Pepto Diarrhea Control Side Effects
Generic Name: loperamide
Note: This page contains side effects data for the generic drug loperamide. It is possible that some of the dosage forms included below may not apply to the brand name Pepto Diarrhea Control.
For the Consumer
Applies to loperamide: oral capsule, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral tablet, oral tablet chewable
As well as its needed effects, loperamide (the active ingredient contained in Pepto Diarrhea Control) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking loperamide, check with your doctor immediately:Rare
- loss of appetite
- stomach pain (severe) with nausea and vomiting
If any of the following side effects occur while taking loperamide, check with your doctor or nurse as soon as possible:Rare
- Skin rash
Minor Side Effects
Some loperamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:Rare
- Dizziness or drowsiness
- dryness of mouth
For Healthcare Professionals
Applies to loperamide: compounding powder, oral capsule, oral liquid, oral suspension, oral tablet, oral tablet chewable
Necrotizing enterocolitis with perforation was reported in two women following short courses (24 hours and 3 days) of loperamide (the active ingredient contained in Pepto Diarrhea Control) for the treatment of acute diarrhea with fever. Resected bowel in both cases revealed extensive mucosal hemorrhage and necrosis.
Toxic megacolon has been reported in association with the use of loperamide to treat symptoms of ulcerative colitis and pseudomembranous colitis due to antibiotic therapy. In one patient treated for ulcerative colitis, abdominal symptoms seemed to improve in the days before requiring emergency laparotomy.
Loperamide has also been implicated in a case of appendicitis. A 35-year-old male self-treated traveler's diarrhea with loperamide at greater than the recommended daily dose for seven days. Three days later, an appendalith was noted during an emergency appendectomy. The authors speculated that fecal stasis induced by loperamide increases the risk of fecalith and appendalith formation, the latter being associated with the pathogenesis of appendicitis.
Gastrointestinal side effects reported during loperamide therapy are often likely due to the underlying illness and include nausea, vomiting, dyspepsia, abdominal cramps, and anorexia.
Cases of paralytic ileus associated with abdominal distention have been reported rarely. Many of these reports had occurred in a setting with acute dysentery, overdose, and children less than 2-years-old.[Ref]
Gastrointestinal side effects have included nausea, vomiting, dyspepsia, abdominal cramps, anorexia, abdominal pain, abdominal distention, dry mouth, abdominal discomfort, and constipation. Gastrointestinal side effects have rarely included ileus, toxic megacolon and necrotizing enterocolitis, with or without perforation.[Ref]
Severe central nervous system depression may occur with overdose.[Ref]
Nervous system side effects have rarely included drowsiness, tiredness, dizziness and severe central nervous system depression.[Ref]
While structurally related to meperidine and diphenoxylate, abuse potential is very low with loperamide (the active ingredient contained in Pepto Diarrhea Control) At therapeutic doses, it does not produce euphoria.
In opioid addicted monkeys, loperamide in high doses did prevent withdrawal symptoms.
A 26-year-old male with a history of opioid and alcohol abuse, began taking loperamide for the treatment of acute diarrhea. Despite denying euphoric effects from the drug, he gradually increased his intake to 320 mg per day. Attempts to stop the drug resulted in acute withdrawal (chest pain, shortness of breath, chills, diaphoresis, abdominal discomfort, nausea, and vomiting). Methadone relieved the symptoms. A slow methadone taper in an inpatient setting was successful in treating the physical dependence.[Ref]
Other side effects have rarely included physical dependence.[Ref]
Hypersensitivity side effects have included skin rash. Anaphylactic shock and anaphylactoid reactions have been reported rarely.[Ref]
Dermatologic side effects have included rash, pruritus, urticaria, and angioedema. Bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and Toxic Epidermal Necrolysis (TEN) have been reported rarely.[Ref]
Genitourinary side effects have included urinary retention.[Ref]
1. Walley T, Milson D "Loperamide related toxic megacolon in Clostridium difficile colitis." Postgrad Med J 66 (1990): 582
2. Brown JW "Toxic megacolon associated with loperamide therapy." JAMA 241 (1979): 501-2
3. "Product Information. Imodium (loperamide)." Janssen Pharmaceutica, Titusville, NJ.
4. Ericsson CD, Johnson PC "Safety and efficacy of loperamide." Am J Med 88 (1990): s10-4
5. Olm M, Gonzalez FJ, Garcia-Valdecasas JC, Fuster J, Bertran A, Milla J "Necrotising colitis with perforation in diarrhoic patients treated with loperamide." Eur J Clin Pharmacol 40 (1991): 415-6
6. Katz JP, Sturmann KM "Appendicitis associated with loperamide hydrochloride abuse." Ann Pharmacother 27 (1993): 369-70
7. Hill MA, Greason FC "Loperamide dependence." J Clin Psychiatry 53 (1992): 450
It is possible that some side effects of Pepto Diarrhea Control may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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