Introduction
If you have osteoporosis, your doctor may prescribe Prolia (denosumab) as a treatment.
Osteoporosis is a condition that causes your bones to weaken. Prolia is prescribed for certain adults with this condition.
Prolia is also used to help prevent bone fractures in people with breast or prostate cancer who are taking certain medications.
The active drug in Prolia is denosumab, which is a biologic medication. (A biologic is made from parts of living organisms.) It’s given by subcutaneous injection (a shot under your skin). If you and your doctor decide that Prolia is working well for you, you’ll likely use this drug long term.
For more information about Prolia, including details about its uses, see this in-depth article on the drug.
Like other drugs, Prolia injections can cause mild or serious side effects. Keep reading to learn more.
What are the more common side effects of Prolia?
These are just a few of the more common side effects reported by people who took Prolia in studies. These side effects can vary depending on which condition the drug is being used to treat or prevent.
More common side effects in females* using Prolia for osteoporosis after menopause include:
- back pain
- pain in the arms and legs
- pain in the muscles
- high cholesterol
- bladder infection
More common side effects in males* using Prolia for osteoporosis include:
- back pain
- joint pain†
- common cold symptoms, like a runny nose or sore throat
More common side effects in people using Prolia for osteoporosis caused by taking glucocorticoid drugs include:
- back pain
- bronchitis
- headache
- high blood pressure
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
* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.
† To learn more about this side effect, see “Side effects explained” below.
What are the mild side effects of Prolia?
Mild side effects in females* using Prolia for osteoporosis after menopause include:
- back pain
- pain in the arms and legs
- pain in the muscles
- high cholesterol
- bladder infection
- upper respiratory tract infections, such as the common cold
- itchiness
- sciatica (a shooting pain from the lower back down to one of the legs)
Mild side effects in males* using Prolia for osteoporosis include:
- back pain
- joint pain†
- common cold symptoms, like a runny nose or sore throat
Mild side effects in people using Prolia for osteoporosis caused by taking glucocorticoid drugs include:
- back pain
- high blood pressure
- bronchitis
- headache
- upset stomach
- urinary tract infection
- upper abdomen (belly) pain
Mild 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
* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.
† To learn more about this side effect, see “Side effects explained” below.
In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And don’t stop using Prolia unless your doctor tells you to.
Prolia may cause mild side effects other than the ones listed above. See the Prolia medication guide for more information.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Prolia, visit MedWatch.
What are the serious side effects of Prolia?
Serious side effects from Prolia aren’t common, but they may occur.
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 (inflammation of the skin)
- low blood calcium level
- dental and jaw-related side effects*
- allergic reaction*
* To learn more about this side effect, see “Side effects explained” below.
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.
FAQs about Prolia’s side effects
Get answers to some frequently asked questions about Prolia’s side effects.
What are the dangers of using Prolia?
Most people who use Prolia don’t have serious side effects. But as with many other drugs, serious side effects can occur with Prolia. For more information, see the “What are the serious side effects of Prolia?” section above.
You could be at higher risk for certain side effects due to other medical conditions you may have. To learn more, see the “Warnings for Prolia” section below.
How long do side effects from Prolia last?
It depends. 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. They should mention long-term side effects as well as short-term side effects.
Does Prolia cause weight gain?
No, it 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.
If you experience swelling or are concerned about your weight while using Prolia, talk with your doctor.
* This side effect was reported only in females using Prolia to treat osteoporosis after menopause. In this article, we use the term “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.
If I experience side effects from Prolia, can they be reversed?
It’s possible, depending on the side effect. Some Prolia side effects can be treated. For example:
- Mild pain, such as in the muscles or joints, or a headache. Your doctor may recommend using an over-the-counter pain reliever, such as Tylenol (acetaminophen) or Advil (ibuprofen), to treat this side effect.
- Bladder infection. For this side effect, your doctor will likely prescribe an antibiotic.
- Decreased bone production (bones take longer to form new tissue). Bone production typically returns to normal about 24 months after your last dose of Prolia.
Your doctor will choose the best treatment for you based on your health and the side effects Prolia is causing. If you have questions about treating side effects from 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.
Side effects explained
Learn more about some of the side effects Prolia may cause.
Dental and jaw-related side effects
Although rare, it’s possible to have dental and jaw-related side effects from using Prolia.
Symptoms of dental and jaw-related side effects can include:
- loosening of the teeth
- jaw pain or numbness
- mouth infections
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 denosumab, the active drug in Prolia, is used for more than 2 years.
What might help
Before you begin treatment with Prolia, your doctor should examine your mouth. They may recommend that you see a dentist before starting Prolia.
You should practice good oral hygiene while using Prolia, including brushing and flossing your teeth. This can help prevent dental and jaw-related side effects that Prolia might cause.
If you notice any symptoms of dental or jaw-related side effects 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.
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 have reported severe joint pain while using Prolia.
What might help
If you have any 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 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 to above-normal values 9 months after the last dose. “Bone turnover” refers to how quickly your bones replace old bone tissue with new bone tissue. Bone turnover usually takes 24 months after the last dose of Prolia to return to normal.
What might help
If you use Prolia, you’ll likely get an injection once every 6 months. To avoid an increased risk of bone fractures, it’s important that you don’t miss a dose. If you do miss an injection, call your doctor or pharmacy to reschedule as soon as possible. (Prolia injections are only given by a healthcare professional.)
