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    It initially was developed by the biotechnology company ICOS , and then again developed and marketed worldwide by Lilly ICOS, LLC, the joint venture of ICOS Corporation and Eli Lilly and Company . Cialis tablets, in 2.5 mg, 5 mg, 10 mg, and 20 mg doses, are yellow, film-coated, and almond-shaped.
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    Tadalafil was approved in May 2009 in the United States for the treatment of pulmonary arterial hypertension 3 and is under regulatory review in other regions for this condition.
    Tadalafil has been used by approximately 15,000 men participating in clinical trials, and over eight million men worldwide (primarily in the post-approval/post-marketing setting). 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 . These side effects reflect the ability of PDE5 inhibition to cause vasodilation (cause blood vessels to widen), and usually go away after a few hours.
    In May 2005, the U.S. Food and Drug Administration found that tadalafil (along with other PDE5 inhibitors) was associated with vision impairment related to NAION ( non-arteritic anterior ischemic optic neuropathy ) in certain patients taking these drugs in the post-marketing (outside of clinical trials) setting.
    Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION unrelated to PDE5 use, including: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking.
    Given the small number of NAION events with PDE5 use (fewer than one in one million), the large number of users of PDE5 inhibitors (millions) and the fact that this event occurs in a similar population to those who do not take these medicines, the FDA concluded that they were not able to draw a cause and effect relationship, given these patients underlying vascular risk factors or anatomical defects.
    However, the label of all three PDE5 inhibitors was changed to alert clinicians to a possible association.

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