Levitra (Vardenafil)

PDE5 Inhibitor for Erectile Dysfunction

Rx – Prescription Only ATC: G04BE09 PDE5 Inhibitor
Active Ingredient
Vardenafil (as hydrochloride)
Available Forms
Film-coated tablets
Strengths
5 mg, 10 mg
Common Brands
Levitra, Vardenafil STADA, Vardenafil Accord
Medically reviewed | Last reviewed: | Evidence level: 1A
Levitra (vardenafil) is a prescription medication used to treat erectile dysfunction (ED) in adult men. It belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which work by increasing blood flow to the penis during sexual stimulation. Vardenafil is taken as a film-coated tablet approximately 25 to 60 minutes before sexual activity and requires sexual arousal to be effective.
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Quick Facts About Levitra

Active Ingredient
Vardenafil
(as hydrochloride salt)
Drug Class
PDE5i
PDE5 Inhibitor
ATC Code
G04BE09
Urologicals
Common Uses
ED
Erectile Dysfunction
Available Forms
Tablets
5 mg and 10 mg
Prescription Status
Rx Only
Prescription required

Key Takeaways About Levitra

  • Effective ED treatment: Levitra (vardenafil) is a proven PDE5 inhibitor that helps men achieve and maintain erections during sexual stimulation, with effects lasting 4–5 hours
  • Take 25–60 minutes before activity: The recommended starting dose is 10 mg taken approximately 25 to 60 minutes before sexual activity, with a maximum of one dose per day
  • Never combine with nitrates: Taking Levitra with nitrate medications (used for chest pain) or nitric oxide donors can cause a severe, life-threatening drop in blood pressure
  • Avoid heavy meals and grapefruit: A high-fat meal can delay the onset of action, and grapefruit juice can unpredictably increase drug levels in the blood
  • Seek immediate help for prolonged erections: An erection lasting more than 4 hours (priapism) requires urgent medical attention to prevent permanent damage

What Is Levitra and What Is It Used For?

Levitra contains the active ingredient vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED) in adult men. It works by enhancing the natural erectile response when a man is sexually stimulated, making it easier to achieve and maintain an erection sufficient for satisfactory intercourse.

Erectile dysfunction is a common condition affecting at least 1 in 10 men at some point in their lives. It is defined as the persistent inability to achieve or maintain an erection firm enough for sexual intercourse. The causes can be physical (such as cardiovascular disease, diabetes, hormonal imbalances, or neurological conditions), psychological (anxiety, depression, stress, or relationship issues), or a combination of both. Regardless of the underlying cause, the physiological mechanism involves insufficient blood flow to the erectile tissue of the penis.

Under normal circumstances, sexual stimulation triggers the release of nitric oxide (NO) from nerve endings and endothelial cells in the corpus cavernosum of the penis. Nitric oxide activates the enzyme guanylate cyclase, which increases levels of cyclic guanosine monophosphate (cGMP). Elevated cGMP causes the smooth muscle cells in the penile arteries and the corpus cavernosum to relax, allowing increased blood flow into the penis and resulting in an erection. The erection subsides when cGMP is broken down by the enzyme phosphodiesterase type 5 (PDE5).

Vardenafil works by selectively inhibiting PDE5, thereby slowing the breakdown of cGMP. This allows cGMP to accumulate to higher levels and persist for longer, which prolongs and enhances the smooth muscle relaxation and blood flow that produce an erection. It is critical to understand that Levitra does not cause erections on its own – it requires sexual stimulation to trigger the release of nitric oxide. Without sexual arousal, vardenafil has no effect on penile blood flow.

Clinical trials have demonstrated that vardenafil significantly improves erectile function across a wide range of patient populations, including men with diabetes mellitus, those who have undergone radical prostatectomy, and men with varying degrees of ED severity. The European Association of Urology (EAU) and the American Urological Association (AUA) both recommend PDE5 inhibitors as first-line pharmacotherapy for erectile dysfunction.

Good to know:

Levitra was first approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in 2003. It is available as a branded product (Levitra, manufactured by Bayer AG) and in several generic formulations (e.g. Vardenafil STADA, Vardenafil Accord). Generic vardenafil contains the same active ingredient at the same dose and is considered bioequivalent to the branded product.

What Should You Know Before Taking Levitra?