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 are new or unusual feelings of pain in the hip, thigh, or groin.
What might help
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
Like most drugs, Prolia can cause an allergic reaction in some people.
Symptoms can be mild or serious and can include:
- skin rash
- itchiness
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
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 an over-the-counter oral antihistamine, such as Benadryl (diphenhydramine), or topical product, such as hydrocortisone cream, to manage your symptoms.
If your doctor confirms you had a mild allergic reaction to Prolia, they’ll decide if you should continue using it.
If you have symptoms of a severe allergic reaction, such as swelling or trouble 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 had a serious allergic reaction to Prolia, they may have you switch to a different treatment.
Keeping track of side effects
During your Prolia treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.
Your side effect notes can include things like:
- what dose of drug you were taking when you had the side effect
- how soon after starting that dose you had the side effect
- what your symptoms were from the side effect
- how it affected your daily activities
- what other medications you were also taking
- any other information you feel is important
Keeping notes and sharing them with your doctor will help your doctor learn more about how the drug affects you. And your doctor can use this information to adjust your treatment plan if needed.
Warnings for Prolia
Prolia may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you use Prolia. Factors to consider include those listed below.
Scheduled dental surgery or tooth extraction. Prolia can cause dental side effects, including jaw necrosis (death of jawbone tissue). Having dental work, such as surgery or a tooth extraction, can increase your risk for this side effect. Before beginning treatment with Prolia, be sure to tell your doctor about any dental work you’ve scheduled.
Low blood calcium level. Prolia can cause a low blood calcium level. People who already have this condition may see it worsen if they use Prolia. Talk with your doctor about whether your blood calcium level is safe enough for you to use Prolia. Treatments that can raise your calcium to a safe level are available.
Surgery on your thyroid or parathyroid. Having surgery on the thyroid gland or one of the parathyroid glands can increase the risk of a low blood calcium level. Prolia can also cause a decrease in blood calcium level as a side effect. If you’ve had surgery on one of these glands, tell your doctor before you begin treatment with Prolia.
Trouble absorbing minerals. People with this condition aren’t able to absorb calcium in their blood as usual. Prolia can also cause a low blood calcium level. People who have trouble absorbing minerals may be at higher risk for a low blood calcium level if they use Prolia. Talk with your doctor if you have trouble absorbing minerals before you use Prolia. They may suggest a treatment that can raise your blood calcium level to normal.
Kidney problems, such as chronic kidney disease. Like Prolia, kidney problems can cause a decrease in your blood calcium level. Talk with your doctor about whether your kidney function is safe enough for you to use Prolia.
Allergic reaction. If you’ve had an allergic reaction to Prolia or any of its ingredients, you shouldn’t use this drug. Ask your doctor which other medications are better options for you.
Alcohol use and Prolia
There aren’t any known interactions between alcohol and Prolia. But alcohol can raise the risk of both osteoporosis and bone fractures. Alcohol can also make you more likely to fall, which can increase your risk for fractures.
Talk with your doctor about how much alcohol is safe for you to consume while using Prolia.
Pregnancy and breastfeeding while using Prolia
Pregnancy. You shouldn’t use Prolia if you’re pregnant or planning to become pregnant. The drug may harm a developing fetus. Before starting Prolia treatment, your doctor may give you a pregnancy test to make sure you’re not pregnant.
If you can become pregnant, you should use an effective form of birth control during Prolia treatment. And you should continue to use birth control for at least 5 months after your last dose of the drug.
Talk with your doctor about safe treatments for your condition if you’re pregnant or planning to become pregnant.
Breastfeeding. It isn’t known whether Prolia passes into human breast milk. It also isn’t known if Prolia in breast milk could cause side effects in a breastfed child. The manufacturer recommends either using Prolia or breastfeeding, but not both.
Talk with your doctor about the best treatment and feeding options for your situation.
What to ask your doctor
Prolia may help treat your osteoporosis. But the drug may also cause side effects. Most of these side effects aren’t common. When they occur, side effects are typically mild and go away on their own after a few days. But in rare cases, Prolia can cause serious side effects.
If you have questions about Prolia’s side effects, talk with your doctor or pharmacist. Asking questions can help you feel more prepared and confident in your treatment. Here are a few questions to get you started:
- Are there ways to reduce my risk for side effects from Prolia?
- Do any of the medications I take increase my risk for Prolia’s side effects? If so, which side effects?
- I receive dialysis. How might this affect potential side effects of Prolia?
Ask a pharmacist
Q:
Is my risk for bone fractures higher if I leave my osteoporosis untreated instead of using Prolia? I’m worried about taking a drug for weakened bones that may put me at risk for breaking a bone.
Anonymous patient
A:
Yes, your risk for bone fractures is higher if you leave osteoporosis untreated. In studies, the risk of bone fracture was higher in people who didn’t receive treatment for osteoporosis compared with those who used Prolia.
Additionally, without treatment for osteoporosis, your bones may become weaker.
It’s recommended that you take Prolia as prescribed by your doctor to prevent bone fractures if you have osteoporosis.
Melissa Badowski, PharmD, MPH, FCCAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.
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 other 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.
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