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); severely low blood calcium levels may lead to hospitalisation and may even be life-threatening.
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®.
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