Before taking Levitra, inform your doctor about all your medical conditions, especially cardiovascular disease, liver or kidney problems, and any other medications you are taking. Levitra has several absolute contraindications, including concurrent use of nitrates and certain antiviral medications.

Contraindications

You should not take Levitra if any of the following apply to you:

  • Allergy to vardenafil or any other ingredient in the tablet – signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and difficulty breathing
  • History of severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis after taking vardenafil
  • Taking nitrate medications (such as glyceryl trinitrate for angina) or nitric oxide donors (such as amyl nitrite, sometimes known as “poppers”) – the combination can cause a dangerous, potentially fatal drop in blood pressure
  • Taking ritonavir or indinavir (HIV protease inhibitors) – these drugs significantly increase vardenafil blood levels
  • Aged over 75 years and taking ketoconazole or itraconazole (antifungal medications)
  • Severe heart or liver disease – the risks of sexual activity and the drug itself may be too great
  • Currently receiving kidney dialysis (end-stage renal disease)
  • Recent stroke or heart attack – your cardiovascular system needs time to recover before sexual activity is safe
  • Low blood pressure (hypotension) – vardenafil can lower blood pressure further
  • Hereditary retinal disorders (such as retinitis pigmentosa)
  • History of non-arteritic anterior ischaemic optic neuropathy (NAION) – a condition involving sudden vision loss due to reduced blood supply to the optic nerve
  • Taking riociguat (used for pulmonary arterial hypertension) – PDE5 inhibitors amplify the blood pressure-lowering effect of riociguat

Warnings and Precautions

Talk to your doctor or pharmacist before taking Levitra if you have or have had any of the following conditions:

  • Heart problems – sexual activity carries a degree of cardiovascular risk. Your doctor should assess your fitness for sexual activity before prescribing Levitra. The EAU recommends stratifying cardiovascular risk using the Princeton III Consensus before prescribing PDE5 inhibitors
  • Heart rhythm disorders (arrhythmias) or congenital heart conditions affecting the ECG, particularly a prolonged QT interval
  • Anatomical deformities of the penis – conditions such as Peyronie’s disease, penile angulation, or cavernosal fibrosis may increase the risk of complications
  • Conditions predisposing to priapism – sickle cell disease, multiple myeloma, and leukaemia can increase the risk of prolonged, painful erections that require emergency treatment
  • Peptic ulcer disease (gastric or duodenal ulcers)
  • Bleeding disorders such as haemophilia – vardenafil’s vasodilatory effects may theoretically worsen bleeding
  • Using other ED treatments concurrently – do not combine Levitra film-coated tablets with other PDE5 inhibitors or other erectile dysfunction therapies
Serious skin reactions:

Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with vardenafil use. Stop taking Levitra and seek immediate medical attention if you develop a rash with blistering, skin peeling, sores in your mouth, throat, nose, or genitals, or if you experience fever and flu-like symptoms followed by a widespread painful rash.

Vision and hearing changes:

If you experience sudden loss or decrease in vision (partial or complete) in one or both eyes, or if your vision becomes distorted, blurred, or dim while taking Levitra, stop taking the medication immediately and contact your doctor. Sudden hearing loss or deafness has also been reported. These events require urgent medical evaluation.

Pregnancy and Breastfeeding

Levitra is not intended for use by women. It is prescribed exclusively for the treatment of erectile dysfunction in adult men. There are no clinical data on the use of vardenafil in pregnant or breastfeeding women, and the drug should not be used by women under any circumstances.

Children and Adolescents

Levitra is not indicated for use in children or adolescents under 18 years of age. There are no paediatric indications for vardenafil, and its safety and efficacy have not been established in this population.

Driving and Operating Machinery

Levitra can cause dizziness or affect vision in some individuals. If you experience these symptoms after taking the medication, you should not drive or operate machinery until the effects have fully resolved. Be particularly cautious the first time you take Levitra, as you will not yet know how the medication affects you personally.

How Does Levitra Interact with Other Drugs?

Levitra has clinically significant interactions with several classes of medication, most critically with nitrates (absolutely contraindicated), HIV protease inhibitors, antifungal agents, certain antibiotics, alpha-blockers, and antiarrhythmic drugs. Always tell your doctor about all medications you are taking.

Vardenafil is primarily metabolised by the liver enzyme CYP3A4, with minor contributions from CYP2C9. Drugs that inhibit CYP3A4 can significantly increase vardenafil blood levels, while drugs that induce it can decrease them. Additionally, vardenafil has pharmacodynamic interactions with medications that affect blood pressure, heart rhythm, or the nitric oxide–cGMP pathway. The following tables summarise the most important clinical interactions.

