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Precautions and Warnings With Risedronate Delayed-Release

When taking risedronate delayed-release, good dental hygiene is important because the drug has been linked to osteonecrosis of the jaw in rare cases. In addition, if you are having a dental procedure, tell your healthcare provider you are taking risedronate delayed-release. Understanding precautions and warnings such as these can help ensure a safe, effective treatment process.

What Should I Tell My Healthcare Provider?

Prior to taking risedronate delayed-release (Atelvia™), talk with your healthcare provider if you have:
  • Low blood calcium (hypocalcemia)
  • An inability to sit upright or stand for 30 minutes
  • Kidney disease, including kidney failure (renal failure)
  • Difficulty swallowing or other problems with your esophagus
  • Any allergies, including to food, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding
  • Planning to have a dental procedure.
Make sure to tell your healthcare provider about any other medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With Risedronate Delayed-Release

Warnings and precautions to be aware of prior to taking this product include the following:
  • In rare cases, bisphosphonates (including risedronate delayed-release) have caused a condition called osteonecrosis of the jaw. This is a serious, possibly disfiguring, problem in which the bone of the jaw dies. Often, there are symptoms (such as pain, infection, or loosening of the teeth), but sometimes there are no symptoms until a person notices exposed bone.  
This problem is most common when bisphosphonates are given by IV, but is still possible when these medications are taken orally. People who have dental procedures such as a tooth extraction seem to be at higher risk. Be sure to take good care of your mouth and teeth by seeing your dentist frequently. Let your healthcare provider know right away if you think you may have osteonecrosis of the jaw. 
  • There have been rare reports of unusual broken thigh bones in people taking bisphosphonate medications like risedronate delayed-release. It is not yet clear if the medications are to blame, since the fractures could simply be due to osteoporosis or other factors. These fractures typically were not caused by trauma or injury. Let your healthcare provider know if you have unexplained groin or thigh pain, as these are sometimes signs of thigh fractures.
  • Risedronate delayed-release, like all bisphosphonate medications, can irritate or damage the esophagus and stomach. This can lead to indigestion, heartburn, or even ulcers. Let your healthcare provider know if you notice any of these problems while taking the drug. Failing to remain upright for 30 minutes after a risedronate delayed-release dosage increases the risk of esophageal problems.
  • It is important to closely follow the instructions for taking risedronate delayed-release. Not doing so could increase your risk of side effects or may make the drug ineffective (see Risedronate Delayed-Release Dosage for more information).
  • It is important that you get enough calcium and vitamin D while taking risedronate delayed-release, either through your diet or by supplementation. Calcium and vitamin D are necessary for rebuilding bone and preventing further bone loss, and risedronate delayed-release cannot work if you do not get enough of these substances. Also, taking calcium and vitamin D may help prevent low blood calcium.
  • This product may not be recommended for people with severe kidney disease.
  • Bisphosphonates can cause extreme muscle or bone pain. This usually goes away once the medication is stopped.
  • Risedronate delayed-release can potentially react with a number of medications (see Drug Interactions With Risedronate Delayed-Release).
  • This drug is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy (see Atelvia and Pregnancy).
  • It is not known if risedronate delayed-release passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Atelvia and Breastfeeding).
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