Prolia (denosumab) can cause side effects that range from mild to serious. Examples include joint pain and tooth and jaw-related side effects. If side effects from Prolia become difficult to tolerate, talk with your doctor about coping tips or other treatment options.

Prolia is an injection prescribed for certain adults with osteoporosis, a condition that causes your bones to weaken. Prolia is also used to help prevent bone fractures in people with breast or prostate cancer who are taking certain medications.

The active ingredient in Prolia is denosumab. (An active ingredient is what makes a drug work.) This is a biologic medication, which means it’s made from parts of living organisms.

Like other drugs, Prolia injections can cause mild or serious side effects. Keep reading to learn more.

Prolia has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effects explained” section.

Prolia can cause side effects, some more common than others. These side effects may be temporary, lasting a few days to weeks. Talk with your doctor if side effects do not go away, get worse, or become difficult to manage.

In studies the following lists contain a few of the more common side effects reported by people who used Prolia. These side effects can vary depending on which condition the drug is being used to treat or help prevent.

When using Prolia for osteoporosis after menopause

More common side effects in females using Prolia for osteoporosis after menopause include:

When using Prolia for osteoporosis

More common side effects in males using Prolia for osteoporosis include:

When using Prolia for osteoporosis caused by glucocorticoid drugs

More common side effects in people using Prolia for osteoporosis caused by taking glucocorticoid drugs include:

When using Prolia to help prevent bone loss

More common side effects in people receiving certain treatments for breast or prostate cancer while also using Prolia to help prevent bone loss include:

  • joint pain
  • back pain
  • pain in the arms and legs
  • pain in the muscles

Note: In this article, we use the terms “female” and “male” to refer to someone’s sex assigned at birth. For more information, see this article about the difference between sex and gender.

Mild side effects have been reported with this drug. These include:

  • back pain
  • joint pain (To learn more about this side effect, see “Side effects explained.”)
  • pain in the arms and legs
  • pain in the muscles
  • high cholesterol
  • high blood pressure
  • bladder infection
  • respiratory infections, such as the common cold and bronchitis
  • itchiness
  • sciatica (shooting pain from the lower back down to one of the legs)
  • upper abdominal pain

In most cases, these side effects should be temporary. And some may be easily managed. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. Do not stop using Prolia unless your doctor recommends it.

Prolia may cause mild side effects other than the ones listed above. See the Prolia prescribing information to learn more.

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Serious side effects from Prolia aren’t common, but they may occur. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Prolia’s prescribing information.

Serious side effects that have been reported with Prolia include:

  • severe bone, joint, or muscle pain
  • serious infections, including serious urinary tract infections or skin infections
  • unusual fractures in the thigh bone
  • decreased bone production (bones take longer to form new tissue)
  • risk of bone fractures after skipping or stopping treatment
  • skin problems, including dermatitis
  • dental and jaw-related side effects
  • boxed warning: risk of seriously low blood calcium level
  • allergic reaction

To learn more about some of these side effects, see “Side effects explained.”

If you develop serious side effects while using Prolia, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while using Prolia and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Most side effects from Prolia are mild and go away on their own after a few days. Although rare, Prolia may cause some long-term side effects. These include:

  • High cholesterol: If you develop this side effect, you may need medication to treat it.
  • Low blood calcium level: This side effect usually won’t go away on its own, but it can be treated with medication.
  • Unusual fractures in the thigh bone: Bone breaks can take months to heal.
  • Dental and jaw-related side effects: These side effects may take time to heal.

Before you start treatment with Prolia, your doctor and pharmacist will discuss potential side effects of Prolia and how long they may last. They should mention long-term side effects as well as short-term side effects.

To learn more about some of these side effects, see “Side effects explained.”

Learn more about some of the side effects Prolia may cause.

Risk of severely low blood calcium levels

Prolia has a boxed warning about the risk of severely low blood calcium levels. A boxed warning is the most serious warning from the FDA. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Prolia can cause low blood calcium levels in people with advanced chronic kidney disease. This condition can be severe and, in some cases, life threatening. It was not a common side effect reported in studies of Prolia.

Low blood calcium levels may cause symptoms such as:

  • fatigue (low energy)
  • difficulty swallowing or speaking
  • seizures
  • parkinsonism
  • muscle spasms or stiffness
  • bone and mineral problems
  • irregular heartbeat

Factors that can increase the risk of severely low blood calcium levels when using Prolia include:

  • chronic kidney disease
  • certain mineral and bone conditions

If you have low blood calcium levels before starting Prolia, talk with your doctor. They’ll likely recommend that you supplement your diet with calcium, vitamin D, or both. This is meant to help increase the amount of calcium in your blood.

If you have this condition during treatment with Prolia, your doctor will likely recommend the same treatment to help increase your blood calcium levels. They’ll continue to monitor you for signs of this condition while you receive the drug.

Dental and jaw-related side effects

Although rare, it’s possible to have dental and jaw-related side effects from using Prolia.

Side effects of Prolia on your teeth, mouth, and jaw can cause:

One potential complication is jaw necrosis (death of jawbone tissue). This may cause teeth to become loose and need to be removed. According to the American Dental Association, the risk of jaw necrosis increases if you use denosumab, the active drug in Prolia, for more than 2 years.

Before you begin treatment with Prolia, your doctor will likely examine your mouth. They may recommend that you see a dentist before starting Prolia.

Be diligent about brushing and flossing your teeth while using Prolia. Good oral hygiene can help prevent dental and jaw-related side effects that Prolia might cause.

If you notice any symptoms of this side effect while using Prolia, contact your doctor or dentist right away. You should also contact your doctor or dentist if you experience pain or slow healing following dental surgery.

Note: Before you have any dental procedure, be sure to tell your dentist that you’re using Prolia.

Joint pain

Pain, including joint pain, is a possible side effect of Prolia. Joint pain was mild in studies. But after these studies were done, some people reported severe joint pain while using Prolia.

If you have joint pain while using Prolia, talk with your doctor.

But if your pain is severe, it’s important to contact your doctor right away. They may want to check you for fractures. Fractures can cause joint pain, even when the fracture isn’t in the joint itself.

Your doctor may recommend treatment for your pain, depending on the severity. They may also recommend that you stop using Prolia and try a different medication for your condition.

Risk of bone fractures after skipping or stopping treatment

Skipping a dose of Prolia or stopping the use of the drug increases the risk of bone fractures. This includes an increased risk of multiple bone fractures in the spine.

When stopping Prolia, bone turnover increases for a time. “Bone turnover” refers to how quickly your bones replace old bone tissue with new bone tissue. Having increased bone turnover raises your risk of bone fractures. Bone turnover takes about 24 months after the last dose of Prolia to return to a typical rate.

To avoid an increased risk of bone fractures, it’s important that you don’t miss a dose. (Prolia is given as an injection by a healthcare professional once every 6 months.) If you miss an injection, call your doctor or pharmacy to reschedule as soon as possible.

If you and your doctor agree that it’s best for you to stop using Prolia, ask your doctor about other medications you could take. They may recommend another treatment for your condition to help your bones stay strong and healthy.

Unusual fractures in the thigh bone

While rare, Prolia has caused unusual fractures in the thigh bone. Symptoms of a thigh bone fracture include new or unusual sensations of pain in the hip, thigh, or groin area.

While using Prolia, contact your doctor right away if you notice new or unusual pain in your hip, thigh, or groin. Sometimes, this pain occurs before a fracture occurs. You may notice a dull, aching pain weeks or even months before a fracture happens.

If you have new or unusual pain in your hip, thigh, or groin, your doctor will likely have you temporarily stop Prolia. They’ll weigh your risks against the possible benefits of continuing the drug and discuss your treatment options with you.

Allergic reaction

For some people, Prolia can cause an allergic reaction.

In general, symptoms of an allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Prolia treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Prolia, they may have you switch to a different treatment.

Get answers to some frequently asked questions about Prolia’s side effects.

How long after beginning Prolia injection do side effects start?

It depends. Some side effects can start soon after your first dose of Prolia. But other side effects may take longer to start, and some may not start until after you stop receiving Prolia injections.

For example, the risk of bone fractures is higher after you stop receiving Prolia or if you miss a dose. To learn more about the risk of bone fractures, see the “Side effects explained” section.

Talk with your doctor if you have questions about when specific side effects are expected to start with Prolia. They can also suggest ways to manage side effects that become bothersome.

Do most people tolerate Prolia well?

Yes. Most people who start Prolia continue receiving the drug as long as the benefits of the medication outweigh the side effects.

Many of the mild side effects reported with Prolia should be temporary. Serious side effects aren’t common with Prolia treatment, but they can occur.

If you receive Prolia and have side effects that are difficult to tolerate, be sure to talk with your doctor. They can recommend methods to help relieve your symptoms, or they may prescribe a different medication to treat your condition.

Does Prolia cause weight gain?

No, Prolia doesn’t cause weight gain. Weight gain wasn’t reported as a side effect in studies of people using Prolia.

However, some people did report fluid retention (buildup of fluid), which caused swelling in their arms or legs. Swelling can cause weight to increase. This side effect was reported only in females using Prolia to treat osteoporosis after menopause.

If you experience swelling or are concerned about your weight while using Prolia, talk with your doctor.

Does Prolia cause hair loss?

In studies, people using Prolia didn’t report hair loss as a side effect. However, hair loss has been reported by people using Prolia after these studies. So it isn’t known whether Prolia or something else caused the hair loss.

For example, certain cancer treatments can cause hair loss. In people with prostate or breast cancer who are using Prolia, hair loss may be due to using a drug other than Prolia.

If you’re concerned about hair loss while using Prolia, talk with your doctor. They may be able to recommend ways to address this side effect.

Consider the following important information before starting Prolia.

Prolia has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects explained” section.

Other precautions

Prolia can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Prolia is a good treatment option for you.

Talk with your doctor about your health history before you start Prolia. They’ll help determine whether there may be dangers of using Prolia given your health history. Be sure to tell them if any of the following factors apply to you:

  • planned dental surgery or tooth extraction
  • previous surgery on your thyroid gland or parathyroid glands
  • problems absorbing minerals
  • kidney problems, such as chronic kidney disease
  • receiving Xgeva, which contains the same active ingredient (denosumab) as Prolia
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding
  • alcohol consumption

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.