Major Interactions (Contraindicated or Avoid)

Major Drug Interactions with Levitra
Drug Category Effect Recommendation
Nitroglycerin / Isosorbide mononitrate Nitrates (angina treatment) Severe, potentially life-threatening hypotension due to synergistic vasodilation via the NO–cGMP pathway Absolutely contraindicated. Never combine
Amyl nitrite (“poppers”) Nitric oxide donor (recreational) Severe hypotension, syncope, cardiovascular collapse Absolutely contraindicated. Never combine
Ritonavir / Indinavir HIV protease inhibitors Very strong CYP3A4 inhibition dramatically increases vardenafil levels (up to 49-fold with ritonavir) Contraindicated with ritonavir and indinavir
Riociguat Guanylate cyclase stimulator (pulmonary hypertension) Additive hypotensive effect via the cGMP pathway Contraindicated. Do not combine
Quinidine / Procainamide / Amiodarone / Sotalol Class IA and III antiarrhythmics Potential additive QT prolongation and risk of cardiac arrhythmias Avoid combination. Seek specialist advice

Moderate Interactions (Use with Caution)

Moderate Drug Interactions with Levitra
Drug Category Effect Recommendation
Ketoconazole / Itraconazole Antifungal agents Potent CYP3A4 inhibition increases vardenafil blood levels significantly Reduce vardenafil dose. Contraindicated in patients over 75 years
Erythromycin / Clarithromycin Macrolide antibiotics CYP3A4 inhibition increases vardenafil levels (approximately 4-fold with erythromycin) Reduce vardenafil dose to 5 mg when combined with erythromycin or clarithromycin
Alpha-adrenergic blockers (tamsulosin, doxazosin, terazosin) Prostate / hypertension treatment Additive blood pressure-lowering effect; risk of symptomatic hypotension and dizziness Stabilise alpha-blocker dose first. Start vardenafil at 5 mg. Separate doses by at least 6 hours
Other antihypertensives (ACE inhibitors, ARBs, beta-blockers, diuretics) Blood pressure medications Additive blood pressure lowering Monitor blood pressure. Generally well tolerated but use with awareness

Food, Drink, and Grapefruit

Levitra can be taken with or without food, but the onset of action may be delayed if taken after a heavy or high-fat meal. For the fastest onset of effect, take Levitra on an empty stomach or after a light meal.

You should avoid grapefruit juice while taking Levitra. Grapefruit inhibits CYP3A4 in the gut wall, which can lead to increased and unpredictable vardenafil blood levels, potentially amplifying both therapeutic effects and side effects.

Alcohol: While there is no absolute contraindication, alcohol consumption can independently worsen erectile function and may increase the risk of side effects such as dizziness, headache, and low blood pressure. It is advisable to limit alcohol intake when using Levitra.

What Is the Correct Dosage of Levitra?

The recommended starting dose for most men is 10 mg, taken approximately 25 to 60 minutes before sexual activity. Your doctor may adjust the dose to 5 mg based on efficacy and tolerability. Do not take more than one dose per day.

Always take Levitra exactly as your doctor has prescribed. Do not change your dose without consulting your doctor. Swallow the tablet whole with a glass of water. Levitra should only be taken when needed, before planned sexual activity – it is not a medication that you take every day.

Adults

Erectile Dysfunction

Recommended starting dose: 10 mg, taken approximately 25–60 minutes before sexual activity

Dose adjustment: Your doctor may reduce the dose to 5 mg if 10 mg is too strong, or if side effects are troublesome

Maximum frequency: One tablet per day (once in any 24-hour period)

With sexual stimulation, you may achieve an erection from approximately 25 minutes up to 4–5 hours after taking the tablet. Levitra does not cause an erection without sexual stimulation.

Dose Adjustments for Specific Populations

Hepatic Impairment (Liver Disease)

Mild to moderate impairment: Start with 5 mg. Your doctor may increase cautiously based on response and tolerability.

Severe impairment: Levitra is contraindicated.

Renal Impairment (Kidney Disease)

Mild to moderate impairment: No dose adjustment required.

Severe impairment / dialysis: Levitra is contraindicated in patients on kidney dialysis.

Patients Taking CYP3A4 Inhibitors

With erythromycin or clarithromycin: Maximum dose 5 mg.

