Important Safety Information for Viagra® (sildenafil)

(Including Branded and Generic Options)

What is Sildenafil?

Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor approved for the treatment of erectile dysfunction (ED). It enhances blood flow to the penis during sexual stimulation, improving erectile function.


Who Should NOT Use Sildenafil?

Do not use sildenafil if:

  • You are taking nitrates or nitric oxide donors, such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs called “poppers.” Combining these with sildenafil can cause a severe drop in blood pressure, which may be life-threatening.
  • You are allergic to sildenafil or any of its ingredients.
  • You take guanylate cyclase (GC) stimulators, such as riociguat, as sildenafil can amplify their blood pressure-lowering effects.

How to Use Sildenafil

As-Needed Use:

  • Take 1 tablet approximately 30-60 minutes before sexual activity.
  • Do not exceed 1 dose in a 24-hour period.
  • Important Notes:
    • Sildenafil can be taken with or without food, but a high-fat meal may delay its effectiveness.
    • Avoid consuming large amounts of alcohol (more than 5 drinks) as it may reduce the effectiveness and increase side effects.
    • Never mix sildenafil with other ED medications or PDE5 inhibitors.

What Should You Tell Your Healthcare Provider?

Before starting sildenafil, provide a complete medical history, including:

  • All medications you are currently taking, including over-the-counter drugs, supplements, and herbal remedies.
  • Your medical conditions, especially if you have a history of:
    • Heart problems, such as angina, heart failure, irregular heartbeat, or recent heart attack.
    • Low or high blood pressure or conditions affecting blood pressure regulation.
    • Stroke or life-threatening arrhythmia in the last 6 months.
    • Vision problems, such as non-arteritic anterior ischemic optic neuropathy (NAION).
    • Hearing issues, such as sudden hearing loss or tinnitus.
    • Kidney or liver disease, which may require dosage adjustments.
    • Bleeding disorders or stomach ulcers.
    • Priapism, a condition causing painful, prolonged erections.

Possible Drug Interactions

Sildenafil may interact with certain medications or substances, increasing the risk of side effects or altering drug efficacy:

  • Nitrates and Alpha-Blockers: Can cause severe drops in blood pressure.
  • CYP3A4 Inhibitors: Medications like ritonavir, ketoconazole, and erythromycin may increase sildenafil levels, leading to adverse effects.
  • Alcohol: Consuming large quantities may amplify blood pressure-lowering effects and increase dizziness.

Always consult your healthcare provider for guidance before combining sildenafil with any other medications.


Serious Risks and Side Effects

If you experience the following, stop taking sildenafil and seek immediate medical attention:

  1. Prolonged Erection (Priapism): Erections lasting more than 4 hours can cause permanent damage to the penis.
  2. Vision Changes: Sudden loss of vision may indicate non-arteritic anterior ischemic optic neuropathy (NAION).
  3. Hearing Changes: Sudden hearing loss, often with ringing in the ears, requires urgent medical attention.
  4. Severe Allergic Reactions: Symptoms include rash, swelling, or difficulty breathing.

Most Common Side Effects

Sildenafil is generally well-tolerated. Common side effects include:

  • Headache
  • Flushing (warmth or redness in the face, neck, or chest)
  • Indigestion
  • Nasal congestion
  • Back pain
  • Muscle pain
  • Vision changes (e.g., blue-tinted vision, sensitivity to light)

Important Precautions

  • Sexual Activity: Patients with heart conditions should discuss whether it is safe to engage in sexual activity.
  • Not for Protection Against STDs: Sildenafil does not prevent sexually transmitted infections. Practice safe sex.
  • Missed Dose: Sildenafil is not intended for regular daily use. Take as prescribed for sexual activity.

Reporting Side Effects

If you experience side effects, report them to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, consult the full prescribing information or contact your healthcare provider.

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