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:
Incidence not known
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:
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.
It is very important that your doctor check your progress at regular visits after you have received zoledronic acid injection. If your condition has improved, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if your condition is coming back and if a second treatment is needed. You will need a yearly dose of this medicine if you are being treated for postmenopausal osteoporosis, so check with your doctor regularly.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
You should not use other medicines that also contain zoledronic acid, such as Reclast® or Zometa®. Using these medicines together may increase your chance for more serious side effects.
This medicine may rarely cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving the medicine.
This medicine may cause low calcium in your blood. Check with your doctor immediately if you have numbness or tingling around the mouth, or if you have muscle spasms.
Tell your doctor right away if you have agitation; blood in the urine; confusion; decreased urine output; depression; dizziness; headache; irritability; lethargy; muscle twitching; nausea; rapid weight gain; seizures; stupor; swelling of the face, ankles, or hands; or unusual tiredness or weakness. These could be symptoms of serious kidney problems.
Your doctor will need to know if you have a history of problems with your mouth or teeth (e.g., gum disease). Make sure your doctor knows if you have been treated with a bisphosphonate medicine, such as alendronate (Fosamax®), etidronate (Didronel®), pamidronate (Aredia®), risedronate (Actonel®), or tiludronate (Skelid®) in the past.
You may need to have a dental exam before you start using this medicine.
It is important that you check with your doctor before having any dental procedures or surgeries done while you are receiving zoledronic acid. Tell your doctor right away if you have jaw tightness, swelling, numbing, or pain or a loose tooth. This could be symptoms of a severe problem of your jaw.
Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe muscle, bone, or joint pain after receiving this medicine.
This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription (e.g., other medicines that also contain zoledronic acid) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes.
For hypercalcemia, this medicine is usually given only once. If your doctor decides that you need additional doses, you will receive the medicine again after at least 7 days have passed. This treatment will continue until your body responds to the medicine.
For bone cancer and multiple myeloma, this medicine is usually given every 3 to 4 weeks. This treatment will continue until your body responds to the medicine.
For osteoporosis, this medicine is usually given once a year and will continue until your body responds to the medicine.
You may also receive other medicines to help keep your body from losing too much fluid.
Your doctor may also give you vitamins containing Vitamin D and calcium. Tell your doctor if you are unable to take these supplements.
Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems. However, it is very important to not drink too much liquid. Talk to your doctor about the right amount of liquids for you.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Zoledronic acid injection is not indicated for use in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zoledronic acid injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving zoledronic acid injection.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Zoledronic acid injection is used to treat hypercalcemia (high levels of calcium in the blood) that may occur in patients with some types of cancer. It is also used to treat a cancer called multiple myeloma (tumors formed by the cells of the bone marrow) or certain types of bone metastases (the spread of cancer to the bone).
Zoledronic acid injection is used to treat Paget’s disease of the bone in men and women. It is also used in men with osteoporosis and in women with osteoporosis who have gone through menopause. This medicine is used to reduce the risk of having more fractures in patients who have had a recent hip fracture.
This medicine is to be administered only by or under the supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, zoledronic acid is used in certain patients with the following medical conditions: