.

Skin problems may occur after receiving Prolia®. Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, rash, or swollen skin.

It is important that you tell all of your doctors that you are receiving denosumab injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.

The needle cover of the prefilled Prolia® syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thigh, groin, or hips.

Check with your doctor right away if you have severe muscle, bone, or joint pain after receiving Prolia®.

Do not suddenly stop receiving this medicine without checking first with your doctor. Doing so may increase your risk for more fractures. Talk to your doctor about other medicines that you can take.

Hypercalcemia may occur after stopping Xgeva® treatment in patients with growing bones. Tell your doctor right away if you have confusion, constipation, depression, dry mouth, headache, incoherent speech, increased urination, loss of appetite, metallic taste, muscle weakness, nausea, stomach pain, thirst, unusual tiredness, or vomiting.

Serious side effects of denosumab

Along with its needed effects, denosumab 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 denosumab:

Other side effects of denosumab

Some side effects of denosumab 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 denosumab: subcutaneous solution.

General adverse events

The most commonly reported side effects were asthenia, fatigue, back pain, hypophosphatemia, hypocalcemia, and nausea.^[Ref]

Hypersensitivity

• Postmarketing reports: Anaphylaxis, rash, urticaria, facial swelling, erythema^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (21%), cough (15%)
• Common (1% to 10%): Upper respiratory tract infection, pneumonia, pharyngitis, nasopharyngitis^[Ref]

Cardiovascular

• Common (1% to 10%): Angina pectoris, atrial fibrillation^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (35%), arthralgia (14%), pain in extremity (12%)
• Common (1% to 10%): Musculoskeletal pain, bone pain, myalgia, spinal osteoarthritis
• Rare (less than 0.1%): Atypical femoral fractures
• Frequency not reported: Osteonecrosis of the jaw, atypical subtrochanteric and diaphysealfemoral fractures
• Postmarketing reports: Musculoskeletal pain including severe cases, multiple vertebral fractures following discontinuation of this drug^[Ref]

Metabolic

• Very common (10% or more): Hypophosphatemia (32%), hypocalcemia (including fatal cases) (18%)
• Common (1% to 10%): Hypercholesterolemia
• Postmarketing reports: Severe symptomatic hypocalcemia, severe symptomatic hypercalcemia following treatment discontinuation^[Ref]

Dermatologic

• Very common (10% or more): Dermatitis (11%), eczema (11%), rash (11%)
• Common (1% to 10%): Pruritus, hyperhidrosis
• Uncommon (0.1% to 1%): Cellulitis
• Postmarketing reports: Cutaneous and mucosal lichenoid drug eruptions (e.g., lichen planus-like reactions), alopecia^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (31%), diarrhea (20%)
• Common (1% to 10%): Upper abdominal pain, flatulence, gastroesophageal reflux disease, constipation, abdominal discomfort, tooth extraction
• Uncommon (0.1% to 1%): Pancreatitis, diverticulitis^[Ref]

Nervous system

• Very common (10% or more): Headache (13%)
• Common (1% to 10%): Vertigo, sciatica^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infections, cystitis^[Ref]

Hematologic

• Common (1% to 10%): Anemia^[Ref]

Endocrine

• Postmarketing reports: Marked elevation in serum PTH in patients with severe renal impairment (CrCl less than 30 mL/min) or receiving dialysis^[Ref]

Immunologic

• Common (1% to 10%): Herpes zoster, serious infections (nonfatal cases)
• Uncommon (0.1% to 1%): Serious Infections (fatal cases)^[Ref]

Receptor activator of nuclear factor kappa-B ligand (RANKL) is expressed on activated T and B lymphocytes and in lymph nodes; therefore, a RANKL inhibitor such as this drug may increase the risk of infection. A study of postmenopausal women with osteoporosis (n=7808), has shown a higher incidence of nonfatal serious infections in those receiving this drug compared with placebo (4% vs 3.3%). Hospitalizations due to serious infections in the abdomen (0.9% vs 0.7%), urinary tract (0.7% vs. 0.5%), ear (0.1% vs. 0%) and skin, including erysipelas and cellulitis (0.4% vs. less than 0.1%) were reported. Endocarditis was reported in 3 patients receiving this drug and no placebo patients. The incidence of infections resulting in death was 0.2% in both groups and the incidence of opportunistic infections was the same in both groups.^[Ref]

Ocular

• Common (1% to 10%): Cataracts^[Ref]

Oncologic

• Common (1% to 10%): New malignancies
• Uncommon (0.1% to 1%): Basal cell carcinoma^[Ref]

New malignancies were reported in 4.8% of patients receiving this drug (placebo=4.3%); new malignancies included breast (0.9%), reproductive system (0.5%), and gastrointestinal system (0.9%). A causal relationship to drug exposure has not been established.^[Ref]

Other

• Very common (10% or more): Asthenia (45%), fatigue (45%)
• Common (1% to 10%): Peripheral edema
• Uncommon (0.1% to 1%): Ear infection^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia^[Ref]

See also:

Frequently asked questions

• How long should you take Xgeva for?
• How many years should you take Prolia?
• Is Xgeva a chemotherapy drug?
• Does Xgeva cause bone pain?
• Does Xgeva cause low blood pressure?

Further information

Denosumab 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