"The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis."...
(risedronate sodium) Tablets
ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclastmediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na •2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following:
Molecular Weight: Anhydrous: 305.10 Hemi-pentahydrate: 350.13
Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.
All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg—ferric oxide yellow, lactose monohydrate; 30 mg—lactose monohydrate; 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake.
What are the possible side effects of risedronate (Actonel, Atelvia)?
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,...
What are the precautions when taking risedronate sodium (Actonel)?
Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, etidronate, pamidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: esophagus problems (such as esophageal stricture, achalasia), difficult or painful swallowing, low blood calcium levels (hypocalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease, stomach/intestinal disorders (such as ulcers).
Some people taking risedronate may have serious jawbone problems. Your doctor...
Last reviewed on RxList: 4/14/2015
This monograph has been modified to include the generic and brand name in many instances.
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