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More than 4,000 men have participated in more than 60 studies that characterized the safety and efficacy profile of Cialis. In primary efficacy studies involving 1,112 men (804 Cialis, 308 placebo) with mild to severe ED, up to 81 percent of those treated with Cialis reported improved erections compared with 35 percent of those taking placebo1.

The most commonly reported adverse events were headache, upset stomach, nasal congestion, backache, muscle ache, dizziness, and flushing. The adverse events reported with Cialis were transient and generally mild or moderate. As with other PDE5 inhibitors, the use of Cialis is contraindicated in patients who are taking nitrates. It should not be taken by patients with certain heart diseases for whom sexual activity itself is not advisable.

Cialis is not approved for sale in the United States. Lilly ICOS received an approvable letter for Cialis from the Food and Drug Administration in April 2002.

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