{
 "query": "raloxifene",
 "ingredient": "raloxifene",
 "slug": "raloxifene",
 "rxcui": "72143",
 "brands": [
  "Evista"
 ],
 "names": [
  "raloxifene",
  "raloxifene hydrochloride"
 ],
 "classes": [
  {
   "id": "G03XC",
   "name": "Selective estrogen receptor modulators"
  }
 ],
 "alternatives": [
  "bazedoxifene",
  "ospemifene"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 21
  },
  "boxed_warning": "WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STRO Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets, USP ( 5.1 ) . Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride tablets, USP ( 4.1 ). Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke ( 5.2 , 14.5 ). WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE See full prescribing information for complete boxed warning. Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets, USP ( 5.1 ). Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride tablets, USP ( 4.1 ). Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke ( 5.2 , 14.5 )...",
  "indications_and_usage": "Raloxifene hydrochloride tablets, USP is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. ( 1.1 ) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. ( 1.2 ) Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. ( 1.3 ) Important Limitations: Raloxifene hydrochloride tablets, USP is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. 1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women Raloxifene hydrochloride tablets, USP is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies ( 14.1 , 14.2 )] . 1.2 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis Raloxifene hydrochloride tablets, USP is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies ( 14.3 )] . 1.3 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of ...",
  "contraindications": "Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ( 4.1 ) Pregnancy, women who may become pregnant, and nursing mothers. ( 4.2 , 8.1 , 8.3 ) 4.1 Venous Thromboembolism Raloxifene hydrochloride tablets, USP is contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see Warnings and Precautions ( 5.1 )] . 4.2 Pregnancy, Women Who May Become Pregnant, and Nursing Mothers Raloxifene hydrochloride tablets, USP is contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers [see Use in Specific Populations ( 8.1 , 8.3 )] . Raloxifene hydrochloride tablets, USP may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. In rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses \u22650.1 mg/kg (\u22650.04 times the human dose based on surface area, mg/m 2...",
  "warnings_and_cautions": "Venous Thromboembolism : Increased risk of deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. Discontinue use 72 hours prior to and during prolonged immobilization. ( 5.1 , 6.1 ) Death Due to Stroke : Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. No increased risk of stroke was seen in this trial. Consider risk-benefit balance in women at risk for stroke. ( 5.2 , 14.5 ) Cardiovascular Disease : Raloxifene hydrochloride tablets, USP should not be used for the primary or secondary prevention of cardiovascular disease. ( 5.3 , 14.5 ) Premenopausal Women : Use is not recommended. ( 5.4 ) Hepatic Impairment : Use with caution. ( 5.5 ) Concomitant Use with Systemic Estrogens : Not recommended. ( 5.6 ) Hypertriglyceridemia : If previous treatment with estrogen resulted in hypertriglyceridemia, monitor serum triglycerides. ( 5.7 ) 5.1 Venous Thromboembolism In clinical trials, raloxifene-treated women had an increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Other venous thromboembolic events also could occur. A ...",
  "warnings": "",
  "adverse_reactions": "Adverse reactions (>2% and more common than with placebo) include: hot flashes, leg cramps, peripheral edema, flu syndrome, arthralgia, sweating. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy\u2019s Laboratories, Inc at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies 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. The data described below reflect exposure to raloxifene in 8429 patients who were enrolled in placebo-controlled trials, including 6666 exposed for 1 year and 5685 for at least 3 years. Osteoporosis Treatment Clinical Trial (MORE) \u2014 The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo- controlled trial. Duration of treatment was 36 months, and 5129 postmenopausal women were exposed to raloxifene (2557 received 60 mg/day, and 2572 received 120 mg/day). The incidence of all-cause mortality was similar among groups: 23 (0.9%) placebo,...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Boxed Warning 9/2007 Indications and Usage, Invasive Breast Cancer Risk Reduction ( 1 ) 9/2007 Warnings and Precautions, Death Due to Stroke ( 5.2 ) 7/2007 Warnings and Precautions, Cardiovascular Disease ( 5.3 ) 7/2007 Warnings and Precautions, Renal Impairment ( 5.8 ) 7/2007",
  "information_for_patients": "See FDA-approved Medication Guide . Physicians should instruct their patients to read the Medication Guide before starting therapy with Raloxifene hydrochloride tablets, USP and to reread it each time the prescription is renewed. 17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation For osteoporosis treatment or prevention, patients should be instructed to take supplemental calcium and/or vitamin D if intake is inadequate. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, chronically ill, or with gastrointestinal malabsorption syndromes) should be instructed to take additional vitamin D if needed. Weight-bearing exercises 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 Patient Immobilization Raloxifene hydrochloride tablets, USP should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and patients should be advised to avoid prolonged restrictions of movement during travel because of the increas...",
