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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

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

  • Cases of torsades de pointes (a life-threatening abnormal heart rhythm), cardiac arrest, and death have been reported with the use of a higher-than-recommended dosages of loperamide.
  • Loperamide is contraindicated in pediatric patients younger than 2 years of age.
  • Avoid higher-than-recommended dosages of loperamide in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions.

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.4 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:

  • allergic reaction to loperamide
  • colitis that is severe
  • diarrhea caused by antibiotics
  • dysentery (bloody stools and fever)

Tell your doctor if you have or have had:

  • condition in which constipation must be avoided
  • dehydration
  • infectious diarrhea
  • liver problems

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Call your doctor immediately if diarrhea continues past two days or if you get a fever. To prevent severe constipation, stop taking this drug once your diarrhea stops.
  • Call your doctor if you develop difficulty urinating.[6]
  • Until you know how you react to this drug, do not drive or perform other activities requiring alertness. Loperamide may cause drowsiness.
  • Have regular checkups if you use loperamide for a long time.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Be sure you drink enough liquids.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat or direct light. Do not let the liquid form freeze. Keep out of reach of children.

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:

  • appetite loss
  • bloated feeling
  • constipation
  • nausea or vomiting
  • skin rash
  • stomach pain that is severe<

Call your doctor if these symptoms continue:

  • dizziness
  • drowsiness
  • dry mouth

last reviewed March 31, 2021