Prescription medicine
Ibandronate First approved as Boniva
Ibandronate (Boniva) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $2.68 per ibandronate sodium 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ibandronate FDA label on DailyMed (effective March 18, 2026, Aurobindo Pharma Limited); the NDA 21455 record on Drugs@FDA; every ibandronate label on DailyMed.
Highlights of the record
FDA label of March 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageIbandronate sodium is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis.
Forms and strengths
- 150 mg
- 3 mg/3ml
Film-coated tablet; tablet; injection (solution); injection.
On the market
- Earliest approval on file
- May 16, 2003 Boniva, Hoffmann La Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first March 19, 2012; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.68 per tablet Ibandronate sodium 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,078 through July 30, 2026
What is ibandronate used for?
From the label: indications and usageIbandronate sodium is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. ( 1.1 ) 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. ( 1.2 ) 1.1 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium tablets increase bone mineral density (BMD) and reduce the incidence of vertebral fractures. 1.2 Important Limitations of Use The optimal duration of use has not been determined. […]
Conditions named in the indications of ibandronate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Bisphosphonate.
Source: FDA drug label (Ibandronate Sodium), Aurobindo Pharma Limited, effective March 18, 2026 (SPL set 86c0b4ae-5e38-4efe-88af-50ac560e294f), via openFDA; the full label on DailyMed
What does the patient leaflet for ibandronate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ibandronate sodium tablets?Ibandronate sodium tablets may cause serious side effects including: Esophagus problems Low calcium levels in your blood (hypocalcemia) Bone, joint or muscle pain Severe jaw bone problems (osteonecrosis) Unusual breaks in thigh and other bones 1. Esophagus problems. Some people who take ibandronate sodium tablets may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed. It is important that you take ibandronate sodium tablets exactly as prescribed to help lower your chance of getting esophagus problems (see the section “How should I take ibandronate sodium tablets?”). Stop taking ibandronate sodium tablets and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow. 2. Low calcium levels in your blood (hypocalcemia). Ibandronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking ibandronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take ibandronate sodium tablets. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: Spasms, twitches, or cramps in your muscles Numbness or tingling in your fingers, toes, or around your mouth Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take ibandronate sodium tablets. Take calcium and vitamin D as your doctor tells you to. 3. Bone, joint, or muscle pain. […]
Source: FDA drug label (Ibandronate Sodium), Aurobindo Pharma Limited, effective March 18, 2026 (SPL set 86c0b4ae-5e38-4efe-88af-50ac560e294f), via openFDA; the full label on DailyMed
Is there a generic for ibandronate (Boniva)?
The FDA approved the first generic ibandronate on March 19, 2012. 16 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ibandronate from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ibandronate (Boniva)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.68 per Ibandronate sodium 150 mg tablet, down 13% from $3.08 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ibandronate sodium 150 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ibandronate 3 mg/3 mL syringe | Generic | $52.65 per mL | $157.94 per syringe | -1% |
| Ibandronate sodium 150 mg tablet | Generic | $2.68 per tablet | $80.25 | -13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ibandronate label say about other medicines?
The ibandronate label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Do not take within 60 minutes of dosing. ( 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. |
| Ranitidine | drug interactions | H 2 Blockers In healthy volunteers, co-administration with ranitidine resulted in a 20% increased bioavailability of ibandronate, which was not considered to be clinically relevant (see CLINICAL PHARMACOLOGY [12.3] ). |
Source: FDA drug label (Ibandronate Sodium), Aurobindo Pharma Limited, effective March 18, 2026 (SPL set 86c0b4ae-5e38-4efe-88af-50ac560e294f), via openFDA; the full label on DailyMed
What do FAERS reports show for ibandronate?
The FDA Adverse Event Reporting System holds 3,078 reports that list ibandronate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 295 are coded as a death and 688 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ibandronate?
5 other medicines are given the same way (oral) and in the same FDA class as ibandronate or labeled mainly for the same use (osteoporosis), the same class first. Osteoporosis lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Alendronate | Osteoporosis | 16 labelers | $0.256 per tablet 70 mg tablet | No current entry |
| Risedronate | Osteoporosis | 8 labelers | $12.91 per tablet 150 mg tablet | No current entry |
| Alendronate and cholecalciferol | Osteoporosis | none listed | $52.51 per unit 70 mg-5600 unit | No current entry |
| Raloxifene | Osteoporosis | 17 labelers | $0.223 per tablet 60 mg tablet | No current entry |
| Bazedoxifene and estrogens conjugated | Osteoporosis | none listed | $6.48 per tablet 0.45-20 mg tablet | No current entry |
Every medicine labeled for the same conditions as ibandronate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ibandronate
- 5 medicines for the same use
- Other bisphosphonates
- the pharmacologic class, with prices and generics
- Ibandronate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other