MEDICATION SAFETY
Vardenafil safety summary
- INN
- vardenafil hydrochloride
- PDE5 inhibitor
- oral tablet (film-coated or orodispersible)
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.
What it's used for
Prescribed for adult men with erectile dysfunction.
- 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
Reported by more than 1 in 100 patients.
- 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.
WHEN TO CALL THE DOCTOR
Call us through the in-app chat if you notice…
- 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.
OFFICIAL SOURCE
This summary is condensed from the regulator's full product leaflet for ease of reading. The complete document — every interaction, dose adjustment and reporting note — is one click away.
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.