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avanafil

Spedra · ATC code G04BE10

Key facts
Active substance
avanafil
Drug class
Drug used in erectile dysfunction
ATC code
G04BE10
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Spedra 50 mg tablets · Spedra 100 mg tablets · Spedra 200 mg tablets
Marketing authorisation holder
Phoenix Labs Unlimited Company
Information as of
2026-10-27

Key facts

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

What it is used for

  • Treatment of erectile dysfunction in adult men

Dosing

  • Recommended dose 100 mg as needed approximately 15 to 30 minutes before sexual activity; may be increased to a maximum of 200 mg or decreased to 50 mg based on efficacy and tolerability
  • Maximum once per day; taking it with food may delay onset
  • No dose adjustment in elderly or diabetic patients or in mild to moderate renal impairment
  • Mild to moderate hepatic impairment (Child-Pugh A/B): start with the minimum efficacious dose
  • Moderate CYP3A4 inhibitors (e.g. erythromycin, diltiazem, fluconazole, verapamil): no more than 100 mg, at least 48 hours between doses
  • Patients stable on alpha-blocker therapy: start at 50 mg

Contraindications

  • Organic nitrates or nitric oxide donors (e.g. amyl nitrite); guanylate cyclase stimulators such as riociguat
  • Myocardial infarction, stroke or life-threatening arrhythmia within the last 6 months
  • Resting hypotension (below 90/50 mmHg) or hypertension (above 170/100 mmHg); unstable angina, angina with intercourse, heart failure NYHA Class 2 or greater
  • Severe hepatic (Child-Pugh C) or renal impairment (creatinine clearance below 30 mL/min)
  • Loss of vision in one eye due to NAION; known hereditary degenerative retinal disorders
  • Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, clarithromycin, itraconazole)

Important warnings

  • Consider cardiovascular status before treatment; avanafil potentiates the hypotensive effect of nitrates
  • Erections lasting 4 hours or more (priapism) require immediate medical assistance
  • Sudden visual disturbances (e.g. NAION, CSCR): stop treatment and consult a physician immediately
  • Alpha-blockers: additive blood pressure lowering possible

Side effects

  • Most common: headache, flushing, nasal and sinus congestion, back pain
  • Others include dizziness, somnolence and blurred vision

Interactions

  • Nitrates: contraindicated; if nitrates are medically necessary within 12 hours of avanafil in a life-threatening situation, only under close medical supervision
  • Potent CYP3A4 inhibitors are contraindicated; moderate CYP3A4 inhibitors limit the dose
  • Alpha-blockers and other blood pressure-lowering medicines: risk of symptomatic hypotension

Pregnancy and breastfeeding

  • Not indicated for use in women; no data on pregnancy or breastfeeding

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 →

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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)

  • SpedraPhoenix Labs Unlimited Company · EMEA/H/C/002581

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Spedra
Liechtenstein
Spedra
Norway
Spedra

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. Spedra – 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/spedra-epar-product-information_en.pdf
  2. 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.