With ketoconazole or itraconazole: Maximum dose 5 mg (contraindicated if over 75 years).

With ritonavir or indinavir: Contraindicated – do not use.

Elderly Patients (65 years and older)

No routine dose adjustment is required based on age alone. However, elderly patients may be more susceptible to side effects and drug interactions, so doctors may start with a lower dose and adjust based on tolerability.

Overdose

Overdose Warning:

Taking more Levitra than prescribed may increase the frequency and severity of side effects, including severe back pain, muscle pain, and visual disturbances. There is also an increased risk of priapism (a painful erection lasting more than 4 hours), which is a medical emergency requiring immediate treatment. If you suspect an overdose, contact your doctor or local poison control centre immediately. There is no specific antidote for vardenafil overdose; treatment is supportive and symptomatic.

Children and Adolescents

Levitra is not indicated for use in children or adolescents under 18 years of age. There are no approved paediatric dosing recommendations for vardenafil.

What Are the Side Effects of Levitra?

The most common side effect of Levitra is headache, affecting more than 1 in 10 users. Other common side effects include flushing, nasal congestion, and digestive discomfort. Most side effects are mild to moderate and typically resolve on their own. However, rare but serious side effects – including sudden vision or hearing loss, cardiac events, and priapism – require immediate medical attention.

Like all medicines, Levitra can cause side effects, although not everybody experiences them. Most side effects are mild to moderate in severity and transient in nature. The side effects listed below are categorised by frequency according to regulatory convention.

Seek immediate medical attention if you experience:
  • Sudden partial or complete loss of vision in one or both eyes
  • Distorted, blurred, or dim vision
  • Sudden hearing loss or deafness
  • Chest pain, irregular heartbeat, or severe dizziness
  • An erection lasting more than 4 hours (priapism) – this is a medical emergency
  • Severe skin rash with blistering, peeling, or mouth sores (signs of Stevens-Johnson syndrome)

Very Common

May affect more than 1 in 10 people

  • Headache

Common

May affect up to 1 in 10 people

  • Dizziness
  • Flushing (hot flushes, facial redness)
  • Nasal congestion or runny nose
  • Indigestion (dyspepsia)

Uncommon

May affect up to 1 in 100 people

  • Swelling of the skin, face, lips, or throat (angioedema)
  • Sleep disturbances (insomnia)
  • Numbness or reduced sense of touch
  • Drowsiness or somnolence
  • Visual effects: red eyes, changes in colour perception, eye pain or discomfort, light sensitivity
  • Tinnitus (ringing in the ears), vertigo
  • Rapid heart rate or palpitations
  • Shortness of breath
  • Nasal congestion (stuffy nose)
  • Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, nausea, dry mouth
  • Elevated liver enzymes in blood tests
  • Skin rash, skin redness (erythema)
  • Back or muscle pain, elevated creatine phosphokinase (muscle enzyme), muscle stiffness
  • Prolonged erections
  • General malaise

Rare and Very Rare

May affect up to 1 in 1,000 people or fewer

  • Eye inflammation (conjunctivitis)
  • Allergic reaction
  • Anxiety
  • Fainting (syncope)
  • Memory loss (amnesia)
  • Seizures
  • Increased intraocular pressure (glaucoma), increased tear production
  • Cardiac effects: heart attack, altered heart rhythm, angina
  • High or low blood pressure
  • Nosebleeds (epistaxis)
  • Skin sensitivity to sunlight (photosensitivity)
  • Painful erections (priapism)
  • Chest pain
  • Temporary reduced blood flow to parts of the brain
  • Blood in urine (haematuria), penile bleeding, blood in semen (haematospermia)
  • Sudden death (reported in men with pre-existing cardiovascular disease)
  • Cerebral haemorrhage (brain bleeding)
  • Stevens-Johnson syndrome, toxic epidermal necrolysis (severe skin reactions)
  • Sudden vision loss or distortion (possibly NAION)

Most men who experienced the serious cardiovascular events listed above had pre-existing heart conditions. It is not always possible to determine whether these events were directly caused by vardenafil, the sexual activity itself, or underlying cardiovascular disease. If you experience any side effects not listed here, or if any side effect becomes severe, consult your doctor or pharmacist promptly.

Reporting side effects:

It is important to report suspected adverse reactions after a medicine has been authorised. Reporting helps ensure ongoing monitoring of the medicine’s benefit-risk balance. You can report side effects to your national medicines agency or through the European Medicines Agency’s reporting system.

