Avanafil is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction in adult males. It is available as tablets for oral use. MedsAcross supplies Avanafil for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males. Avanafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction
Source: US FDA prescribing information
The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cGMP, producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Avanafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of NO by inhibiting PDE5, which is responsible for degradation of cGMP in the corpus cavernosum. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation. Studies in vitro have shown that avanafil is selective for PDE5.
Source: US FDA prescribing information
• The starting dose is 100 mg taken as early as approximately 15 minutes before sexual activity, on an as needed basis. • Take avanafil tablet no more than once a day. • Based on efficacy and/or tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity or decreased to 50 mg taken approximately 30 minutes before sexual activity. Use the lowest dose that provides benefit. • Avanafil tablet may be taken with or without food. • Do not use avanafil tablet with strong CYP3A4 inhibitors. • If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period. • In patients on stable alpha-blocker therapy, the recommended starting dose of avanafil tablet is 50 mg.
Source: US FDA prescribing information
• Administration of avanafil tablet to patients using any form of organic nitrate is contraindicated. • Hypersensitivity to any component of the avanafil tablet. • Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat
Source: US FDA prescribing information
Evaluation of erectile dysfunction (ED) should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing avanafil, it is important to note the following: • Patients should not use avanafil if sexual activity is inadvisable due to cardiovascular status or any other reason. • Use of avanafil with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension. • Patients should seek emergency treatment if an erection lasts greater than 4 hours. • Patients should stop avanafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Avanafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.
Source: US FDA prescribing information
Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain
Source: US FDA prescribing information
• Avanafil can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol. • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure
Source: US FDA prescribing information
Store at controlled room temperature 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Avanafil, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Avanafil 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Avanafil 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Avanafil 50 mg tabletOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 3 presentations of Avanafil and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Avanafil on 27 April 2012, according to Drugs@FDA.
Yes. Avanafil has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Avanafil is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Avanafil is classified under ATC code G04BE10 (Avanafil).
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