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Prolia Side Effects

Generic name: denosumab

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

Note: This document contains side effect information about denosumab. Some dosage forms listed on this page may not apply to the brand name Prolia.

Applies to denosumab: subcutaneous solution.

Serious side effects of Prolia

Along with its needed effects, denosumab (the active ingredient contained in Prolia) 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:

More common

Less common

Rare

Incidence not known

Other side effects of Prolia

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:

Less common

Incidence not known

For Healthcare Professionals

Applies to denosumab: subcutaneous solution.

Cardiovascular

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

General

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

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]

Common (1% to 10%): Herpes zoster, serious infections (nonfatal cases)

Uncommon (0.1% to 1%): Serious Infections (fatal cases)[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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Prolia (denosumab). Amgen USA. 2010.

4. Product Information. Xgeva (denosumab). Amgen USA. 2018.

Further information

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.