Brand Names: Actonel

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 other 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 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.

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 risedronate 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 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.

Risedronate 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.