{ "query": "alendronate", "ingredient": "alendronate", "slug": "alendronate", "rxcui": "46041", "brands": [], "names": [ "alendronate", "alendronate sodium" ], "classes": [], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 22 }, "boxed_warning": "", "indications_and_usage": "is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitation 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 ( 1.3 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1) .] 1.2 Treatment to Increase Bone Mass in Men With Osteoporosis BINOSTO is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2) ] . 1.3 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of BINOSTO for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a period...", "contraindications": "is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) ] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.3) ; Warnings and Precautions (5.1) ] Do not administer BINOSTO to patients at increased risk of aspiration Hypocalcemia [see Warnings and Precautions (5.2) ] Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2) ] . Abnormalities of the esophagus which delay emptying such as stricture or achalasia ( 4 , 5.1 ) Inability to stand/sit upright for at least 30 minutes ( 4 , 5.1 ) Increased risk of aspiration. ( 4 ) Hypocalcemia ( 4 , 5.2 ) Hypersensitivity to any component of this product ( 4 , 6.2 )", "warnings_and_cautions": "Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur. ( 5.1 ) Hypocalcemia can worsen and must be corrected prior to use. ( 5.2 ) Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. ( 5.3 ) Osteonecrosis of the Jaw has been reported. ( 5.4 ) Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered. ( 5.5 ) Sodium Content: Each tablet contains 603 mg sodium, equivalent to 1532 mg NaCl. Use caution in patients on sodium restriction. ( 5.7 ) 5.1 Upper Gastrointestinal Adverse Reactions BINOSTO, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when BINOSTO is given to patients with active upper gastrointestinal problems (suc...", "warnings": "", "adverse_reactions": "The following clinically significant adverse drug reactions are described elsewhere in the labeling: Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1) ] Mineral Metabolism [see Warnings and Precautions (5.2) ] Musculoskeletal Pain [see Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.5) ] Renal Impairment [see Warnings and Precautions (5.6) ] Patients sensitive to High Sodium Intake [see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence greater than or equal to 3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Radius Health, Inc. at 1-855-672-3487 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical pra...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Warnings and Precautions, Atypical Fractures Including Femoral Fractures ( 5.5 ) 02/2026", "information_for_patients": "See FDA-approved patient labeling (Medication Guide) . Instruct patients to read the Medication Guide before starting therapy with BINOSTO and to reread it each time the prescription is renewed. 17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist. 17.2 Dosing Instructions Instruct patients that it is necessary to follow all dosing instructions for BINOSTO: BINOSTO should only be taken upon arising for the day and must be taken at least 30 minutes before the first food, beverage, or medication of the day. Instruct patients not to attempt to swallow, chew, or suck on the tablet because of a potential for oropharyngeal ulceration. Instruct patients to dissolve the effervescent tablet in 4 ounces room temperature plain water only (not mineral water or flavored water). Instruct patients to wait at least 5 minutes after the effervescence stops and then stir the solution ...", "spl_medguide": "MEDICATION GUIDE BINOSTO \u00ae (BIN-oss-tow) (alendronate sodium) effervescent tablets for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2026 What is the most important information I should know about BINOSTO? BINOSTO can 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 BINOSTO 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 BINOSTO exactly as prescribed to help lower your chance of getting esophagus problems. (See the section \" How should I take BINOSTO? \") Stop taking BINOSTO and call your healthcare provider 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). BINOSTO may lower the calcium levels in your blood. If you have low blood calcium before ...", "clinical_studies": "14.1 Treatment of Osteoporosis in Postmenopausal Women BINOSTO (alendronate sodium) effervescent tablet 70 mg is bioequivalent to alendronate sodium tablet 70 mg. The fracture reduction efficacy and bone mineral density changes attributed to BINOSTO are based on clinical trial data of alendronate sodium 10 mg daily and alendronate sodium 70 mg weekly. Daily Dosing The efficacy of