Sildenafil is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction. It is available as tablets, powder for oral suspension and oral films for intravenous use. MedsAcross supplies Sildenafil 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.
Sildenafil citrate tablets are indicated for the treatment of erectile dysfunction. Sildenafil citrate tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
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 cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.
Source: US FDA prescribing information
• For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil citrate tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity. • Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg. • Maximum recommended dosing frequency is once per day
Source: US FDA prescribing information
• Administration of sildenafil citrate tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate tablets were shown to potentiate the hypotensive effect of nitrates. • Known hypersensitivity to sildenafil or any component of tablet. • Administration with guanylate cyclase (GC) stimulators, such as riociguat
Source: US FDA prescribing information
• Patients should not use sildenafil citrate tablets if sexual activity is inadvisable due to cardiovascular status. • Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate tablets with caution in patients predisposed to priapism. • Patients should stop sildenafil citrate tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Sildenafil citrate tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION. • Patients should stop sildenafil citrate tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing.
Source: US FDA prescribing information
The following are discussed in more detail in other sections of the labeling: • Cardiovascular • Prolonged Erection and Priapism • Effects on the Eye • Hearing Loss • Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives • Adverse Reactions with the Concomitant Use of Ritonavir • Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies • Effects on Bleeding • Counseling Patients About Sexually Transmitted Diseases The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash
Source: US FDA prescribing information
• Sildenafil citrate tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and anti-hypertensives. • With concomitant use of alpha-blockers, initiate sildenafil citrate tablets at 25 mg dose. • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil citrate tablets exposure • Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period • Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
20 presentations of Sildenafil, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Sildenafil 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sildenafil 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sildenafil 50 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sildenafil 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sildenafil 10 mg/mL powder for oral suspensionOralGeneric name | — | US FDA | Available on request |
| Viagra 100 mg tabletOral | Viatris Specialty | US FDA | Available on request |
| Viagra 50 mg tabletOral | Viatris Specialty | US FDA | Available on request |
| Revatio 20 mg tabletOral | Viatris Specialty | US FDA | Available on request |
| Sildenafil 100 mg oral filmOralGeneric name | — | US FDA | Available on request |
| Sildenafil 25 mg oral filmOralGeneric name | — | US FDA | Available on request |
| Sildenafil 50 mg oral filmOralGeneric name | — | US FDA | Available on request |
| Sildenafil 75 mg oral filmOralGeneric name | — | US FDA | Available on request |
| Viagra 25 mg tabletOral | Viatris Specialty | US FDA | Available on request |
| Vybrique 100 mg oral filmOral | IBSA Pharma | US FDA | Available on request |
| Vybrique 25 mg oral filmOral | IBSA Pharma | US FDA | Available on request |
| Vybrique 50 mg oral filmOral | IBSA Pharma | US FDA | Available on request |
| Vybrique 75 mg oral filmOral | IBSA Pharma | US FDA | Available on request |
| Revatio 10 mg/12.5 mL injectionIntravenous | Viatris Specialty | US FDA | Available on request |
| Sildenafil 10 mg/12.5 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Revatio 10 mg/mL powder for oral suspensionOral | Viatris Specialty | US FDA | Available on request |
3 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Sildenafil in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 20 presentations of Sildenafil and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Sildenafil, including Revatio, Viagra, Vybrique.
Yes. The US FDA first approved Sildenafil on 27 March 1998, according to Drugs@FDA.
Yes. Sildenafil has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Sildenafil is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Sildenafil is classified under ATC code G04BE03 (Sildenafil).
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