How Should You Store Levitra?

Store Levitra tablets at room temperature, away from light and moisture, out of the reach and sight of children. Do not use the tablets after the expiry date printed on the packaging.

Keep Levitra in its original blister packaging to protect the tablets from moisture and light. No special temperature storage conditions are required. Check the expiry date (marked “EXP” on the carton) before use; the expiry date refers to the last day of the stated month.

Do not flush unused tablets down the toilet or throw them in household waste. Return any unused or expired medication to your pharmacy for safe and environmentally responsible disposal. Proper pharmaceutical waste disposal protects water supplies and ecosystems from contamination.

What Does Levitra Contain?

Each Levitra film-coated tablet contains vardenafil (as hydrochloride) as its active ingredient, along with several inactive ingredients necessary for tablet manufacture and the film coating.

Active Ingredient

The active substance is vardenafil. Each 5 mg tablet contains 5 mg vardenafil (as vardenafil hydrochloride). Each 10 mg tablet contains 10 mg vardenafil (as vardenafil hydrochloride).

Inactive Ingredients (Excipients)

The other ingredients are:

  • Tablet core: Crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica
  • Film coating: Macrogol 400, hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172)

Tablet Appearance and Packaging

5 mg tablets: Orange, round, film-coated tablets with the BAYER logo on one side and the strength (5) on the other.

10 mg tablets: Orange, round, film-coated tablets with the BAYER logo on one side and the strength (10) on the other.

Available in blister packs of 2, 4, 8, 12, or 20 tablets. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Bayer AG, 51368 Leverkusen, Germany.

How Does Levitra Work in the Body?

Levitra works by selectively inhibiting phosphodiesterase type 5 (PDE5), the enzyme that breaks down cyclic GMP in the penile erectile tissue. By preserving cGMP levels during sexual stimulation, vardenafil enhances and prolongs smooth muscle relaxation and blood flow to the penis, facilitating a firmer and more sustained erection.

The process of achieving an erection is a complex neurovascular event. When a man is sexually aroused, signals from the brain travel along nerve pathways to the penis, where the parasympathetic nerve terminals and endothelial cells release nitric oxide (NO). Nitric oxide activates the enzyme soluble guanylate cyclase in the smooth muscle cells of the corpus cavernosum, which catalyses the conversion of guanosine triphosphate (GTP) to cyclic guanosine monophosphate (cGMP).

Elevated cGMP triggers a cascade of intracellular events that result in the relaxation of smooth muscle fibres in the trabecular arterioles and sinusoidal spaces of the corpus cavernosum. This relaxation allows arterial blood to flow into and fill the expanding sinusoidal spaces, compressing the subtunical venular plexuses against the tunica albuginea. This compression restricts venous outflow, trapping blood within the penis and producing a rigid erection – a mechanism known as the corporal veno-occlusive mechanism.

Under normal physiological conditions, the erection subsides when cGMP is hydrolysed (broken down) by the enzyme PDE5, which is highly concentrated in the corpus cavernosum. Vardenafil selectively inhibits PDE5, slowing the degradation of cGMP. This allows cGMP to accumulate to higher concentrations and persist for longer, thereby enhancing and prolonging the erectile response. Crucially, this mechanism is entirely dependent on the initial release of nitric oxide through sexual stimulation – without arousal, no erection occurs.

Selectivity

Vardenafil is highly selective for PDE5 compared to other phosphodiesterase isoenzymes. It has over 1,000-fold greater selectivity for PDE5 than for PDE1, PDE2, PDE3, and PDE4. This selectivity minimises effects on other organ systems. However, vardenafil does have some activity against PDE6, an enzyme found in the retina, which may account for the occasional visual side effects (changes in colour perception, light sensitivity) reported by some users.

Pharmacokinetic Profile

After oral administration, vardenafil is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations (Cmax) are typically reached within 30 to 120 minutes (median 60 minutes). The absolute bioavailability is approximately 15%, due to extensive first-pass metabolism in the gut wall and liver. Absorption is not significantly affected by food, although a high-fat meal may delay the time to peak concentration by approximately 1 hour.

