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Detailed information

There were three subjects who had a standing SBP of lt; 85 mmHg. All three were taking VIAGRA 100 mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness. There were four subjects with a decrease from baseline in standing systolic BP gt; 30 mmHg following VIAGRA 100 mg, one subject with a decrease from baseline in standing systolic BP gt; 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP gt; 30 mmHg following both VIAGRA and placebo. While there were no severe adverse events potentially related to blood pressure reported in this study, one subject reported moderate vasodilatation after both VIAGRA 50 mg and 100 mg.

Based on animal data, VIAGRA is not predicted to increase the risk of adverse developmental outcomes in humans. Animal Data. No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 200 mgkgday during organogenesis.

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