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These highlights do not include all the information needed to use RISEDRONATE SODIUM delayed-release tablets safely and effectively. See full prescribing information for RISEDRONATE SODIUM delayed-release tablets.RISEDRONATE SODIUM delayed-release tablets for oral use.Initial U.S. Approval: 1998
Medication labelWhy this: Advisory · dailymed-prescription
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 [see Clinical Studies (14.1) ]. 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.
- generic_name
- risedronate sodium hemi-pentahydrate
- product_names
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE
- ndc
- 0115-1426, 0115-1426-34
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en