Important Information

Actonel is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Selected Safety Information for Actonel

Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).

Bisphosphonates, including Actonel, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers.
Actonel should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur.

There have been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients treated with bisphosphonates. Most cases were reported in cancer patients receiving intravenous bisphosphonates, but some have been in patients treated orally for osteoporosis. Most cases were reported in patients undergoing dental procedures such as tooth extraction.

Most common adverse reactions reported in >10% of patients treated with Actonel and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis)
have been reported rarely.

Please see Full Prescribing Information for Actonel.

Download Information Regarding Osteonecrosis of the Jaw

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ACTONEL is co-promoted by The Alliance for Better Bone Health,
an alliance between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.