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Progestin • Over-the-Counter (OTC)

Levonorgestrel

Brand Names: Mirena, Morning After, My Way, Morning After Pill, Fem Choice Morning After, Option 2

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-10-29 • RxNorm RxCUI 804156 • 9 Linked .gov / PubMed Citations • Governance: Dr. Marcus Thorne, MD, FACC (NPI #1184629314)
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

Levonorgestrel Key Takeaways

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

87%
Patient “Worth It” (15)
$99.88
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Levonorgestrel

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Dr. Vance (AI Pharmacology & Interaction Agent)

Levonorgestrel Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 804156 • NDC 50419-423

Mirena is a progestin-containing intrauterine system (IUS) indicated for: ; Prevention of pregnancy for up to 8 years ( 1.1 ) ; Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years. ( 1.2 ) 1.1 Contraception Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year.

12.1 Mechanism of Action The local mechanism by which continuously released LNG contributes to the contraceptive effectiveness of Mirena has not been conclusively demonstrated. Studies of Mirena and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium .

With Terminal t½ estimated at 10–15 hrs depending on renal/hepatic reserve (Levonorgestrel) residence kinetics and F ≈ 51%–63% systemic availability after standard oral Levonorgestrel administration bioavailability, Levonorgestrel undergoes levonorgestrel undergoes cyp3a4-mediated hepatic metabolism prior to excretion and establishes therapeutic activity over time to peak concentration spans 1 to 3 hrs under levonorgestrel maintenance.

Standard adult regimens span 1.5 mg/1 Tablet, 19.5 mg/1 Intrauterine Device, 1.5 mg/1.5mg Tablet, 13.5 mg/1 Intrauterine Device, 52 mg/1 Intrauterine Device. Prescribers screen specifically against the use of mirena is contraindicated when one or more of the following conditions exist:; pregnancy or suspicion of pregnancy; for use as post-coital contraception (emergency contraception), while community micro-logs most frequently note headache (11% of reports), nausea (8.2% of reports), dizziness (6.1% of reports).

CYP450 & Metabolic Pathways: CYP3A4
Key Monitored Interactions:
CYP3A4 Metabolic Inhibitors & Inducers Moderate

Review concurrent CYP3A4 substrates and inhibitors when titrating Levonorgestrel maintenance doses.

Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Levonorgestrel (progestin).

Half-Life
Terminal t½ estimated at 10–15 hrs depending on renal/hepatic reserve (Levonorgestrel)
Bioavailability
F ≈ 51%–63% systemic availability after standard oral Levonorgestrel administration
Metabolism & Clearance
Levonorgestrel undergoes CYP3A4-mediated hepatic metabolism prior to excretion
Clinical Onset
Time to peak concentration spans 1 to 3 hrs under Levonorgestrel maintenance

Standard Adult Titration & Dosages

1.5 mg/1 Tablet 19.5 mg/1 Intrauterine Device 1.5 mg/1.5mg Tablet 13.5 mg/1 Intrauterine Device 52 mg/1 Intrauterine Device

Absolute & Relative Contraindications

  • The use of Mirena is contraindicated when one or more of the following conditions exist:
  • Pregnancy or suspicion of pregnancy
  • For use as post-coital contraception (emergency contraception)

Logged Side-Effect Incidence (15 Reports)

Headache 11%
Nausea 8.2%
Dizziness 6.1%
Fatigue 5.9%
Diarrhea 4.5%
Dry mouth 4.5%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (15)
Nausea FAERS: 8.2% • Logs: 8.2%
Fatigue FAERS: 5.9% • Logs: 5.9%
Diarrhea FAERS: 4.5% • Logs: 4.5%
Headache FAERS: 11% • Logs: 11%
Dizziness FAERS: 6.1% • Logs: 6.1%
Dry mouth FAERS: 4.5% • Logs: 4.5%
Dr. Lin (AI PubMed Clinical Trial Lead)

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

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Treatment with liraglutide--a once-daily GLP-1 analog--does not reduce the

Both reached C(max) ~1.5 hours later with liraglutide.

Journal of clinical pharmacology • 2011-12-15 • Randomized Controlled Trial
N = 21 88/100 PMID 21228406 ↗
New Insights on Two levonorgestrel-releasing intrauterine systems for the treatment of heavy: What a 300-Participant Study Found

Donasert ® has equivalent real-world benefits and safety during the first 6 months foralleviation of HMB compared to the reference device, Mirena ®.

The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception • 2021-12-15 • Phase III Randomized Trial
N = 300 87/100 PMID 34180315 ↗
Can This Approach Help? Inside the Latest Research on Levonorgestrel 52-mg Intrauterine Device real-world benefits and safety After

The Sponsor, Medicines360, designed the study and oversaw its conduct, including funding the trial and providing all study product free of charge to participants.

Obstetrics and gynecology • 2023-05-01 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 37023451 ↗
Can This Approach Help? Inside the Latest Research on How the body absorbs the medicine and biotransformation of orally administered

It is concluded that, compared with an equivalent dose of PE1S, daily repeated oral administration of E2V yields consistently lower peripheral plasma levels of E2 and its principal metabolites.

Maturitas • 1990-11-15 • Randomized Controlled Trial
Multi-cohort 82/100 PMID 2124648 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Levonorgestrel Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 804156
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $6.3177/unit (~$189.53/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $99.88 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $244.71 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 15 Anonymous DotMD Community Micro-Logs $114.86 / mo View logs ↓

Levonorgestrel Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Levonorgestrel RxNorm Concept ID 804156 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $6.3177 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $244.71 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $99.88 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 87.00% Worth It (15 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Levonorgestrel Patient Community, Cohort Filters & Dosage Logs

Cross-verified Levonorgestrel (progestin) monograph synthesizing RxNorm 804156, openFDA FAERS signals, and $99.88–$244.71 cash benchmarks.

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

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