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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.

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 →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

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.

How to Take It

Take one 70 mg Binosto tablet once a week. Dissolve the tablet in about 4 ounces of plain water at room temperature. Wait 5 minutes after the fizzing stops, stir for 10 seconds, and then drink the solution. Take it at least 30 minutes before you eat, drink, or take other medicines in the morning. Do not lie down for at least 30 minutes after taking Binosto.

This is a plain-language summary of alendronate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

Stop taking Binosto if you become pregnant. Bisphosphonates can stay in your bones for many years and could potentially harm the baby's skeleton.

This is a plain-language summary of alendronate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss your weekly dose, take it the next morning after you remember. Do not take two doses on the same day. Go back to your regular weekly schedule.

This is a plain-language summary of alendronate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store Binosto tablets at room temperature (68°F to 77°F) in the original blister pack, away from moisture.

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

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.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for alendronate each year to the FDA Adverse Event Reporting System (FAERS).

-2,00002,0004,0006,0008,00010,000 200320062009201220152018202120242025 5,285

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.

fewest reports most reports

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

Female 76,873 (86%)
Male 12,151 (14%)

Age Distribution

0–17 309
18–44 7,191
45–64 18,310
65–74 15,962
75+ 15,899

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

DEATH 2,940
FATIGUE 2,297
HYPERTENSION 2,233
GENERAL PHYSICAL HEALTH DETERIORATION 2,175
SYSTEMIC LUPUS ERYTHEMATOSUS 2,129
TYPE 2 DIABETES MELLITUS 2,102
GLOSSODYNIA 2,095
RHEUMATOID ARTHRITIS 2,088
ARTHRALGIA 2,061
HYPOAESTHESIA 2,058

Reactions in Hospitalization Reports

FEMUR FRACTURE 6,662
FALL 6,341
ARTHRALGIA 5,721
HYPERTENSION 5,409
FATIGUE 5,117
PAIN 5,096
OSTEOARTHRITIS 4,674
DYSPNOEA 4,329
RHEUMATOID ARTHRITIS 4,199
NAUSEA 4,122

Source: FDA FAERS (Adverse Event Reporting System) 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

moderate aspirin

( 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.

What to do: Use caution when taking these drugs together. Tell your doctor if you have any stomach pain or heartburn.

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.

What to do: Talk to your doctor about timing your doses, as you may need to take these medications at different times of the day.

This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

Can I chew or swallow the Binosto tablet?
No, you must dissolve the tablet in water first. Do not chew or swallow the undissolved tablet.
Can I use flavored water to dissolve the tablet?
No, only use plain room temperature water.
What if I can't stand or sit upright for 30 minutes?
You should not take Binosto if you cannot stay upright for at least 30 minutes.
Can I take Binosto with other medications?
Wait at least 30 minutes after taking Binosto before taking any other oral medications.
What should I do if I experience heartburn after taking Binosto?
Stop taking Binosto and contact your doctor if you develop new or worsening heartburn, difficulty swallowing, or pain when swallowing.
Do I still need to take calcium and vitamin D supplements?
Yes, take calcium and vitamin D supplements if you don't get enough from your diet.
Can I take Binosto at bedtime?
No, do not take Binosto at bedtime or before getting up for the day.
What if I have kidney problems?
Binosto is not recommended if you have severe kidney problems (creatinine clearance less than 35 mL/min).
Can I take Binosto if I have problems with my esophagus?
You should not take Binosto if you have problems with your esophagus that delay emptying, such as a stricture or achalasia.
Is it okay to take NSAIDs with Binosto?
Talk to your doctor before taking NSAIDs with Binosto, as it may increase the risk of stomach irritation.
What are the common side effects of alendronate?
The most commonly reported side effects of alendronate include Abdominal pain, Acid reflux, Constipation, Diarrhea, Upset stomach. Based on 98,033 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does alendronate interact with other medications?
Yes, alendronate has 2 known drug interactions. Notable interactions include aspirin, levothyroxine. Always inform your doctor about all medications you are taking.
What drug class is alendronate?
alendronate belongs to the Bisphosphonate drug class. It requires a prescription (Rx). Binosto treats osteoporosis, a condition that weakens bones and makes them more likely to break.
Is there a generic version of alendronate?
Yes, generic alendronate is available from 6 manufacturers. The generic costs $0.61 per unit compared to $35.13 for the brand version, saving approximately 98%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is alendronate safe during pregnancy?
Stop taking Binosto if you become pregnant. Bisphosphonates can stay in your bones for many years and could potentially harm the baby's skeleton. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has alendronate been recalled?
There is 1 recall associated with alendronate products. This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 7, 2026

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

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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: February 24, 2025

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page