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Reclast

"Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

But the panel backed off giving any sp"...

Reclast

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Reclast Consumer (continued)

SIDE EFFECTS: Nausea, tiredness, flu-like symptoms (e.g., fever, chills, muscle/joint aches), dizziness, headache, or pain/redness/swelling at the injection site may occur. Most of these side effects are mild and occur within 3 days of treatment. Flu-like symptoms may be reduced by taking acetaminophen or ibuprofen after the treatment. If any of these effects worsen or last more than 4 days, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, unusual weakness, eye problems (e.g., redness/itching/swelling, sensitivity to light), muscle spasms, numb/tingling skin, irregular heartbeat, sores in jaw/mouth.

Get medical help right away if you have any serious side effects, including: change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Reclast (zoledronic acid injection) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates such as alendronate or risedronate; or if you have trouble breathing (wheezing) after taking aspirin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, low calcium levels in the blood, problem taking calcium/vitamin D supplements, recent or planned dental surgery (e.g., tooth removal), certain gut problems (malabsorption, surgery on the small intestine), treatment with zoledronic acid (e.g., for cancer), parathyroid/thyroid problems (e.g., hypoparathyroidism, thyroid/parathyroid surgery), severe loss of body water (dehydration).

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop using zoledronic acid before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication may cause severe kidney problems, especially in the elderly. Consult your doctor or pharmacist for more information. To help prevent harm to your kidneys, drink plenty of fluids unless otherwise directed by your doctor. (See also How to Use section.)

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for information on reliable forms of birth control.

It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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