Imotil Side Effects

Generic Name: loperamide

Note: This page contains information about the side effects of loperamide. Some of the dosage forms included on this document may not apply to the brand name Imotil.

Not all side effects for Imotil may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to loperamide: oral capsule, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral tablet, oral tablet chewable

In addition to its needed effects, some unwanted effects may be caused by loperamide (the active ingredient contained in Imotil). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking loperamide:

Rare
  • Bloating
  • constipation
  • 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

Some of the side effects that can occur with loperamide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Gastrointestinal

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

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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