NuLYTELY Side Effects

Please note - some side effects for NuLYTELY may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of NuLYTELY - for the Consumer

NuLYTELY Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NuLYTELY Solution:

Bloating; nausea; rectal irritation; stomach fullness or cramps; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; hoarseness; muscle weakness; persistent or severe nausea and vomiting; severe bloating or abdominal swelling; severe stomach pain; slow or irregular heartbeat; vomiting of blood.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

NuLYTELY Side Effects - for the Professional

NuLYTELY

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring 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 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 reaction following the administration of PEG-ELS 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” infiltrate on chest X-ray after vomiting and aspirating PEG.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Mallory-Weiss tears are quite rare. In one study it occurred in only 0.06% of over 3,000 patients.

Complete rectal prolapse was reported in a 71-year-old who had been given 4 L of PEG-ELS. The patient was observed for 2 days and had no recurrence of the prolapse.

Gastrointestinal side effects have included nausea, vomiting, gas, bloating, complaints of bad taste, anal irritation, and abdominal discomfort. A small percentage of patients who received PEG-ELS have reportedly experienced Mallory-Weiss tears of the esophagus and esophageal perforation. In addition, at least one case of rectal prolapse has been reported.

Cardiovascular

Cardiac arrhythmias, especially increased ventricular ectopy, have been associated with PEG-ELS use.

Cardiovascular side effects have included arrhythmias.

Hypersensitivity

Hypersensitivity side effects have rarely included anaphylaxis. Rash, urticaria, lip and facial swelling, dyspnea, chest tightness, and throat tightness have been reported during postmarketing experience.

A 70-year-old male developed shortness of breath, wheezing, skin flushing, and lowered blood pressure after drinking a second glass of PEG-ELS.

Dermatologic

Dermatologic side effects have rarely included urticaria.

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