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
- Back pain
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- cracked, dry, or scaly skin
- difficult, burning, or painful urination
- frequent urge to urinate
- muscle or bone pain
- pain in the arms or legs
- rash
- skin rash, encrusted, scaly, and oozing
- swelling
Less common
- Arm or jaw pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- chest pain, discomfort, heaviness, or tightness
- chills
- confusion
- congestion
- cough
- difficulty with breathing
- difficulty with moving
- dryness or soreness of the throat
- ear congestion
- fast or irregular heartbeat
- fever
- headache
- hoarseness
- joint pain
- loss of voice
- muscle cramps in the hands, arms, feet, legs, or face
- muscle stiffness
- numbness and tingling around the mouth, fingertips, hands, or feet
- pain in the lower back, bottom, upper leg, or hips
- painful blisters on the trunk of the body
- pale skin
- rapid weight gain
- runny or stuffy nose
- seizures
- sneezing
- stomach cramps
- swollen joints
- tender, swollen glands in the neck
- tremor
- trouble swallowing
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- voice changes
Rare
- Blood in the stool
- change in bowel habits
- clear or bloody discharge from the nipple
- constipation
- darkened urine
- difficulty with eating
- dimpling of the breast skin
- indigestion
- inverted nipple
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- loss of appetite
- lower back or side pain
- lump in the breast or under the arm
- lump or swelling in the abdomen or stomach
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent crusting or scaling of the nipple
- raised, firm, and bright red patches of the skin on the arm or leg
- redness or swelling of the breast
- sore on the skin of the breast that does not heal
- stomach discomfort
- unexplained weight loss
- vomiting
- yellow eyes or skin
Incidence not known
- Black, tarry stools
- heavy feeling in the jaw
- loose teeth
- mood or mental changes
- pain, swelling, or numbness in the mouth or jaw
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
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
- Dizziness or lightheadedness
- excess air or gas in the stomach or bowels
- feeling of constant movement of self or surroundings
- feeling of fullness
- heartburn
- lack or loss of strength
- passing gas
- redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
- sensation of spinning
- trouble sleeping
- upper abdominal or stomach pain
Incidence not known
- Loss or thinning of the hair
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]
