{
 "query": "ibandronate",
 "ingredient": "ibandronate",
 "slug": "ibandronate",
 "rxcui": "115264",
 "brands": [],
 "names": [
  "ibandronate",
  "ibandronate sodium"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 6,
   "INTRAVENOUS": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. ( 1.1 ). Limitations of Use The 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. ( 1.2 ). 1.1 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations of Use Theoptimalduration of use has not been determined. The safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.",
  "contraindications": "Ibandronate sodium tablets are 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 60 minutes ( see Dosage and Administration [2.2] , and Warnings and Precautions [5.1] ) Hypocalcemia ( see Warnings and Precautions [5.2 ] ) Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis have been reported ( see Adverse Reactions [6.2] ). Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia ( 4 , 5.1 ) Inability to stand or sit upright for at least 60 minutes ( 4 , 5.1 ) Hypocalcemia ( 4 ) Hypersensitivity to ibandronate sodium tablets ( 4 )",
  "warnings_and_cautions": "Upper gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions and discontinue use if new or worsening symptoms occur. ( 5.1 ) Hypocalcemia may worsen during treatment. Correct hypocalcemia before use. ( 5.2 ) Severe Bone, Joint, and Muscle Pain may occur. Consider discontinuing use if 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 Ibandronate sodium tablets, 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 ibandronate sodium tablets are given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseas...",
  "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 )] Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.2 )] Musculoskeletal [see Warnings and Precautions ( 5.3 )] Jaw Osteonecrosis [see Warnings and Precautions ( 5.4 )] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.5 )] Severe Renal Impairment [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (greater than 5%) are back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 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 practice. Treatment and Prevention of Postmenopausal Osteoporosis Daily Dosing The safety of ibandronate sodium tablets 2.5 mg once da...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions, Atypical Fractures Including Femoral Fractures ( 5.5 ) 10/2025",
  "information_for_patients": "\"See FDA-approved patient labeling (Medication Guide)\" 17.1 Information for Patients Instruct patients to read the Medication Guide carefully before taking ibandronate sodium tablets and to re-read it each time the prescription is renewed because it contains important information the patient should know about ibandronate sodium tablets The Medication Guide also includes the dosing instructions in order to maximize absorption and clinical benefit. Ibandronate sodium tablets should be taken at least 60 minutes before the first food or drink (other than water) of the day and before taking any oral medication or supplementation including calcium, antacids or vitamins (see DRUG INTERACTIONS [7.1] ) . To facilitate delivery to the stomach, and thus reduce the potential for esophageal irritation, ibandronate sodium tablets should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking ibandronate sodium tablets. Patients should not eat, drink anything except for water, or take other medications for 60 minutes after taking ibandronate sodium tablets. Plain water...",
  "spl_medguide": "MEDICATION GUIDE MEDICATION GUIDE Ibandronate Sodium (eye-ban-droe-nate soe-dee-um) Tablets Read the Medication Guide that comes with ibandronate sodium tablets 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 your treatment. Talk to your doctor if you have any questions about ibandronate sodium tablets. What is the most important information I should know about ibandronate sodium tablets? Ibandronate sodium tablets may cause serious side effects including: 1. Esophagus problems 2. Low calcium levels in your blood (hypocalcemia) 3. Bone, joint or muscle pain 4. Severe jaw bone problems (osteonecrosis) 5. Unusual bone fractures including thigh bone fractures 1 . Esophagus problems. Some people who take ibandronate sodium tablets 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. \u2022 It is important that you take ibandronate sodium tablets exactly as prescribed to help lower your chance of getting esoph...",
