What is the FDA-approved use of sildenafil?

Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

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Who should not use sildenafil?

Do not use sildenafil if:

• You are taking a class of medications called nitric oxide donors, including organic nitrates or organic nitrites in any form. Sildenafil can increase the blood pressure-lowering effect of nitrates.
• You have a known allergy to sildenafil.
• You are taking a class of medications called guanylate cyclase (GC) stimulators, such as riociguat. Sildenafil can increase the blood pressure-lowering effect of these medications.

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How should I take sildenafil?

Sildenafil can be taken with or without food. Take about 30 minutes to 1 hour before anticipated sexual activity.

Do not take sildenafil more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors.

You should take the medication exactly as prescribed. If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Good Life-affiliated provider for guidance.

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What should I tell my Good Life-affiliated provider before using sildenafil?

• Sildenafil has certain drug interactions. It’s important to tell your Good Life-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
• Some medications to watch out for include:
  • Nitrates, alpha-blockers, and antihypertensives: When these medications are taken with sildenafil, a sudden drop in blood pressure can occur.
  • CYP3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole and erythromycin: These medications increase sildenafil levels in the blood stream, which can cause a sudden drop in blood pressure and prolonged erection.
• It’s important to share your entire medical history with your provider. In particular, tell your provider if you have or have a past history of:
  • Cardiovascular risk that prevents you from partaking in sexual activity
  • Chest pain requiring nitroglycerin
  • Predisposition to priapism (painful erection that lasts >4 hours)
  • Ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis)
  • Severely impaired autonomic control of blood pressure
  • Myocardial infarction, stroke, or life-threatening arrhythmia
  • Low or high blood pressure
  • Cardiac failure or coronary artery disease causing unstable angina
  • Anterior ischemic optic neuropathy (NAION) or a “crowded” optic disc.
  • Bleeding disorders or ulcers
  • Kidney or liver disease
  • Pulmonary hypertension
  • Retinitis pigmentosa

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

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What are the most serious side effects that I or a caregiver should monitor for when taking sildenafil?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment.

• Cardiac risk of sexual activity: ED medication should not be used by men for whom sexual activity is not advised because of their underlying cardiovascular status.
• Prolonged erections: Seek immediate emergency treatment for an erection lasting more than 4 hours.
• Effects on the eye: Seek medical care and stop medication if you experience a sudden loss of vision in one or both eyes. Sudden loss of vision could be a sign of non arteritic anterior ischemic optic neuropathy (NAION).
• Sudden hearing loss: Stop medication and seek prompt medical attention if you experience a sudden decrease or loss of hearing, which may be accompanied by ringing in the ears.
• Co-administering with alpha-blockers or other blood pressure-lowering drugs: If you are taking a medication to lower your blood pressure or taking an alpha-blocker, sildenafil may increase the blood-pressure-lowering effect, leading to a sudden drop in blood pressure. When starting sildenafil, monitor carefully for signs of low blood pressure, including dizziness, lightheadedness, or fainting.

• Co-administering with ritonavir: If you are taking a medication called ritonavir at the same time as taking sildenafil, ritonavir can increase the amount of sildenafil in your system. Monitor for lowered blood pressure, fainting, and prolonged erection.

• Combination with other PDE-5 inhibitors: Do not take sildenafil more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors.

• Effects on bleeding: Sildenafil has no effect on bleeding time when taken alone or with aspirin; however, there have been reports of bleeding with the use of sildenafil. Tell your Good Life-affiliated provider if you have a history of bleeding disorders or ulcers.
• Sexually transmitted infections: Sildenafil does not protect against sexually transmitted diseases. Use safe sex practices.

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What are the most common side effects of sildenafil?

• Headache
• Flushing
• Indigestion
• Vision changes
• Nasal congestion
• Back pain
• Muscle pain
• Nausea
• Dizziness
• Rash

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

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