Alendronate
Alendronate is a bisphosphonate (bone-strengthening medicine) used to treat and prevent osteoporosis, treat glucocorticoid-induced osteoporosis, and treat Paget's disease of bone, depending on the product.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 26 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Alendronate (Fosamax) is a bone-strengthening bisphosphonate that attaches to bone and slows the cells that break it down. It is the usual first choice to treat and prevent osteoporosis and is also used for Paget's disease of bone in some products, on the market since the late 1990s and available generically. Most people tolerate it well, with heartburn or indigestion the usual complaints, but how well it works and how gentle it is on the esophagus (food tube) depend on taking it with plain water, then nothing else for 30 minutes while staying upright. Stop it and get help for trouble or pain swallowing or chest pain behind the breastbone, and report new thigh or groin pain promptly.
Clinical pearls
- Plain water means exactly that, because mineral water, coffee and orange juice all reduce how much alendronate you absorb.
- Get enough calcium and vitamin D, but take calcium supplements and antacids at least 30 minutes after alendronate, never alongside it.
- Tell your dentist you take alendronate, and report jaw pain or slow healing after dental work.
- The best length of treatment is not established, so your prescriber should regularly reassess whether you still need it.
Patient information guide A plain-language walkthrough of Alendronate, written from its FDA label.
What Alendronate is used for
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Alendronate is a bisphosphonate used for bone conditions. Uses depend on the product.
- Treatment of osteoporosis in postmenopausal women (all supported products, including Binosto effervescent tablets and the oral solution).
- Prevention of osteoporosis in postmenopausal women (Alendronate, Alendronate Sodium and Fosamax tablets).
- Treatment to increase bone mass in men with osteoporosis (all supported products).
- Glucocorticoid-induced osteoporosis in men and women with low bone density taking steroid medicine (Alendronate, Alendronate Sodium and Fosamax tablets).
- Paget's disease of bone in men and women (Alendronate, Alendronate Sodium and Fosamax tablets).
How Alendronate works
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Alendronate binds to bone, especially where bone is being broken down. There it reduces the activity of osteoclasts, the cells that resorb (break down) bone.
Bone turnover slows, and bone formation exceeds breakdown at remodeling sites. Over time, bone mass gradually rises. Once built into bone, alendronate is inactive, so the medicine must be taken continuously to keep suppressing osteoclasts.
Alendronate dosage
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Alendronate is taken by mouth, as a tablet, an effervescent tablet (Binosto) or an oral solution. Depending on the product and condition, it is taken once a day or once a week. Your prescriber chooses the schedule.
- Take it when you get up, at least 30 minutes before food, drink or other medicines.
- Use plain water only. Coffee, juice, mineral water and food cut absorption sharply.
- Stay upright for at least 30 minutes and until after your first food.
- Never take it at bedtime.
- Follow your product's label for missed doses and ask your pharmacist if unsure.
Dosing details from the FDA-approved label
From the Alendronate prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Treatment of Osteoporosis in Postmenopausal Women
- Binosto: one 70 mg effervescent tablet once weekly
- Fosamax and alendronate sodium tablets: 70 mg (tablet or oral solution) once weekly or 10 mg tablet once daily
- Binosto: dissolve in 4 ounces room temperature plain water, wait at least 5 minutes after effervescence stops, stir for approximately 10 seconds; take at least 30 minutes before the first food, beverage, or medication of the day. Tablets: swallow whole with 6-8 ounces plain water at least 30 minutes before first food, drink or medication
- Treatment to Increase Bone Mass in Men With Osteoporosis
- Binosto: one 70 mg effervescent tablet once weekly
- Fosamax and alendronate sodium tablets: 70 mg (tablet or oral solution) once weekly or 10 mg tablet once daily
- Take at least 30 minutes before the first food, beverage, or medication of the day; do not lie down for at least 30 minutes and until after first food of the day
- Prevention of Osteoporosis in Postmenopausal Women
- 35 mg tablet once weekly or 5 mg tablet once daily
- Swallow tablet whole with 6-8 ounces plain water at least 30 minutes before first food, drink or medication of the day
- Glucocorticoid-Induced Osteoporosis
- 5 mg tablet once daily
- 10 mg tablet once daily for postmenopausal women not receiving estrogen
- Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D
- Paget's Disease of Bone
- 40 mg once a day for six months
- Re-treatment may be considered after a six-month post-treatment evaluation period in patients who have relapsed or failed to normalize serum alkaline phosphatase
