The most commonly observed adverse events (incidence of >5% and twice that of placebo) were oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence, particularly after meals containing more fat than recommended. These and other commonly observed events were generally mild and transient, but for some people they may continue for 6 months or longer.

XENICAL is contraindicated in patients with chronic malabsorption syndrome or cholestasis. Organic causes of obesity, such as hypothyroidism, should be excluded before prescribing XENICAL. XENICAL is not recommended for use during pregnancy and should not be taken by nursing mothers.

To reduce the chance of a drug interaction resulting in reduced levels of cyclosporine, XENICAL and cyclosporine should not be taken within 2 hours of each other. More frequent monitoring of cyclosporine levels should be considered in patients taking both drugs (see WARNINGS).

Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin supplement containing fat-soluble vitamins once a day at least 2 hours before or after taking XENICAL.

For a full discussion of safety and efficacy, please see the Complete Product Information.