  "clinical_studies": "14.1 Treatment of Postmenopausal Osteoporosis Daily Dosing The effectiveness and safety of ibandronate sodium tablets were demonstrated in a randomized, double-blind, placebo-controlled, multinational study (Treatment Study) of 2946 women aged 55 to 80 years, who were on average 21 years postmenopause, who had lumbar spine BMD 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1 to L4], and who had 1 to 4 prevalent vertebral fractures. Ibandronate sodium tablets were evaluated at oral doses of 2.5 mg daily and 20 mg intermittently. The main outcome measure was the occurrence of new radiographically diagnosed vertebral fractures after 3 years of treatment. The diagnosis of an incident vertebral fracture was based on both qualitative diagnosis by the radiologist and quantitative morphometric criterion. The morphometric criterion required the dual occurrence of 2 events: a relative height ratio or relative height reduction in a vertebral body of at least 20%, together with at least a 4 mm absolute decrease in height. All women received 400 international units vitamin D and 500 mg calcium supplementation per day. Effect on Fracture Incidence Ibandronate sodium ...",
  "brand_name": "IBANDRONATE SODIUM",
  "manufacturer": "Golden State Medical Supply, Inc.",
  "application_number": "ANDA078948",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260219",
  "set_id": "618e1aff-ccbb-4cee-93f1-fe04e33dacb7",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 14665,
  "serious": 6557,
  "death": 585,
  "hospitalization": 2735,
  "primary_suspect": 14660,
  "top_reactions": [
   [
    "Arthralgia",
    1174
   ],
   [
    "Femur Fracture",
    1042
   ],
   [
    "Pain",
    984
   ],
   [
    "Pain In Extremity",
    863
   ],
   [
    "Back Pain",
    825
   ],
   [
    "Diarrhoea",
    801
   ],
   [
    "Nausea",
    754
   ],
   [
    "Fall",
    715
   ],
   [
    "Myalgia",
    682
   ],
   [
    "Headache",
    657
   ],
   [
    "Fatigue",
    581
   ],
   [
    "Anxiety",
    536
   ],
   [
    "Low Turnover Osteopathy",
    522
   ],
   [
    "Bone Pain",
    499
   ],
   [
    "Dizziness",
    491
   ]
  ],
  "by_year": {
   "2019": 1014,
   "2020": 747,
   "2021": 524,
   "2022": 536,
   "2023": 425,
   "2024": 380,
   "2025": 374,
   "2026": 185
  },
  "by_year_primary": {
   "2019": 1014,
   "2020": 747,
   "2021": 524,
   "2022": 535,
   "2023": 425,
   "2024": 378,
   "2025": 373,
   "2026": 185
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 20,
  "nda": 2,
  "anda": 16,
  "first_approval": "20030516",
  "rems": false,
  "rems_last": "20110701",
  "labeling_supplements": 19,
  "labeling_recent": 1,
  "sponsors": [
   "ACCORD HLTHCARE",
   "APOTEX",
   "APOTEX INC",
   "AUROBINDO PHARMA",
   "AVET LIFESCIENCES",
   "CHEMI SPA",
   "COBALT LABS INC",
   "DR REDDYS LABS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/16/2003"
 },
 "trials": {
  "total": 88,
  "completed": 69,
  "terminated": 10,
  "with_results": 22,
  "industry": 56,
  "phase3": 27,
  "results_share": 0.3188405797101449,
  "terminated_share": 0.11363636363636363
 },
 "pubmed": {
  "rct": 122,
  "meta": 14,
  "recent_rct": 3,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ibandronate"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 858931,
  "beneficiaries": 260911,
  "spend": 25497171.21,
  "by_brand": [
   {
    "brand": "Ibandronate Sodium",
    "claims": 858931,
    "per_claim": 29.684772362,
    "is_generic": true
   }
  ],
  "per_claim": 29.684772362389996
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 936,
  "fills": 858931,
  "per_million": 1089.7266485899333,
  "ratio": 0.3935523377042854,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,090 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 44,
   "letter": "F",
   "why": [
    "122 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 32% 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": [
    "Generic versions approved (16 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are arthralgia, femur fracture, pain, pain in extremity. How would we recognize and handle those?",
  "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.)"
 ]
}