  "spl_medguide": "Medication Guide RALOXIFENE (ral.ox.i.fene) Hydrochloride Tablets, USP 60 mg for oral use Read the Medication Guide that comes with raloxifene hydrochloride tablets before you start taking it and each time you refill your prescription. The information may have changed. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor about raloxifene hydrochloride tablets when you start taking it and at regular checkups. What is the most important information I should know about raloxifene hydrochloride tablets? Serious and life-threatening side effects can occur while taking raloxifene hydrochloride tablets. These include blood clots and dying from stroke: Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with raloxifene hydrochloride tablets. Women who have or have had blood clots in the legs, lungs, or eyes should not take raloxifene hydrochloride tablets. Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking raloxifene hydrochloride tablets. Before starting raloxifene h...",
  "clinical_studies": "14.1 Treatment of Postmenopausal Osteoporosis Effect on Fracture Incidence The effects of raloxifene on fracture incidence and BMD in postmenopausal women with osteoporosis were examined at 3 years in a large randomized, placebo-controlled, double-blind, multinational osteoporosis treatment trial (MORE). All vertebral fractures were diagnosed radiographically; some of these fractures also were associated with symptoms (i.e., clinical fractures). The study population consisted of 7705 postmenopausal women with osteoporosis as defined by: a) low BMD (vertebral or hip BMD at least 2.5 standard deviations below the mean value for healthy young women) without baseline vertebral fractures or b) one or more baseline vertebral fractures. Women enrolled in this study had a median age of 67 years (range 31 to 80) and a median time since menopause of 19 years. Effect on Bone Mineral Density Raloxifene 60 mg administered once daily, increased spine and hip BMD by 2 to 3%. Raloxifene decreased the incidence of the first vertebral fracture from 4.3% for placebo to 1.9% for raloxifene (relative risk reduction = 55%) and subsequent vertebral fractures from 20.2% for placebo to 14.1% for raloxifene...",
  "brand_name": "Raloxifene hydrochloride",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA206384",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20180427",
  "set_id": "6fd63a06-5bc5-4c50-9b85-b09c89100b80",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 8130,
  "serious": 3232,
  "death": 265,
  "hospitalization": 1317,
  "primary_suspect": 8127,
  "top_reactions": [
   [
    "Pain In Extremity",
    425
   ],
   [
    "Body Height Decreased",
    423
   ],
   [
    "Drug Ineffective",
    411
   ],
   [
    "Pain",
    401
   ],
   [
    "Arthralgia",
    391
   ],
   [
    "Muscle Spasms",
    374
   ],
   [
    "Fatigue",
    364
   ],
   [
    "Nausea",
    337
   ],
   [
    "Fall",
    312
   ],
   [
    "Headache",
    307
   ],
   [
    "Diarrhoea",
    288
   ],
   [
    "Dizziness",
    280
   ],
   [
    "Off Label Use",
    280
   ],
   [
    "Bone Density Decreased",
    254
   ],
   [
    "Back Pain",
    250
   ]
  ],
  "by_year": {
   "2019": 468,
   "2020": 379,
   "2021": 294,
   "2022": 262,
   "2023": 229,
   "2024": 211,
   "2025": 195,
   "2026": 120
  },
  "by_year_primary": {
   "2019": 468,
   "2020": 379,
   "2021": 294,
   "2022": 261,
   "2023": 229,
   "2024": 210,
   "2025": 195,
   "2026": 120
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20191204",
   "reason": "Failed Dissolution Specifications: Low out of specification results obtained during stability testing.",
   "firm": "American Health Packaging",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 10,
  "nda": 2,
  "anda": 8,
  "first_approval": "19971209",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 6,
  "labeling_recent": 0,
  "sponsors": [
   "AMNEAL PHARMS",
   "AUROBINDO PHARMA",
   "CADILA PHARMS LTD",
   "GLENMARK PHARMS LTD",
   "INVAGEN PHARMS",
   "LILLY",
   "SCIEGEN PHARMS",
   "TEVA PHARMS USA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/09/1997"
 },
 "trials": {
  "total": 86,
  "completed": 72,
  "terminated": 4,
  "with_results": 15,
  "industry": 38,
  "phase3": 19,
  "results_share": 0.20833333333333334,
  "terminated_share": 0.046511627906976744
 },
 "pubmed": {
  "rct": 350,
  "meta": 24,
  "recent_rct": 10,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "raloxifene",
   "Evista"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 710154,
  "beneficiaries": 170494,
  "spend": 32808174.45,
  "by_brand": [
   {
    "brand": "Raloxifene HCl",
    "claims": 707799,
    "per_claim": 45.045969943,
    "is_generic": true
   },
   {
    "brand": "Evista",
    "claims": 2355,
    "per_claim": 392.64627176,
    "is_generic": false
   }
  ],
  "per_claim": 46.19867585059015
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 525,
  "fills": 710154,
  "per_million": 739.2762696541878,
  "ratio": 0.26698796850400974,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "739 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 55,
   "letter": "D",
   "why": [
    "350 randomized trials and 24 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 21% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)",
    "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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (8 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are pain in extremity, body height decreased, pain. How would we recognize and handle those?",
  "Why this one over bazedoxifene, ospemifene? What would make you pick one of those instead?",
  "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.)"
 ]
}