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Molecule

Risedronate

Also known as risedronate sodium, risedronate sodium monohydrate
Available on requestBone health
Presentations
5
Brands
0
Manufacturers
0
Available from stock
0

Risedronate is a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Risedronate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Bisphosphonate
ATC classification
M05BA07 Risedronate · Bone disease treatments, subgroup M05B, subgroup M05BA
US FDA first approval
27 March 1998
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII KM2Z91756ZRxCUI 73056CAS 105462-24-6DrugBank DB00884Q408724

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Risedronate sodium tablets are a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis. Treatment to increase bone mass in men with osteoporosis. Treatment and prevention of glucocorticoid-induced osteoporosis. Treatment of Paget’s disease. Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

Source: US FDA prescribing information

How it works

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that risedronate treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

Source: US FDA prescribing information

Dosing overview

Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month. Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week. Men with Osteoporosis: 35 mg once-a-week. Glucocorticoid-Induced Osteoporosis: 5 mg daily. Paget’s Disease: 30 mg daily for 2 months. Instruct patients to: Swallow tablet whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day Avoid lying down for 30 minutes. Take supplemental calcium and vitamin D if dietary intake is inadequate

Source: US FDA prescribing information

Contraindications

Risedronate sodium is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia Inability to stand or sit upright for at least 30 minutes Hypocalcemia Known hypersensitivity to risedronate sodium or any of its excipients. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes. Hypocalcemia. Known hypersensitivity to any component of this product

Source: US FDA prescribing information

Warnings and precautions

Products Containing Same Active Ingredient: Patients receiving Atelvia should not be treated with risedronate sodium. Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur. Hypocalcemia may worsen and must be corrected prior to use. Osteonecrosis of the Jaw has been reported. Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered

Source: US FDA prescribing information

Side effects

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient Upper Gastrointestinal Adverse Reactions Mineral Metabolism Jaw Osteonecrosis Musculoskeletal Pain Atypical Fractures Including Femoral Fractures Renal Impairment Glucocorticoid-Induced Osteoporosis Laboratory Test Interactions Most common adverse reactions reported in greater than 10% of patients treated with risedronate and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely

Source: US FDA prescribing information

Interactions

No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of risedronate

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

5 presentations of Risedronate, sorted by availability.

MedicineManufacturerRegisterAvailability
Risedronate 35 mg tabletOralGeneric name—US FDAAvailable on request
Risedronate 30 mg tabletOralGeneric name—US FDAAvailable on request
Risedronate 5 mg tabletOralGeneric name—US FDAAvailable on request
Risedronate 150 mg tabletOralGeneric name—US FDAAvailable on request
Risedronate 75 mg tabletOralGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 March 1998Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Risedronate in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Risedronate available for export from India?

Yes, on request. MedsAcross lists 5 presentations of Risedronate and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Risedronate approved by the US FDA?

Yes. The US FDA first approved Risedronate on 27 March 1998, according to Drugs@FDA.

Does Risedronate need cold chain shipping?

No listed presentation of Risedronate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Risedronate in?

Risedronate is classified under ATC code M05BA07 (Risedronate).

References

  1. Risedronate Sodium prescribing information (Teva Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 30 March 2026

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