Note: This document contains side effect information about denosumab. Some of the dosage forms listed on this page may not apply to the brand name Prolia.
Applies to denosumab: subcutaneous solution
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:
Incidence not known
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:
Applies to denosumab: subcutaneous solution
Common (1% to 10%): Angina pectoris, atrial fibrillation
Postmarketing reports: Anaphylaxis, rash, urticaria, facial swelling, erythema
Very common (10% or more): Dyspnea (21%), cough (15%)
Common (1% to 10%): Upper respiratory tract infection, pneumonia, pharyngitis, nasopharyngitis
The most commonly reported side effects were asthenia, fatigue, back pain, hypophosphatemia, hypocalcemia, and nausea.
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
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
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
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
Very common (10% or more): Headache (13%)
Common (1% to 10%): Vertigo, sciatica
Common (1% to 10%): Urinary tract infections, cystitis
Common (1% to 10%): Anemia
Postmarketing reports: Marked elevation in serum PTH in patients with severe renal impairment (CrCl less than 30 mL/min) or receiving dialysis
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.
Common (1% to 10%): Herpes zoster, serious infections (nonfatal cases)
Uncommon (0.1% to 1%): Serious Infections (fatal cases)
Common (1% to 10%): Cataracts
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.
Common (1% to 10%): New malignancies
Uncommon (0.1% to 1%): Basal cell carcinoma
Very common (10% or more): Asthenia (45%), fatigue (45%)
Common (1% to 10%): Peripheral edema
Uncommon (0.1% to 1%): Ear infection
Common (1% to 10%): Insomnia
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Prolia