7 Prolia Side Effects You Should Know About

If you’re living with osteoporosis, it’s important to discuss the available treatment options with your healthcare provider. These medications can help keep your bones healthy and prevent fractures (broken bones).

One option you and your provider may consider is Prolia (denosumab). It’s an osteoporosis medication that’s given as an injection twice a year. But before starting Prolia, there are some things you should know, 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.

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Common Prolia side effects (those that were experienced by at least 5% of people in clinical) include:

• Back pain

• Pain in the hands or feet

• Other muscle pain

• Raised cholesterol

• Vertigo

• Bladder infections

Rare but serious Prolia side effects are also possible, including:

• A higher risk of serious infections

• Serious skin reactions

• Low blood calcium levels

• Thigh fractures

• A higher risk of any type of fractures if you stop Prolia

• Osteonecrosis of the jaw (ONJ)

Be sure to discuss these risks with your healthcare provider. 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.

You should talk to your healthcare provider 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

People taking Prolia reported raised cholesterol levels. But the data surrounding this side effect isn’t strong.

Researchers didn’t watch for this side effect with cholesterol blood tests. Instead, it was measured by the number of people reporting if 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.

There are certain lifestyle changes that 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 provider may routinely monitor your cholesterol levels while you’re receiving Prolia. They can help you 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 ear. People taking Prolia in studies most commonly reported bladder infections (cystitis). 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 healthcare provider 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). Your provider can help determine if you need treatment with a prescription medication, such as an antibiotic.

4. Low blood calcium levels

Prolia may lower your blood calcium levels. This is more likely to happen if you have severe kidney disease or are receiving dialysis. Although rare, this Prolia side effect can become serious. In severe cases, low calcium levels can lead to abnormal heart rhythms or seizures.

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. Your healthcare provider can let you know if you should take more than this.

Your provider should regularly check for low calcium levels with blood tests. Seek help if you experience symptoms of low calcium, such as muscle spasms or tingling in 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 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 healthcare provider 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 to your provider.

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 unfold.

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 provider. 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 healthcare provider will likely ask you to have a dental exam. And certain procedures may need to be avoided while receiving Prolia. If dental issues arise, your provider and dentist will likely work together to determine a safe treatment plan.

While taking Prolia, try your best to maintain good oral hygiene and keep all 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.

When should I contact my healthcare provider about Prolia side effects?

Be sure to check in with a healthcare provider if milder side effects are bothersome or persistent. In some cases, they may indicate a more serious problem. It never hurts to double check if anything seems unusual.

If you have symptoms of an infection, such as a fever or painful urination, contact your provider. You may need a prescription treatment to clear your infection.

Some issues should be addressed right away. Get medical help if you experience any of these symptoms:

• Rash or itchy, red skin

• Trouble breathing or swelling or the face or throat

• Muscle cramps or spasms

• Redness, tenderness, or warmth of any body part

• Toothaches, gum changes, or jaw pain

• New or unusual hip, thigh, or groin pain

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Written by:

Tegan Smedley, PharmD, APh

Tegan Smedley, PharmD, APh, has 10 years of experience as a pharmacist. She has worked in a variety of settings, including retail, hospital, and ambulatory care.

Edited by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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