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Safety Information

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Possible side effects

Like all medicines, Prolia® (denosumab) can cause side effects, although not everybody gets them.
Uncommonly, patients receiving Prolia® may develop skin infections (predominantly cellulitis). Please tell your doctor immediately if you develop any of these symptoms while being on treatment with Prolia®: swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.
Rarely, patients receiving Prolia ® may develop pain in the mouth and/or jaw, swelling or non-healing of sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw(osteonecrosis). Tell your doctor and dentist immediately if you experience such symptoms while being treated with Prolia ® or after stopping treatment.
Rarely, patients receiving Prolia ® may have low calcium levels in the blood (hypocalcaemia). Symptoms include spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion, or loss of consciousness. If any of these apply to you, tell your doctor immediately. Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation which is seen by electrocardiogram (ECG).
Rarely unusual fractures of the thigh bone may occur in patients receiving Prolia ®. Contact your doctor if you experience new or unusual pain in your hip, groin or thigh as this may be an early indication of a possible fracture of the thigh bone.
Rarely, allergic reactions may occur in patients receiving Prolia ®. Symptoms include swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin, wheezing or difficulty breathing. Please tell your doctor if you develop any of these symptoms while being treated with Prolia ®.

Very Common side effects (may affect more than 1 in 10 people):

  • Bone, joint, and/or muscle pain which is sometimes severe
  • Arm or leg pain (pain in extremity)

Common side effects (may affect up to 1 in 10 people):

  • Painful urination, frequent urination, blood in the urine, inability to hold your urine
  • Upper respiratory tract infection
  • Pain, tingling or numbness that moves down your leg (sciatica)
  • Constipation
  • Abdominal discomfort
  • Rash
  • Skin condition with itching, redness and/or dryness (eczema)

Uncommon side effects (may affect up to 1 in 100 people):

  • Fever, vomiting and abdominal pain or discomfort (diverticulitis)
  • Ear infection

Not Known (frequency cannot be estimated from the available data):

Ear pain, discharge from the ear and/or an ear infection could be signs of bone damage in the ear so please consult your doctor.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine. Adverse events should also be reported to Amgen Limited on +44 (0) 1223 436441.