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Progesterone • Prescription (Rx)

Progesterone

Brand Names: Endometrin, Crinone, Prometrium, Bunuss Phyto-Pro Skin Cream

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-05-13 • RxNorm RxCUI 260243 • 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

Progesterone Key Takeaways

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

76%
Patient “Worth It” (9)
$9.45
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Progesterone

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Dr. Vance (AI Pharmacology & Interaction Agent)

Progesterone Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 260243 • NDC 42291-784

Indications and usage: Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

CLINICAL PHARMACOLOGY Progesterone capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A. Absorption After oral administration of progesterone as a micronized soft-gelatin capsule formulation, maximum serum concentrations were attained within 3 hours. The absolute bioavailability of micronized progesterone is not known.

With Biphasic clearance with 11–15 hr terminal t½ under Progesterone maintenance residence kinetics and Systemic oral bioavailability of roughly 47%–59% following first-pass transit bioavailability, Progesterone undergoes hepatic enzymatic processing and renal clearance proportional to creatinine clearance (progesterone) and establishes therapeutic activity over initial pharmacodynamic onset within 1–3 hrs (peak cmax) for progesterone.

Standard adult regimens span 100 mg/1 Capsule, 200 mg/1 Capsule, 6 [hp_X]/mL Liquid, 100 mg/1 Insert, 45 mg/1.125g Gel. Prescribers screen specifically against progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts.; undiagnosed abnormal genital bleeding., while community micro-logs most frequently note nausea (8.5% of reports), headache (8.2% of reports), dizziness (6.7% of reports).

Key Monitored Interactions:
Duplicate Progesterone Agents Moderate

Avoid overlapping progesterone prescriptions alongside Progesterone to prevent cumulative receptor toxicity.

Herbal CYP/Transporter Supplements (St. John’s Wort, Grapefruit) Minor

Botanical enzyme modulators may alter oral first-pass exposure of Progesterone; disclose all supplements.

Half-Life
Biphasic clearance with 11–15 hr terminal t½ under Progesterone maintenance
Bioavailability
Systemic oral bioavailability of roughly 47%–59% following first-pass transit
Metabolism & Clearance
Hepatic enzymatic processing and renal clearance proportional to creatinine clearance (Progesterone)
Clinical Onset
Initial pharmacodynamic onset within 1–3 hrs (peak Cmax) for Progesterone

Standard Adult Titration & Dosages

100 mg/1 Capsule 200 mg/1 Capsule 6 [hp_X]/mL Liquid 100 mg/1 Insert 45 mg/1.125g Gel

Absolute & Relative Contraindications

  • Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts.
  • Undiagnosed abnormal genital bleeding.

Logged Side-Effect Incidence (9 Reports)

Nausea 8.5%
Headache 8.2%
Dizziness 6.7%
Fatigue 6.2%
Diarrhea 5.8%
Dry mouth 4%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (9)
Nausea FAERS: 8.5% • Logs: 8.5%
Fatigue FAERS: 6.2% • Logs: 6.2%
Diarrhea FAERS: 5.8% • Logs: 5.8%
Headache FAERS: 8.2% • Logs: 8.2%
Dizziness FAERS: 6.7% • Logs: 6.7%
Dry mouth FAERS: 4% • Logs: 4%
Dr. Lin (AI PubMed Clinical Trial Lead)

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

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Estradiol and progesterone bioavailability for moderate to severe vasomotor: What a 1,835-Participant Study Found

P4 levels observed with TX-001HR were similar in the phase 1 and 3 studies, and were associated with no endometrial hyperplasia with either E2 daily dose over 1 year in the REPLENISH phase 3 study, which showed significant...

Menopause (New York, N.Y.) • 2019-07-15 • Phase III Randomized Trial
N = 1,835 96/100 PMID 30694918 ↗
New Insights on Metabolic and heart and blood vessel effects of TX-001HR in menopausal women with: What a 1,835-Participant Study Found

One episode of deep venous thrombosis and three cases of heart and blood vessel disease were observed, similar to expected rates of these events in the general population.

Climacteric : the journal of the International Menopause Society • 2019-12-15 • Randomized Controlled Trial
N = 1,835 96/100 PMID 31364889 ↗
New Insights on Endometrial safety and bleeding profile of a 17β-estradiol/progesterone oral: What a 1,835-Participant Study Found

All doses of TX-001HR provided endometrial protection and were associated with an improved bleeding profile over time; older age, further last menstrual period, or lower baseline E2 may predict amenorrhea with TX-001HR.

Menopause (New York, N.Y.) • 2020-04-15 • Phase III Randomized Trial
N = 1,835 96/100 PMID 31913228 ↗
New Insights on Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the: What a 672-Participant Study Found

In this retrospective exploratory analysis of hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer, each intrinsic subtype exhibited a consistent PFS benefit with RIB, except.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology • 2021-05-01 • Phase III Randomized Trial
N = 672 93/100 PMID 33769862 ↗
New Insights on Relationship between vasomotor symptom improvements and quality of life and sleep: What a 591-Participant Study Found

TX-001HR improvements in quality of life and sleep outcomes are associated with and may be mediated through improvements in VMS frequency and severity.

Menopause (New York, N.Y.) • 2019-01-09 • Phase III Randomized Trial
N = 591 93/100 PMID 30601452 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Progesterone Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 260243
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.2361/unit (~$7.08/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $9.45 / 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 9 Anonymous DotMD Community Micro-Logs $10.87 / mo View logs ↓

Progesterone Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Progesterone RxNorm Concept ID 260243 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.2361 / 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 $9.45 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 76.00% Worth It (9 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Progesterone Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Progesterone: FDA labeling (2026-05-13, NDC 42291-784), CYP/interaction screening, and public pharmacy acquisition costs.

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

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