"Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.
But the panel backed off giving any sp"...
Actonel Patient Information Including Side Effects
Brand Names: Actonel, Atelvia
Generic Name: risedronate (Pronunciation: rih SED ro nayt)
- What is risedronate (Actonel)?
- What are the possible side effects of risedronate (Actonel)?
- What is the most important information I should know about risedronate (Actonel)?
- What should I discuss with my healthcare provider before taking risedronate (Actonel)?
- How should I take risedronate (Actonel)?
- What happens if I miss a dose (Actonel)?
- What happens if I overdose (Actonel)?
- What should I avoid while taking risedronate (Actonel)?
- What other drugs will affect risedronate (Actonel)?
- Where can I get more information?
What is risedronate (Actonel)?
Risedronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.
Risedronate is used to treat or prevent osteoporosis in men and women. Risedronate is also used to treat Paget's disease of bone.
Risedronate may also be used for purposes not listed in this medication guide.
Actonel 30 mg
oblong, white, imprinted with 30MG, RSN
Actonel 35 mg
octagonal, orange, orange, imprinted with RSN, 35 mg
Actonel 5 mg
oblong, yellow, imprinted with 5 mg, RSN
What are the possible side effects of risedronate (Actonel)?
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 risedronate and call your doctor at once if you have a serious side effect such as:
- chest pain;
- difficulty or pain when swallowing;
- pain or burning under the ribs or in the back;
- new or worsening heartburn;
- severe or ongoing indigestion;
- severe joint, bone, or muscle pain;
- new or unusual pain in your thigh or hip; or
- jaw pain, numbness, or swelling.
Less serious side effects may include:
- flu symptoms, muscle pain;
- mild stomach pain or upset stomach;
- diarrhea, constipation;
- mild joint or back pain; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.
Read the Actonel (risedronate sodium) Side Effects Center for a complete guide to possible side effects »
What is the most important information I should know about risedronate (Actonel)?
Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate 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 with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.
Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.
Use only plain water (not mineral water) when taking a risedronate tablet.
For at least the first 30 minutes after taking a risedronate 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 risedronate 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.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.
Talk with your doctor about the risks and benefits of using this medication.
Additional Actonel Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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