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Limited Use
[what does this mean?]
Generic drug name:
loperamide
(loe PER a mide)
Brand name(s):
IMODIUM,
IMODIUM A-D,
IMODIUM MULTI-SYMPTOM RELIEF
GENERIC:
available
FAMILY:
Drugs for Diarrhea
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
No data are available for loperamide. Use during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.
Breast-feeding Warning
No information is available from either human or animal studies. Since it is likely that this drug, like many others, is excreted in human milk, you should consult with your doctor if you are planning to nurse.
Safety Warnings For This Drug [top]
FDA Black-Box Warning
WARNING: TORSADES DE POINTES AND SUDDEN DEATH
Product Warnings
Ask a doctor or pharmacist before use if you are taking antibiotics.
When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.
Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.
Facts About This Drug [top]
Loperamide is used to treat severe diarrhea. The drug, which is available in both prescription and over-the-counter forms, works through opioid receptors in the intestines. When it was first marketed, loperamide was thought to have minimal effects on the opioid receptors in the brain and, therefore, little risk of misuse and abuse. However, there is now evidence that the drug does have significant potential for misuse and abuse. [1]
Loperamide should never replace rehydration, which is the...
Loperamide is used to treat severe diarrhea. The drug, which is available in both prescription and over-the-counter forms, works through opioid receptors in the intestines. When it was first marketed, loperamide was thought to have minimal effects on the opioid receptors in the brain and, therefore, little risk of misuse and abuse. However, there is now evidence that the drug does have significant potential for misuse and abuse. [1]
Loperamide should never replace rehydration, which is the first-line treatment for diarrhea. The World Health Organization has warned against the use of this drug in children.[2] The U.S. Centers for Disease Control and Prevention has concluded: “Little evidence exists to support the use of nonspecific drug therapy [for acute diarrhea] in children, and much information exists to the contrary.”[3]
When older adults get diarrhea, they have a greater risk than younger adults of experiencing complications from the loss of fluid, sodium and potassium chloride, as well as other electrolytes. If you occasionally have short-term diarrhea, it is best to treat it using oral rehydration solution (see Diarrhea) rather than drugs. If nondrug treatments do not control your diarrhea, ask your doctor if loperamide is appropriate for you. If you use loperamide, do not take more than four 2-milligram (mg) capsules per day (total of 8 mg).[4] The first dose should be two 2-mg capsules, followed by one capsule after each episode of diarrhea until the maximum dose is reached. An overdose can depress your breathing severely and can cause coma, permanent brain damage, abnormal heart rhythm and sometimes death.
If you still have diarrhea after using loperamide for two days, or if you develop a fever, stop taking the drug and call your doctor.[4]
Regulatory Actions
2016: The Food and Drug Administration (FDA) announced that taking higher-than-recommended doses of loperamide can cause serious heart problems that can lead to death. A black-box warning about this risk was added to the labeling for the drug.
2018: The FDA announced that it continues to receive reports of heart problems and death when loperamide is taken at higher-than-recommended dosages. The FDA is working with manufacturers to change the packaging of the drug to help promote safe use.[5]
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
Evaluations of Drug Interactions 2003 lists no drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods as causing “highly clinically significant” or “clinically significant” interactions when used together with the drug in this section. We also found no interactions in the drug’s FDA-approved professional package inserts. However, as the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.
Some other drugs that you may be taking (either over-the-counter or prescription drugs) can interact with this one, causing adverse effects. Ask your doctor what these drugs are and let him or her know if you are taking any of them.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
last reviewed September 30, 2024