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On October 6, 2011, active the.S. 15 16 In 1993, the Bothell, Washington biotechnology company icos Corporation began studying compound IC351, a phosphodiesterase type 5 (PDE5) enzyme inhibitor. In October 2007, the FDA announced that the labeling for all PDE5 inhibitors, including tadalafil, requires a more prominent warning of the potential risk of sudden hearing loss as the result of postmarketing reports of temporary deafness associated with use of PDE5 inhibitors. CGMP relaxes smooth muscle and increases blood flow to the corpus cavernosum. The most common side effects when using tadalafil are headache, stomach discomfort or pain, indigestion, burping, acid reflux, back pain, muscle aches, flushing, and stuffy or runny nose. 22 Although many parents objected to the Cialis ad being aired during the Super Bowl, Janet Jackson 's halftime " wardrobe malfunction " overshadowed Cialis. United Therapeutics for an upfront payment of 150 million. A b c Elliott, Stuart (April 25, 2004). 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