Loperamide Side Effects

Brand Names: Imodium, Diar-Aid

Please note - some side effects for Loperamide 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 Loperamide - for the Consumer

Loperamide/Simethicone

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Loperamide/Simethicone. Seek medical attention right away if any of these SEVERE side effects occur when using Loperamide/Simethicone:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.

Loperamide

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Loperamide. Seek medical attention right away if any of these SEVERE side effects occur when using Loperamide:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.

Loperamide Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Loperamide Capsules. Seek medical attention right away if any of these SEVERE side effects occur when using Loperamide Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.

Loperamide Solution

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported for with Loperamide Solution. Seek medical attention right away if any of these SEVERE side effects occur when using Loperamide Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.

Loperamide Side Effects - for the Professional

Loperamide

Clinical Trial Data

The adverse effects reported during clinical investigations of Loperamide hydrochloride are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with Loperamide hydrochloride were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.

The adverse events reported are summarized irrespective of the causality assessment of the investigators.

The adverse events with an incidence of 1% or greater, which were reported at least as often in patients on Loperamide hydrochloride as on placebo, are presented in the table below.

The adverse events with an incidence of 1% or greater, which were more frequently reported in patients on placebo than on Loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.

The adverse events with an incidence of 1% or greater, which were reported at least as often in patients on Loperamide hydrochloride as on placebo, are presented in the table below.

The adverse events with an incidence of 1% or greater, which were more frequently reported in patients on placebo than on Loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

The adverse events with an incidence of 1% or greater in patients from all studies are given in the table below.

Post-marketing Experience

The following adverse events have been reported:

Skin and Subcutaneous Tissue Disorders: Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported with use of Loperamide.

Immune System Disorders: Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of Loperamide.

Gastrointestinal Disorders: Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon.

Renal and Urinary Disorders: Urinary retention

Nervous System Disorders: Drowsiness, dizziness

General Disorders and Administrative Site Conditions: Tiredness

A number of the adverse events reported during the clinical investigations and post-marketing experience with Loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

Side Effects by Body System

Gastrointestinal

Necrotizing enterocolitis with perforation was reported in two women following short courses (24 hours and 3 days) of loperamide 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.

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.

Nervous system

Severe central nervous system depression may occur with overdose.

Nervous system side effects have rarely included drowsiness, tiredness, dizziness and severe central nervous system depression.

Other

While structurally related to meperidine and diphenoxylate, abuse potential is very low with loperamide. At therapeutic doses, it does not produce euphoria.

In opiate-addicted monkeys, loperamide in high doses did prevent withdrawal symptoms.

A 26-year-old male with a history of opiate 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.

Other side effects have rarely included physical dependence.

Hypersensitivity

Hypersensitivity side effects have included skin rash. Anaphylactic shock and anaphylactoid reactions have been reported rarely.

Dermatologic

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.

Genitourinary

Genitourinary side effects have included urinary retention.

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