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Viagra, Sildenafil citrate, is used to treat problems of erectile dysfunction. Like any other drugs, Viagra has adverse events which were generally transient and mild and moderate in nature. Over 3700 patients (aged 19-87 years) were given VIAGRA in clinical trials worldwide. More than 550 patients were treated for more than one year. In placebo-controlled clinical studies, the rate due to adverse events for discontinuing Viagra. The incidence of some adverse events increased with dose in flexible-dose studies. The nature of some adverse events in flexible-dose studies, which more closely reflect the recommended dosage regimen, was similar to that for fixed-dose studies.

The most commonly reported adverse reactions were headache and flushing. At doses above the recommended dose range, adverse events were reported more frequently. Dizziness, abnormal vision (blurred vision, increased sensitivity to light), chromatopsia (mild to and transient, predominantly color tinge to vision), palpitation, rhinitis (nasal congestion) and dyspepsia were the common reported adverse reactions.

In an analysis of double-blind, placebo-controlled trials, there were no differences in the incidence rate of myocardial infarction or in the rate of cardiovascular mortality for patients receiving sildenafil citrate to those receiving placebo. The rates of myocardial infarction (death of a segment of heart muscle) were 1.1/100 person-years for men receiving sildenafil and for those receiving placebo. The rates of cardiovascular mortality were 0.3/100 person-years for men receiving sildenafil and those receiving placebo.

The following adverse events were reported during post-marketing surveillance of sildenafil citrate: • Immune system disorders: hypersensitivity reaction (including skin rash) • Cardiac disorders: tachycardia (increase in the heart rate above normal) • Vascular disorders: hypotension, syncope, epistaxis (nosebleed) • Gastrointestinal disorders: vomiting • Eye disorders: eye pain, red eyes or bloodshot eyes • Reproductive system and breast disorders: prolonged erection and/or priapism (persistent painful erection)