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 70 mg BINOSTO effervescent tablet once weekly. ( 2.1 , 2.2 ) Instruct patients to: ( 2.3 ) Dissolve one tablet of BINOSTO in approximately half a glass of plain room temperature water (4 oz). Wait at least 5 minutes after the effervescence stops, stir the solution for approximately 10 seconds and consume contents. Swallow solution at least 30 minutes before the first food, beverage, or medication of the day. Avoid lying down for at least 30 minutes after taking BINOSTO and until after the first food of the day. 2.1 Treatment of Osteoporosis in Postmenopausal Women The recommended dosage is one 70 mg effervescent tablet once weekly. 2.2 Treatment to Increase Bone Mass in Men With Osteoporosis The recommended dosage is one 70 mg effervescent tablet once weekly. 2.3 Important Administration Instructions Instruct patients to do the following to assure adequate drug absorption and to decrease the risk of esophageal adverse reactions: Waiting less than 30 minutes, or taking BINOSTO with food, beverages (other than plain water) or other medications will lessen the effect of BINOSTO by decreasing its absorption into the body [see Drug Interactions ( 7.1 )] . Take BINOSTO upon arising for the day and at least 30 minutes before the first food, beverage, or medication of the day. Dissolve the effervescent tablet in 4 ounces room temperature plain water only (not mineral water or flavored water). Wait at least 5 minutes after the effervescence stops and then stir the solution for approximately 10 seconds and ingest. Avoid lying down for at least 30 minutes after taking BINOSTO and until after their first food of the day. Do not take BINOSTO at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse reactions [see Warnings and Precautions ( 5.1 )] . 2.4 Recommendations for Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions ( 5.2 )] . Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Alendronate side effects
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Most side effects involve the stomach and muscles or bones.
Common side effects
- Abdominal pain
- Acid regurgitation
- Heartburn or indigestion
- Nausea
- Constipation
- Diarrhea
- Bone, muscle or joint pain
When to get medical help
- Trouble or pain with swallowing, chest pain behind the breastbone, or new or worsening heartburn: stop the medicine and get medical attention. These can be signs of esophagus irritation.
- Severe bone, joint or muscle pain: call your doctor, as the medicine may need to be stopped.
- New thigh or groin pain: tell your doctor right away. It can signal an unusual thigh bone fracture.
- Jaw pain, or slow healing after dental work: tell your doctor and dentist. This can signal osteonecrosis of the jaw (damage to jaw bone).
- Hives or swelling of the face, lips or throat: get medical help, as these can be allergic reactions.
- Severe skin reactions, such as blistering or peeling: get medical help.
- Muscle cramps, numbness or tingling that may signal low calcium: call your doctor.
Alendronate warnings and precautions
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- Esophagus irritation: can cause sores, bleeding, narrowing or a hole. Lying down after a dose or continuing despite symptoms raises the risk.
- Low calcium: must be corrected before starting. Other mineral problems, such as vitamin D deficiency, should be treated.
- Severe bone, joint or muscle pain: can start days to months after starting. Stop and call your doctor if it is severe.
- Osteonecrosis of the jaw: linked to dental procedures, poor oral hygiene and other risk factors. The risk may rise with longer use.
- Unusual thigh bone fractures: often preceded by dull thigh or groin pain.
- Duration: the best length of treatment is unknown. People at low fracture risk may consider stopping after 3 to 5 years.
Alendronate interactions
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Several things can reduce absorption or add to stomach irritation.
- Calcium supplements, antacids and products with multivalent cations: they interfere with absorption. Wait at least 30 minutes.
- Food, coffee, orange juice and mineral water: they greatly reduce absorption.
- Aspirin products: more upper stomach and esophagus side effects at higher daily alendronate doses.
- NSAIDs: can irritate the stomach, so use caution together.
- Levothyroxine: slightly lowered alendronate absorption with Binosto.
Interactions listed in the FDA-approved label
From the Alendronate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Calcium supplements, antacids, or oral medications containing multivalent cations: Co-administration will interfere with absorption of alendronate. Instruct patients to wait at least one-half hour after taking the alendronate before taking any other oral medications.
- Aspirin: The incidence of upper gastrointestinal adverse events was increased in patients receiving daily doses of alendronate sodium greater than 10 mg with aspirin-containing products. Use caution when co-prescribing aspirin.
