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The clinical significance of the decreased sperm concentrations in the two studies is unknown. There have been no studies evaluating the effect of tadalafil on fertility in men [see CLINICAL PHARMACOLOGY] . Tadalafil was not carcinogenic to rats or mice when administered daily for 2 years at dosesup to 400 mg/kg/day. Physicians should discuss with patients the contraindication of CIALIS with regular and/or intermittent use of organic nitrates.

Visual disturbances have been reported with phosphodiesterase-5 (PDE-5) inhibitors, including tadalafil. Sudden vision loss in one or both eyes may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION)