Imodium Multi-Symptom Relief

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Loperamide falls into category C. There are no adequate and well-controlled studies in pregnant women. Loperamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Very upset stomach or throwing up.
• Belly pain.
• Hard stools (constipation).
• Swelling of belly.
• Fever.
• Black, tarry, or bloody stools.
• Not able to pass urine or change in how much urine is passed.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to loperamide / simethicone: oral tablet, oral tablet chewable

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 travelers' diarrhea with loperamide at greater than recommended daily dose for seven days. Three days later, an appendolith was noted during an emergency appendectomy. The authors speculated that fecal stasis induced by loperamide increases the risk of fecalith and appendolith 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 with use of loperamide. Many of these reports had occurred in a setting with acute dysentery, overdose, and children less than 2 years old.[Ref]

Gastrointestinal side effects of loperamide 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]

Nervous system

Nervous system side effects of loperamide have rarely included drowsiness, tiredness, dizziness and severe central nervous system depression.[Ref]

Severe central nervous system depression may occur with overdose of loperamide.[Ref]

Other

Other side effects of loperamide have rarely included physical dependence.[Ref]

While structurally related to meperidine and diphenoxylate, abuse potential is very low with loperamide. 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]

Hypersensitivity

Hypersensitivity side effects of loperamide have included skin rash. Anaphylactic shock and anaphylactoid reactions have been reported rarely.[Ref]

Dermatologic

Dermatologic side effects have associated with loperamide therapy 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

Genitourinary side effects of loperamide have included urinary retention.[Ref]

General

Simethicone has no known side effects.[Ref]

Some side effects of Imodium Multi-Symptom Relief may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.