- Nonsteroidal anti-inflammatory drugs (NSAIDs): The label says it may be administered to patients taking NSAIDs; in a 3-year study the incidence of upper gastrointestinal adverse events was similar with alendronate sodium 5 or 10 mg/day and placebo, but NSAID use is associated with gastrointestinal irritation. Use caution during concomitant use.
- Levothyroxine: The bioavailability of alendronate was slightly decreased when co-administered with levothyroxine in healthy subjects.
Read the label’s full interactions text
7 DRUG INTERACTIONS Calcium supplements, antacids or oral medications containing multivalent cations interfere with absorption of alendronate. ( 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. ( 7.2 , 7.3 ) 7.1 Calcium Supplements/Antacids Co-administration of BINOSTO and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of BINOSTO. Therefore, instruct patients to wait at least one-half hour after taking BINOSTO before taking any other oral medications. 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. 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) BINOSTO may be administered to patients taking NSAIDs. In a 3-year, controlled, clinical study (n=2027) during which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in patients taking alendronate sodium 5 or 10 mg/day compared to those taking placebo. However, since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with BINOSTO. 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 )] .
7.1 Calcium Supplements/Antacids Co-administration of BINOSTO and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of BINOSTO. Therefore, instruct patients to wait at least one-half hour after taking BINOSTO before taking any other oral medications.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Alendronate
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- Do not use with esophagus narrowing or achalasia, inability to sit or stand upright for 30 minutes, low blood calcium, or allergy to any ingredient.
- The oral solution should not be given to people at higher risk of aspiration.
- Use caution with active stomach or esophagus problems.
- Not recommended with creatinine clearance under 35 mL/min. No adjustment is needed at 35 to 60 mL/min.
- Pregnancy: stop when pregnancy is recognized. Bisphosphonates stay in bone for years, so there is a potential risk of fetal harm.
- Breastfeeding: it is not known whether it passes into breast milk, so discuss with your doctor.
- Not indicated for children.
- Older adults: no overall differences in safety or effectiveness, though some may be more sensitive.
- Liver problems: no dose adjustment is needed.
Alendronate overdose
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Too much alendronate may cause low calcium and phosphate and stomach or esophagus problems such as upset stomach, heartburn, esophagitis, gastritis or ulcer. The label advises giving milk or antacids to bind the drug. Do not induce vomiting, and stay fully upright. Seek medical help right away.
What Alendronate does in the body
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Alendronate binds to bone mineral and inhibits osteoclasts, reducing bone resorption. Markers of bone breakdown fell by roughly 50% to 70% in long-term studies. Bone formation markers also fall over time because the two processes are linked. Small, usually symptomless drops in blood calcium and phosphate can occur.
How your body processes Alendronate
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Very little alendronate is absorbed by mouth (under 1%), and food or drinks other than water nearly eliminate absorption. It is not metabolized. About half of an intravenous dose is cleared in the urine, and the rest goes to bone. Its terminal half-life is estimated to exceed 10 years because it is slowly released from the skeleton. Binosto 70 mg effervescent tablets and alendronate sodium 70 mg tablets are bioequivalent.
How to store Alendronate
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Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Alendronate
25 supplements and herbal products have documented interactions with Alendronate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 15
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Alendronate: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Alendronate — the kind of thing our pharmacy team would talk through with you at the counter.
What is alendronate for?
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How do I take it correctly?
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What side effects are normal, and when should I call?
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Can I take my calcium or vitamins with it?
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Do I need to tell my dentist?
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Is it safe in pregnancy?
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Is Alendronate available over the counter?
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When was Alendronate first available?
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Who makes Alendronate?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Alendronate on HelloPharmacist
Alendronate forms and strengths (how it comes)
Alendronate is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Alendronate, Alendronate Sodium and Fosamax tablets are used for osteoporosis in postmenopausal women (treatment and prevention) and in men.
- Alendronate, Alendronate Sodium and Fosamax tablets are also used for glucocorticoid-induced osteoporosis and Paget's disease of bone.
- Binosto effervescent tablets are used only to treat osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.
- Alendronate, Alendronate Sodium and Fosamax tablets should be swallowed whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, drink or medicine of the day.
- Binosto is dissolved in about 4 ounces of plain room-temperature water. Wait at least 5 minutes after fizzing stops, stir, and drink it.
- Binosto is taken once weekly, per its label.
