Vardenafil — evidence-based review (for educational purposes only)

Disclaimer: This article is for informational and educational purposes only. It does not replace medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional regarding personal medical decisions.

Quick summary

• Vardenafil is a prescription medication used to treat erectile dysfunction (ED) in adult men.
• It belongs to a class of drugs called PDE5 inhibitors, which improve blood flow to the penis during sexual stimulation.
• Clinical trials show it is effective for many men with ED, including those with diabetes or after prostate surgery.
• Common side effects include headache, flushing, nasal congestion, and indigestion; serious side effects are rare but possible.
• It should not be used with nitrates or certain heart medications due to risk of severe low blood pressure.

What is known

What vardenafil is and how it works

Vardenafil is an oral medication approved for the treatment of erectile dysfunction. It works by inhibiting the enzyme phosphodiesterase type 5 (PDE5). This enzyme breaks down cyclic guanosine monophosphate (cGMP), a molecule that helps relax smooth muscle in blood vessels.

When a man is sexually stimulated, nitric oxide is released in the penis, increasing cGMP levels. By blocking PDE5, vardenafil helps maintain higher cGMP levels, allowing better blood flow and facilitating an erection. Importantly, the drug does not cause an erection without sexual stimulation.

Effectiveness in clinical studies

Randomized controlled trials and meta-analyses have consistently shown that PDE5 inhibitors, including vardenafil, significantly improve erectile function compared to placebo. Improvements are typically measured using validated questionnaires such as the International Index of Erectile Function (IIEF).

Evidence suggests that vardenafil:

• Improves the ability to achieve and maintain erections sufficient for intercourse.
• Is effective in men with diabetes-related ED.
• May help men with ED after prostate surgery, although response rates may be lower in severe nerve damage.

Major urological associations, such as the European Association of Urology (EAU), recommend PDE5 inhibitors as first-line therapy for ED, unless contraindicated.

Safety profile and common side effects

Vardenafil is generally well tolerated. The most commonly reported side effects include:

• Headache
• Facial flushing
• Nasal congestion
• Dyspepsia (indigestion)
• Dizziness

These effects are usually mild to moderate and temporary. Rare but serious risks include:

• Sudden vision or hearing changes
• Priapism (an erection lasting more than 4 hours)
• Significant drop in blood pressure, especially when combined with nitrates

Who should not use vardenafil

Vardenafil is contraindicated in men who:

• Use nitrate medications (e.g., nitroglycerin) for chest pain
• Have certain serious cardiovascular conditions
• Are advised to avoid sexual activity due to cardiac risk

Men taking alpha-blockers or certain antiarrhythmic medications may require careful evaluation before use. Full prescribing information is available from regulatory authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

What is unclear / where evidence is limited

Although vardenafil has been studied extensively, some areas remain less certain:

• Long-term comparative effectiveness: Direct head-to-head trials comparing vardenafil with other PDE5 inhibitors over many years are limited.
• Use in complex medical cases: Evidence is less robust in men with severe neurological disorders or advanced cardiovascular disease.
• Psychological components of ED: While the medication improves blood flow, outcomes may vary when ED is primarily psychogenic.
• Real-world adherence: Many studies are short-term; long-term satisfaction and continued use depend on multiple factors, including partner dynamics and expectations.

As with many medications, clinical trial participants may not fully represent all patient populations.

Overview of approaches

Management of erectile dysfunction typically follows a stepwise, evidence-based approach.

1. Lifestyle and risk factor modification

Guidelines emphasize improving cardiovascular health. Measures may include:

• Regular physical activity
• Smoking cessation
• Weight management
• Control of blood pressure and diabetes

Because ED can be an early marker of cardiovascular disease, evaluation of heart health is often recommended. You may find related discussions in our Blog articles on men’s health.

2. Oral medications (PDE5 inhibitors)

Vardenafil is one of several approved PDE5 inhibitors. Others include sildenafil, tadalafil, and avanafil. Choice depends on factors such as duration of action, side effects, cost, and patient preference.

Typical dosing information is described in official prescribing documents (for example, the FDA-approved label available via the FDA database linked above). Patients should follow their physician’s instructions and not adjust doses without consultation.

3. Other medical options

• Vacuum erection devices
• Penile injections (e.g., alprostadil)
• Hormone therapy in men with confirmed testosterone deficiency
• Surgical penile implants in selected cases

For general educational materials, see our Sin categoría resources section.

4. Psychological and relationship support

When stress, anxiety, or relationship factors contribute to ED, counseling or sex therapy may improve outcomes, alone or combined with medication.

Evidence table

Statement	Confidence level	Why
Vardenafil improves erectile function compared to placebo.	High	Supported by multiple randomized controlled trials and guideline endorsements.
Vardenafil is effective in men with diabetes-related ED.	High	Demonstrated in subgroup analyses and dedicated clinical trials.
Vardenafil is superior to other PDE5 inhibitors.	Low to Medium	Limited long-term head-to-head trials; differences are generally modest.
ED treatment with PDE5 inhibitors improves overall cardiovascular outcomes.	Low	Observational signals exist, but causality has not been firmly established.

Practical recommendations

General safety measures

• Do not combine vardenafil with nitrates or recreational “poppers.”
• Inform your doctor about all medications and supplements you take.
• Seek emergency care for chest pain during sexual activity.
• Seek urgent help if an erection lasts longer than 4 hours.

When to see a doctor

• If ED persists for more than a few weeks.
• If you have heart disease, diabetes, or high blood pressure.
• If you experience sudden vision or hearing changes.
• If ED is causing emotional distress or relationship strain.

How to prepare for a consultation

• List your symptoms and how long they have been present.
• Note all current medications, including over-the-counter products.
• Be ready to discuss lifestyle factors (smoking, alcohol, exercise).
• Consider whether stress, anxiety, or relationship issues may play a role.

For broader discussions about sexual health and prevention, explore our health education blog section.

Sources

• European Association of Urology (EAU). Guidelines on Sexual and Reproductive Health. Available at: https://uroweb.org/guidelines/sexual-and-reproductive-health
• U.S. Food and Drug Administration (FDA). Drug approval database and prescribing information for vardenafil (Levitra). Available at: https://www.accessdata.fda.gov/
• European Medicines Agency (EMA). Levitra (vardenafil) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/levitra
• American Urological Association (AUA). Erectile Dysfunction Guideline. Available at: https://www.auanet.org/guidelines