Lactulose Side Effects

Brand Names: Constulose, Enulose, Generlac

Please note - some side effects for Lactulose may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lactulose - for the Consumer

Lactulose Crystals

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 Lactulose Crystals:

Belching; gas; stomach cramps.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; high blood sugar (excessive thirst or urination, confusion, flushing, rapid breathing, or fruity breath odor).

Lactulose 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 Lactulose Solution:

Belching; gas; stomach cramps.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; high blood sugar (excessive thirst or urination, confusion, flushing, rapid breathing, or "fruity" breath odor).

Lactulose Side Effects - for the Professional

Lactulose

Precise frequency data are not available.

Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.

Nausea and vomiting have been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

Gastrointestinal

Diarrhea is an indication of overdose. Severe diarrhea may lead to hypovolemia, hypokalemia, and hypernatremia, especially in elderly or acutely ill patients. If diarrhea develops, the dosage should be reduced.

Pneumatosis cystoides intestinalis may occur with lactulose therapy as a result of increased intracolonic pressure caused by ammonia sequestration in the bowel, and particularly when there is a concomitant breach of intestinal mucosal integrity.

Gastrointestinal side effects have included abdominal cramps, gaseous distention, flatulence, belching, bowel distention, cramping, nausea and vomiting, and with excessive doses, diarrhea. Colonic dilatation has been reported in elderly patients. Rare cases of pneumatosis cystoides intestinalis have been reported.

Metabolic

Metabolic side effects have included hypernatremia, hypokalemia and hyperchloremic metabolic acidosis. An isolated case of severe and intractable lactic acidosis has been reported.

Fluid and electrolyte disturbances, including severe hypokalemia, hypernatremia and hyperchloremic metabolic acidosis, typically occur as a result of severe diarrhea and subsequent fluid loss. A case of fatal lactulose-induced lactic acidosis in the absence of diarrhea has also been reported. Elderly and/or acutely ill patients may be at increased risk for adverse metabolic effects with lactulose.

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