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Viagra - FDA prescribing information, side effects and uses

Publication date: 2019-04-09 04:00

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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. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to 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 [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS ].

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Urogenital: cystitis , nocturia , urinary frequency, breast enlargement, urinary incontinence , abnormal ejaculation , genital edema and anorgasmia.

VIAGRA was administered to over 8755 patients (aged 69-87 years) during pre-marketing clinical trials worldwide. Over 555 patients were treated for longer than one year.

One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 655 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=678) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of VIAGRA. On a global improvement question, 88% of patients reported improved erections on VIAGRA versus 67% on placebo. Diary data indicated that on VIAGRA, 59% of attempts at sexual intercourse were successful compared to 68% on placebo.

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking VIAGRA. Most, but not all, of these men had heart problems before taking VIAGRA. It is not known if VIAGRA caused these problems.

This Patient Information leaflet summarizes the most important information about Viagra. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Viagra that is written for health professionals.

There was no impairment of fertility in rats given sildenafil up to 65 mg/kg/day for 86 days to females and 657 days to males, a dose producing an AUC value of more than 75 times the human male AUC.

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