Vardenafil — evidence‑based review (general information, not medical advice)

Quick summary

• Vardenafil is a prescription medicine used to help treat erectile dysfunction (ED).
• It belongs to a drug class called PDE‑5 inhibitors, which help increase blood flow to the penis during sexual stimulation.
• Large clinical trials show it is more effective than placebo for many men with ED.
• It does not increase sexual desire and does not work without sexual arousal.
• Side effects are usually mild to moderate but can be serious in rare cases.

What is known

What vardenafil is

Vardenafil is an oral medication approved in many countries for the treatment of erectile dysfunction.
Erectile dysfunction means difficulty achieving or maintaining an erection firm enough for sexual activity.
Vardenafil is sold under brand names such as Levitra® and Staxyn® (availability varies by country).

How it works (mechanism of action)

Vardenafil is a phosphodiesterase type 5 (PDE‑5) inhibitor. During sexual stimulation, nitric oxide is released in penile tissue.
This leads to increased levels of a chemical messenger called cyclic GMP (cGMP), which relaxes smooth muscle and allows more blood to flow into the penis.
PDE‑5 normally breaks down cGMP. By inhibiting PDE‑5, vardenafil helps cGMP stay active longer, supporting an erection.

Evidence for effectiveness

Multiple randomized, placebo‑controlled trials have shown that vardenafil improves erectile function scores compared with placebo.
Benefits have been observed in men with ED from different causes, including diabetes, aging, and psychological factors.
Improvements are typically measured using validated tools such as the International Index of Erectile Function (IIEF).

How quickly it acts and how long it lasts

Evidence suggests that vardenafil may start working within about 30–60 minutes for many users.
Its effects generally last several hours, but it is not intended to provide continuous erectile support throughout the day.
Individual response varies based on health status, food intake, and other medications.

Safety profile and common side effects

The most commonly reported side effects include headache, flushing, nasal congestion, indigestion, and dizziness.
These effects are usually mild and temporary.
Rare but serious adverse events can include sudden vision or hearing changes and prolonged erections (priapism), which require urgent medical care.

What is unclear / where evidence is limited

While vardenafil has been studied extensively, some areas remain uncertain:

• Long‑term outcomes: Most studies focus on short‑ to medium‑term use; data on very long‑term continuous use are limited.
• Comparisons between PDE‑5 inhibitors: Head‑to‑head trials comparing vardenafil directly with sildenafil or tadalafil are limited and results are mixed.
• Use in complex medical conditions: Evidence is less robust for men with severe heart disease, advanced kidney or liver disease, or multiple interacting medications.
• Psychological factors: Medication alone may not fully address ED when anxiety, depression, or relationship issues are major contributors.

Overview of approaches

Management of erectile dysfunction often involves more than one approach. Vardenafil is one option within a broader framework that may include:

• Medical evaluation: Identifying underlying causes such as cardiovascular disease, diabetes, or hormonal issues.
• Lifestyle measures: Regular physical activity, stopping smoking, moderating alcohol intake, and managing stress.
• Medication options: PDE‑5 inhibitors like vardenafil, sildenafil, tadalafil, or avanafil.
• Non‑drug options: Vacuum erection devices, counseling, or other therapies depending on the cause.

Typical dosing ranges for vardenafil are described in official prescribing information from regulatory agencies.
For example, the U.S. FDA label provides standardized dosing guidance and safety warnings:
FDA prescribing information for vardenafil.
Dosage decisions should always be made with a licensed healthcare professional.

Statement	Confidence level	Why
Vardenafil improves erectile function compared with placebo	High	Supported by multiple randomized controlled trials and regulatory approval
Vardenafil works for all causes of ED	Medium	Effective in many causes, but response varies and may be limited by severe disease
Vardenafil is safer or more effective than other PDE‑5 inhibitors	Low	Few direct comparison trials and mixed results
Long‑term daily use has well‑defined benefits and risks	Low	Limited long‑term continuous‑use data

Practical recommendations

The following general points may help individuals considering or already using vardenafil:

• Seek medical advice first: ED can be an early sign of cardiovascular disease or other health problems.
• Review medications: Some drugs, especially nitrates and certain heart medications, can interact dangerously with vardenafil.
• Watch for warning signs: Chest pain, fainting, vision loss, or erections lasting longer than four hours require urgent care.
• Prepare for a consultation: Be ready to discuss symptoms, medical history, current medications, and lifestyle factors.

For broader background reading, you may find these related pages useful:
Understanding erectile dysfunction,
How prescription medicines are evaluated,
Men’s health basics.

Sources

• U.S. Food and Drug Administration (FDA). Vardenafil prescribing information.
• European Association of Urology (EAU). Guidelines on Sexual and Reproductive Health.
• National Institute for Health and Care Excellence (NICE). Erectile dysfunction overview.
• Mayo Clinic. Erectile dysfunction and PDE‑5 inhibitors.