Prescription medication · Bisphosphonate
alendronate
Also sold as Fosamax. Binosto treats osteoporosis, a condition that weakens bones and makes them more likely to break.
Data updated 2026-05-15
- 98,033
- FDA reportsOften reported
- 2
- InteractionsFew interactions
- 98% less
- Generic vs brandHuge savings
- 1
- Recall record
What the data shows
alendronate (Fosamax) is a prescription Bisphosphonate, more reported than most tracked drugs (98,033 FDA reports), whose generic costs a fraction of the brand (about 98% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
alendronate (Fosamax) is a prescription Bisphosphonate. Binosto treats osteoporosis, a condition that weakens bones and makes them more likely to break.
Binosto is a medicine that helps make your bones stronger. It is used to treat osteoporosis in women after menopause and in men.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$35.13/unit
Generic Price
$0.61/unit
Generic Savings
98%
Generic Available
Yes (6 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Binosto treats osteoporosis, a condition that weakens bones and makes them more likely to break.
Common side effects
Abdominal pain, Acid reflux, Constipation
Key warnings
Binosto can cause problems with your esophagus.
The sections below are summarized in plain English from alendronate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Binosto belongs to a class of drugs called bisphosphonates. It works by slowing down the breakdown of bone in your body. This helps to increase bone density and reduce the risk of fractures.
Side Effects (from patient reports)
Based on 98,033 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for alendronate, by number of reports
- Pain
Pain
13,527 reports
- Fatigue
Fatigue
12,775 reports
- Femur Fracture
Femur Fracture
11,334 reports
- Arthralgia
Arthralgia
11,003 reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
9,937 reports
- Alopecia
Alopecia
9,882 reports
- Abdominal Discomfort
Abdominal Discomfort
9,812 reports
- Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
8,987 reports
- Rash
Rash
8,726 reports
- Pemphigus
Pemphigus
8,686 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for alendronate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where alendronate sits
alendronate has more FDA adverse-event reports than 85% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is alendronate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 98,033 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
98,033
Reports Mentioning Death
11,123
11.3% of reports — not proof of cause
Hospitalization Reports
36,609
Top Indication
Osteoporosis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | PAIN | 13,527 |
| 2 | FATIGUE | 12,775 |
| 4 | FEMUR FRACTURE | 11,334 |
| 5 | ARTHRALGIA | 11,003 |
| 6 | RHEUMATOID ARTHRITIS | 9,937 |
| 7 | ALOPECIA | 9,882 |
| 8 | ABDOMINAL DISCOMFORT | 9,812 |
| 9 | SYSTEMIC LUPUS ERYTHEMATOSUS | 8,987 |
| 10 | RASH | 8,726 |
| 11 | PEMPHIGUS | 8,686 |
| 12 | FALL | 8,164 |
| 13 | GLOSSODYNIA | 8,076 |
| 14 | ARTHROPATHY | 8,061 |
| 15 | SWELLING | 7,603 |
| 16 | NAUSEA | 7,565 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Binosto can cause problems with your esophagus. Follow the directions for taking it carefully. If you have new or worsening heartburn, pain when swallowing, or chest pain, stop taking Binosto and call your doctor. This medicine may also cause severe bone, joint, or muscle pain. If you develop these symptoms, stop taking Binosto and contact your doctor.
Known Drug Interactions
( 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti- inflammatory drugs that may worsen gastrointestinal irritation. 7.2 Aspirin In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products.
Mechanism: Both of these medicines can be hard on your stomach and esophagus. Using them together increases the chance of developing irritation or ulcers in your digestive system.
7.4 Levothyroxine The bioavailability of alendronate was slightly decreased when BINOSTO and levothyroxine were co-administered to healthy subjects [see Clinical Pharmacology (12.3) ] .
Mechanism: Taking these two drugs at the same time can prevent the body from absorbing enough alendronate into the system.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I chew or swallow the Binosto tablet?
Can I use flavored water to dissolve the tablet?
What if I can't stand or sit upright for 30 minutes?
Can I take Binosto with other medications?
What should I do if I experience heartburn after taking Binosto?
Do I still need to take calcium and vitamin D supplements?
Can I take Binosto at bedtime?
What if I have kidney problems?
Can I take Binosto if I have problems with my esophagus?
Is it okay to take NSAIDs with Binosto?
What are the common side effects of alendronate?
Does alendronate interact with other medications?
What drug class is alendronate?
Is there a generic version of alendronate?
What pregnancy or breastfeeding source fields are listed for alendronate?
Has alendronate been recalled?
Active Recalls
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Hikma Pharmaceuticals USA INC
Related Medications in Bisphosphonate
Other drugs grouped near alendronate - same-class peers and common alternatives.
abaloparatide
Tymlos
Tymlos is a medicine to treat osteoporosis.
Compare with alendronate →
calcitonin
Miacalcin, Fortical
Calcitonin is a medicine that helps manage calcium levels in your body.
Compare with alendronate →
denosumab
Prolia, Xgeva
Stoboclo is a medicine that helps to treat osteoporosis and increase bone mass.
Compare with alendronate →
ibandronate
Boniva
Ibandronate (Boniva) is a medicine that helps treat and prevent bone loss in women after menopause.
Compare with alendronate →
risedronate
Actonel
Risedronate sodium delayed-release tablets help treat osteoporosis after menopause.
Compare with alendronate →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for alendronate: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 98,033.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.35%.
- metoprolol Δ 0.00 pts · 246,252 reports · Beta-Blocker 11.34%death share
- ferrous sulfate Δ 0.01 pts · 47,788 reports · Iron Supplement 11.34%death share
- rasagiline Δ 0.01 pts · 3,152 reports · MAO-B Inhibitor 11.36%death share
- nifedipine Δ 0.06 pts · 45,410 reports · Calcium Channel Blocker 11.28%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on alendronate
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What the FDA Data Shows for alendronate
The FDA label for alendronate (sold under brand names such as Fosamax) classifies it as a prescription-only medication in the Bisphosphonate class. Binosto treats osteoporosis, a condition that weakens bones and makes them more likely to break. Official labeling lists 7 commonly reported side effects, including Abdominal pain, Acid reflux, Constipation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 98,033 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.61 versus $35.13 for the brand - a 98% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: February 24, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages