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Molecule

Alendronate

Also known as alendronate sodium
Available on request
Presentations
8
Brands
2
Manufacturers
2
Available from stock
0

Alendronate is a bisphosphonate indicated for treatment and prevention of osteoporosis in postmenopausal women, among other approved uses. It is available as tablets, oral solution and effervescent tablets. MedsAcross supplies Alendronate 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
US FDA first approval
29 September 1995
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, Oral solution, Effervescent tablet
Identifiers
UNII 2UY4M2U3RARxCUI 203152CAS 121268-17-5DrugBank DBSALT000315Q27105722

Clinical information

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

Uses

FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women. Treatment to increase bone mass in men with osteoporosis. Treatment of glucocorticoid-induced osteoporosis. Treatment of Paget's disease of bone. 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

Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [ 3 H]alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [ 3 H]alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active.

Source: US FDA prescribing information

Dosing overview

Although alendronate tablets 5 mg, 10 mg, 35 mg, and 40 mg are available in the marketplace, FOSAMAX is no longer marketed in the 5 mg, 10 mg, 35 mg, and 40 mg strengths. Although an oral solution of alendronate may be available in the marketplace, FOSAMAX oral solution is no longer marketed. Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg (tablet or oral solution) once weekly. Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. Glucocorticoid-induced osteoporosis: 5 mg daily, or 10 mg daily in postmenopausal women not receiving estrogen. Paget's disease: 40 mg daily for six months. Instruct patients to: Swallow tablets whole with 6-8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. Swallow oral solution followed by at least 2 ounces of water.

Source: US FDA prescribing information

Contraindications

FOSAMAX 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 Do not administer FOSAMAX oral solution to patients at increased risk of aspiration. Hypocalcemia Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported. Abnormalities of the esophagus which delay emptying such as stricture or achalasia. Inability to stand/sit upright for at least 30 minutes. Do not administer FOSAMAX oral solution to patients at increased risk of aspiration. Hypocalcemia.

Source: US FDA prescribing information

Warnings and precautions

Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur. Hypocalcemia can worsen and must be corrected prior to use. Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. Osteonecrosis of the Jaw has been reported. 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: Upper Gastrointestinal Adverse Reactions Mineral Metabolism Musculoskeletal Pain Osteonecrosis of the Jaw Atypical Fractures Including Femoral Fractures Renal Impairment Glucocorticoid-Induced Osteoporosis Most common adverse reactions (greater than or equal to 3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea.

Source: US FDA prescribing information

Interactions

Calcium supplements, antacids, or oral medications containing multivalent cations interfere with absorption of alendronate. Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation.

Source: US FDA prescribing information

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

All presentations

8 presentations of Alendronate, sorted by availability.

MedicineManufacturerRegisterAvailability
Alendronate 70 mg tabletOralGeneric name—US FDAAvailable on request
Alendronate 35 mg tabletOralGeneric name—US FDAAvailable on request
Alendronate 10 mg tabletOralGeneric name—US FDAAvailable on request
Alendronate 70 mg/75 mL oral solutionOralGeneric name—US FDAAvailable on request
Alendronate 5 mg tabletOralGeneric name—US FDAAvailable on request
Binosto 91.37 mg effervescent tabletOralRadius HealthUS FDAAvailable on request
Alendronate 40 mg tabletOralGeneric name—US FDAAvailable on request
Fosamax 70 mg tabletOralOrganonUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

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 29 September 1995Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Alendronate available for export from India?

Yes, on request. MedsAcross lists 8 presentations of Alendronate and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Alendronate have?

The catalogue lists 2 brand names for Alendronate, including Binosto, Fosamax.

Is Alendronate approved by the US FDA?

Yes. The US FDA first approved Alendronate on 29 September 1995, according to Drugs@FDA.

Does Alendronate need cold chain shipping?

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

References

  1. FOSAMAX prescribing information (Organon). U.S. National Library of Medicine, DailyMed. Retrieved 12 March 2026

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