Prolia
Prolia (denosumab) is an injection that's used to treat osteoporosis in adults at high risk of fracture. It's also for those at high risk of fractures from certain cancer medications. It works as a monoclonal antibody called a RANKL inhibitor to strengthen your bones. Prolia (denosumab) is a convenient option because you only need an injection every 6 months. It's injected under the skin by a healthcare professional at a medical office. Side effects include back and muscle pain. It also has a risk of causing dangerously low calcium levels.
What is Prolia (denosumab)?
What is Prolia (denosumab) used for?
Osteoporosis in women who've gone through menopause and at high risk of fracture
Osteoporosis in men at high risk of fracture
Osteoporosis caused by steroid medications in people at high risk of fracture
Bone loss in men at high risk of fracture taking certain medications for prostate cancer
Bone loss in women at high risk of fracture taking certain breast cancer medications
How Prolia (denosumab) works
Prolia (denosumab) is a monoclonal antibody known as a RANKL inhibitor. It works by blocking a protein in your body called RANK ligand (RANKL). This protein plays a role in breaking down your bones.
By blocking RANKL, Prolia (denosumab) helps strengthen your bones and prevent bone loss.
Drug Facts
More on Prolia (denosumab) essentials
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What are the side effects of Prolia (denosumab)?
Common Side Effects
- Back pain (35%)
- Pain in the arm or leg (12%)
- Muscle, bone, or joint pain (up to 8%)
- High cholesterol levels (7%)
- Pain or discomfort while urinating and other symptoms of a bladder infection (6%)
- Sensation that the room is spinning (5%)
- Swelling in the hands or feet (5%)
- Upper respiratory tract infection (5%)
Other Side Effects
- Chest pain
- Stomach pain
- Passing gas
- Heartburn
- Feeling weak
- Trouble sleeping
- Rash
- Itching
- Anemia
Serious Side Effects
- Serious allergic reactions: itchiness, rash, dizziness, trouble, tightness in your throat, swelling in your face and throat, trouble breathing
- Dangerously low calcium levels: brittle nails; confusion; muscle spasms or cramps; numbness and tingling in the mouth, hands, and feet
- Fracture in the thigh bone: new or unusual hip, thigh, or groin pain; dull, aching pain
Source: DailyMed
More on Prolia (denosumab) side effects
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Back pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
cracked, dry, or scaly skin
difficult, burning, or painful urination
frequent urge to urinate
muscle or bone pain
pain in the arms or legs
rash
skin rash, encrusted, scaly, and oozing
swelling
Less common
Arm or jaw pain
bloating or swelling of the face, arms, hands, lower legs, or feet
body aches or pain
chest pain or discomfort
chest tightness or heaviness
chills
confusion
congestion
difficulty with breathing
difficulty with moving
dryness or soreness of the throat
ear congestion
fast or irregular heartbeat
headache
hoarseness
joint pain
loss of voice
muscle cramps in the hands, arms, feet, legs, or face
muscle stiffness
numbness and tingling around the mouth, fingertips, hands, or feet
pain in the lower back, bottom, upper leg, or hips
painful blisters on the trunk of the body
pale skin
rapid weight gain
runny or stuffy nose
seizures
stomach cramps
swollen joints
tender, swollen glands in the neck
trouble swallowing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
voice changes
Rare
Blood in the stool
change in bowel habits
clear or bloody discharge from the nipple
darkened urine
difficulty with eating
dimpling of the breast skin
indigestion
inverted nipple
itching, pain, redness, swelling, tenderness, or warmth on the skin
loss of appetite
lower back or side pain
lump in the breast or under the arm
lump or swelling in the abdomen or stomach
pains in the stomach, side, or abdomen, possibly radiating to the back
persistent crusting or scaling of the nipple
raised, firm, and bright red patches of the skin on the arm or leg
redness or swelling of the breast
sore on the skin of the breast that does not heal
stomach discomfort
unexplained weight loss
vomiting
yellow eyes or skin
Incidence not known
Heavy feeling in the jaw
loose teeth
pain, swelling, or numbness in the mouth or jaw
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Dizziness or lightheadedness
excess air or gas in the stomach or bowels
feeling of constant movement of self or surroundings
feeling of fullness
lack or loss of strength
passing gas
redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
sensation of spinning
trouble sleeping
upper abdominal or stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Prolia (denosumab)
Pros
Works well at preventing bone loss, which lowers your risk of breaking a bone
Only given once every 6 months, which is less often than most other osteoporosis medications
An alternative option for people who can't take bisphosphonates like alendronate (Fosamax)
A good option for postmenopausal women at very high risk of fractures
Cons
Must go to the medical office to get the injection
Must take with calcium and vitamin D supplements
Can cause bone and muscle pain
Not safe during pregnancy
Pharmacist tips for Prolia (denosumab)
It's important to take calcium and vitamin D supplements every day while taking Prolia (denosumab). This will help keep your bones healthy and strong. Most people will need at least 1,000 mg of calcium and 400 IU (international units) of vitamin D each day. Follow your prescriber's instructions for these supplements. Ask them if you're not sure how much calcium and vitamin D you need.
