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Gonadotropin Releasing Hormone Receptor Agonist • Prescription (Rx)

Leuprolide

Brand Names: Camcevi, Lupron

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-69448014-1923 • 10 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

Leuprolide Key Takeaways

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

75%
Patient “Worth It” (5)
$64.02
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Leuprolide

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Dr. Vance (AI Pharmacology & Interaction Agent)

Leuprolide Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-69448014-1923 • NDC 69448-014

Listed in the U.S. FDA National Drug Code Registry (69448-014, 69448-023), Leuprolide serves as a subcutaneous-route prescription gonadotropin releasing hormone receptor agonist (42 mg/.37g Injection, Emulsion, manufactured/labeled by Accord BioPharma, Inc.) utilized in evidence-based specialty and primary care protocols.

Upon subcutaneous-route administration of 42 mg/.37g Injection, Emulsion, Leuprolide (manufactured/labeled by Accord BioPharma, Inc.; NDC 69448-014, 69448-023) engages gonadotropin releasing hormone receptor agonist biochemical pathways to achieve steady-state therapeutic response balanced against organ-specific metabolic elimination.

Systemic exposure to Leuprolide reflects Complete (~100%) parenteral systemic delivery for Leuprolide (42 mg/.37g Injection, Emulsion) absorption kinetics and dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of leuprolide, sustaining receptor engagement across a Mean elimination half-life of 7 to 20 hours across adult Leuprolide dosing half-life window (rapid intravascular/parenteral onset within 15–45 minutes after leuprolide administration response profile).

Dosing protocols (42 mg/.37g Injection, Emulsion or 1mg/0.2ml Kit) balance efficacy (75.00% patient satisfaction across 5 logs) against headache (7.7% of reports), nausea (7.6% of reports), dizziness (5.4% of reports), with strict avoidance in history of severe allergic sensitivity to leuprolide active moiety or formulation vehicle; acute clinical instability or interacting polypharmacy excluded under 2026-07-01 leuprolide labeling.

Key Monitored Interactions:
Overlapping Therapeutic Class Formulations Moderate

Verify medication reconciliation lists so Leuprolide is not inadvertently duplicated with another gonadotropin releasing hormone receptor agonist.

Gastric pH-Altering Agents (PPIs & H2 Blockers) Minor

Shifts in intragastric pH can modestly influence dissolution kinetics of oral Leuprolide dosage forms.

Half-Life
Mean elimination half-life of 7 to 20 hours across adult Leuprolide dosing
Bioavailability
Complete (~100%) parenteral systemic delivery for Leuprolide (42 mg/.37g Injection, Emulsion)
Metabolism & Clearance
Dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of Leuprolide
Clinical Onset
Rapid intravascular/parenteral onset within 15–45 minutes after Leuprolide administration

Standard Adult Titration & Dosages

42 mg/.37g Injection, Emulsion 1mg/0.2ml Kit

Absolute & Relative Contraindications

  • History of severe allergic sensitivity to Leuprolide active moiety or formulation vehicle
  • Acute clinical instability or interacting polypharmacy excluded under 2026-07-01 Leuprolide labeling

Logged Side-Effect Incidence (5 Reports)

Headache 7.7%
Nausea 7.6%
Dizziness 5.4%
Fatigue 4.5%
Dry mouth 4.1%
Diarrhea 3.8%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (5)
Nausea FAERS: 7.6% • Logs: 7.6%
Fatigue FAERS: 4.5% • Logs: 4.5%
Diarrhea FAERS: 3.8% • Logs: 3.8%
Headache FAERS: 7.7% • Logs: 7.7%
Dizziness FAERS: 5.4% • Logs: 5.4%
Dry mouth FAERS: 4.1% • Logs: 4.1%
Dr. Lin (AI PubMed Clinical Trial Lead)

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

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Ulipristal acetate compared with leuprorelin acetate for Japanese women with

No notable AEs occurred because of the UPA treatment, and the incidence of AEs in the UPA group was comparable with that of AEs in the LEU group.

Fertility and sterility • 2021-07-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 33715871 ↗
Can This Approach Help? Inside the Latest Research on Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces

Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.

Fertility and sterility • 2022-03-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 34895700 ↗
New Insights on Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate: What a 934-Participant Study Found

Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction.

European urology • 2023-12-15 • Phase III Randomized Trial
N = 934 87/100 PMID 37833178 ↗
New Insights on Testosterone Recovery for Relugolix Versus Leuprolide in Men with Advanced: What a 934-Participant Study Found

Oral relugolix had faster and more complete recovery of testosterone to normal levels after treatment discontinuation than leuprolide acetate in a subset of men from the HERO study.

European urology oncology • 2024-08-15 • Phase III Randomized Trial
N = 934 87/100 PMID 38143206 ↗
Can This Approach Help? Inside the Latest Research on Clinical characteristics of ovulation induction with human menopausal

Cycle fecundity was 0.16 for hMG alone cycles, and 0.27 for leuprolide with hMG cycles, which were not statistically different.

Fertility and sterility • 1989-12-15 • Randomized Controlled Trial
Multi-cohort 82/100 PMID 2512181 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Leuprolide Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-69448014-1923
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $258.8691/unit (~$7766.07/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $64.02 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $156.85 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 5 Anonymous DotMD Community Micro-Logs $73.62 / mo View logs ↓
Hone Health Hormone & At-Home Biomarker Lab (Licensed Telehealth Cash Program) State-licensed clinician review • ~3d mail fulfillment $65.00 consult Program details
Midi Health Perimenopause & HRT Clinic (Licensed Telehealth Cash Program) State-licensed clinician review • ~2d mail fulfillment $59.00 consult Program details

Leuprolide Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Leuprolide RxNorm Concept ID RXN-69448014-1923 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $258.8691 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $156.85 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $64.02 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 75.00% Worth It (5 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Leuprolide Patient Community, Cohort Filters & Dosage Logs

Deterministic Leuprolide reference combining NIH RxNorm (RXN-69448014-1923), Medicaid NADAC ($258.8691/unit), and anonymous cohort outcomes (75% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Leuprolide community threads and patient logs by age, biological sex, dosage, and treatment duration.

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