Denosumab: Uses, Side Effects

Denosumab is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

The Prolia brand of denosumab is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture. Prolia is also used to increase bone mass in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer.

This medication guide provides information about the Prolia brand of denosumab. Xgeva is another brand of denosumab used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone.

Denosumab may also be used for purposes not listed in this medication guide.

Important Information

This medication guide provides information about the Prolia brand of denosumab. Xgeva is another brand of denosumab used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone.

You should not receive denosumab if you have low levels of calcium in your blood (hypocalcemia).

Prolia can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

Before taking this medicine

You should not receive Prolia if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).

While you are using Prolia, you should not receive Xgeva, another brand of denosumab.

To make sure Prolia is safe for you, tell your doctor if you have:

  • kidney disease (or if you are on dialysis);
  • a weak immune system (caused by disease or by using certain medicines);
  • a history of hypoparathyroidism (decreased functioning of the parathyroid glands);
  • a history of thyroid surgery;
  • a history of surgery to remove part of your intestine;
  • any condition that makes it hard for your body to absorb nutrients from food (malabsorption); or
  • if you are allergic to latex.

Denosumab may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, gum infection, or slow healing after dental work.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Denosumab can harm an unborn baby or cause birth defects. Do not use Prolia if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. denosumab may also slow the production of breast milk. You should not breast-feed while using denosumab.

Side effects

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or unusual pain in your thigh, hip, or groin;
  • severe pain in your joints, muscles, or bones;
  • skin problems such as dryness, peeling, redness, itching, blisters, bumps, oozing, or crusting; or
  • low levels of calcium in your blood (hypocalcemia)–numbness or tingly feeling around your mouth or in your fingers or toes, muscle tightness or contraction, overactive reflexes.

Serious infections may occur during treatment with Prolia. Call your doctor right away if you have signs of infection such as:

  • fever, chills, night sweats;
  • swelling, pain, tenderness, warmth, or redness anywhere on your body;
  • pain or burning when you urinate;
  • increased or urgent need to urinate;
  • severe stomach pain; or
  • cough, feeling short of breath.

Common side effects may include:

  • bladder infection (painful or difficult urination);
  • back pain, muscle pain; or
  • pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Prolia?

Other drugs may interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.


Keywords: denosumab; Prolia. 

* The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.