Polyethyleneside effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment Colonic mucosal ulcerations and ischemic colitis Patients with significant gastrointestinal disease Aspiration The following adverse reactions associated with the use of PEG-3350 and Electrolytes for Oral Solution were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure.

Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration.

Nervous system: tremor, seizure Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]. Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation. To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.