Molecule
Vardenafil is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction. It is available as tablets and orally disintegrating tablets. MedsAcross supplies Vardenafil 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.
Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
Source: US FDA prescribing information
Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMP-specific phosphodiesterase type 5 (PDE5), therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP.
Source: US FDA prescribing information
Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability. A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age. Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. The maximum recommended dosing frequency is one tablet per day. Vardenafil hydrochloride tablets may be taken with or without food.
Source: US FDA prescribing information
Administration with nitrates and nitric oxide donors. Administration with guanylate cyclase (GC) stimulators, such as riociguat
Source: US FDA prescribing information
The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Before prescribing vardenafil hydrochloride tablets, it is important to note the following: Cardiovascular Effects: Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status. Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. Effects on the Eye: Patients should stop use of vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION).
Source: US FDA prescribing information
The following serious adverse reactions with the use of vardenafil hydrochloride tablets (vardenafil) are discussed elsewhere in the labeling: Cardiovascular Effects Priapism Effects on Eye Sudden Hearing Loss QT Prolongation Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.
Source: US FDA prescribing information
Vardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Tablets Nitrates: Concomitant use of vardenafil hydrochloride tablets and nitrates and nitric oxide donors is contraindicated. The blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after vardenafil and increases in heart rate when taken at 1, 4 and 8 hours after vardenafil were potentiated by a 20 mg dose of vardenafil hydrochloride tablets in healthy middle-aged subjects. These effects were not observed when vardenafil hydrochloride tablets 20 mg were taken 24 hours before the nitroglycerin (NTG).
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted within15-30°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.
6 presentations of Vardenafil, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Vardenafil 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Vardenafil 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Vardenafil 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Vardenafil 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Vardenafil 10 mg orally disintegrating tabletOralGeneric name | — | US FDA | Available on request |
| Vardenafil 11.85 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.
Conditions linked to Vardenafil in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 6 presentations of Vardenafil and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Vardenafil on 19 August 2003, according to Drugs@FDA.
Yes. Vardenafil has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Vardenafil is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Vardenafil is classified under ATC code G04BE09 (Vardenafil).
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