- With these tablet products, do not lie down for at least 30 minutes after taking and until after your first food.
Oral solution
How this form is used
- Alendronate Sodium Oral Solution is used to treat osteoporosis in postmenopausal women.
- Alendronate Sodium Oral Solution is used to increase bone mass in men with osteoporosis.
- Alendronate Sodium Oral Solution is taken once weekly, per its label.
- Alendronate Sodium Oral Solution should be swallowed and followed by at least 2 ounces of water.
- Alendronate Sodium Oral Solution should be taken at least 30 minutes before the first food, drink or medicine of the day, and you should stay upright for at least 30 minutes.
- Alendronate Sodium Oral Solution should not be given to people at increased risk of aspiration.
Alendronate on the U.S. market: products, makers and brands
How Alendronate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
17 companies list 36 Alendronate product records with the FDA, mostly as tablet, oral solution; the earliest marketing or approval year on record is 1995. Brand names on the directory include Binosto, Fosamax; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Alendronate is used (Medicaid data)
A general measure of how commonly Alendronate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Alendronate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Alendronate prescribed? Of the 1,601 medications we measure, Alendronate ranks #231 by Medicaid prescriptions — more than 86% of them.
Utilization by Alendronate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
alendronic acid 70 MG Oral Tablet Most dispensed
Summed across the 7 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904431
alendronic acid 35 MG Oral Tablet
Summed across the 5 of 42 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904396
alendronic acid 10 MG Oral Tablet
Summed across the 4 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904419
alendronic acid 0.933 MG/ML Oral Solution
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 904447
alendronic acid 70 MG Effervescent Oral Tablet
Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1248077
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Alendronate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 19 of 129 listed Alendronate NDCs with Medicaid activity.
Compare Alendronate products
A representative set of FDA-listed product records for Alendronate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 70 mg/75 mL | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 70 mg/75 mL | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 35 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 70 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 5 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 10 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 35 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 40 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 70 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 35 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 70 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 35 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 70 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 35 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 70 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 35 mg | Oral | Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | ANDA | View NDC → |
| 70 mg | Oral | Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | ANDA | View NDC → |
| 35 mg | Oral | Marlex Pharmaceuticals, Inc. | ANDA | View NDC → |
| 70 mg | Oral | Marlex Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 35 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 70 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 70 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 70 mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 70 mg | Oral | Organon LLC | NDA | View NDC → |
| 70 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 70 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 91.37 mg | Oral | Radius Health, Inc. | NDA | View NDC → |
| 35 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 70 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 10 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 35 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 70 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
Showing 36 of 36 products — FDA National Drug Code Directory. See every product, package size and price: browse all 36 Alendronate NDCs →
Alendronate side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Alendronate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Alendronate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Alendronate FDA approval history
How Alendronate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Alendronate recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Alendronate recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59. Lots: Lot # AC2040A, Exp Date: 04/2026 FDA record D-0526-2026 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 46041 3 dose forms · 7 strengths
-
Dose form (SCDF) Effervescent Oral Tablet RxCUI 1536440In current FDA listingsClinical drug / strength (SCD) alendronic acid 70 MGRxCUI 1248077 -
Dose form (SCDF) Oral Solution RxCUI 904446In current FDA listingsClinical drug / strength (SCD) alendronic acid 0.933 MG/MLRxCUI 904447 -
Dose form (SCDF) Oral Tablet RxCUI 904395In current FDA listingsClinical drug / strength (SCD) alendronic acid 10 MGRxCUI 904419alendronic acid 35 MGRxCUI 904396alendronic acid 40 MGRxCUI 904405alendronic acid 5 MGRxCUI 904425alendronic acid 70 MGRxCUI 904431
Look up RxCUI 46041 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Alendronate supply and shortage status
Whether Alendronate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Alendronate costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 35 mg | $0.337 per tablet | NDC details & price history |
| Solution · Oral | 70 mg/75 mL | $0.683 per mL | NDC details & price history |
| Tablet, Effervescent · Oral | 91.37 mg | $71.23 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Alendronate brand names
Alendronate is sold under 2 brand names in the FDA directory — Binosto, Fosamax. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Alendronate: manufacturers and labelers
17 companies list Alendronate products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals of New York LLC, A-S Medication Solutions, Aurobindo Pharma Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Alendronate drug class (RxNorm)
Alendronate belongs to the Bisphosphonate class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Alendronate page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →