PDE5 Inhibitor · FDA-approved (2003) · Prescription required
Levitra®
(Vardenafil)
Levitra was the third PDE5 inhibitor to reach the US market, approved in August 2003. It works essentially the same way as Viagra® — on-demand, food-sensitive, with a similar few-hour window — but it carries one distinguishing safety consideration the others don’t: a documented effect on cardiac QT interval.
Overview
What Levitra is and how it works
Vardenafil, sold as Levitra®, is a PDE5 inhibitor that works the same way as sildenafil (Viagra®) — enhancing blood flow to the penis in response to sexual stimulation, not creating arousal on its own. It’s available as film-coated tablets (5mg, 10mg, 20mg) and as Staxyn®, an orally disintegrating 10mg tablet approved separately in 2010 — the two formulations are not interchangeable milligram for milligram.
Onset and duration track closely with sildenafil — roughly 30 to 60 minutes to take effect, lasting a few hours — rather than tadalafil’s much longer window. Like sildenafil, a high-fat meal can meaningfully delay and blunt its effect, arguably more noticeably than with some other options in this drug class.
Some men tolerate vardenafil better than sildenafil, or respond to it when sildenafil hasn’t worked well — individual response varies enough across this drug class that switching within it is a reasonable step if one option isn’t working.
The distinguishing safety consideration
QT interval prolongation — read this if you’re on other heart medications
A clinical study measuring the effect of Levitra on cardiac QT interval found that therapeutic (10mg) and supratherapeutic (80mg) doses produced increases in QTc interval comparable to a known QT-prolonging antibiotic used as an active control. A separate postmarketing study found an additive QT effect when Levitra was combined with another QT-prolonging drug.
As a result, Levitra should be avoided in men taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, and used with caution in men with a personal or family history of congenital long QT syndrome. This is a real, distinguishing consideration that sildenafil’s label doesn’t carry in the same way — worth flagging directly to your prescriber if you take any heart-rhythm medication.
A required post-marketing study
The FDA’s mandated retinal safety study
As a condition of approval, the FDA required Bayer to conduct a dedicated Phase IV study examining visual/retinal changes with repeated vardenafil use compared to sildenafil and placebo — because PDE5 inhibitors, sildenafil in particular, can have some cross-reactivity with PDE6 receptors found in the retina. This kind of required, completed post-marketing safety study is a real part of how this drug class continues to be monitored after approval.
How it compares
Levitra vs. Viagra vs. Cialis
| Feature | Levitra® (Vardenafil) | Viagra® (Sildenafil) | Cialis® (Tadalafil) |
|---|---|---|---|
| FDA approval | 2003 | 1998 | 2003 |
| Onset | 30–60 min | 30–60 min | ~30–45 min, up to 2 hrs |
| Duration | 4–5 hours | 4–5 hours | Up to 36 hours |
| Food sensitivity | Notable delay with high-fat meals | Notable delay with high-fat meals | Largely unaffected by food |
| QT prolongation warning | Yes — distinguishing feature | Not to the same degree | Not to the same degree |
| Available generic | Yes | Yes | Yes |
Is it right for you?
Who typically considers Levitra
Men who haven’t responded well to sildenafil, or tolerate vardenafil better
Men without a personal or family history of long QT syndrome or arrhythmia
Men not currently taking Class IA or Class III antiarrhythmic medications
Men comfortable with the same food-timing considerations as sildenafil
Common questions
Frequently asked questions
Is Levitra safe for my heart?
Like all PDE5 inhibitors, Levitra is contraindicated with nitrate medications. It also carries a distinct QT-interval effect documented on its FDA label, meaning it should be avoided with certain antiarrhythmic medications and used cautiously in men with a personal or family history of long QT syndrome. Discuss your full medication list and any heart rhythm history with your prescriber.
Are Levitra and Staxyn the same thing?
Both contain vardenafil, but Staxyn® is an orally disintegrating 10mg tablet approved separately in 2010, and it is not interchangeable milligram-for-milligram with the standard Levitra tablet. Follow your prescriber’s specific dosing instructions for whichever formulation you’re prescribed.
Does food affect how well Levitra works?
Yes. A high-fat meal can meaningfully delay and reduce Levitra’s effect, similarly to sildenafil. Taking it on an emptier stomach generally gives more predictable timing.
Related
Other ED medications
Talk to a provider about Levitra
Search our directory of vetted physicians, or ask in the forum to hear from men who have tried it.
Key sources: FDA prescribing information for LEVITRA (vardenafil), NDA 021400 · FDA Phase IV commitment retinal function study, NCT00461565
This page is for informational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Always consult a licensed physician before starting or changing any medication. Levitra® and Staxyn® are registered trademarks of Bayer. PhallusMD does not endorse specific providers or products.
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