Medical Editor: John P. Cunha, DO, FACOEP
What Is Imodium?
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).
What Are Side Effects of Imodium?
Imodium may cause serious side effects including:
- diarrhea that is watery or bloody,
- stomach pain or bloating,
- ongoing or worsening diarrhea,
- fast or pounding heartbeats,
- fluttering in your chest,
- shortness of breath, and
- lightheadedness
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Imodium include
- dizziness,
- drowsiness,
- tiredness,
- constipation,
- stomach pain,
- skin rash, or
- itching.
Tell your doctor if you experience serious side effects of Imodium including
- severe constipation/nausea/vomiting,
- stomach or abdominal pain, or
- uncomfortable fullness of the stomach or abdomen.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Imodium
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.
What Drugs, Substances, or Supplements Interact with Imodium?
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.
Imodium During Pregnancy and Breastfeeding
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.
Additional Information
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.
QUESTION
Bowel regularity means a bowel movement every day. See Answer2 pharmacies near 63101 have coupons for imodium (Brand Names:Imodium for 6 Tablets)
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Stop taking loperamide and call your doctor at once if you have:
- diarrhea that is watery or bloody;
- stomach pain or bloating;
- ongoing or worsening diarrhea; or
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).
Common side effects may include:
- constipation;
- dizziness, drowsiness;
- nausea; or
- stomach cramps.
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.
SLIDESHOW
Inflammatory Bowel Disease (IBD) Causes, Symptoms, Treatment See SlideshowSIDE 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)
© 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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