Tiredness, weakness, headache, back pain, diarrhea, and nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: jaw pain, new or unusual thigh/hip/groin pain, bone/joint/muscle pain, shortness of breath.
Denosumab may cause very serious (rarely fatal) low levels of calcium in the blood, especially if you have kidney problems. Take calcium and vitamin D as directed by your doctor. (See also How to Use section.) Get medical help right away if you have any symptoms of low calcium such as: severe muscle spasms/cramps, mental/mood changes (such as irritability or confusion), numbness/tingling (especially around lips/mouth or in fingers/toes), seizures, severe dizziness/fainting, fast/irregular heartbeat.
Denosumab can affect your immune system. You may be more likely to get a serious infection, such as a skin, ear, stomach/gut, or bladder infection. Tell your doctor right away if you develop any signs of infection, such as: fever/chills, red/swollen/tender/warm skin (with or without pus), severe abdominal pain, ear pain/discharge, trouble hearing, frequent/painful/burning urination, pink/bloody urine.
Denosumab can cause skin problems such as dryness, peeling, redness, itching, small bumps/patches, or blisters. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash or if any of these symptoms persist or worsen.
Denosumab may cause high levels of calcium in the blood weeks to months after treatment has stopped, especially if you have not reached your final adult height. Tell your doctor right away if you have any symptoms of high calcium after you have stopped using denosumab such as: nausea, vomiting, headache, unusual tiredness.
After your treatment with denosumab is stopped, you may be at increased risk for bone fractures in your spine. This risk is greater if you have bone loss (osteoporosis) or have had broken bones. If your treatment is stopped, talk with your doctor about other medicines you can take.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.