Non-peptide

Vardenafil

Vardenafil is FDA-approved for erectile dysfunction, first as Levitra. For that use the evidence grade is strong-human. With nitrate heart drugs, it can drop blood pressure dangerously. The brand tablets are discontinued, and FDA keeps finding vardenafil hidden in products sold as supplements.

fda-approvedchecked Evidence grade strong-human · our assessmentVerified

This page has not been individually reviewed by a clinician.

Fact sheet · 6 facts

every row cites its source and its date
FactValueTierCheckedSource
Also calledLevitra, Staxynprimaryaccessdata.fda.gov
Classnon-peptideprimaryaccessdata.fda.gov
Regulatory statusfda-approvedprimaryaccessdata.fda.gov
Status source read2026-10-26primaryaccessdata.fda.gov
Evidence gradestrong-humanour assessmentpeptideindex.ai
Label dosingFrom the Levitra and Staxyn labels. Levitra is taken as needed, about 60 minutes before sex, no more than once a day. Most men start with 10 mg, which may go up to 20 mg or down to 5 mg. Men on a stable alpha-blocker and men with moderate liver disease start at 5 mg. For men 65 or older, the label says to consider a 5 mg start. Some drugs, such as ritonavir, limit the dose to 2.5 mg in 24 or 72 hours. Staxyn is one 10 mg tablet that melts on the tongue, taken without liquid, no more than once a day. It is not swapped mg for mg with Levitra. The prescriber sets the dose.primaryaccessdata.fda.gov

Short answer

Vardenafil is FDA-approved for erectile dysfunction, first as Levitra. For that use the evidence grade is strong-human. With nitrate heart drugs, it can drop blood pressure dangerously. The brand tablets are discontinued, and FDA keeps finding vardenafil hidden in products sold as supplements.

Our assessment, drawn from the sources below.

What it is

Vardenafil is a drug that blocks an enzyme called PDE5 [1] [2]. It is not a peptide.

It treats erectile dysfunction, which means trouble getting or keeping an erection [1]. As Levitra, it is a tablet taken by mouth about an hour before sex [1]. As Staxyn, it is a tablet that melts on the tongue [2]. Sexual stimulation is still needed for it to help [1]. FDA first approved vardenafil as Levitra in 2003 [3] [5].

What the evidence shows

Evidence grade: strong-human · our assessment

The evidence grade is strong-human for erectile dysfunction [1] [12] [15]. In a 2003 trial, men with erectile dysfunction took vardenafil or a dummy pill for 26 weeks [12]. All three doses beat the dummy pill on every main measure [12]. A 2021 review of 14 trials with 3,221 men found the same [15]. The review said the best dose and length of use are not settled [15].

In a 2003 trial, 440 men had erectile dysfunction after prostate surgery [13]. Better erections were reported by about 6 in 10 on vardenafil and about 1 in 8 on the dummy pill [13]. A 2008 trial of 628 men tested it right after prostate surgery [14]. Taken nightly, it did not bring back natural erections better than the dummy pill [14].

In a 2009 study in rats with diabetes, vardenafil helped heart and blood vessel function [18]. Nobody has shown this in people.

Known risks

  • Taken with nitrate heart drugs, such as nitroglycerin, it can drop blood pressure to dangerous levels. Both labels say never to combine them [1] [2].
  • The labels say no one knows how long after a dose a nitrate can be given without that danger [1].
  • Both labels also say not to take it with riociguat, a drug for high blood pressure in the lungs [1] [2].
  • It can change the heart's rhythm, measured as the QT interval. People born with a long QT, or on some heart rhythm drugs, should avoid it [1] [2].
  • Some drugs, such as ritonavir and some antibiotics and antifungals, raise its level in the blood. The labels limit or bar its use with them [1] [2].
  • Sudden loss of sight in one or both eyes has been reported. It can be a sign of damage to the nerve of the eye, called NAION [1] [16].
  • Sudden loss of hearing has been reported. The labels say to stop it and get medical care right away [1] [2].
  • An erection that lasts more than 4 hours needs emergency care [1] [2].
  • Taken with alpha-blockers or other blood pressure drugs, it can lower blood pressure too far, and some people faint [1].
  • Men whose heart is too weak for sex should not use it [1] [2].
  • The labels say not to use it on kidney dialysis or with severe liver disease [1] [2].
  • Staxyn holds phenylalanine, which can harm people with phenylketonuria. It is not the same as a Levitra tablet and cannot be swapped for one [2].
  • In the label's studies, the most common problems were headache, flushing, a stuffy nose and upset stomach [1] [12].
  • Products sold as supplements may hold hidden vardenafil. A person on nitrates may take it without knowing [8] [9].

What nobody knows yet

  • Nobody knows for sure if the drug itself causes NAION. The 2015 study was observational, so it shows a link, not proof of cause [1] [16].
  • A 2021 review found vardenafil helped erections. It said the best dose and length of use are still not settled [15].
  • In a 2008 trial, men took it every night after prostate surgery. Their own erections came back no better than on a dummy pill [14].
  • It is not known if inhaled vardenafil helps people with high blood pressure in the lungs. A US study tested a single inhaled dose [19].
  • A 2009 study in diabetic rats found it helped heart and blood vessel function. Nobody has shown this in people [18].
  • Nobody can say which products sold as supplements hide vardenafil. FDA says it cannot test every such product [9].

Legitimate ways to get it

The legal way to get vardenafil is a prescription [1] [2]. Levitra and Staxyn are approved for erectile dysfunction, though Drugs@FDA lists both brands as discontinued [3] [4]. FDA may keep approving generic copies that refer to Levitra [5].

Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [6].

No trial of vardenafil is open now. Past US trials tested it with a dummy pill and as an inhaled powder [19] [20]. The trials block on this page lists open trials with their dates.

  • Approved product

    Approved by FDA as a prescription tablet for erectile dysfunction. Drugs@FDA lists the brand as discontinued; FDA may keep approving generic copies that refer to it.

    Brand names: Levitra

    Manufacturer: Bayer HealthCare

    Indication: Treatment of erectile dysfunction.

    accessdata.fda.gov

  • Approved product

    Approved by FDA as a prescription tablet that melts on the tongue, for erectile dysfunction. Drugs@FDA lists it as discontinued.

    Brand names: Staxyn

    Manufacturer: Bayer HealthCare

    Indication: Treatment of erectile dysfunction.

    accessdata.fda.gov

  • Lawful compounding

    Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.

    fda.gov

Recruiting trials

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

No open trials in the snapshot of .clinicaltrials.gov

How people are getting it anyway

This section describes what happens and is not a recommendation.

One way of getting vardenafil outside a prescription shows up in FDA's records [8] [9] [11]. It is products sold as supplements for sexual enhancement with vardenafil hidden inside. FDA lab tests found it in such products, and their labels did not list it [8] [9] [10]. FDA warned about such products in 2016, 2020 and 2023 [8] [9] [10]. In 2025, FDA found a pain reliever hidden in one of them too [10].

In 2021, FDA said it bought 26 sexual enhancement products on one large website [11]. Each held sildenafil, tadalafil or vardenafil, and no label listed it [11]. A 2018 study of FDA warnings found hidden drugs were common in sexual enhancement supplements [17] [21]. FDA warns the hidden drug can react with nitrates and drop blood pressure to dangerous levels [8] [9].

  • Counterfeit or diverted

    Products sold as dietary supplements for sexual enhancement with vardenafil hidden inside and not listed on the label.

    The lawFDA says a product with vardenafil cannot be a dietary supplement, because Levitra was approved first, and one with undeclared vardenafil is a misbranded drug.fda.gov

    Documented riskFDA warns the hidden drug may react with nitrates, such as nitroglycerin, and lower blood pressure to dangerous levels.fda.gov

    Documented riskFDA says it cannot test every product sold as a supplement for hidden drugs.fda.gov

    Documented riskFDA lab tests found a pain reliever not listed on the label in one such product, which could lead to a liver-harming overdose.fda.gov

    Enforcement FDA told consumers not to buy or use a sexual enhancement product its lab found to hold vardenafil.fda.gov

    Enforcement FDA told consumers not to buy or use a sexual enhancement product bought online that its lab found to hold vardenafil.fda.gov

    Enforcement FDA warning letter to an online retailer that shipped products sold as supplements with undeclared sildenafil, tadalafil or vardenafil.fda.gov

    Enforcement FDA told consumers not to buy or use a sexual enhancement product its lab found to hold tadalafil and vardenafil.fda.gov

Sources

  1. [1]Levitra (vardenafil) tablets label, revised March 2023Label · primary
  2. [2]Staxyn (vardenafil) orally disintegrating tablets label, revised April 2023Label · primary
  3. [3]Drugs@FDA: Levitra (vardenafil) tablets, application 021400Regulatory · primary
  4. [4]Drugs@FDA: Staxyn (vardenafil) orally disintegrating tablets, application 200179Regulatory · primary
  5. [5]Federal Register: Levitra tablets were not withdrawn for reasons of safety or effectiveness, 3 May 2023Regulatory · primary
  6. [6]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
  7. [7]FDA: 503A bulk drug substances category listRegulatory · primary
  8. [8]FDA public notification: sexual enhancement product with hidden vardenafil, 2016Regulatory · primary
  9. [9]FDA public notification: sexual enhancement product bought online with hidden vardenafil, 2020Regulatory · primary
  10. [10]FDA public notification: sexual enhancement product with hidden tadalafil and vardenafil, 2023 and 2025Regulatory · primary
  11. [11]FDA warning letter on products sold as supplements with undeclared sildenafil, tadalafil or vardenafil, 26 July 2021Regulatory · primary
  12. [12]Randomized 26-week trial: vardenafil for erectile dysfunction, 2003Rct · peer-reviewed
  13. [13]Randomized trial: vardenafil for erectile dysfunction after prostate removal, 2003Rct · peer-reviewed
  14. [14]Randomized trial: nightly or as-needed vardenafil after nerve-sparing prostate removal, 2008Rct · peer-reviewed
  15. [15]Systematic review and meta-analysis: vardenafil for erectile dysfunction, 2021Systematic review · peer-reviewed
  16. [16]Case-crossover study: sudden optic nerve damage (NAION) and PDE5 inhibitor use, 2015Human trial · peer-reviewed
  17. [17]Study: unapproved drug ingredients in dietary supplements named in FDA warnings, 2007 to 2016Reference · peer-reviewed
  18. [18]Rat study: vardenafil and heart function in experimental diabetes, 2009Animal · peer-reviewed
  19. [19]ClinicalTrials.gov NCT04266197: inhaled vardenafil in pulmonary arterial hypertensionReference · primary
  20. [20]ClinicalTrials.gov NCT00379756: vardenafil compared with placebo in erectile dysfunctionReference · primary
  21. [21]CNN: nearly 800 dietary supplements contain unapproved drug ingredients, October 2018Reference · established-news

Last verified · 6 facts · 9 sources

Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021400

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Information, not medical advice.

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