Imodium Side Effects, and Drug Interactions - Loperamide

Imodium Side Effects, and Drug Interactions - Loperamide

SIDE EFFECTS

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 following patient complaints have been reported and are listed in decreasing order of frequency with the exception of hypersensitivity reactions which is listed first since it may be the most serious.

- Hypersensitivity reactions (including skin rash) have been reported with loperamide hydrochloride use.

• Abdominal pain, distention or discomfort
• Nausea and vomiting
• Constipation
• Tiredness
• Drowsiness or dizziness
• Dry mouth

In postmarketing experiences, there have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children of less than two years of age.

DRUG ABUSE AND DEPENDENCE

Abuse: A specific clinical study designed to assess the abuse trial of loperamide hydrochloride at high doses resulted in a finding of extremely low abuse potential.

Dependence: Studies in morphine-dependent monkeys demonstrated that loperamide hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal. However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects, performed after a single high dose, or after more than two years of therapeutic use of loperamide hydrochloride, was negative. Orally administered loperamide hydrochloride (loperamide formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.

DRUG INTERACTIONS

There was no evidence in clinical trials of drug interactions with concurrent medications.