No black box warning on record for Sildenafil

As of the latest FDA labeling reviewed, Sildenafil (sildenafil citrate) does not carry a black box warning. Standard warnings and precautions still apply — see the full Sildenafil medicine page for the complete safety profile.

Other warnings & precautions

Nitrate Contraindication: Sildenafil is absolutely contraindicated with any nitrate formulation (including emergency nitroglycerin). The combination causes severe, potentially life-threatening hypotension. Inform ALL patients with cardiovascular disease about this interaction before prescribing. Patients should be instructed to inform all healthcare providers about sildenafil use if they ever need emergency cardiac treatment.
Cardiovascular Risk Assessment: Sexual activity itself places a hemodynamic demand on the heart. Patients with cardiovascular disease should be evaluated for cardiac fitness for sexual activity before prescribing sildenafil. Not recommended for patients with recent MI (within 90 days), recent stroke, unstable angina, resting hypotension, or severe heart failure.
Priapism: Erections lasting more than 4 hours require immediate medical attention. Prolonged priapism can cause permanent erectile dysfunction due to penile ischemia. Patients should be counseled to seek immediate medical care if an erection lasts longer than 4 hours.
Vision and Hearing Loss: Cases of sudden decrease or loss of vision and sudden decrease or loss of hearing have been reported. These may be related to NAION or other vascular events. Advise patients to stop and seek medical attention if sudden visual or hearing changes occur.

Other warnings & precautions

Nitrate Contraindication: Sildenafil is absolutely contraindicated with any nitrate formulation (including emergency nitroglycerin). The combination causes severe, potentially life-threatening hypotension. Inform ALL patients with cardiovascular disease about this interaction before prescribing. Patients should be instructed to inform all healthcare providers about sildenafil use if they ever need emergency cardiac treatment.

Cardiovascular Risk Assessment: Sexual activity itself places a hemodynamic demand on the heart. Patients with cardiovascular disease should be evaluated for cardiac fitness for sexual activity before prescribing sildenafil. Not recommended for patients with recent MI (within 90 days), recent stroke, unstable angina, resting hypotension, or severe heart failure.

Priapism: Erections lasting more than 4 hours require immediate medical attention. Prolonged priapism can cause permanent erectile dysfunction due to penile ischemia. Patients should be counseled to seek immediate medical care if an erection lasts longer than 4 hours.

Vision and Hearing Loss: Cases of sudden decrease or loss of vision and sudden decrease or loss of hearing have been reported. These may be related to NAION or other vascular events. Advise patients to stop and seek medical attention if sudden visual or hearing changes occur.

Sildenafil Black Box Warning

No black box warning on record for Sildenafil

Other warnings & precautions

Sildenafil Black Box Warning

No black box warning on record for Sildenafil

Other warnings & precautions