Ibandronate is a bisphosphonate indicated for the treatment and prevention of post-menopausal osteoporosis, among other approved uses. It is available as tablets and injection for oral and intravenous use. MedsAcross supplies Ibandronate 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
From the regulator-approved product information. Each section names its source.
Ibandronate Sodium Tablets are a bisphosphonate indicated for the treatment and prevention of post-menopausal osteoporosis. Limitations of Use The 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
The action of ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.
Source: US FDA prescribing information
• Take one 150 mg tablet once monthly on the same day each month. • Instruct patient to: • Swallow whole tablet with 6 to 8 oz of plain water only, at least 60 minutes before the first food, beverage, or medication of day. Avoid lying down for at least 60 minutes after taking Ibandronate Sodium Tablets. • Do not eat, drink (except for water), or take other medication for 60 minutes after taking Ibandronate Sodium Tablets. • Take supplemental calcium and vitamin D if dietary intake inadequate
Source: US FDA prescribing information
Ibandronate 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 60 minutes • Hypocalcemia • Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis 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 60 minutes. • Hypocalcemia. • Hypersensitivity to ibandronate sodium
Source: US FDA prescribing information
Upper gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions and discontinue use if new or worsening symptoms occur. Hypocalcemia may worsen during treatment. Correct hypocalcemia before use. Severe Bone, Joint, and Muscle Pain may occur. Consider discontinuing use if 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
The following clinically significant adverse drug reactions are described elsewhere in the labeling: • Upper Gastrointestinal Adverse Reactions • Hypocalcemia and Mineral Metabolism • Musculoskeletal • Jaw Osteonecrosis • Atypical Fractures Including Femoral Fractures • Severe Renal Impairment The most common adverse reactions (greater than 5%) are back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia.
Source: US FDA prescribing information
• Calcium supplements, antacids and some oral medications may interfere with absorption of ibandronate. Do not take within 60 minutes of dosing. • Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted between 15° and 30°C (59° and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Ibandronate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ibandronate 150 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ibandronate 3 mg/3 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 16 May 2003 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Ibandronate in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Ibandronate and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Ibandronate on 16 May 2003, according to Drugs@FDA.
No listed presentation of Ibandronate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ibandronate is classified under ATC code M05BA06 (Ibandronic acid).
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