Skip to content
Safety information · Internal patient-safety page

Vardenafil safety summary

Vardenafil treats erectile dysfunction by relaxing blood vessels in the penis so blood flow can support an erection during sexual stimulation. Effect onset is fast, often within 25 minutes, with a window of about 4–5 hours.

Vardenafil 5/10/20mg

What it's used for

  • Standard starting dose 10 mg, taken 25–60 minutes before sexual activity, no more than once per day.
  • Available as film-coated tablets and as orodispersible 10 mg tablets that dissolve on the tongue.
  • Sexual stimulation is required for the medicine to work.

Most common side effects

  • Headache.
  • Flushing.
  • Stuffy nose.
  • Indigestion or nausea.
  • Dizziness.

Serious side effects: stop and seek care

  • Erection lasting more than 4 hours (priapism): A&E.
  • Sudden vision loss (NAION) or sudden hearing loss.
  • Chest pain during or shortly after sex: emergency services.
  • Severe allergic reaction.
  • Irregular or prolonged ECG QT changes: relevant if you have a known QT-prolongation risk.

Who should not take it

  • Any nitrate medicine or amyl-nitrite recreational drug (“poppers”).
  • Riociguat or any guanylate-cyclase stimulator.
  • Class III or IV heart failure, severe arrhythmia or known long-QT syndrome.
  • Severe liver impairment, severe kidney impairment requiring dialysis.
  • Recent heart attack, stroke or unstable angina in the last 6 months.

Interactions to flag

  • Class IA / III antiarrhythmics (quinidine, amiodarone): vardenafil is not recommended.
  • Alpha-blockers: talk to the doctor; combination needs careful timing.
  • Strong CYP3A4 inhibitors (ritonavir, ketoconazole, clarithromycin): lower dose required, ritonavir is contraindicated.
  • Other PDE5 inhibitors: never combine.
  • Grapefruit juice can raise plasma levels.

Message us in the app chat if you notice any of these

  • Side effects that persist beyond a few hours or affect daily activities.
  • Palpitations, fainting or chest discomfort during sex: A&E first.
  • A new medication started since your consultation, especially heart-rhythm or antifungal medicines.
AEMPS CIMA: Vardenafil

This page summarises information from the regulator-approved leaflet for reference only. It is not medical advice and does not replace the assessment of an EU-licensed doctor. Your doctor will review your individual history, dose and interactions during your consultation.

Back to your consultation