Actonel (Risedronate) Drug Information

  • Why is this medication prescribed?

    Actonel (risedronate) tablets and delayed-release (long-acting tablets) are used to prevent and treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change of life,' end of menstrual periods). Actonel (risedronate) tablets are also used to treat osteoporosis in men, and in men and women who are taking glucocorticoids (a type of corticosteroid medication that may cause osteoporosis). Actonel (risedronate) tablets are also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Actonel (risedronate) is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

  • How should this medicine be used?

    Actonel (risedronate) comes as a tablet and a delayed-release tablet to take by mouth. The delayed-release tablets are usually taken once a week in the morning, immediately after breakfast. The tablets are usually taken on an empty stomach once a day in the morning, once a week in the morning, once monthly in the morning, or once monthly for two mornings in a row depending on your condition and the dosage prescribed by your doctor. If you are taking Actonel (risedronate) once a week, once monthly, or once monthly for 2 days in a row, take it on the same day every week or month or the same 2 days in a row every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Actonel (risedronate) exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.

    Actonel (risedronate) may not work properly and may damage the esophagus (tube that connects the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:

    • You must take Actonel (risedronate) tablets immediately after you get out of bed in the morning and before you eat or drink anything. You must take Actonel (risedronate) delayed-release tablets immediately after breakfast. Never take Actonel (risedronate) at bedtime or before you wake up and get out of bed for the day.
    • Swallow the tablets with a full glass (6 to 8 ounces [180 to 240 mL]) of plain water while you are sitting or standing. Swallow the delayed-release tablets with at least 4 ounces (120 mL) of plain water while you are sitting or standing. Never take Actonel (risedronate) with tea, coffee, juice, mineral water, milk, other dairy drinks, or any liquid other than plain water.
    • Swallow the tablets and delayed-release tablets whole. Do not split, chew, or crush them. Do not suck on the tablets or hold them in your mouth for any length of time.
    • After you take Actonel (risedronate), do not eat, drink, or take any other medications for at least 30 minutes. Do not lie down for at least 30 minutes after you take Actonel (risedronate). Sit upright or stand upright until at least 30 minutes have passed.

    Actonel (risedronate) controls osteoporosis and Paget's disease of bone but does not cure these conditions. Actonel (risedronate) helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take Actonel (risedronate) even if you feel well. Do not stop taking Actonel (risedronate) without talking to your doctor, but talk to your doctor from time to time about whether you still need to take Actonel (risedronate).

    Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with Actonel (risedronate) and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

  • Other uses for this medicine

    This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

  • What special precautions should I follow?

    Before taking Actonel (risedronate):

    • tell your doctor and pharmacist if you are allergic to Actonel (risedronate), any other medications, or any of the ingredients in Actonel (risedronate) tablets or delayed-release tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); cancer chemotherapy; or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). If you are taking the delayed-release tablets, you should also tell your doctor if you are taking an H2 blocker such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) or a proton pump inhibitor such as esomeprazole (Nexium), lansoprazole (Prilosec), omeprazole (Prevacid, Zegarid), pantoprazole (Protonix), and rabeprazole (AcipHex).Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • you should know that Actonel and Atelvia both contain Actonel (risedronate). You cannot take both of these medications at the same time.
    • if you are taking any other oral medications including vitamins, supplements, or antacids, take them at least 30 minutes after you take Actonel (risedronate).
    • tell your doctor if you have or have ever had a low level of calcium in your blood or any problems with your esophagus and if you are unable to sit upright or stand upright for at least 30 minutes. Your doctor may tell you that you should not take Actonel (risedronate).
    • tell your doctor if you are undergoing radiation therapy; if you have or have ever had difficulty swallowing; heartburn; ulcers or other problems with your stomach; anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; or dentalor kidney disease.
    • tell your doctor if you are pregnant or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because Actonel (risedronate) may remain in your body for years after you stop taking it. Call your doctor if you become pregnant during or after your treatment with Actonel (risedronate).
    • you should know that Actonel (risedronate) may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments before you start to take Actonel (risedronate). Be sure to brush your teeth and clean your mouth properly while you are taking Actonel (risedronate). Talk to your doctor before having any dental treatments while you are taking this medication.
    • you should know that Actonel (risedronate) may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take Actonel (risedronate). Although this type of pain may begin after you have taken Actonel (risedronate) for some time, it is important for you and your doctor to realize that it may be caused by Actonel (risedronate). Call your doctor right away if you experience severe pain at any time during your treatment with Actonel (risedronate). Your doctor may tell you to stop taking Actonel (risedronate) and your pain may go away after you stop taking the medication.
    • talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.
  • What special dietary instructions should I follow?

