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This safety information provides critical details on the potential risks and necessary precautions associated with using this medication. Please read carefully and consult with your healthcare provider if you have any questions or concerns.

• Heart Problems: Inform your healthcare provider if you have any heart conditions before starting vardenafil. It is advised against the use of vardenafil for individuals who have recently experienced heart attacks, strokes, or have certain heart conditions, due to potential risks to heart health. Notably, those with high or low blood pressure or those taking other medications that cause QT prolongation should exercise caution.

• Low Blood Pressure: Vardenafil can cause significant drops in blood pressure, especially when taken with medications like alpha blockers or those for treating high blood pressure or chest pain (angina). It is crucial to avoid combining vardenafil with nitrates or medications like Adempas (riociguat) as this can dangerously lower blood pressure. Your healthcare provider may suggest regular blood pressure monitoring.

• Prolonged Erection (Priapism): Some individuals may experience an erection lasting more than 4 hours, which can lead to permanent damage if not treated promptly. Those with conditions such as sickle cell anemia, multiple myeloma, or leukemia, or with certain penile conditions, are at increased risk. Seek immediate medical help if your erection lasts longer than 4 hours or if you experience pain.

• Vision Changes: Sudden changes in vision in one or both eyes require urgent medical attention. Though rare, some have reported eye damage that could be permanent. Individuals with a "crowded" optic disc are at higher risk. Ensure your healthcare provider is aware of your full medical history.

• Hearing Loss: Vardenafil has been associated with hearing loss in some cases, sometimes accompanied by tinnitus and dizziness. Discontinue use and contact your healthcare provider immediately if you experience hearing changes.

• Drug Interactions: Vardenafil can interact with other medications, leading to severe side effects. It is critical to disclose all medications you are currently taking to your healthcare provider. Avoid using vardenafil with nitrates, certain blood pressure medications, alpha blockers, and some antifungals or antivirals like oral azole antifungals and ritonavir (Norvir).

• Contraindications: Do not use vardenafil if you are taking nitrate medications for chest pain or guanylate cyclase (GC) stimulators such as Adempas (riociguat), as these can pose serious health risks.

For any concerns or if you suspect an overdose, contact your healthcare provider or emergency services immediately.

Common side effects:

• headaches
• flushing
• stuffy or runny nose
• dizziness

Less common but important to monitor:

• indigestion
• back pain
• nausea
• sinus inflammation
• flu-like symptoms

Serious side effects:

• sudden decrease in vision
• sudden loss of hearing
• erection lasting more than four hours
• dangerously low blood pressure
• seizures
• temporary memory loss
• allergic reactions

Interactions with high risk of serious adverse effects and should be avoided:

• Nitrates (such as nitroglycerin, isosorbide)
• Recreational drugs known as 'poppers' containing amyl or butyl nitrite

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Riociguat
• Vericiguat
• Alpha blockers (such as doxazosin, tamsulosin)
• Azole antifungals (such as itraconazole, ketoconazole)
• Macrolide antibiotics (such as clarithromycin, erythromycin)
• Ritonavir
• Other medications containing vardenafil or similar drugs used for erectile dysfunction or pulmonary hypertension (such as sildenafil, tadalafil)