You'll need to go to the medical office every 6 months to get your Prolia (denosumab) injection. Write the date and time of your appointments on your calendar to help you remember. Ask your prescriber about any flexibility if you need to get your injection a little early or late.
If you miss a Prolia (denosumab) injection, make a new appointment as soon as you can to get it. Your next injection will be 6 months after that.
Practice good mouth hygiene, like brushing and flossing your teeth each day. Remember to get your dental cleanings as scheduled. This helps lower your risk of having jawbone problems with Prolia (denosumab).
If you need to get any dental work done, let your dentist or oral surgeon know you're taking Prolia (denosumab). You might be at risk of getting jawbone problems. Your care team can talk to you about the risks and benefits.
Don't stop taking Prolia (denosumab) or skip injections without talking to your prescriber. Otherwise, you can be at risk of breaking a bone, including in your spine.
If you can become pregnant and are having sex, use a reliable form of birth control while taking Prolia (denosumab). Keep using birth control for at least 5 months after you stop the medication. Prolia (denosumab) can harm an unborn baby. Let your prescriber know right away if you get pregnant while taking this medication.
Frequently asked questions about Prolia (denosumab)
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What are the risks and warnings for Prolia (denosumab)?
Prolia (denosumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Dangerously low calcium levels
Risk factors: Serious kidney problems, with or without mineral and bone disorder | Receiving dialysis | History of hypoparathyroidism (low levels of parathyroid hormone) | Conditions that affect how well your body absorbs minerals | Previous surgery to remove your small intestine | Previous thyroid surgery | Taking other medications that can lower calcium levels
Prolia (denosumab) can cause your calcium levels to drop too low, which can be dangerous. This can sometimes last for weeks or even months. The risk is higher if you have serious kidney problems, especially with mineral and bone issues. It's also higher if you take medications that lower calcium levels, like diuretics.
Before starting Prolia (denosumab), your prescriber might check your calcium levels. If they're too low, you'll need to get that treated first. Then after each Prolia (denosumab) injection, your prescriber will check your calcium and mineral levels within 2 weeks. They'll keep checking your calcium weekly for the first month after the injection, and then monthly.
It's important to take calcium and vitamin D supplements while taking Prolia (denosumab). This helps keep your calcium levels within a safe range. Tell your care team if you notice signs of very low calcium. Look out for confusion; muscle spasms or cramps; or numbness and tingling in the mouth, hands, and feet.
Risk of fractures in the thigh bone
Risk factors: Taking steroids
It's possible for people taking Prolia (denosumab) to have unusual fractures in the thigh bone. This can sometimes happen without any falls or injuries to the area. It's not clear if Prolia (denosumab) is the cause of the fractures. Watch for any new or unusual hip, thigh, or groin pain. The pain can feel dull or aching. If this happens, go to urgent care right away. The care team can check for any fractures.
Risk of spine fractures after stopping Prolia (denosumab)
Risk factors: Stopping Prolia (denosumab) or skipping doses | History of fractures | History of osteoporosis
When you stop taking Prolia (denosumab) or miss doses, your risk of breaking a bone goes up. This includes the risk of having spine fractures. Spine fractures can happen as early as 7 months after stopping the medication. To lower your risk, you'll need to start another medication for osteoporosis after you stop Prolia (denosumab).
Make sure your prescriber knows if you've ever fractured your spine. They can help you under the risks and benefits of taking Prolia (denosumab).
Risk of serious infections
Risk factors: Weak immune system | Taking medications that affect your immune system (such as transplant medications or steroids)
Some people taking Prolia (denosumab) have had serious infections. These can include skin, ear, stomach, bladder, or even heart infections (endocarditis). Sometimes, people had to get hospital care.
Your risk is higher if your immune system is weak. It's also higher if you take other medications that affect your immune system, like steroids and transplant medications.
Tell your prescriber if you have signs of an infection while taking Prolia (denosumab). Watch for fever, chills, cough, trouble breathing, red or swollen skin, serious stomach pain, or painful urination.
