{ "query": "cholecalciferol", "ingredient": "cholecalciferol", "slug": "cholecalciferol", "rxcui": "2418", "brands": [ "D-Vi-Sol", "Decara", "Delta D3", "Dialyvite Vitamin D3 Max", "Maximum D3", "Thera-D" ], "names": [ "cholecalciferol" ], "classes": [ { "id": "A11CC", "name": "Vitamin D and analogues" } ], "alternatives": [ "alfacalcidol", "calcifediol", "calcitriol", "dihydrotachysterol", "ergocalciferol" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 88, "INTRAVENOUS": 1 }, "boxed_warning": "", "indications_and_usage": "is a combination of a bisphosphonate and vitamin D indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitations of use : FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. ( 1.3 ) 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 FOSAMAX \u00ae PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX PLUS D 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 FOSAMAX PLUS D is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2) ] . 1.3 Important Limitations of Use FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX PLUS D for the treatment of ost...", "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) ] 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 ( 2.3 , 4 , 5.1 ) 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 ) 5.1 Upper Gastrointestinal Adverse Reactions FOSAMAX PLUS D, 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 FOSAMAX PLUS D is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers). Esophageal adver...", "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) ] Most common adverse reactions (greater than or equal to 3%) for alendronate are: abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 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 practice. FOSAMAX Treatment of Osteoporosis in Postmenopau...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Warnings and Precautions, Atypical Fractures Including Femoral Fractures ( 5.5 ) 2/2026", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Instruct patients to read the Medication Guide before starting therapy with FOSAMAX PLUS D and to reread it each time the prescription is renewed. Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium if intake is inadequate. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) should take additional vitamin D if needed [see Dosage and Administration (2.4) ] . Patients with gastrointestinal malabsorption syndromes may require additional vitamin D supplementation. 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. Dosing Instructions Instruct patients that the expected benefits of FOSAMAX PLUS D may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been show...", "spl_medguide": "MEDICATION GUIDE FOSAMAX \u00ae PLUS D (FOSS-ah-max PLUS D) (alendronate sodium/cholecalciferol) Tablets Read the Medication Guide that comes with FOSAMAX \u00ae PLUS D before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about FOSAMAX PLUS D. What is the most important information I should know about FOSAMAX PLUS D? FOSAMAX PLUS D 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 Esophagus problems. Some people who take FOSAMAX PLUS D 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 PLUS D exactly as prescribed to help lower your chance of getting esophagus problems. (See the section \"How should I take FOSAMAX PLUS D tablet?\") Stop taking FOSAMAX PLUS ...", "clinical_studies": "14.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX Daily The efficacy of FOSAMAX 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 Incidence To assess the effects of FOSAMAX on the incidence of vertebral fractures (detected by digitized radiography; approximately one third of these were clinically symptomatic), the U.S. and Multinational studies were combined in an analysis that compared placebo to the pooled dosage groups of FOSAMAX (5 o...", "brand_name": "FOSAMAX PLUS D", "manufacturer": "Organon LLC", "application_number": "NDA021762", "pharm_class_epc": [ "Vitamin D [EPC]" ], "route": [ "ORAL" ], "effective_time": "20260203", "set_id": "10307e7e-9a84-4aa1-8c5c-4b209cffe4d1", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 318505, "serious": 199346, "death": 21785, "hospitalization": 99064, "primary_suspect": 317759, "top_reactions": [ [ "Fatigue", 30480 ], [ "Diarrhoea", 22318 ], [ "Nausea", 22271 ], [ "Off Label Use", 20877 ], [ "Headache", 20376 ], [ "Drug Ineffective", 19509 ], [ "Pain", 18238 ], [ "Dyspnoea", 16657 ], [ "Dizziness", 16215 ], [ "Arthralgia", 15765 ], [ "Asthenia", 14225 ], [ "Fall", 14134 ], [ "Vomiting", 12990 ], [ "Malaise", 11834 ], [ "Rash", 11603 ] ], "by_year": { "2019": 25459, "2020": 24846, "2021": 22444, "2022": 24296, "2023": 22227, "2024": 24066, "2025": 24721, "2026": 12120 }, "by_year_primary": { "2019": 25449, "2020": 24815, "2021": 22389, "2022": 24099, "2023": 22114, "2024": 23907, "2025": 24622, "2026": 12048 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 0, "nda": 0, "anda": 0, "first_approval": "", "rems": false, "rems_last": "", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [], "unapproved": false, "first_approval_fmt": "" }, "trials": { "total": 3308, "completed": 2118, "terminated": 262, "with_results": 470, "industry": 482, "phase3": 391, "results_share": 0.2219074598677998, "terminated_share": 0.07920193470374849 }, "pubmed": { "rct": 189, "meta": 9, "recent_rct": 41, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "cholecalciferol", "D-Vi-Sol", "Decara", "Delta D3", "Dialyvite Vitamin D3 Max", "Maximum D3", "Thera-D" ], "source": "bulk-index" }, "partd": null, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 95, "letter": "A", "why": [ "Death share in reports is near or below the FAERS average (0.8x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 45, "letter": "F", "why": [ "189 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 22% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 95, "letter": "A", "why": [ "No recalls on record since 2016", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "No generic version approved: brand-only pricing (-30)", "5 same-class alternatives exist" ], "weight": 0.1 } }, "total": 81, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over alfacalcidol, calcifediol, calcitriol? What would make you pick one of those instead?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "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.)" ] }