Denosumab (Subcutaneous Route)

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Side Effects

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:

• 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

• Abdominal or stomach cramps
• Arm, back, 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
• Mood or mental changes
• 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

• 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

• 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:

• 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

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.

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