Prescription medicine
Alendronate Brand names: Binosto, Fosamax
Alendronate (Fosamax) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.256 per alendronate sodium 70 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the alendronate FDA label on DailyMed (effective March 12, 2026, Organon LLC); the NDA 20560 record on Drugs@FDA; every alendronate label on DailyMed.
Highlights of the record
FDA label of March 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use: Optimal duration of use has not been determined.
Forms and strengths
- 5 mg
- 10 mg
- 35 mg
- 40 mg
- 70 mg
- 91.37 mg
- 70 mg/75ml
Tablet; solution; effervescent tablet.
On the market
- Earliest approval on file
- September 29, 1995 Fosamax, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first February 6, 2008; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 16 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- December 5, 2031 Binosto tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.256 per tablet Alendronate sodium 70 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2016 0 Class I among all firms' recalls; latest April 7, 2026
- FAERS reports
- 100,325 through July 30, 2026
What is alendronate used for?
From the label: indications and usageFOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) 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. ( 1.6 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX ® is indicated for the treatment of osteoporosis in postmenopausal women. […]
Conditions named in the indications of alendronate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Bisphosphonate.
Source: FDA drug label (FOSAMAX), Organon LLC, effective March 12, 2026 (SPL set 14e931fd-2c5f-4d90-b7db-5980706f4a56), via openFDA; the full label on DailyMed
What does the patient leaflet for alendronate 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 FOSAMAX?FOSAMAX can cause serious side effects including: 1. Esophagus problems 2. Low calcium levels in your blood (hypocalcemia) 3. Bone, joint, or muscle pain 4. Severe jaw bone problems (osteonecrosis) 5. Unusual breaks in thigh and other bones 1. Esophagus problems. Some people who take FOSAMAX 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 FOSAMAX exactly as prescribed to help lower your chance of getting esophagus problems. (See the section " How should I take FOSAMAX? ") Stop taking FOSAMAX 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). FOSAMAX may lower the calcium levels in your blood. If you have low blood calcium before you start taking FOSAMAX, it may get worse during treatment. Your low blood calcium must be treated before you take FOSAMAX. 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 FOSAMAX. Take calcium and vitamin D as your doctor tells you to. 3. Bone, joint, or muscle pain. Some people who take FOSAMAX develop severe bone, joint, or muscle pain. 4. Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take FOSAMAX. Your doctor should examine your mouth before you start FOSAMAX. […]
Source: FDA drug label (FOSAMAX), Organon LLC, effective March 12, 2026 (SPL set 14e931fd-2c5f-4d90-b7db-5980706f4a56), via openFDA; the full label on DailyMed
Is there a generic for alendronate (Fosamax)?
The FDA approved the first generic alendronate on February 6, 2008. 17 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists alendronate from 16 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Fosamax tablets; a patent listed only for Binosto tablets runs to December 5, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2008 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alendronate (Fosamax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.256 per Alendronate sodium 70 mg tablet, down 2% from $0.260 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Alendronate sodium 70 mg tablet (generic)
- Fosamax 70 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alendronate sod 70 mg/75 mL | Generic | $0.683 per mL | n/a | -2% |
| Alendronate sodium 10 mg tablet | Generic | $0.111 per tablet | $3.34 | -8% |
| Alendronate sodium 35 mg tablet | Generic | $0.281 per tablet | $8.44 | -5% |
| Alendronate sodium 70 mg tablet | Generic | $0.256 per tablet | $7.69 | -2% |
| Binosto 70 mg effervescent tablet | Brand | $71.23 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $2,136.78 | -0.9% |
| Fosamax 70 mg tablet | Brand | $38.70 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,161.12 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has alendronate been recalled?
The FDA's Enforcement Report lists 2 recalls naming alendronate since 2016: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 7, 2026 | Class II | Hikma Pharmaceuticals USA INC | This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. |
| February 11, 2016 | Class II | Sun Pharma Global Fze | Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the alendronate label say about other medicines?
The alendronate label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name alendronate. 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 | DRUG INTERACTIONS Calcium supplements, antacids, or oral medications containing multivalent cations interfere with absorption of alendronate. ( 2.6 , 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. |
| Levothyroxine | drug interactions | The bioavailability of alendronate was slightly decreased when BINOSTO and levothyroxine were co-administered to healthy subjects [see Clinical Pharmacology (12.3) ]. |
| Prednisone | warnings and precautions | The risk versus benefit of FOSAMAX for treatment at daily dosages of glucocorticoids less than 7.5 mg of prednisone or equivalent has not been established [see Indications and Usage (1.4) ]. |
Other labels that name alendronate
Source: FDA drug label (FOSAMAX), Organon LLC, effective March 12, 2026 (SPL set 14e931fd-2c5f-4d90-b7db-5980706f4a56), via openFDA; the full label on DailyMed
What do FAERS reports show for alendronate?
The FDA Adverse Event Reporting System holds 100,325 reports that list alendronate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,884 are coded as a death and 37,737 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 alendronate?
4 other medicines are given the same way (oral) and in the same FDA class as alendronate 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 |
|---|---|---|---|---|
| Risedronate | Osteoporosis | 8 labelers | $12.91 per tablet 150 mg tablet | No current entry |
| Ibandronate | Osteoporosis | 6 labelers | $2.68 per tablet 150 mg tablet | 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 alendronate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does alendronate compare with medicines for the same use?
3 side-by-side pages set alendronate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to alendronate
- 4 medicines for the same use
- Other bisphosphonates
- the pharmacologic class, with prices and generics
- Alendronate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other