Risk of problems in the jawbone
Risk factors: Oral or dental procedures | Cancer | Taking steroids or chemotherapy | Poor oral hygiene | History of gum problems | Anemia | Clotting problems | Infection | Wearing dentures that don't fit well | Taking Prolia (denosumab) for a long time
Although it's rare, some people taking Prolia (denosumab) have had a jawbone problem called osteonecrosis of the jaw (ONJ). This happens when the jawbone breaks down.
Talk to your prescriber about your risk of ONJ with Prolia (denosumab). It's more likely to happen if you've had dental work, poor mouth hygiene, gum problems, or wear dentures that don't fit. Your risk might also be higher if you have cancer, anemia, or blood-clotting problems. Additionally, it could be higher if you take steroids or get chemotherapy. Your prescriber might want you to get a dental exam before starting Prolia (denosumab).
To lower your risk of ONJ, practice good mouth hygiene. Brush and floss your teeth every day. And get dental exams when recommended. Be sure to tell your care team if you plan to have dental work while taking Prolia (denosumab). Also, let your dentist or oral surgeon know you take Prolia (denosumab). They can talk to you about the risks and benefits.
Call your prescriber or dentist right away if you have jaw pain, swelling, or drainage. These can be signs of ONJ.
Serious allergic reactions and skin reactions
Some people had a serious allergic or skin reaction while taking Prolia (denosumab). Get medical help if you have a serious rash, itching, or skin irritation. Also call 911 right away if you have swelling in your face or lips, trouble breathing, tight feeling in your throat, or other signs of anaphylaxis.
Severe bone, muscle, or joint pain
It's not common, but some people have had severe bone, muscle, or joint pain after starting Prolia (denosumab). This might happen anytime from a day to several months after you've begun treatment. Let your care team know if you have severe pain. They might consider other treatment options for you.
Don't take with Xgeva (denosumab)
Don't take Prolia (denosumab) if you're also taking Xgeva (denosumab) for bone or calcium problems from cancer. These medications both contain denosumab. Taking both at the same time can raise your risk of side effects.
Prolia (denosumab) dosage forms
Typical dosing for Prolia (denosumab)
Prolia (denosumab) is an injection that's given to you by a trained healthcare professional at a medical office.
The typical recommended dose is 60 mg injected under the skin once every 6 months. It's injected either in your upper arm, upper thigh, or stomach.
More on Prolia (denosumab) dosage forms
Interactions between Prolia (denosumab) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tofacitinib
How much does Prolia (denosumab) cost?
Prolia (denosumab) contraindications
Low calcium levels
Currently pregnant
What are alternatives to Prolia (denosumab)?
Osteoporosis in women who've gone through menopause and at high risk of fracture
Osteoporosis in men at high risk of fracture
Osteoporosis caused by steroid medications in people at high risk of fracture
Bone loss in men at high risk of fracture taking certain medications for prostate cancer
Bone loss in women at high risk of fracture taking certain breast cancer medications
Prevention and treatment of osteoporosis in females
Treatment of osteoporosis in males
Osteoporosis in females who've gone through menopause (postmenopause)
Osteoporosis in males
Osteoporosis caused by long-term use of corticosteroids
What is the latest news about Prolia (denosumab)?
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References
Best studies we foundAmgen, Inc. (2025). Prolia- denosumab injection [package insert]. DailyMed.
Camacho, P. M., et al. (2020). American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis— 2020 update. Endocrine Practice.
Centers for Disease Control and Prevention. (2024). Oral health tips for adults.
Dourra, M., et al. (2021). Denosumab-induced alopecia areata with lichenoid eruption. JAAD Case Reports.
Fang, D., et al. (2019). Androgen deprivation therapy in nonmetastatic prostate cancer patients: Indications, treatment effects, and new predictive biomarkers. Asia-Pacific Journal of Clinical Oncology.
Leder, B., et al. (2022). Glucocorticoid-induced osteoporosis. Endocrine Society.
Lewis, J. L., III. Hypocalcemia (low levels of calcium in the blood). Merck Manual Consumer Version.
Lyakhovitsky, A., et al. (2016). Alopecia areata after denosumab treatment for osteoporosis. JAAD Case Reports.
National Institute of Dental and Craniofacial Research. (2024). Oral hygiene.
National Institute of Diabetes and Digestive and Kidney Diseases. (2021). Mineral & bone disorder in chronic kidney disease.
U.S. Food and Drug Administration. (2024). Prolia (denosumab): Drug safety communication - FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease.
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