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Imodium

Last reviewed on RxList: 10/18/2016
Imodium Side Effects Center

Last reviewed on RxList 8/30/2016

Imodium (loperamide hydrochloride) is an antidiarrheal used to treat diarrhea. Imodium is also used to reduce the amount of stool in people who have an ileostomy (re-routing of the bowel through a surgical opening in the stomach). Imodium is available in generic form and over-the-counter (OTC). Common side effects of Imodium include

Tell your doctor if you experience serious side effects of Imodium including

The recommended initial adult dose of Imodium is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16mg (eight capsules). In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation Imodium A-D Liquid 1 mg/5 mL should be used; for ages 6 to 12, either capsules or A-D Liquid may be used. Imodium may interact with saquinavir (Invirase). Other drugs may interact with Imodium. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Imodium should be used only if recommended by a physician. This drug passes into breast milk but is unlikely to have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Imodium (loperamide hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Imodium Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking loperamide and call your doctor at once if you have a serious side effect such as:

  • stomach pain or bloating;
  • ongoing or worsening diarrhea;
  • diarrhea that is watery or bloody; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • dizziness;
  • drowsiness, tired feeling;
  • constipation;
  • mild stomach pain; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Imodium (Loperamide Hcl)

Imodium Professional Information

SIDE EFFECTS

Clinical Trial Data

The adverse effects reported during clinical investigations of IMODIUM® (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with IMODIUM® (loperamide hcl) 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.

1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below.

  Acute Diarrhea
Loperamide
Hydrochloride
Placebo
No. of treated patients 231 236
Gastrointestinal AE%
Constipation

2.6%

0.8%

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea

The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below.

  Chronic Diarrhea
Loperamide
Hydrochloride
Placebo
No. of treated patients 285 277
Gastrointestinal AE%
Constipation

5.3%

0.0%
Central and peripheral
nervous system AE%

Dizziness

1.4%

0.7%

The adverse events with an incidence of 1.0% 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.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea

The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below.

  Acute Diarrhea Chronic Diarrhea All Studiesa
No. of treated patients 1913 1371 3740
Gastrointestinal AE%
Nausea 0.7% 3.2% 1.8%
Constipation 1.6% 1.9% 1.7%
Abdominal cramps 0.5% 3.0% 1.4%
a. All patients in all studies, including those in which it was not specified if the adverse events occurred in patients with acute or chronic diarrhea.

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 IMODIUM (loperamide hcl) .

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 IMODIUM (loperamide hcl) .

Gastrointestinal disorders

Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon (see CONTRAINDICATIONS and WARNINGS).

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.

Drug Abuse And Dependence

Abuse

A specific clinical study designed to assess the abuse potential of loperamide 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 IMODIUM® (loperamide hydrochloride), was negative. Orally administered IMODIUM® (loperamide hcl) (loperamide formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.

Read the entire FDA prescribing information for Imodium (Loperamide Hcl)

Related Resources for Imodium

Read the Imodium User Reviews »

© Imodium Patient Information is supplied by Cerner Multum, Inc. and Imodium Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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