Vardenafil

Vardenafil

Approved uses

• Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
• Vardenafil tablets are indicated for the treatment of erectile dysfunction.

Forms and strengths

• Vardenafil tablets USP, 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate), 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate), 10 mg (equivalent to 11.852 mg...
• Vardenafil tablets, 2.5 mg are white to off-white colored, round, biconvex, bevel edged, film-coated tablets, debossed with "10" on one side and "68" on other side.
• Vardenafil tablets, 10 mg are light yellow to orange colored, round, biconvex, bevel edged, film-coated tablets, de bossed with "10" on one side and "70" on other side.

How it is taken

• Vardenafil 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 should be considered in patients ≥ 65 years of age.
• Vardenafil tablets are taken orally, approximately 60 minutes before sexual activity.
• The maximum recommended dosing frequency is one tablet per day.
• Vardenafil tablets may be taken with or without food.
• If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil should be adjusted as follows: Ritonavir: No more than 2.5 mg in a 72-hour period Cobicistat: No more than 2.5 mg in a 72 hours period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200...

Must not be used when

• Administration with nitrates and nitric oxide donors
• Administration with guanylate cyclase (GC) stimulators, such as riociguat

Interactions

• Vardenafil can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.

Warnings and precautions

• Cardiovascular Effects: Patients should not use vardenafil 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, 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). Vardenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.
• Sudden Hearing Loss: Patients should stop vardenafil and seek medical attention in the event of sudden decrease or loss in hearing.
• Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).
• QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil.
• 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, it is important to note the following:

Common side effects

• Most common adverse reactions reported (≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.

Pregnancy

Vardenafil is not indicated for use in females. There are no data with the use of vardenafil in pregnant women to inform any drug-associated risks. In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of vardenafil during organogenesis at exposures for unbound vardenafil and its major metabolite at approximately 100 and 29 times, respectively, the maximum recommended human dose (MRHD)...

How it acts

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.

Label holder:

Zydus Pharmaceuticals USA Inc.

Label version:

5 January 2026

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.