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vardenafil

Levitra · ATC code G04BE09

Brand names: Levitra, Vardenaristo, Vardegin, Cimlitrol, Lovitrec, Vareksil, Varoni

Key facts
Active substance
vardenafil
Drug class
Drug used in erectile dysfunction
ATC code
G04BE09
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Levitra 5 mg film-coated tablets / Levitra10 mg film-coated tablets / Levitra 20 mg film-coated tablets · Levitra 10 mg orodispersible tablets
Marketing authorisation holder
Bayer AG
Information as of
2026-10-27

Key facts

Vardenafil is a phosphodiesterase type 5 (PDE5) inhibitor. It is used to treat erectile dysfunction in adult men; sexual stimulation is required for it to work.

What it is used for

  • Erectile dysfunction in adult men

Dosing

  • Film-coated tablets: 10 mg as needed about 25 to 60 minutes before sexual activity; 5 mg or 20 mg depending on efficacy and tolerability; at most once per day
  • 10 mg orodispersible tablets: not bioequivalent to 10 mg film-coated tablets; maximum 10 mg/day
  • Mild to moderate hepatic impairment: start at 5 mg; moderate impairment maximum 10 mg
  • Severe renal impairment (creatinine clearance <30 ml/min): consider starting at 5 mg
  • With CYP3A4 inhibitors such as erythromycin or clarithromycin, do not exceed 5 mg

Contraindications

  • Nitrates or nitric oxide donors; guanylate cyclase stimulators such as riociguat
  • Loss of vision in one eye due to NAION
  • Men for whom sexual activity is inadvisable (e.g. unstable angina, severe heart failure)
  • Potent CYP3A4 inhibitors ritonavir and indinavir; hypersensitivity

Important warnings

  • Consider cardiovascular status before treatment; mild, transient decreases in blood pressure
  • Serious cardiovascular events reported in temporal association, mostly in patients with risk factors
  • Caution in left ventricular outflow obstruction (e.g. aortic stenosis)
  • Sudden visual loss requires prompt medical assessment

Side effects

  • Very common: headache
  • Common: dizziness, flushing, nasal congestion, dyspepsia
  • Uncommon to rare, among others: visual disturbance, syncope, allergic reactions; not known: NAION

Interactions

  • Nitrates and nitric oxide donors: contraindicated
  • Potent CYP3A4 inhibitors (indinavir increased AUC 16-fold); ritonavir and indinavir contraindicated
  • Alpha-blockers: symptomatic hypotension possible; start only when stabilised on the alpha-blocker

Pregnancy and breastfeeding

  • Not indicated for use by women

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Vardenafil1a Pharma Gmbh, Holsten Pharma Gmbh, Accord Healthcare B.V., Sandoz Gmbh, Krka, D.D., Novo Mesto · 5 register entries
  • VardenaristoAristo Pharma Gmbh (Art 57) · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • VardeginTad Pharma Gmbh · 1 register entry
  • Vardenafil1 A Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Hormosan Pharma Gmbh, Holsten Pharma Gmbh, Zentiva Pharma Gmbh, Biomo Pharma Gmbh, Hexal Ag, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Abz-Pharma Gmbh · 10 register entries
  • VardenaristoAristo Pharma Gmbh (Art 57) · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • CimlitrolPHARMAPLACE İLAÇ TİC. A.Ş. · 2 register entries
  • LevitraBAYER TÜRK KİMYA SAN. LTD. ŞTİ. · 3 register entries
  • LovitrecDEVA HOLDİNG A.Ş. · 3 register entries
  • VareksilVEFA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • VaroniDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 21 more European countries
Belgium
Vardenafil Krka, Vardenafil Sandoz
Bulgaria
Варденафил Стада, Виавардис
Croatia
Viavardis
Denmark
Vardenafil "stada", Vardenafil Krka
Estonia
Vardenafil Sandoz, Vardenafil Sanoswiss
Finland
Vardenafil Krka, Vardenafil Stada
France
Vardenafil Accord, Vardenafil Biogaran, Vardenafil Krka, Vardenafil Sandoz, Vardenafil Viatris
Hungary
Vardenafil Holsten, Vardenafil Kappler
Iceland
Levitra
Ireland
Vardenafil Krka
Italy
Dionifil, Elutatis, Vaderic, Vardenafil Accord, Vardenafil Doc, Vardenafil Eg, Vardenafil Krka, Vardenafil Mylan, Vardenafil Pensa, Vardenafil Sandoz, Vardenafil Teva Generics, Vardenafil Teva Italia, Vardenafil Zentiva
Latvia
Vardenafil Sandoz
Liechtenstein
Levitra
Lithuania
Vardenafil Sanoswiss
Netherlands
Vardenafil Accord, Vardenafil Teva
Norway
Levitra, Vardenafil Krka
Poland
Vardenafil Holsten, Viavardis
Portugal
Vardenafil Aristo, Vardenafil Ciclum, Vardenafil Farmoz, Vardenafil Generis, Vardenafil Krka, Vardenafil Mylan, Vardenafil Tecnigen, Vardenafil Tolife
Slovenia
Viavardis
Spain
Levatik, Sarilen, Vardenafilo Aurovitas, Vardenafilo Cinfa, Vardenafilo Flas Qualigen, Vardenafilo Flas Stadagen, Vardenafilo Krka, Vardenafilo Pensa, Vardenafilo Qualigen, Vardenafilo Stada, Vardenafilo Tecnigen, Vardenafilo Teva, Vardenafilo Tevagen
Sweden
Vardenafil Krka, Vardenafil Stada

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Levitra – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/levitra-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC G04BE.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.