Note: This document contains side effect information about lactulose. Some dosage forms listed on this page may not apply to the brand name Duphalac.
Applies to lactulose: oral powder for solution, oral solution, oral syrup.
Serious side effects of Duphalac
Along with its needed effects, lactulose (the active ingredient contained in Duphalac) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking lactulose:
Incidence not known
- Confusion
- decreased urine
- dizziness
- dry mouth
- fainting
- fast or irregular heartbeat
- increased thirst
- irritability
- lightheadedness
- loss of appetite
- mood changes
- muscle pain, cramps, or twitching
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- restlessness
- seizures
- severe diarrhea
- swelling of the feet or lower legs
- trouble breathing
- unusual tiredness or weakness
Other side effects of Duphalac
Some side effects of lactulose may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Bloated
- excess air or gas in the stomach or intestines
- full feeling
- passing gas
- stomach or intestinal cramps
For Healthcare Professionals
Applies to lactulose: compounding solution, oral powder for reconstitution, oral solution, oral syrup, oral and rectal liquid.
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 (the active ingredient contained in Duphalac) 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.[Ref]
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.[Ref]
Metabolic
Metabolic side effects have included hypernatremia, hypokalemia and hyperchloremic metabolic acidosis. An isolated case of severe and intractable lactic acidosis has been reported.[Ref]
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.[Ref]
