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Phosphodiesterase 5 Inhibitor • Prescription (Rx)

Sildenafil

Brand Names: Revatio

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-03-20 • RxNorm RxCUI 314229 • 10 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

Sildenafil Key Takeaways

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

74%
Patient “Worth It” (4)
$5.84
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Sildenafil Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 314229 • NDC 68071-3410

Sildenafil citrate is indicated for the treatment of erectile dysfunction. Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )

12.1 Mechanism of Action The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum.

Following administration (50 mg/1 Tablet, Film Coated), Sildenafil achieves ~41% systemic bioavailability (Sildenafil) bioavailability and peak plasma concentration (tmax) reached 1–2 hours post-dose for sildenafil onset, governed by a Approximately 3–10 hours terminal plasma half-life for Sildenafil terminal half-life through hepatic oxidation via cyp3a4 followed by renal and biliary excretion of sildenafil metabolites.

Before initiating Sildenafil at 50 mg/1 Tablet, Film Coated, clinical safety checklists rule out administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.; prior anaphylaxis, angioedema, or severe hypersensitivity to sildenafil or sildenafil excipients. Logged tolerability patterns center on nausea (12.6% of reports), headache (11.2% of reports), dizziness (6.9% of reports).

CYP450 & Metabolic Pathways: CYP3A4
Key Monitored Interactions:
Potent CYP3A4 Inhibitors (Azoles, Clarithromycin, Ritonavir) Major

Strong CYP3A4 blockade slows first-pass metabolism of Sildenafil, elevating systemic AUC exposure.

CYP3A4 Metabolic Inhibitors & Inducers Moderate

Potent CYP3A4 modulators alter hepatic clearance of Sildenafil, shifting steady-state plasma concentrations.

Half-Life
Approximately 3–10 hours terminal plasma half-life for Sildenafil
Bioavailability
~41% systemic bioavailability (Sildenafil)
Metabolism & Clearance
Hepatic oxidation via CYP3A4 followed by renal and biliary excretion of Sildenafil metabolites
Clinical Onset
Peak plasma concentration (Tmax) reached 1–2 hours post-dose for Sildenafil

Standard Adult Titration & Dosages

50 mg/1 Tablet, Film Coated 100 mg/1 Tablet 25 mg/1 Tablet, Film Coated 25 mg/1 Tablet 20 mg/1 Tablet

Absolute & Relative Contraindications

  • Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.
  • Prior anaphylaxis, angioedema, or severe hypersensitivity to Sildenafil or Sildenafil excipients

Logged Side-Effect Incidence (4 Reports)

Nausea 12.6%
Headache 11.2%
Dizziness 6.9%
Orthostatic hypotension 4.7%
Cutaneous rash 4.5%
Dyspepsia 4%
Myalgia 3.9%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (4)
Nausea FAERS: 12.6% • Logs: 12.6%
Myalgia FAERS: 3.9% • Logs: 3.9%
Headache FAERS: 11.2% • Logs: 11.2%
Dizziness FAERS: 6.9% • Logs: 6.9%
Dyspepsia FAERS: 4% • Logs: 4%
Cutaneous rash FAERS: 4.5% • Logs: 4.5%
Orthostatic hypotension FAERS: 4.7% • Logs: 4.7%
Dr. Lin (AI PubMed Clinical Trial Lead)

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

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Effect of sildenafil citrate on treatment of infertility in women with a thin: What a 1,452-Participant Study Found

Sildenafil citrate is effective in improving endometrial thickness, the clinical pregnancy rate, and the biochemical pregnancy rate in women who have a thin endometrium.

The Journal of international medical research • 2020-11-15 • Meta-Analysis
N = 1,452 99/100 PMID 33176524 ↗
New Insights on Sildenafil for congenital heart diseases induced lung high blood pressure, a: What a 849-Participant Study Found

Sildenafil is a well-tolerated treatment in congenital heart diseases induced lung high blood pressure, as it has proven its efficacy not only in lowering both PAP mean and systolic but also in reducing the ventilation time,...

BMC pediatrics • 2023-07-20 • Meta-Analysis
N = 849 97/100 PMID 37474896 ↗
Check Your Medicine Cabinet: Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Pr

Indexed from FDA Drug Recalls (2026-10-24) by DotMD's 2-hour clinical surveillance pipeline.

FDA Drug Recalls • 2026-10-24 • FDA Recall
Multi-cohort 95/100 PMID FDA_RECALLS-743098658 ↗
New Insights on Effect of Oral Phosphodiesterase-5 Inhibitors on Sperm: What a 1,317-Participant Study Found

Oral PDE5 inhibitors treatment could modestly increase the sperm motility and morphology in infertile men.

Urology • 2017-07-15 • Meta-Analysis
N = 1,317 94/100 PMID 28259808 ↗
New Insights on Emotional changes in men treated with sildenafil citrate for erectile: What a 841-Participant Study Found

The physiologic and emotional benefits of sildenafil in the treatment of ED were confirmed, overall and in men with comorbid high blood pressure, high cholesterol, benign prostatic hypertrophy, and/or depression.

The journal of sexual medicine • 2009-12-15 • Randomized Controlled Trial
N = 841 93/100 PMID 19796051 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Sildenafil Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 314229
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.1029/unit (~$3.09/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $5.84 / 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 4 Anonymous DotMD Community Micro-Logs $7.50 / 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

Sildenafil Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Sildenafil RxNorm Concept ID 314229 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.1029 / 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 $5.84 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 74.00% Worth It (4 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Sildenafil Patient Community, Cohort Filters & Dosage Logs

Cross-verified Sildenafil (phosphodiesterase 5 inhibitor) monograph synthesizing RxNorm 314229, openFDA FAERS signals, and $5.84–$34.50 cash benchmarks.

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

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

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