Vardenafil | Oral Tablet
Important Safety Information: Vardenafil | Oral Tablet
Vardenafil is an FDA approved oral medication prescribed to support men experiencing erectile dysfunction. It belongs to a class of medications known as phosphodiesterase type 5 inhibitors and works by increasing blood flow to the penis during sexual stimulation. Vardenafil does not increase sexual desire but may help improve the ability to achieve and maintain an erection when sexually aroused.
This product is dispensed as a compounded formulation prepared by a licensed compounding pharmacy. Compounded medications have not been reviewed by the FDA for safety or efficacy. Review important medication safety information.
What is this?
This Important Safety Information summarizes key warnings and precautions for Vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This medication should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.
Most Serious Warnings
Product can cause:
Severe allergic reactions, including rash, hives, swelling of the face, lips, tongue, or throat
Sudden decrease or loss of vision in one or both eyes
Sudden decrease or loss of hearing, sometimes with ringing in the ears or dizziness
Prolonged erection lasting more than 4 hours (priapism), which may cause permanent damage
Severe drop in blood pressure, especially when taken with nitrates or certain other medications
Chest pain, heart attack, stroke, or irregular heartbeat in individuals with underlying heart disease
Who Should NOT Take Vardenafil
Do not take this medication if you:
Take nitrates (such as nitroglycerin) or nitric oxide donors
Use recreational drugs known as “poppers” that contain amyl nitrate or butyl nitrate
Have been advised to avoid sexual activity due to cardiovascular risk
Have severe liver impairment
Have severe low blood pressure or uncontrolled high blood pressure
Have had a recent heart attack, stroke, or life threatening arrhythmia
Have a known allergy to vardenafil or any ingredient in the formulation
Before Taking Vardenafil, Tell Your Healthcare Provider if You:
Have heart disease, chest pain, irregular heartbeat, or other cardiovascular conditions
Have a history of stroke or heart attack
Have high or low blood pressure
Have liver or kidney disease
Have a history of vision problems, including retinitis pigmentosa
Have a bleeding disorder or active stomach ulcer
Have anatomical deformation of the penis or conditions that may predispose you to priapism such as sickle cell anemia, leukemia, or multiple myeloma
Take alpha blockers, antifungal medications, certain antibiotics, HIV protease inhibitors, or other medications that may interact
Use prescription, over the counter, herbal supplements, alcohol, or recreational drugs
Possible Side Effects
Common (mild to moderate):
Headache
Flushing
Nasal congestion
Upset stomach or indigestion
Dizziness
Back pain
Serious (seek medical care immediately):
Erection lasting more than 4 hours
Sudden vision loss or changes in vision
Sudden hearing loss or ringing in the ears
Chest pain, shortness of breath, or fainting
Severe allergic reaction with swelling or difficulty breathing
While Taking Vardenafil
Tell your healthcare provider immediately if you:
Experience chest pain during sexual activity
Develop a prolonged or painful erection
Notice sudden changes in vision or hearing
Feel lightheaded, dizzy, or faint
Experience symptoms of a serious allergic reaction
Avoid using more than the prescribed dose. Do not combine with other PDE5 inhibitors unless directed by your provider.
Pregnancy and Fertility
Vardenafil is not indicated for use in women. It should only be used by the individual for whom it is prescribed.
Overdose
Symptoms of overdose may include:
Severe dizziness or fainting
Irregular heartbeat
Prolonged erection
Severe headache
If overdose is suspected, seek emergency medical attention or contact Poison Control right away.
Missed Dosage
Vardenafil is typically taken as needed prior to sexual activity. If you miss a scheduled dose and are on a daily regimen, take the missed dose as soon as you remember unless it is close to the time of your next dose. Do not double the dose.
Storage
Store at room temperature
Protect from moisture and heat
Keep out of reach of children and pets
Medication Disposal
Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication down the toilet unless instructed. Contact your pharmacy for disposal information or ask about medication take back programs.
Telemedicine Disclosure
This prescription may have been issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.
Disclaimer
This summary does not include all information about Vardenafil and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
