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Common Side Effects

Denosumab has been studied thoroughly in clinical trials, in which the side effects of a group of people taking the drug were documented and then compared to another group taking a placebo (an injection with no active ingredient) or a different medication used to treat the same conditions. As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the group receiving the placebo or the other medication.
 
In these studies, the most common side effects of denosumab (Prolia) for osteoporosis treatment included:
 
  • Back pain -- in up to 34.7 percent of people
  • Pain in an extremity (arm or leg) -- up to 11.7 percent
  • Skin reactions (such as rashes or eczema) -- up to 10.8 percent
  • Musculoskeletal pain (pain in muscles, bones, tendons, and ligaments) -- up to 7.6 percent
  • High cholesterol -- up to 7.2 percent
  • Bladder infections -- up to 5.9 percent
  • A spinning sensation (vertigo) -- up to 5 percent
  • Upper respiratory tract infections (such as the common cold) -- up to 4.9 percent
  • Swelling or water retention in the hands, arms, legs, or feet -- up to 4.9 percent
  • Sciatica -- up to 4.6 percent.
     
Keep in mind that for most of these common side effects, there was little difference between the group who received denosumab and the group who received the placebo. For instance, while 34.7 percent of people who were given denosumab experienced back pain, almost as many (34.6 percent) of the people who were given the placebo also experienced back pain.
 
Common side effects of denosumab (Xgeva) for preventing cancer-related bone problems included:
 
  • General weakness and/or fatigue -- in up to 45 percent of people
  • Low phosphate blood levels (hypophosphatemia) -- up to 32 percent
  • Nausea -- up to 31 percent
  • Shortness of breath -- up to 21 percent
  • Diarrhea -- up to 20 percent
  • Low blood calcium levels (hypocalcemia) -- up to 18 percent
  • Cough -- up to 15 percent
  • Headache -- up to 13 percent.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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