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

Get emergency medical help if you have any of these signs of an allergic reaction while taking denosumab (the active ingredient contained in Prolia) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• numbness or tingly feeling around your mouth or in your fingers or toes, fast or slow heart rate, muscle cramps or contraction, overactive reflexes; or

• trouble breathing.

Less serious side effects of denosumab may include:

• feeling weak or tired;

• diarrhea, nausea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.
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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.

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