This 3-year clinical study tested the safety of Prolia® in over 7700 women with postmenopausal osteoporosis aged 60 to 90 years. Approximately half of the women took Prolia®, while the other half were untreated (given a placebo injection).
The most common side effects of Prolia® (greater than 5% and more common than placebo)
|Back pain||34.7% (1347 people)||34.6% (1340 people)|
|Pain in the arms and legs||11.7% (453 people)||11.1% (430 people)|
|Muscle pain||7.6% (297 people)||7.5% (291 people)|
|High cholesterol||7.2% (280 people)||6.1% (236 people)|
|Bladder infection||5.9% (228 people)||5.8% (225 people)|
Serious allergic reactions have happened in people who take Prolia®. Symptoms of an allergic reaction include: trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.
Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. You should not take Prolia® if you have a low blood calcium. Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.
Severe jaw bone problems (osteonecrosis) may occur. Before you start Prolia®, it is important to let your doctor know if you are experiencing dental problems, and to receive routine dental care during treatment with Prolia®.
Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. These kinds of fractures include pain in your hip, groin, or thigh.
Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.
Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.
Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.
It's important to understand an osteoporosis treatment's side effects. It is also important to understand that not treating your postmenopausal osteoporosis with a high risk for fracture can be risky.
To find out if Prolia® is right for you, discuss with your doctor the risks of side effects and the risks of not treating your osteoporosis.
What are the possible side effects of Prolia®?
It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.
The most common side effects of Prolia® in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).
The most common side effects of Prolia® in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache.
The most common side effects of Prolia® in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and legs, and muscle pain. Additionally, in Prolia®-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture.
Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.
Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.