Actonel, also known as risedronate and risedronate sodium, is in a group of medicines called bisphosphonates (bis-FOS-fo-nayts). It alters the cycle of bone formation and breakdown in the body. Actonel slows bone loss while increasing bone mass, which may prevent bone fractures.
Actonel is used to treat or prevent osteoporosis in men and women. Actonel is also used to treat Paget's disease of bone.
Actonel may also be used for other purposes not listed in this medication guide.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Actonel and call your doctor at once if you have any of these serious side effects:
chest pain;
difficulty or pain when swallowing;
pain or burning under the ribs or in the back;
new or worsening heartburn;
severe joint, bone, or muscle pain; or
jaw pain, numbness, or swelling.
Less serious side effects may include:
mild heartburn or stomach upset;
diarrhea, gas, or constipation;
mild joint or back pain; or
headache.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Do not take a Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.
Take the Actonel tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.
Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Actonel tablet.
For at least the first 30 minutes after taking a Actonel tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.
Some people using medicines similar to Actonel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.
Actonel is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.
Do not take a Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.
Before using Actonel, tell your doctor if you have:
low blood calcium (hypocalcemia);
a vitamin D deficiency;
kidney disease; or
an ulcer in your stomach or esophagus.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
Some people using medicines similar to Actonel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.
You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Caution is advised if you are pregnant or planning to become pregnant in the future. This medication may stay in your body for many years. Its effects on an unborn baby are not known. It may or may not be harmful to an unborn baby. Discuss the risks and benefits with your doctor before starting treatment with Actonel.
It is not known whether Actonel passes into breast milk or if it could harm a nursing baby. Do not breast-feed while taking Actonel.
Take Actonel exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.
Actonel tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day or once each week. The stronger tablets may be taken only 1 or 2 times each month. Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.
Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.
Take the Actonel tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take a Actonel tablet only once a week, take it on the same day each week and always first thing in the morning.
Take each Actonel tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Actonel tablet.
Do not crush, chew, or suck the Actonel tablet. Swallow the pill whole.
After taking a Actonel tablet, carefully follow these instructions:
Do not lie down or recline for at least 30 minutes after taking Actonel.
Do not eat or drink anything other than plain water.
Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking Actonel. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.
To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
Actonel is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.
Store Actonel tablets at room temperature away from moisture and heat.
If you take Actonel tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.
If you take Actonel tablets once a week, or once or twice per month: If you forget to take Actonel on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.
Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.
Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.
Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an Actonel tablet.
Do not lie down for at least 30 minutes after you take a Actonel tablet.
Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Actonel. If you use these other medicines, do not that take them for at least 30 minutes after taking a Actonel tablet.
Before using Actonel, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.
There may be other drugs that can affect Actonel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Your pharmacist can provide more information about Actonel.