The following adverse reactions have been identified during post-approval use of NuLYTELY. 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 NuLYTELY. 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.
Read the NuLytely (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) Side Effects Center for a complete guide to possible side effects
Drugs that May Lead to Fluid and Electrolyte Abnormalities
Use caution when prescribing NuLYTELY for patients who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see WARNINGS AND PRECAUTIONS] in patients taking these concomitant medications.
Potential for Altered Drug Absorption
Oral medication administered within one hour of the start of administration of NuLYTELY may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.
Concurrent use of stimulant laxatives and NuLYTELY may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking NuLYTELY.
Last reviewed on RxList: 10/7/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional NuLytely Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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