Vardenafil is highly protein-bound (approximately 95%, primarily to albumin and alpha-1-acid glycoprotein). It is extensively metabolised by the liver, predominantly by CYP3A4 with a minor contribution from CYP2C9. The major circulating metabolite (M1, desethyl vardenafil) has similar PDE5 selectivity but contributes only approximately 7% of the overall pharmacological effect. The terminal elimination half-life is approximately 4–5 hours. The primary route of excretion is via the faeces (approximately 91–95% of the dose), with only about 2–6% excreted in the urine.

Frequently Asked Questions About Levitra

Levitra (vardenafil) is used to treat erectile dysfunction (ED) in adult men. It belongs to the PDE5 inhibitor class and works by increasing blood flow to the penis during sexual stimulation, helping to achieve and maintain an erection sufficient for satisfactory sexual intercourse. It does not increase sexual desire and requires sexual stimulation to work.

Levitra typically begins working within 25 to 60 minutes after taking a tablet. With sexual stimulation, you may achieve an erection within this timeframe. The effects can last for 4 to 5 hours, during which it becomes easier to achieve an erection. The onset may be delayed if taken after a heavy or high-fat meal, so taking it on an empty stomach or after a light meal is recommended for fastest effect.

While moderate alcohol consumption is not absolutely contraindicated with Levitra, alcohol can independently impair erectile function and may increase the risk of side effects such as dizziness, headache, flushing, and low blood pressure. For the best results, it is advisable to limit or avoid alcohol when taking Levitra. Heavy alcohol use can negate the benefits of the medication entirely.

Levitra (vardenafil), sildenafil (Viagra), and tadalafil (Cialis) are all PDE5 inhibitors used to treat erectile dysfunction. They share a similar mechanism of action but differ in their pharmacokinetic profiles. Vardenafil and sildenafil have similar onset times (30–60 minutes) and duration (4–6 hours), while tadalafil has a much longer half-life and can last up to 36 hours. Some studies suggest vardenafil has slightly higher biochemical potency for PDE5. The choice between them depends on individual response, side effect profile, and lifestyle considerations. Consult your doctor to determine which is most appropriate for you.

Levitra is contraindicated in men with severe heart problems, recent heart attack or stroke, very low blood pressure, and those taking nitrates for angina. However, many men with stable, well-controlled cardiovascular conditions can safely use Levitra under medical supervision. The European Association of Urology (EAU) recommends that all men undergo a cardiovascular risk assessment before being prescribed a PDE5 inhibitor. Your doctor will evaluate whether sexual activity is safe for your heart before prescribing this medication.

Grapefruit and grapefruit juice contain furanocoumarins that inhibit the CYP3A4 enzyme in the gut wall and liver. Since vardenafil is primarily metabolised by CYP3A4, consuming grapefruit products can lead to higher and less predictable blood levels of the drug. This can increase the risk of side effects, including headache, flushing, dizziness, and low blood pressure. It is best to avoid all grapefruit products while taking Levitra.

References

This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.

  1. Salonia A, Bettocchi C, Boeri L, et al. EAU Guidelines on Sexual and Reproductive Health. European Association of Urology. Updated 2023. Arnhem: EAU Guidelines Office.
  2. Burnett AL, Nehra A, Breau RH, et al. Erectile Dysfunction: AUA Guideline. Journal of Urology. 2018;200(3):633–641. doi:10.1016/j.juro.2018.05.004
  3. European Medicines Agency (EMA). Levitra (vardenafil) – Summary of Product Characteristics. EMA product information database. Last updated January 2025.
  4. Hatzimouratidis K, Amar E, Eardley I, et al. Guidelines on Male Sexual Dysfunction: Erectile Dysfunction and Premature Ejaculation. European Urology. 2010;57(5):804–814.
  5. Porst H, Rosen R, Padma-Nathan H, et al. The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. International Journal of Impotence Research. 2001;13(4):192–199.
  6. Nehra A, Jackson G, Miner M, et al. The Princeton III Consensus recommendations for the management of erectile dysfunction and cardiovascular disease. Mayo Clinic Proceedings. 2012;87(8):766–778.
  7. World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
  8. British National Formulary (BNF). Vardenafil. NICE BNF monograph. Accessed December 2025.

Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in urology, clinical pharmacology, and sexual medicine.

Medical Writers

Board-certified physicians specialising in urology and clinical pharmacology with documented academic and clinical experience in male sexual health.

Medical Reviewers

Independent review board ensuring clinical accuracy, adherence to international guidelines (EAU, AUA, NICE, WHO), and evidence level 1A standards.

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All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.