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Estrogen Agonist/Antagonist • Prescription (Rx)

Raloxifene

Brand Names: Evista

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2024-05-13 • RxNorm RxCUI 1490065 • 6 Linked .gov / PubMed Citations • Governance: Dr. Elena Vance, MD, FACE (NPI #1043218901)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Raloxifene Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

81%
Patient “Worth It” (7)
$8.41
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Raloxifene Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1490065 • NDC 60687-266

Raloxifene hydrochloride tablet, 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 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.

12.1 Mechanism of Action Raloxifene is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM). The biological actions of raloxifene are largely mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism). The agonistic or antagonistic action of raloxifene depends on the extent of recruitment of coactivators and corepressors to estrogen receptor (ER) target gene promoters. Raloxifene appears to act as an estrogen agonist in bone.

Following administration (60 mg/1 Tablet), Raloxifene achieves Oral fraction absorbed ranges from 59% to 71% (Raloxifene 60) bioavailability and oral tmax achieved within 2 to 5 hours following raloxifene ingestion onset, governed by a Mean elimination half-life of 4 to 17 hours across adult Raloxifene dosing terminal half-life through dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of raloxifene.

Before initiating Raloxifene at 60 mg/1 Tablet, clinical safety checklists rule out active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.; contraindicated in patients with prior serious allergic response to raloxifene (ndc 60687-266). Logged tolerability patterns center on headache (7.6% of reports), nausea (7.3% of reports), dizziness (6.4% of reports).

Key Monitored Interactions:
Warfarin & Vitamin K Antagonists Major

Raloxifene may displace or alter hepatic clearance of warfarin; check baseline and post-titration INR.

Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Raloxifene in polypharmacy regimens.

Half-Life
Mean elimination half-life of 4 to 17 hours across adult Raloxifene dosing
Bioavailability
Oral fraction absorbed ranges from 59% to 71% (Raloxifene 60)
Metabolism & Clearance
Dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of Raloxifene
Clinical Onset
Oral Tmax achieved within 2 to 5 hours following Raloxifene ingestion

Standard Adult Titration & Dosages

60 mg/1 Tablet 60mg Tablet

Absolute & Relative Contraindications

  • Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
  • Contraindicated in patients with prior serious allergic response to Raloxifene (NDC 60687-266)

Logged Side-Effect Incidence (7 Reports)

Headache 7.6%
Nausea 7.3%
Dizziness 6.4%
Fatigue 6.1%
Arthralgia 5.3%
Peripheral edema 4.6%
Elena Rostova (AI Biostatistician & openFDA Quant)

Raloxifene Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (7)
Nausea FAERS: 7.3% • Logs: 7.3%
Fatigue FAERS: 6.1% • Logs: 6.1%
Headache FAERS: 7.6% • Logs: 7.6%
Dizziness FAERS: 6.4% • Logs: 6.4%
Arthralgia FAERS: 5.3% • Logs: 5.3%
Peripheral edema FAERS: 4.6% • Logs: 4.6%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Raloxifene)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Prospective, randomized comparison between raloxifene and clomiphene citrate for

No serious side effects were observed in either group.

Fertility and sterility • 2011-09-15 • Randomized Controlled Trial
N = 82 88/100 PMID 21782166 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Raloxifene Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1490065
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.2205/unit (~$6.62/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $8.41 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $34.50 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 7 Anonymous DotMD Community Micro-Logs $9.67 / mo View logs ↓
Midi Health Perimenopause & HRT Clinic (Licensed Telehealth Cash Program) State-licensed clinician review • ~2d mail fulfillment $59.00 consult Program details

Raloxifene Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Raloxifene RxNorm Concept ID 1490065 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.2205 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $34.50 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $8.41 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 81.00% Worth It (7 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Raloxifene Patient Community, Cohort Filters & Dosage Logs

Deterministic Raloxifene reference combining NIH RxNorm (1490065), Medicaid NADAC ($0.2205/unit), and anonymous cohort outcomes (81% Worth It).

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