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In the phase 3 Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) trials, bloating, nausea, abdominal pain, and vomiting were the most common drug-related adverse events reported with the use of Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) (see Table 2). Since diarrhea was considered as a part of the efficacy of Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) diarrhea was not defined as an adverse event in the clinical trials. 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.

No patient in the clinical studies developed predefined postural changes in vital signs with concomitant symptoms of lightheadedness or syncope.

Table 2: Frequency of drug-related* adverse events ( ≥ 2%) of patients in the phase 3 Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) trials (Studies A and B)

Electrolyte Changes

In Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) trials, changes in serum electrolytes (including phosphate, calcium, potassium, and sodium) have been observed in patients taking Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) Tablets.

In the Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) phase 3 trials, 96% and < 1% of patients who took Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) (60 grams) and NuLYTELY® (up to 4 liters), respectively, developed hyperphosphatemia (defined as phosphate level > 4.7 mg/dL) on the day of the colonoscopy. In these trials, patients who took Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) and NuLYTELY® had baseline mean phosphate levels of 3.3 and 3.4 mg/dL and subsequently developed on the day of the colonoscopy mean phosphate levels of 7.1, and 3.3 mg/dL, respectively.

Two to three days after colonoscopy, 34%, 66%, and 0% of patients who received Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) had (reactive) hypophosphatemia (defined as phosphate level < 2.4 mg/dL), normal phosphate levels, and hyperphosphatemia, respectively. Two to three days after colonoscopy, 3%, 96%, and 1% of patients who received NuLYTELY® had (reactive) hypophosphatemia normal phosphate levels, and hyperphosphatemia, respectively. Two to three days after colonoscopy, patients who took Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) and NuLYTELY® had mean phosphate levels of 2.6 and 3.3 mg/dL, respectively.

In the Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) phase 3 trials, 47% and 9% of patients who took Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) and NuLYTELY® , respectively, developed hypocalcemia (defined as calcium level < 8.6 mg/dL) on the day of the colonoscopy. The mean changes in calcium levels (from baseline) for the Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) and NuLYTELY® patients were -0.6 and -0.1 mg/dL, respectively. Furthermore, in these trials, 28% and 3% of patients who took Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) and NuLYTELY®, respectively, developed hypokalemia (defined as potassium level < 3.5 mEq/L) on the day of the colonoscopy. The mean changes in potassium levels (from baseline) for the Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) and NuLYTELY® patients were -0.5 and -0.1 mEq/L, respectively. None of the patients who developed hypocalcemia or hypokalemia in the trials required treatment.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) . Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) , or a combination of these factors.

General: Hypersensitivity reactions including anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, paresthesia and swelling of the lips and tongue, and facial swelling.

Cardiovascular: Arrhythmias

Nervous system: Seizures

Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis

Medications administered in close proximity to Visicol® (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) Tablets may not be absorbed from the gastrointestinal tract due to the rapid intestinal peristalsis and watery diarrhea induced by the purgative agent.

Last reviewed on RxList: 4/17/2009
This monograph has been modified to include the generic and brand name in many instances.