02
What Is It?
Vardenafil is a prescription PDE5 inhibitor approved in 2003. It is available as a standard tablet and, in some markets, an orally disintegrating tablet.
Product Profile & Review
FDA APPROVEDPRESCRIPTION
Vardenafil
A potent, highly selective PDE5 inhibitor with a profile similar to sildenafil and an orally disintegrating form.
Also known as: Levitra (brand), Staxyn (ODT brand)
- Written by
- SynMale Editorial
- Originally Published
- October 2026
- Last Updated
- October 2026
- Medical Review
- Not yet independently reviewed
Executive Summary
- What is it?
- Prescription PDE5 Inhibitor (Prescription Medication).
- What does it contain or claim to contain?
- Vardenafil HCl (verified)
- How well verified is this specific product?
- Well Established
- Most important thing to know
- Established PDE5 inhibitor similar to sildenafil, with a distinctive QT-interval warning.
A
Ingredient
Vardenafil hydrochloride
Product Type
Prescription PDE5 Inhibitor
Regulatory Status
FDA Approved
Verification
Well Established
03
Claimed Active Ingredients
- VERIFIED INGREDIENTVardenafil HCl5 / 10 / 20 mg (FDA-approved product)
A claimed ingredient is what a label or seller states. It is not treated as confirmed.
04
What Can We Verify?
Established
- Efficacy established in controlled trials, including in men with diabetes.
- Pharmacokinetics similar to sildenafil.
Uncertain or unverified
- Less widely prescribed today, so fewer real-world comparison data than sildenafil or tadalafil.
05
How It Works
Sexual stimulation releases nitric oxide (NO) in penile tissue. NO raises levels of cyclic GMP (cGMP), which relaxes the smooth muscle of the corpus cavernosum so arteries widen and blood flows in.
The enzyme PDE5 normally breaks cGMP down. PDE5 inhibitors block that enzyme, so cGMP persists and smooth-muscle relaxation is sustained. They do not create arousal—stimulation is still required.
06
Evidence Level
AStrong Clinical Evidence
Grades run from A (strong clinical evidence) to F (unsupported or contradicted). How we grade.
07
Clinical Profile
- Drug Class
- PDE5 Inhibitor
- Typical Onset
- About 25–60 minutes
- Effective Window
- About 4–5 hours
- Half-Life
- About 4–5 hours
- Typical Medical Dosing
- 5 / 10 / 20 mg, as prescribed
- Food Interaction
- High-fat meals can reduce and delay absorption (tablet)
- Alcohol Considerations
- Additive blood-pressure lowering with heavy drinking
- Daily vs On-Demand
- On-demand
08
Benefits / Potential Advantages
- High selectivity for PDE5
- Orally disintegrating option in some markets
- Similar timing to sildenafil
09
Limitations
- Short window
- Food effect on standard tablets
- Caution with certain heart-rhythm (QT) medications
10
Side Effects & Precautions
Common effects
Headache, flushing, nasal congestion, indigestion and dizziness.
Major interactions & warnings
- • Nitrates (e.g. nitroglycerin, isosorbide): combined use can cause a severe, potentially life-threatening drop in blood pressure. Contraindicated.
- • Riociguat and other guanylate cyclase stimulators: contraindicated for the same reason.
- • Alpha-blockers (e.g. doxazosin, tamsulosin): not universally contraindicated, but combined use can lower blood pressure and requires medical guidance on dosing and timing.
- • Significant cardiovascular disease: sexual activity itself carries cardiac load; a clinician should assess fitness before treatment.
- • Priapism: an erection lasting more than 4 hours is a medical emergency.
- • Sudden vision loss (rare NAION reports) or sudden hearing loss: stop use and seek urgent care.
- • QT prolongation: use caution with certain antiarrhythmic medications or congenital QT syndrome.
11
Regulatory Status
FDA ApprovedFDA Cleared DeviceNot FDA ApprovedDietary SupplementCompounded MedicationForeign-Market MedicationUnknownUnverified
FDA-approved for erectile dysfunction.
12
Marketing Claims vs. Evidence
Claim
What the Evidence Shows
“Stronger than sildenafil”
Lower milligram doses reflect potency per mg, not necessarily greater clinical effect.
Review Scorecard
Onset Speed
4.2/5
Duration / Flexibility
3.5/5
Reliability
4.5/5
Tolerability
4.0/5
Overall Score
4.1/5
SynMale scores are editorial comparison tools and are not medical efficacy guarantees.
ⓘ About SynMale Ratings
SynMale numerical ratings are editorial comparison tools informed by:
- Consistency of published clinical efficacy results
- Predictability of onset and duration
- Established dosing information
- Adverse-effect data
- Treatment discontinuation data where available
- Practical dosing flexibility
- Strength and consistency of available clinical evidence
These numbers are not efficacy percentages, clinical success rates, or predictions of individual response.
Full methodology → SynMale Verdict
WELL ESTABLISHED
A well-studied alternative with a profile close to sildenafil.
Bottom Line
What You Should Know
Vardenafil works much like sildenafil, with a similar onset and duration. It is a reasonable alternative for some patients, guided by a clinician. Standard PDE5 safety rules apply, plus caution with heart-rhythm drugs.