Sildenafil — Important Safety Information
PDE5 inhibitor. Contraindicated with nitrates. Watch for prolonged erection, vision/hearing changes, and BP drops.
What is the FDA-approved use of sildenafil?
Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).
Who should not use sildenafil?
- You are taking nitric oxide donors (organic nitrates or nitrites). Sildenafil can increase the blood pressure-lowering effect of nitrates.
- You have a known allergy to sildenafil.
- You are taking guanylate cyclase stimulators, such as riociguat.
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 more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors.
What should I tell my EOS Health-affiliated provider?
Tell your provider all medications you take. Watch for interactions with nitrates, alpha-blockers, antihypertensives, and CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, erythromycin).
Share your full medical history, especially: cardiovascular risk, chest pain requiring nitroglycerin, priapism predisposition, ventricular outflow obstruction, impaired autonomic control of BP, MI/stroke/arrhythmia history, low or high BP, unstable angina, NAION, bleeding disorders, kidney/liver disease, pulmonary hypertension, retinitis pigmentosa.
Most serious side effects
If experiencing a medical emergency, call 911.
- Cardiac risk of sexual activity
- Prolonged erections: Seek emergency treatment for erection lasting more than 4 hours.
- Vision changes: Sudden loss of vision could be a sign of NAION.
- Sudden hearing loss
- Severe BP drop with alpha-blockers, BP-lowering drugs, or ritonavir
- Combination with other PDE-5 inhibitors — do not exceed once per 24 hours
- Effects on bleeding in patients with bleeding disorders or ulcers
- STIs: Sildenafil does not protect against sexually transmitted diseases.
Most common side effects
- Headache, flushing, indigestion, vision changes, nasal congestion, back pain, muscle pain, nausea, dizziness, rash.
You are encouraged to report negative side effects 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.