Polyethyleneside effects

Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal irritation occur less frequently To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities. Cardiac Arrhythmias. Seizures. Renal Impairment. Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative Colitis. Patients with Significant Gastrointestinal Disease. Aspiration. Direct Ingestion. The following adverse reactions have been identified during post-approval use of GaviLyte-N. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of GaviLyte-N. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG.