Prolia (denosumab) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) for the following uses in certain adults:

  • to treat osteoporosis in females* who have gone through menopause
  • to treat osteoporosis in males*
  • to treat osteoporosis in females and males due to drugs called glucocorticoids
  • to stop bone thinning in females who have had breast cancer and are taking drugs that lower estrogen levels
  • to stop bone thinning in males with nonmetastatic prostate cancer† who are taking drugs that lower the levels of hormones such as testosterone

You’ll likely receive Prolia long term if you and your doctor decide that the drug is effective and safe for you.

Here are some fast facts on Prolia:

  • Active ingredient: denosumab
  • Drug class: monoclonal antibody, which is a biologic
  • Drug form: liquid solution in a single-dose prefilled syringe, given as a subcutaneous injection

As with other medications, Prolia can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a basic overview of Prolia, including details about its uses, see this article.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.
† “Nonmetastatic” means the cancer hasn’t spread to other areas of the body.

Prolia can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Common side effects of Prolia can vary depending on which condition the drug is being used to treat.

More common side effects in females* who received Prolia for osteoporosis after menopause included:

More common side effects in males* who received Prolia for osteoporosis included:

More common side effects in people who received Prolia for osteoporosis due to drugs called glucocorticoids included:

More common side effects in people who received Prolia to stop bone thinning due to certain cancer treatments included:

  • joint pain
  • pain in bones† and muscles, including back, arm, and leg pain

For a complete list of all the side effects reported with Prolia, see the drug’s full prescribing information.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.
† To learn more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Prolia use. This list doesn’t include all possible mild side effects of the drug. And some of these side effects are more common with certain uses of Prolia. For more information, you can refer to the drug’s medication guide.

Mild side effects that have been reported with Prolia include:

These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Prolia and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Prolia may cause serious side effects. The list below may not include all possible serious side effects of the drug. And some of these side effects are more common with certain uses of Prolia. For more information, you can refer to the drug’s medication guide.

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

Serious side effects that have been reported and their symptoms include:

  • Fracture of the femur (thighbone) that occurs after a minor injury or due to an unknown cause. Symptoms can include:
    • pain or swelling in the thigh or groin area
    • trouble walking
  • Fracture in the spine after stopping Prolia treatment.* Symptoms can include:
    • pain or swelling in the thigh or groin area
    • trouble walking
  • Serious infection, such as severe urinary tract infection (UTI). Symptoms may include:
    • pain or burning during urination
    • pain in the pelvis or lower back
  • High blood pressure, which may not have any symptoms. Blood pressure that becomes very high may have symptoms that include:
    • flushing (temporary warmth, redness, or deepening of skin color)
    • dizziness
  • Skin problems, such as severe dermatitis (inflammation of the skin). Skin symptoms can include:
    • itchy rash
    • dryness
    • blisters
    • peeling or oozing
  • Jaw and dental side effects.†
  • Severe pain in bones,† muscles, or joints.
  • Allergic reaction.†‡

* To learn more, see “Does Prolia cause long-term side effects?” in the “FAQs about the side effects of Prolia” section below.
† For more information on this side effect, see “Side effect specifics” below.
‡ An allergic reaction is possible after using Prolia. But it’s not clear whether this side effect occurred in clinical studies.

Prolia may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Is weight gain a side effect of Prolia?

No, weight gain wasn’t reported as a side effect of Prolia in clinical studies. But weight gain may be a symptom of a side effect called peripheral edema.

With peripheral edema, fluid builds up in your body and causes swelling in your arms and lower legs. This can cause your weight to change and may explain any weight gain since starting Prolia treatment.

Peripheral edema is a less common side effect that was reported in clinical studies of females* who received Prolia for osteoporosis after menopause.

If you’re concerned about unexplained weight gain while using Prolia, talk with your doctor.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Could hair loss be a side effect of Prolia?

Hair loss wasn’t reported as a side effect during clinical studies of Prolia. But hair loss has been reported by people who have taken Prolia since then.

With these reports, it wasn’t known whether Prolia or something else (such as a different medication) caused the hair loss.

If you’ve noticed hair loss since starting Prolia treatment, talk with your doctor. They may help you identify other possible causes or suggest ways to help manage hair loss.

Can Prolia’s side effects be reversed?

Usually, but it depends. Some side effects of Prolia may go away on their own within a few days or weeks after starting treatment. Other side effects may continue for as long as you receive the medication, but they can often be relieved with other treatments.

For example, an over-the-counter pain reliever can often ease mild pain such as joint or muscle pain, or headache. These treatments may include acetaminophen (Tylenol) or ibuprofen (Advil, Motrin). If your pain is more severe, your doctor may suggest prescription pain medication or physical therapy.

If you have any questions about Prolia’s side effects, talk with your doctor.

Is tingling a side effect of Prolia?

Tingling wasn’t specifically reported as a side effect of Prolia in clinical studies. But tingling may be a symptom of side effects such as sciatica and hypocalcemia.

Sciatica is described as a shooting pain that travels from the lower back down a leg. Weakness and tingling can also occur. Sciatica was a less common side effect in females who received Prolia for osteoporosis after menopause.

Prolia also carries a warning about hypocalcemia, which is a low level of calcium in the blood. Tingling or numbness in the hands, feet, and face can develop as a symptom of severe hypocalcemia. If you have low calcium levels, you should not take Prolia. (To learn more, see the “Precautions for Prolia” section below.)

If you’re concerned about tingling while using Prolia, talk with your doctor.

Does Prolia cause long-term side effects?

It’s possible that some of Prolia’s side effects may be long term, but they’re rare.

Most side effects from Prolia are mild and can go away on their own within a few days or weeks. Others may continue for as long as you take the drug, but they can be easily managed.

Rare, long-term side effects of Prolia include fractures of the spine or femur (thighbone). These are serious. The fractures may require surgeries, take several months to heal, or both.

Before you start Prolia treatment, talk with your doctor about how long Prolia’s side effects may last. They can help you decide whether the possible benefits for your condition outweigh your risks for serious side effects.

Can Prolia cause fatigue or nausea?

Fatigue (low energy) and nausea weren’t specifically reported as side effects in clinical studies of Prolia. But nausea may be a symptom of side effects such as vertigo or constipation.

Vertigo (dizziness) was reported in some females using Prolia for osteoporosis. Motion sickness, nausea, and vomiting can occur as a part of vertigo.

Constipation was also reported as a side effect in females using Prolia for osteoporosis. Nausea can sometimes be a symptom of severe constipation.

If you’re using Prolia and feel fatigued despite getting enough sleep, talk with your doctor. They may be able to help you identify the cause. You should also talk with your doctor if you have nausea during treatment. They can suggest ways to help relieve these side effects.

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

Jaw and dental side effects

Dental and jaw-related side effects have rarely been reported with Prolia treatment. These side effects may include:

  • loose teeth
  • mouth infection
  • pain or numbness in your jaw

It’s not known what percentage of people in clinical trials developed dental or jaw-related side effects.

A severe jawbone problem called osteonecrosis has rarely been reported with Prolia. According to the American Dental Association, your risk of this problem may increase if you receive denosumab (the active drug in Prolia) for longer than 2 years.

What you can do

Before you start Prolia treatment, your doctor will examine the inside of your mouth. They may also have you see your dentist. If they find any cavities or infection, they’ll typically delay having you receive Prolia until your dental problems are treated.

It’s important to practice good oral hygiene during Prolia treatment. This includes proper brushing, flossing, mouthwash use, and regular professional dental cleanings.

If you notice any tooth or jaw pain, or sensitivity while using Prolia, talk with your doctor or dentist right away. Treating any mouth or dental problems early is the best way to help prevent serious dental complications.

Bone pain

Pain, specifically musculoskeletal pain, is one of the most common side effects of Prolia. Musculoskeletal pain refers to pain in your bones, muscles, tendons, and ligaments.

Bone pain from Prolia may be most noticeable in your arms and legs. Muscle pain often contributes to back pain, one of the most common side effects reported in clinical studies of Prolia.

Musculoskeletal pain from Prolia is mild or manageable for most people. But some females* who received Prolia for osteoporosis after menopause had to stop Prolia treatment due to back pain.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

What you can do

You can often relieve mild pain in your back or bones with an over-the-counter (OTC) pain medication. This may include acetaminophen (Tylenol), naproxen (Aleve), and ibuprofen (Advil, Motrin).

If your pain doesn’t ease with OTC options, your doctor may suggest prescription pain medication. They might also recommend physical therapy, massage therapy, or using a heating pad. If your pain becomes severe, your doctor may recommend other treatment options to replace Prolia.

Dizziness

Vertigo (dizziness) was reported in some people who received Prolia for osteoporosis, but this was a less common side effect. No one in clinical studies of Prolia had to stop taking the drug due to dizziness.

What you can do

Dizziness from Prolia is usually mild and may go away on its own within a few days or weeks.

If your dizziness doesn’t go away or becomes severe, talk with your doctor. They may want to check for other causes. They can also suggest ways to relieve this side effect.

High cholesterol

High cholesterol levels can be a side effect of Prolia. This was one of the most common side effects in clinical studies of females who received Prolia for osteoporosis after menopause.

High cholesterol itself doesn’t cause any symptoms. But it can increase your risk of serious health problems, such as heart attack.

What you can do

While you’re receiving Prolia treatment, your doctor will monitor your cholesterol levels with regular blood tests. If your levels are high, they’ll typically recommend lifestyle changes and medication.

Lifestyle changes that can help improve cholesterol levels include exercising regularly and eating a healthy diet. Your doctor may suggest limiting foods that are high in trans fats, such as fried foods.

The most common medications prescribed to lower cholesterol are statins. Some examples are atorvastatin (Lipitor) and rosuvastatin (Crestor).

If you develop high cholesterol with Prolia, your doctor can guide you on which treatment options are right for your condition.

Allergic reaction

As with most drugs, Prolia can cause an allergic reaction in some people. But it’s not clear how often this side effect occurred in clinical studies.

Symptoms can be mild or serious and can include:

  • rash
  • itching
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin, typically in your lips, eyelids, feet, or hands
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Prolia. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you take Prolia. This drug may not be the right treatment for your condition if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:

Upcoming dental procedures. Having dental procedures, including tooth extractions, during Prolia treatment may increase your risk of dental side effects. These include osteonecrosis of the jawbone. (To learn more, see the “Side effect specifics” section above.)

Before starting Prolia treatment, talk with your doctor about any tooth procedures you have scheduled.

Allergic reaction. You should not take Prolia If you’ve ever had an allergic reaction to Prolia or any of its ingredients. Talk with your doctor about which other treatments are better choices for you.

Low blood calcium level. Prolia comes with a warning about a low level of calcium in the blood. This is called hypocalcemia. If you have a low calcium level, you should not take Prolia. Your doctor will order blood tests to check your level before you start using Prolia and regularly during your treatment.

If you develop hypocalcemia, your doctor will typically have you stop using Prolia. They’ll also usually treat the hypocalcemia right away. Your doctor can also advise you on symptoms of low calcium to look for. These can include tingling or numbness in the hands, feet, and face.

Thyroid or parathyroid surgery. If you’ve had surgery on your thyroid or parathyroid glands, you may have an increased risk of a low level of calcium in your blood. Prolia can also increase this risk. So be sure to talk with your doctor about any past or upcoming surgery before starting treatment with the drug.

Kidney problems. Certain kidney problems, such as chronic kidney failure, can cause a low calcium level in your blood. Because Prolia can also cause low blood calcium, your risk may increase if you receive Prolia. Talk with your doctor about the best options for treating your condition.

Problem absorbing minerals. Prolia may lower the level of calcium in your blood. So treatment with the drug requires you to take daily calcium and vitamin D supplements. (Vitamin D helps your body absorb calcium.) This aids in keeping your calcium level within the recommended range.

If you can’t properly absorb calcium or other minerals, be sure to talk with your doctor before using Prolia. The drug could cause your calcium level to drop too low. They’ll likely suggest other treatment options for your condition.

Alcohol and Prolia

Prolia isn’t known to cause any harmful interactions with alcohol.

However, drinking too much alcohol may raise your risk of falling. And if you have osteoporosis, falling could increase your risk of fractures.

If you drink alcohol, talk with your doctor about how much is safe to drink with your condition.

Pregnancy and breastfeeding while taking Prolia

Here’s some information on pregnancy, breastfeeding, and Prolia use.

Pregnancy. It is not safe to receive Prolia during pregnancy. The drug may increase the risk of pregnancy loss. Prolia can also cause bones to not form correctly and reduced growth in a fetus.

If you’re able to become pregnant, your doctor will have you take a pregnancy test before you start Prolia treatment. They’ll need to confirm that you aren’t pregnant.

It’s also recommended that you use birth control while taking Prolia and for 5 months or more after your last dose. If you have a male* sexual partner, they should use birth control during this time as well.

Breastfeeding. If you’re breastfeeding, you should not receive Prolia. This is because it’s not known if Prolia is safe to receive while breastfeeding.

Talk with your doctor

If you’re pregnant or breastfeeding, or considering either, talk with your doctor. They can recommend a treatment option other than Prolia.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Prolia can cause both mild and serious side effects. You should talk with your doctor if you develop any mild side effects that concern you. You should also talk with them if you have any serious side effects during Prolia treatment.

If you’d like to learn more about Prolia, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Your doctor can also help you decide if the benefits of Prolia treatment outweigh your risks of side effects.

You may also want to do some research on your own. These articles might help:

Disclaimer: Medical News Today 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.