    You should eat plenty of foods that are rich in calcium and vitamin D while you are taking Actonel (risedronate). Your doctor will tell you which foods are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

  • What should I do if I forget a dose?

    If you miss a dose of once-daily Actonel (risedronate), do not take it later in the day. Skip the missed dose and take one dose the next morning as usual.

    If you miss a dose of once-weekly Actonel (risedronate), do not take it later in the day. Take one dose the morning after you remember. Then return to taking one dose once each week on your regularly scheduled day.

    If you miss a dose of once-monthly Actonel (risedronate) but remember more than 7 days before your next scheduled dose, take the missed dose the morning after you remember. If you remember less than 7 days before your next scheduled dose, do not take the missed dose. Instead, wait until the morning of your next scheduled dose and then take Actonel (risedronate) as usual.

    If you miss one or both doses of the two days in a row, once-monthly Actonel (risedronate) but remember more than 7 days before your next scheduled dose, you can take the missed doses. Take the first missed dose the morning after you remember and if you missed both doses, take the second missed dose the morning after you take the first one. If you remember less than 7 days before your next scheduled dose, do not take the missed dose(s). Instead, wait until the morning of your next scheduled dose and then take Actonel (risedronate) as usual.

    If you miss doses of Actonel (risedronate) and do not know what to do, call your doctor. Always take Actonel (risedronate) first thing in the morning. Never take a double dose to make up for a missed one, and never take more than one dose in one day.

  • What side effects can this medication cause?

    Actonel (risedronate) may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

    • nausea
    • burping
    • dry mouth
    • stomach pain
    • diarrhea
    • constipation
    • gas
    • headache
    • dizziness
    • weakness
    • leg cramps
    • back pain
    • frequent or urgent need to urinate
    • painful urination

    Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately before you take any more Actonel (risedronate):

    • difficulty swallowing or pain when swallowing
    • new or worsening heartburn
    • chest pain
    • itching
    • rash
    • hives
    • blisters on skin
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • difficulty breathing
    • hoarseness
    • muscle spasms, twitching, or cramps
    • numbness or tingling around mouth or in hands or feet
    • swollen, red, or painful eyes
    • sensitivity to light
    • painful or swollen gums
    • loosening of the teeth
    • numbness or heavy feeling in the jaw
    • poor healing of the jaw
    • dull, aching pain in the hips, groin, or thighs

    Actonel (risedronate) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

    Taking a bisphosphonate medication such as Actonel (risedronate) for osteoporosis may increase the risk that you will break your thigh bone(s). You may feel pain in your hips, groin, or thighs for several weeks or months before the bone(s) break, and you may find that one or both of your thigh bones have broken even though you have not fallen or experienced other trauma. It is unusual for the thigh bone to break in healthy people, but people who have osteoporosis may break this bone even if they do not take Actonel (risedronate). Talk to your doctor about the risks of taking Actonel (risedronate).

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

  • What storage conditions are needed for this medicine?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

  • In case of emergency/overdose

    In case of overdose, give the victim a full glass of milk and call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include:

    • numbness or tingling around mouth or in hands or feet
    • muscle spasms, cramps, or twitches
    • seizures
  • What other information should I know?

    Keep all appointments with your doctor and the laboratory.

    Before having any laboratory test or bone imaging study, tell your doctor and the laboratory personnel that you are taking Actonel (risedronate).

    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

  • Brand Names

    • Actonel®
    • Atelvia®