On February 5, 2026, IBSA USA, the U.S. subsidiary of Swiss pharmaceutical company IBSA, announced that the U.S. Food and Drug Administration (FDA) has approved Vybrique for marketing. This is the first FDA-approved sildenafil oral film indicated for the treatment of erectile dysfunction (ED) in males 18 years of age and older.

Disease Background

Erectile dysfunction (ED) affects 30 million to 50 million men in the United States, with an increasing incidence among men under 40 years of age. While ED prevalence rises with age, it is not exclusive to older populations—cases among younger men continue to grow. This trend highlights the importance of proactive interventions, including maintaining a healthy lifestyle and regular exercise, to reduce ED risk.

Product Features

Vybrique is a single-dose oral film offering discretion and convenience. It dissolves directly on the tongue without the need for water or other liquids, facilitating on-the-go, anytime use. It may be taken 30 minutes to 4 hours prior to sexual activity, with or without food.

Vybrique Product Overview

Vybrique (sildenafil) is the first and currently the only FDA-approved oral film for the treatment of erectile dysfunction in adult males.

Indications

Vybrique (sildenafil) oral film is a prescription medication indicated for the treatment of erectile dysfunction.

This product is not indicated for women or children. The safety and effectiveness of Vybrique in females and adolescents under 18 years of age have not been established.

Important Safety Information

Severe Blood Pressure Risks

Concomitant use of Vybrique with certain medications can cause a sudden and dangerous drop in blood pressure:

Contraindicated with nitrates: Do not use Vybrique with nitrates for any reason.

Potential consequences of severe hypotension: Dizziness, fainting, myocardial infarction, or stroke.

Absolute Contraindications

Concomitant use with guanylate cyclase stimulators: Including riociguat, used for treating pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Hypersensitivity: Patients with known hypersensitivity to sildenafil or any component of Vybrique.

Medical Disclosure

Inform all healthcare providers that you are taking Vybrique. If emergency treatment for heart problems is needed, healthcare providers must know when you last took Vybrique.

Sexual Activity Warnings

If chest pain, dizziness, or nausea occurs during sexual activity, stop immediately and seek medical help. Sexual activity increases cardiac workload, posing higher risks for patients with poor cardiac function, history of heart disease, or myocardial infarction.

Vybrique does not protect against sexually transmitted infections (STIs) including human immunodeficiency virus (HIV).

Severe Adverse Reactions (Require Immediate Medical Attention)

Priapism: Erection lasting more than 4 hours, which can cause permanent damage to the penis.

Sudden vision loss: Sudden blindness in one or both eyes, which may be non-arteritic anterior ischemic optic neuropathy (NAION).

Sudden hearing decrease/loss: May be accompanied by tinnitus and dizziness.

If any of these symptoms occur, discontinue Vybrique immediately and seek medical help.

Medical History to Disclose Before Use

Past or current heart disease (myocardial infarction, arrhythmia, angina, heart failure, aortic stenosis, etc.).

Cardiac surgery within the past 6 months.

History of pulmonary hypertension or stroke.

Hypotension or uncontrolled hypertension.

Penile deformity or history of prolonged erections (>4 hours).

Blood disorders (sickle cell anemia, multiple myeloma, leukemia).

Retinitis pigmentosa or history of severe vision loss (including NAION).

Bleeding disorders or peptic ulcers.

Hepatic or renal impairment, dialysis treatment.

Important Concomitant Medications to Disclose

Nitrates.

Guanylate cyclase stimulators (e.g., riociguat).

Alpha-blockers (e.g., doxazosin): Concomitant use may cause hypotension and fainting.

HIV protease inhibitors (ritonavir, saquinavir).

Oral antifungals (ketoconazole, itraconazole).

Antibiotics (erythromycin), antihypertensives.

Other medications for erectile dysfunction.

Common Adverse Reactions

Most frequent: Headache, facial flushing, stomach upset, nasal congestion/rhinorrhea, dizziness.

Other: Visual abnormalities (color vision changes, blurred vision), back pain, myalgia, nausea, rash.

This is not a complete list of adverse reactions. Consult your doctor for medical questions related to Vybrique use.