What is risedronate used for?

Indications and Usage, quoted from the label by Apotex Corp. (ANDA090877). Cross-references to other label sections are left out.

Postmenopausal Osteoporosis

Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, USP reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures.

Osteoporosis in Men

Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis.

Glucocorticoid-Induced Osteoporosis

Risedronate sodium tablets, USP are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Paget's Disease

Risedronate sodium tablets, USP are indicated for treatment of Paget’s disease of bone in men and women.

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets, USP for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Source: DailyMed label, set id b90f2e5b-10b8-29a7-0360-31bd0dae0ec2, version 15, effective March 2, 2026. NDC 60505-3096, one of 11 listings for this product.

Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA077132). Cross-references to other label sections are left out.

Postmenopausal Osteoporosis

Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures.

Osteoporosis in Men

Risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis.

Glucocorticoid-Induced Osteoporosis

Risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Paget’s Disease

Risedronate sodium tablets are indicated for treatment of Paget’s disease of bone in men and women.

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Source: DailyMed label, set id dddcd321-4d2e-4643-bf3c-7b752b33ba39, version 15, effective March 30, 2026. NDC 0093-3098, one of 3 listings for this product.

Indications and Usage, quoted from the label by Sun Pharmaceutical Industires Inc. (ANDA203925). Cross-references to other label sections are left out.

Postmenopausal Osteoporosis

Risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures.

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium delayed-release tablets for the treatment of osteoporosis are based on clinical data of one year duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Source: DailyMed label, set id 1d9e520b-2fa6-4603-b397-f0fc24fae775, version 4, effective September 9, 2020. NDC 63304-440, one of 1 listing for this product.