The most commonly observed adverse reactions (incidence ≥1%, all treated patients) occurring with the use of Visicol® Tablets are related to the desired purgative effect. Nausea, vomiting, abdominal bloating, abdominal pain, dizziness, and headache occur, and are generally transient and self-limited, requiring no specific treatment. All of these adverse events also occurred in patients who took the PEG-salt solution comparator. Small superficial mucosal ulcerations, typical of those previously reported from the use of liquid preparations of sodium phosphate, and instances of mucosal bleeding have been observed on colonoscopy.

One patient, with no history of heart disease, developed an initial episode of atrial fibrillation after severe vomiting immediately after taking Visicol® Tablets. Another patient, with known arteriosclerotic heart disease, who took the PEG-salt solution comparator developed atrial fibrillation and also vomited. No patient in the clinical studies developed predefined postural changes in vital signs with concomitant symptoms of lightheadedness or syncope.

Serum electrolyte changes have been observed in patients taking Visicol® Tablets, primarily affecting calcium, phosphate, and potassium. These changes essentially corrected within 48 to 72 hours after dosing, were not associated with any clinical adverse events and did not require treatment. No patient developed clinically significant hypocalcemia; among patients receiving Visicol® Tablets 60 grams (n=481) the mean decrease from baseline in calcium level was 0.5 mg/dL. No patient developed a calcium level below 7.1 mg/dL. No clinical adverse events suggestive of hypocalcemia were observed. Mean serum phosphorus levels increased by approximately 3.6 mg/dL transiently after taking Visicol® Tablets with no apparent clinical significance. A reactive decrease in serum phosphorus 2-3 days after dosing was observed; the mean decrease from baseline at that time was 0.7 mg/dL. The mean decrease in serum potassium after taking Visicol® Tablets was 0.5 mEq/L.

Under the direction of a physician, Visicol® Tablets are indicated for cleansing of the bowel when required as a preparation for colonoscopy, in adults 18 years of age or older. Laxatives and purgatives as a group have the potential for abuse by persons with eating disorders who "binge" and "purge".

Medications administered in close proximity to Visicol® Tablets may not be absorbed from the gastrointestinal tract due to the rapid intestinal peristalsis and watery diarrhea induced by the purgative agent.

Because of the mechanism of action of Visicol Tablets, patients should be advised to take only clear liquids by mouth for at least 12 hours prior to starting the purgative regimen.

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