alendronate sodium 10 mg daily was assessed in four clinical trials. Study 1, a three-year, multicenter double-blind, placebo-controlled, US clinical study enrolled 478 patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture; Study 2, a three-year, multicenter double blind placebo controlled Multinational clinical study enrolled 516 patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture; Study 3, the Three-Year Study of the Fracture Intervention Trial (FIT) a study which enrolled 2027 postmenopausal patients with at least one baseline vertebral fracture; and Study 4, the Four-Year Study of FIT: a study which enrolled 4432 postmenopausal patients with low bone mass but without a baseline vertebral fracture. Effect on Fracture Inciden...", "brand_name": "Binosto", "manufacturer": "Radius Health, Inc.", "application_number": "NDA202344", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20260206", "set_id": "09765234-01bc-40f7-b9bb-c167056f3909", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 63376, "serious": 48360, "death": 8863, "hospitalization": 23514, "primary_suspect": 63304, "top_reactions": [ [ "Pain", 11810 ], [ "Fatigue", 11472 ], [ "Drug Ineffective", 10989 ], [ "Alopecia", 9803 ], [ "Rheumatoid Arthritis", 9741 ], [ "Abdominal Discomfort", 9705 ], [ "Systemic Lupus Erythematosus", 9273 ], [ "Pemphigus", 9039 ], [ "Arthralgia", 8916 ], [ "Rash", 8372 ], [ "Glossodynia", 8339 ], [ "Off Label Use", 7705 ], [ "Swelling", 7624 ], [ "Arthropathy", 7418 ], [ "Hand Deformity", 7222 ] ], "by_year": { "2019": 5009, "2020": 5390, "2021": 6613, "2022": 5503, "2023": 4160, "2024": 5986, "2025": 5525, "2026": 2148 }, "by_year_primary": { "2019": 5008, "2020": 5389, "2021": 6606, "2022": 5489, "2023": 4149, "2024": 5968, "2025": 5510, "2026": 2143 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20260407", "reason": "This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.", "firm": "Hikma Pharmaceuticals USA INC", "status": "Ongoing" } ], "recall_total": 1, "drugsfda": { "applications": 20, "nda": 3, "anda": 17, "first_approval": "19950929", "rems": false, "rems_last": "20111201", "labeling_supplements": 54, "labeling_recent": 2, "sponsors": [ "APOTEX", "AUROBINDO PHARMA", "CHARTWELL RX", "CIPLA", "HANGZHOU BINJIANG", "HIKMA", "IMPAX LABS INC", "IPCA LABS LTD" ], "unapproved": false, "first_approval_fmt": "09/29/1995" }, "trials": { "total": 214, "completed": 156, "terminated": 16, "with_results": 56, "industry": 95, "phase3": 61, "results_share": 0.358974358974359, "terminated_share": 0.07476635514018691 }, "pubmed": { "rct": 500, "meta": 39, "recent_rct": 33, "cochrane": [ { "pmid": "39868546", "title": "Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women", "year": "2025" }, { "pmid": "18253985", "title": "Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women", "year": "2008" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "alendronate" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 8816583, "beneficiaries": 2378838, "spend": 77517294.93, "by_brand": [ { "brand": "Alendronate Sodium", "claims": 8814023, "per_claim": 8.692168845, "is_generic": true }, { "brand": "Fosamax", "claims": 1437, "per_claim": 310.10048713, "is_generic": false }, { "brand": "Binosto", "claims": 1123, "per_claim": 408.46341051, "is_generic": false } ], "per_claim": 8.792215184726329 }, "mdl": [ { "number": "2243", "title": "Fosamax (Alendronate Sodium) Products Liability Litigation (No. II)", "judge": "Williams, Karen M.", "court": "NJ", "docket": "1:08-cv-8", "actions": "", "matched": "alendronate" } ], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 13621, "fills": 8816583, "per_million": 1544.9295946059829, "ratio": 0.5579478618169631, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "1,545 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site", "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)" ], "weight": 0.35 }, "evidence": { "score": 73, "letter": "C", "why": [ "500 randomized trials and 39 systematic reviews/meta-analyses indexed in PubMed", "2 independent Cochrane review(s) exist", "Only 36% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 90, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 17 generic makers (-1)", "2 label changes approved since 2021 (-4)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 60, "letter": "D", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Named in 1 active federal multidistrict litigation(s) (-40)" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "Generic versions approved (17 applications)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 83, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are pain, fatigue, alopecia. How would we recognize and handle those?", "This drug is in active federal litigation. What is the claim, and does it affect my risk?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }