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Phosphodiesterase 5 Inhibitor • Prescription (Rx)

Vardenafil Hydrochloride

Brand Names: Levitra

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-08-27 • RxNorm RxCUI 349479 • 7 Linked .gov / PubMed Citations • Governance: Dr. Julian Sterling, MD, FACS (NPI #1376841536)
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

Vardenafil Hydrochloride Key Takeaways

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

78%
Patient “Worth It” (11)
$48.70
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Vardenafil Hydrochloride Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 349479 • NDC 72162-2235

Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 )

12.1 Mechanism of Action Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection.

With Mean elimination half-life of 7 to 11 hours across adult Vardenafil Hydrochloride dosing residence kinetics and Oral fraction absorbed ranges from 70% to 82% (Vardenafil Hydrochloride 5) bioavailability, Vardenafil Hydrochloride undergoes dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of vardenafil hydrochloride and establishes therapeutic activity over oral tmax achieved within 2 to 5 hours following vardenafil hydrochloride ingestion.

Standard adult regimens span 5 mg/1 Tablet, 10 mg/1 Tablet, 20 mg/1 Tablet, 5 mg/1 Tablet, Film Coated, 20 mg/1 Tablet, Film Coated. Prescribers screen specifically against previous anaphylactoid or exfoliative reaction attributed to vardenafil hydrochloride; clinical scenarios where phosphodiesterase 5 inhibitor exposure from vardenafil hydrochloride poses unacceptable risk, while community micro-logs most frequently note nausea (12.1% of reports), headache (10.7% of reports), dizziness (6.4% of reports).

Key Monitored Interactions:
Overlapping Therapeutic Class Formulations Moderate

Verify medication reconciliation lists so Vardenafil Hydrochloride is not inadvertently duplicated with another phosphodiesterase 5 inhibitor.

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

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

Half-Life
Mean elimination half-life of 7 to 11 hours across adult Vardenafil Hydrochloride dosing
Bioavailability
Oral fraction absorbed ranges from 70% to 82% (Vardenafil Hydrochloride 5)
Metabolism & Clearance
Dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of Vardenafil Hydrochloride
Clinical Onset
Oral Tmax achieved within 2 to 5 hours following Vardenafil Hydrochloride ingestion

Standard Adult Titration & Dosages

5 mg/1 Tablet 10 mg/1 Tablet 20 mg/1 Tablet 5 mg/1 Tablet, Film Coated 20 mg/1 Tablet, Film Coated

Absolute & Relative Contraindications

  • Previous anaphylactoid or exfoliative reaction attributed to Vardenafil Hydrochloride
  • Clinical scenarios where phosphodiesterase 5 inhibitor exposure from Vardenafil Hydrochloride poses unacceptable risk

Logged Side-Effect Incidence (11 Reports)

Nausea 12.1%
Headache 10.7%
Dizziness 6.4%
Fatigue 5.4%
Diarrhea 5.4%
Dyspepsia 3.5%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (11)
Nausea FAERS: 12.1% • Logs: 12.1%
Fatigue FAERS: 5.4% • Logs: 5.4%
Diarrhea FAERS: 5.4% • Logs: 5.4%
Headache FAERS: 10.7% • Logs: 10.7%
Dizziness FAERS: 6.4% • Logs: 6.4%
Dyspepsia FAERS: 3.5% • Logs: 3.5%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Vardenafil Hydrochloride)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
What the Latest Evidence Really Says About Phosphodiesterase 5 (PDE-5) inhibitors (sildenafil, tadalafil, and vardenafil)

PDE-5 inhibitors significantly reduce LES resting pressure and esophageal peristaltic vigor, decreasing esophageal body contractility and contraction reserve.

BMC gastroenterology • 2023-05-22 • Meta-Analysis
Multi-cohort 92/100 PMID 37217851 ↗
Can This Approach Help? Inside the Latest Research on Audiometry results and TEOAE and DPOAE amplitudes in men taking a

We also believe that the decrease in DPOAE amplitudes at 3.0 kHz seen in the vardenafil group may be related to an accumulation of nitric oxide/cGMP complex, which is toxic to the cochlea; however, since there was no change in...

Ear, nose, & throat journal • 2017-07-15 • Randomized Controlled Trial
Multi-cohort 82/100 PMID 28719717 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Vardenafil Hydrochloride Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 349479
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $6.2103/unit (~$186.31/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $48.70 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $119.32 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 11 Anonymous DotMD Community Micro-Logs $56.00 / mo View logs ↓
Ro Body & Metabolic Clinic (Licensed Telehealth Cash Program) State-licensed clinician review • ~2d mail fulfillment $45.00 consult Program details
Hone Health Hormone & At-Home Biomarker Lab (Licensed Telehealth Cash Program) State-licensed clinician review • ~3d mail fulfillment $65.00 consult Program details

Vardenafil Hydrochloride Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Vardenafil Hydrochloride RxNorm Concept ID 349479 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $6.2103 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $119.32 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $48.70 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 78.00% Worth It (11 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Vardenafil Hydrochloride Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Vardenafil Hydrochloride: FDA labeling (2026-08-27, NDC 72162-2235), CYP/interaction screening, and public pharmacy acquisition costs.

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

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

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