In the over 100 clinical trials completed to date (involving more than 12,000 patients) no reports of priapism have been observed. Rare reports of priapism have been reported following the administration of other PDE5 inhibitors. There have been rare reports of priapism in post-marketing surveillance of tadalafil. PDE5 inhibitors should be prescribed with caution in patients who have conditions that might predispose them to priapism (sickle cell anemia, multiple myeloma, or leukemia).
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