Denosumab Side Effects

Not all side effects for denosumab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to denosumab: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by denosumab. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking denosumab, check with your doctor or nurse immediately:

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
  • Abdominal or stomach cramps
  • arm or jaw pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • congestion
  • convulsions
  • cough
  • difficulty with breathing
  • difficulty with moving
  • dryness or soreness of the throat
  • ear congestion
  • fast or irregular heartbeat
  • fever or chills
  • 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, or hips
  • pain in the upper leg
  • painful blisters on the trunk of the body
  • pale skin
  • rapid weight gain
  • runny or stuffy nose
  • sneezing
  • swollen joints
  • tender, swollen glands in the neck
  • tremor
  • trouble swallowing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • voice changes
Rare
  • Abdominal or stomach discomfort
  • blood in the stool
  • change in bowel habits
  • clear or bloody discharge from the nipple
  • constipation
  • darkened urine
  • difficulty with swallowing or 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
  • unexplained weight loss
  • vomiting
  • yellow eyes or skin
Incidence not known
  • Heavy feeling in the jaw
  • loose teeth
  • pain, swelling, or numbness in the mouth or jaw

Some of the side effects that can occur with denosumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Dizziness or lightheadedness
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • full feeling
  • 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

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 (up to 34.7%), arthralgia (up to 14.3%), pain in extremity (11.7%)
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[Ref]

Metabolic

Very common (10% or more): Hypophosphatemia (32%), hypocalcemia (including fatal cases, up to 18%)
Common (1% to 10%): Hypercholesterolemia[Ref]

Dermatologic

Very common (10% or more): Dermatitis (10.8%), eczema (10.8%), rash (10.8%)
Common (1% to 10%): Pruritus, hyperhidrosis
Uncommon (0.1% to 1%): Cellulitis[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 (creatinine clearance 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]

Ocular

Common (1% to 10%): Cataracts[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma[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]

References

1. "Product Information. Prolia (denosumab)." Amgen USA, Thousand Oaks, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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