Serious Warnings and Precautions

Potential risk of heart attack, stroke and death from heart or blood vessel problems:

• EVENITY may increase the risk of a heart attack (myocardial infarction), stroke and death from heart or blood vessel problems. The risk is increased in patients who have had a heart attack or stroke, or other types of heart or blood vessel problems. It is not recommended you take EVENITY if you have had a heart attack or stroke. Contact your doctor if you have any heart or blood vessel problems; discuss the benefits and risks of using EVENITY with them.
• During EVENITY treatment, if you have signs or symptoms of heart attack, such as chest pain or pressure, shortness of breath, light-headedness or dizziness, contact your doctor or get medical help right away.
• During EVENITY treatment, if you have signs or symptoms of stroke such as headache, numbness or weakness in the face, arms or legs, difficulty talking, changes in vision or loss of balance, contact your doctor or get medical help right away.

Other warnings you should know about

Serious jaw bone problems (osteonecrosis) can occur during treatment with EVENITY. Your healthcare provider may tell you to see a dentist before you start EVENITY. Take good care of your teeth and gums while you are taking EVENITY. Contact your doctor and dentist right away if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge.

The use of EVENITY in children and adolescents has not been studied.

Stop taking EVENITY and tell your doctor right away if you have:

• Allergic reaction (hypersensitivity); symptoms could include rash, hives, and swelling usually of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing.
• Signs or symptoms of a heart attack, such as chest pain or pressure, shortness of breath, light-headedness or dizziness.
• Signs or symptoms of a stroke including headache, numbness or weakness in the face, arms or legs, difficulty talking, changes in vision or loss of balance.
• Low levels of calcium in the blood (hypocalcemia); symptoms could include spasms, twitches, or muscle cramps and numbness, or tingling in your fingers, toes or around the mouth.
• Jaw bone problems (osteonecrosis of the jaw); such as loose teeth, pain or swelling, or non-healing of sores or discharge.
• Unusual thigh bone fractures (atypical femoral fracture); symptoms could include new or unusual pain in your hip, groin or thigh.

These are not all  the possible symptoms or side effects that you may experience. If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your doctor or healthcare professional.