Key takeaways:
Prolia (denosumab) is a twice-yearly injection for osteoporosis. While well-tolerated, it does have some side effects to know about.
Common Prolia side effects include aches and pains in your muscles and bones. These are typically mild and can be managed at home.
Rare but serious Prolia side effects include low blood calcium levels, thigh bone fractures (breaks), and osteonecrosis (breakdown) of the jaw. You also have a greater risk of any type of fracture if you stop receiving Prolia.
Be sure to go for all recommended blood tests on time while receiving Prolia. You should also keep up with regular dental appointments. These steps can help watch for signs or symptoms of serious side effects.
If you’re living with osteoporosis, it’s good to know about available treatment options. Finding the right osteoporosis medication for you can help keep your bones healthy and prevent fractures (broken bones).
One option to consider is Prolia (denosumab). It’s an osteoporosis medication that’s given as an injection twice a year. Prolia is a safe and effective treatment for many people. But there are some things you should know before starting it, including potential side effects.
Prolia side effects at a glance
Prolia is generally well tolerated. Many people receive their injections and experience little to no side effects. But it’s still important to know what to expect.
Commonly reported Prolia side effects include:
Back pain
Pain in the arms or legs
Stomach pain
Headache
Other muscle pain
Raised cholesterol
Vertigo
Dizziness
Upper respiratory tract infections, such as the common cold
Bladder infections
Joint pain
Raised blood pressure
Upset stomach or indigestion
Sore throat
Swelling of the hands or feet
Rare but serious Prolia side effects are also possible, including:
A higher risk of serious infections
Serious skin reactions
Thigh bone fractures
A higher risk of any type of fractures if you stop Prolia
Osteonecrosis of the jaw (ONJ)
This medication also has a boxed warning for severely low blood calcium levels. A boxed warning is the FDA’s strictest warning for medications. While rare, this side effect can be life-threatening.
This isn’t a full list of all possible Prolia side effects. Be sure to discuss these risks with your healthcare team. Here, we’ll further discuss seven notable Prolia side effects and what to do if they happen to you.
1. Pain
Pain is one of the most common Prolia side effects. It can occur in your back, extremities (hands or feet), or throughout the body. Back pain was the most commonly reported type of pain in clinical trials. Usually, pain from Prolia is relatively mild.
Applying heat or ice packs to the affected areas may be soothing for muscle pain. Gentle stretches and regular movement may also provide relief. And over-the-counter pain relievers, such as Tylenol (acetaminophen), can be a good option for occasional use.
Talk to your prescriber if your pain is persistent or seems severe. This is especially true of pain in the hip, thigh, or groin. Pain in these areas could be a symptom of thigh bone fractures (a serious side effect).
2. Raised cholesterol levels
Some people receiving Prolia reported raised cholesterol levels. But the data surrounding this side effect isn’t strong.
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Researchers didn’t check for this side effect with cholesterol blood tests. Instead, it was measured by the number of people reporting whether they started taking a cholesterol medication during the study. This type of reporting makes it hard to determine if Prolia truly caused this side effect.
Certain lifestyle changes can help promote healthy cholesterol levels, including:
Increasing the amount of fiber in your diet
Lowering the amount of meat you eat
Trying to exercise regularly, or add more movement into your daily routine
Eating more foods that are high in omega-3 fatty acids, such as nuts, seeds, and salmon
Avoiding alcohol or smoking
Your healthcare team may routinely monitor your cholesterol levels while you’re receiving Prolia. They can determine if you could benefit from a cholesterol medication and, if so, which one is best for you.
3. Higher risk of infections
Prolia can increase your risk of certain infections. These can include infections of the skin, urinary tract, and upper respiratory tract. People receiving Prolia in studies most commonly reported bladder infections. But in rare cases, people experienced more serious infections, such as pneumonia.
People who have health conditions or take medications that weaken the immune system may have a higher risk for this Prolia side effect. Experts believe that Prolia may decrease the activity of certain immune cells in the body.
Tell your prescriber if you’re experiencing any symptoms of an infection. General symptoms to look out for include a fever, painful urination, and redness or swelling of any body area (including the skin). A healthcare professional can determine if you need treatment with a prescription medication, such as an antibiotic.
4. Low blood calcium levels
Prolia has a boxed warning about severe hypocalcemia (low blood calcium levels). Although rare, this Prolia side effect can be serious. It’s more likely to happen if you have advanced kidney disease or are receiving dialysis. In severe cases, low calcium levels can lead to abnormal heart rhythms.
Despite this risk, most people can safely use Prolia. Your prescriber should check your calcium level with a blood test before starting Prolia and regularly while receiving it.
