Prolia Side Effects

Generic Name: denosumab

Note: This document contains side effect information about denosumab. Some of the dosage forms listed on this page may not apply to the brand name Prolia.

Some side effects of Prolia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to denosumab: subcutaneous solution

Along with its needed effects, denosumab (the active ingredient contained in Prolia) 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 while taking denosumab:

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
  • Abdominal or stomach cramps
  • 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
  • confusion
  • congestion
  • convulsions
  • cough
  • difficulty with breathing
  • difficulty with moving
  • dryness or soreness of the throat
  • ear congestion
  • fast or irregular heartbeat
  • fever or chills
  • 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, or hips
  • pain in the upper leg
  • painful blisters on the trunk of the body
  • pale skin
  • rapid weight gain
  • runny or stuffy nose
  • sneezing
  • swollen joints
  • tender, swollen glands in the neck
  • tremor
  • trouble swallowing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • voice changes
Rare
  • Abdominal or stomach discomfort
  • blood in the stool
  • change in bowel habits
  • clear or bloody discharge from the nipple
  • constipation
  • darkened urine
  • difficulty with swallowing or 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
  • nausea
  • 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
  • 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 of denosumab 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 intestines
  • feeling of constant movement of self or surroundings
  • full feeling
  • heartburn
  • 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

For Healthcare Professionals

Applies to denosumab: subcutaneous solution

Musculoskeletal

Musculoskeletal side effects have included osteonecrosis of the jaw, back pain, pain in extremity, musculoskeletal pain, bone pain, myalgia, and spinal osteoarthritis.

Metabolic

Metabolic side effects have included hypocalcemia and hypercholesterolemia. Postmarketing reports have included severe symptomatic hypocalcemia including fatal cases.

Dermatologic

Dermatologic side effects have included dermatitis, eczema, rash and pruritus.

General

General side effects have included herpes zoster, peripheral edema and serious skin infections, as well as infections of the abdomen, urinary tract, and ear.

Cardiovascular

Cardiovascular side effects have included angina pectoris and atrial fibrillation.

Gastrointestinal

Gastrointestinal side effects have included upper abdominal pain, flatulence and gastroesophageal reflux disease.

Nervous system

Nervous system side effects have included vertigo, sciatica, insomnia, and asthenia.
.

Respiratory

Respiratory side effects have included upper respiratory tract infection, pneumonia and pharyngitis.

Genitourinary

Genitourinary side effects have included cystitis.

Hematologic

Hematologic side effects have included anemia.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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