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Imodium Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Imodium (loperamide hydrochloride) is an antidiarrheal used to treat diarrhea. It 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. Common side effects of Imodium include dizziness, drowsiness, tiredness, constipation, stomach pain, skin rash, or itching.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Imodium in Detail - Patient Information: Side Effects
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:
- drowsiness, tired feeling;
- mild stomach pain; or
- mild skin rash or itching.
Read the entire detailed patient monograph for Imodium (Loperamide Hcl)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Imodium Overview - Patient Information: Side Effects
If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Stop taking this medication and seek immediate medical attention if any of these unlikely but serious side effects occur: severe constipation/nausea/vomiting, stomach/abdominal pain, uncomfortable fullness of the stomach/abdomen.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Imodium (Loperamide Hcl)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Imodium FDA Prescribing 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.
|No. of treated patients||231||236|
| Gastrointestinal AE%
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.
|No. of treated patients||285||277|
| Gastrointestinal AE%
| Central and peripheral
nervous system AE%
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|
|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) .
Renal and urinary disorders
Nervous system disorders
General disorders and administrative site conditions
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
A specific clinical study designed to assess the abuse potential of loperamide at high doses resulted in a finding of extremely low abuse potential.
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)
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