Important Safety Information

VIAGRA is indicated for the treatment of erectile dysfunction (ED).

The use of VIAGRA and organic nitrates in any form, at any time, is contraindicated.

Before treating ED, physicians should consider the impact of resuming sexual activity and the mild and transient vasodilatory effects of VIAGRA on blood pressure. Physicians should carefully consider whether patients with underlying cardiovascular disease or other more unusual conditions could be adversely affected by vasodilatory effects, especially in combination with sexual activity.

The most common side effects of VIAGRA were headache (16%), flushing (10%), and dyspepsia (7%). Adverse events, including visual effects (3%), were generally transient and mild to moderate.

Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely post-marketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including VIAGRA, and seek medical attention in the event of sudden loss of vision.

Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors, including VIAGRA. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

As there have been infrequent reports of prolonged erections lasting more than 4 hours or priapism with all ED treatments in this drug class, patients should be advised to seek immediate medical attention should these occur. Erections lasting longer than 6 hours can result in penile tissue damage and long-term loss of potency.

VGU00079JJ

Please click here to see full prescribing and patient information for VIAGRA