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Actonel

risedronate

By Procter & Gamble

What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. A side effect may be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away over time. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

  • abdominal pain
  • diarrhea
  • dizziness
  • gas
  • headache
  • heartburn or acid reflux
  • nausea
  • pain in the muscles, joints, or bones
  • skin rash or itching
Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

FDA ADVISORY

November 12, 2008

The FDA has issued a new advisory concerning the use of risedronate. To read the full FDA Advisory, visit the FDA's web site at www.fda.gov.

A previous FDA advisory was issued on January 7, 2008. To read the full FDA advisory, visit the FDA's website at www.fda.gov.

Effects on the esophagus: Risedronate may irritate the lining of the esophagus (the passage from the throat to the stomach). Esophagitis, ulcers, and erosions have been reported for people who take risedronate. In some cases, these effects have been severe and have required hospitalization. Contact your doctor at once if you suddenly experience problems swallowing, find it painful to swallw, develop pain behind the sternum (breastbone), or have new or worsening heartburn.

To ease the passage of the medication to the stomach and thus reduce the risk of irritation of the esophagus, swallow risedronate with a full glass of plain water upon rising for the day. Do not lie down until 30 minutes have passed and you have eaten your first food of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take risedronate at bedtime or before getting up for the day.

Jaw damage: Some people taking this type of medication have developed a type of jaw damage called osteonecrosis of the jaw. This is more likely to occur after dental surgery. Talk to your doctor to find out whether you might be at risk.

Kidneys: Risedronate is not recommended for use by people with severely reduced kidney function.

Low calcium levels or vitamin D deficiency: Your doctor may test you for low calcium levels or vitamin D deficiency before you take risedronate.

Musculoskeletal pain: Severe bone, muscle and joint pain have been reported by some people taking this medication. If you experience any severe symptoms, talk to your doctor about whether you should continue taking this medication.

Pregnancy: Risedronate has not been studied for use by pregnant women. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.

Breast-feeding: This medication passes into breast milk in small amounts. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between risedronate and any of the following:

  • aluminum-containing products
  • antacids
  • calcium supplements
  • iron-containing products
  • magnesium-containing products (such as laxatives)
  • vitamins containing minerals (such as calcium, iron, and magnesium)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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