From the Guidelines
Prolia (denosumab) can cause several side effects, including mild upper GI symptoms and rash/eczema, as noted in the American College of Physicians guideline update 1.
Common Side Effects
The most common side effects of Prolia include:
- Back pain
- Arm or leg pain
- Muscle pain
- High cholesterol levels
- Bladder infections
- Skin conditions like dermatitis or eczema These side effects are generally mild and can be managed with proper treatment and monitoring.
Serious Side Effects
More serious side effects that require immediate medical attention include:
- Jaw bone problems (osteonecrosis)
- Unusual thigh bone fractures
- Serious infections
- Skin problems
- Low calcium levels
- Severe allergic reactions Patients may also experience increased risk of broken bones after stopping Prolia, as well as possible immune system effects.
Monitoring and Prevention
To minimize side effect risks, patients should inform their doctor about all medications they take and any existing health conditions, particularly kidney problems, low calcium levels, or planned dental procedures 1. Regular monitoring of calcium levels is important while on this medication, and patients should take calcium and vitamin D supplements as directed by their healthcare provider. The Expert Panel recommends that serum creatinine should be monitored before each dose of pamidronate or zoledronic acid, in accordance with US Food and Drug Administration (FDA)–approved labeling, but denosumab does not require monitoring of renal function 1.
Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ) is an uncommon but potentially serious complication of intravenous bisphosphonates and denosumab, with a risk that increases with time and reaches 5% when denosumab is continued beyond 3 years 1. All patients should receive a comprehensive dental examination and appropriate preventive dentistry before bone-modifying therapy, and active oral infections should be treated, and sites that are at high risk for infection should be eliminated. While on therapy, patients should maintain excellent oral hygiene and avoid invasive dental procedures, if possible.
From the FDA Drug Label
What are the possible side effects of Prolia? Prolia may cause serious side effects. See "What is the most important information I should know about 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 who are being treated for osteoporosis after menopause are: back pain pain in your arms and legs high cholesterol muscle pain bladder infection The most common side effects of Prolia in men with osteoporosis are: back pain joint pain common cold (runny nose or sore throat) The most common side effects of Prolia in patients with glucocorticoid-induced osteoporosis are: back pain high blood pressure lung infection (bronchitis) 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 muscle pain The possible side effects of Prolia include:
- Serious side effects:
- Increased risk of severe low calcium levels in the blood (hypocalcemia)
- Serious allergic reactions
- Severe jaw bone problems (osteonecrosis)
- Unusual thigh bone fractures
- Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia
- Serious infections
- Common side effects:
- Back pain
- Pain in arms and legs
- High cholesterol
- Muscle pain
- Bladder infection
- Joint pain
- Common cold (runny nose or sore throat)
- High blood pressure
- Lung infection (bronchitis)
- Headache
- Pain in extremity
- Musculoskeletal pain
- Cataracts (in men with nonmetastatic prostate cancer receiving ADT)
- Hypocalcemia (in men with nonmetastatic prostate cancer receiving ADT) 2
From the Research
Prolia Side Effects
Prolia, also known as denosumab, is a medication used to treat osteoporosis and various malignancies. The following are some of the known side effects of Prolia:
- Hypocalcemia (low calcium levels in the blood) 3, 4, 5, 6, 7
- Hypophosphatemia (low phosphate levels in the blood) 3, 4
Risk Factors for Hypocalcemia
Several studies have identified risk factors for hypocalcemia in patients taking Prolia, including:
- Low pretreatment serum calcium levels 5, 6
- High creatinine levels 5
- Low vitamin D levels 5
- Renal impairment 7
- Elevated parathyroid hormone levels 6
Management of Hypocalcemia
The management of hypocalcemia in patients taking Prolia typically involves:
- Discontinuation of Prolia 4
- Intravenous (IV) and oral mineral supplementation 3, 4
- Close monitoring of electrolyte levels 3, 4
- Adequate calcium and vitamin D supplementation 5, 6
Incidence of Hypocalcemia
The incidence of hypocalcemia in patients taking Prolia has been reported to be higher than previously thought, with one study finding a rate of 7.4% 5 and another study finding a rate of 23% 6. The risk of hypocalcemia may be higher in patients with advanced chronic kidney disease (CKD) 7.