Getting enough calcium and vitamin D is important while you’re receiving Prolia. This can help keep your calcium levels within a normal range. Prolia’s manufacturer recommends taking 1,000 mg of calcium and at least 400 IU (international units) of vitamin D per day. If your healthcare team tells you to take a different amount, follow their instructions.
Be sure your healthcare team knows about all your medical conditions, including kidney and thyroid problems. And keep them informed about any new medications, supplements, or planned surgeries. Seek emergency help if you experience symptoms of low calcium, such as muscle spasms or tingling in your hands or feet.
5. Thigh bone fractures
People receiving Prolia may experience thigh bone fractures, but this is rare. It’s not fully understood why this happens or if Prolia is the true cause. Other types of osteoporosis medications, such as Boniva (ibandronate), also carry this warning.
Researchers haven’t found a definite link between Prolia and thigh bone fractures. But to be safe, you should know how to spot symptoms of this complication.
Tell your prescriber about any new or unusual hip, thigh, or groin pain. This could be sudden and intense. But it could also be a dull, aching pain that lasts for weeks or months. To be safe, report any persistent or unusual pain in this area.
6. Fractures after stopping Prolia
Prolia’s bone-building effects are reversible. If you stop receiving Prolia, your bones will likely return to the way they were before you started it. Typically, it takes about 2 years for this process to happen.
During this transition period, your rate of bone loss may be higher than normal. This puts you at a higher risk for fractures during this time. This includes back bone fractures. Usually, these fractures happen within the first year after stopping Prolia.
Never stop Prolia without talking to your healthcare team. It takes careful planning to prevent fractures when stopping this medication. In many cases, it’s recommended to switch to a different osteoporosis medication to maintain your bone health.
7. Osteonecrosis of the jaw
Osteonecrosis of the jaw (ONJ) is a rare Prolia side effect that causes part of the jaw bone to weaken and break down. It’s more likely to happen if you have poor dental health or schedule a dental procedure that involves the jaw. Certain health conditions, such as a history of cancer, can also raise your risk of ONJ.
Before starting Prolia, your prescriber will likely ask you to have a dental exam. And you may need to avoid certain procedures while receiving Prolia. If dental issues arise, your prescriber and dentist should work together to determine a safe treatment plan.
While receiving Prolia, try your best to maintain good oral hygiene and keep all routine dental appointments. Report issues like toothaches, gum changes, or jaw pain to your dentist right away. These are possible symptoms of ONJ and should be evaluated immediately.
Frequently asked questions
Unlike some medications, Prolia doesn’t cause tooth decay or cavities. Teeth aren’t bones, so Prolia doesn’t directly affect them. But Prolia is a bone medication and can affect parts of the jawbone that hold your teeth in place. Be sure to talk to a dentist before scheduling dental procedures that involve your jawbone (like removing teeth). These types of dental procedures can increase your risk for ONJ.
Prolia doesn’t have any known drug interactions. But it’s still important to give your healthcare team a list of all your medications and supplements. Some medications can indirectly make Prolia’s side effects more likely. Examples include medications that lower calcium, such as diuretics (water pills), and medications that raise your risk of infections, such as prednisone.
Prolia starts working within 12 hours of your first injection. And it takes about 3 weeks for it to reach peak levels in your bloodstream. But improving bone density takes longer. Many studies found significant bone density improvement 1 year after starting Prolia. Some studies show that Prolia keeps improving bone density for 10 years or longer.
Unlike some medications, Prolia doesn’t cause tooth decay or cavities. Teeth aren’t bones, so Prolia doesn’t directly affect them. But Prolia is a bone medication and can affect parts of the jawbone that hold your teeth in place. Be sure to talk to a dentist before scheduling dental procedures that involve your jawbone (like removing teeth). These types of dental procedures can increase your risk for ONJ.
Prolia doesn’t have any known drug interactions. But it’s still important to give your healthcare team a list of all your medications and supplements. Some medications can indirectly make Prolia’s side effects more likely. Examples include medications that lower calcium, such as diuretics (water pills), and medications that raise your risk of infections, such as prednisone.
Prolia starts working within 12 hours of your first injection. And it takes about 3 weeks for it to reach peak levels in your bloodstream. But improving bone density takes longer. Many studies found significant bone density improvement 1 year after starting Prolia. Some studies show that Prolia keeps improving bone density for 10 years or longer.
The bottom line
The most common Prolia (denosumab) side effects are mild aches and pains in your muscles and bones. But don’t ignore new or worsening pain in your hip, thigh, or jaw areas. These could be symptoms of something more serious.
Rare but serious Prolia side effects include severely low calcium levels, thigh bone fractures, and osteonecrosis (breakdown) of the jaw (ONJ). Prolia can also raise your risk of certain infections. Your risk of fractures also goes up if you stop Prolia. It’s important to go for recommended blood tests and dental check-ups on time. These can help monitor for early signs of possible complications.
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