Rapid Message Testing with Consumer Panel - Additional Testing of Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)

FDA warns about serious heart problems with high doses of the
antidiarrheal medicine loperamide (Imodium), including from abuse
and misuse
FDA Drug Safety Communication
The U.S. Food and Drug Administration (FDA) is warning that taking higher than
recommended doses of the common over-the-counter (OTC) and prescription diarrhea
medicine loperamide (Imodium), including through abuse or misuse of the product, can
cause serious heart problems that can lead to death. The risk of these serious heart
problems, including abnormal heart rhythms, may also be increased when high doses of
loperamide are taken with several kinds of medicines that interact with loperamide (see
Examples of Drugs that Can Potentially Interact with Loperamide).
The majority of reported serious heart problems occurred in individuals who were
intentionally misusing and abusing high doses of loperamide in attempts to self-treat
opioid withdrawal symptoms or to achieve a feeling of euphoria. We continue to
evaluate this safety issue and will determine if additional FDA actions are needed.
Patients and consumers should only take loperamide in the dose directed by their health
care professionals or according to the OTC Drug Facts label. Do not use more than the
dose prescribed or listed on the label, as doing so can cause severe heart rhythm problems
or death. If your diarrhea lasts more than 2 days, stop taking loperamide and contact your
health care professional. Seek medical attention immediately by calling 911 if you or
someone taking loperamide experiences any of the following:
•
Fainting
•
Rapid heartbeat or irregular heart rhythm
•
Unresponsiveness, meaning that you can’t wake the person up or the person
doesn’t answer or react normally
Ask a pharmacist or your health care professional if you are not sure how much
loperamide to take, how often to take it, or whether a medicine you are taking may
interact with loperamide. Always tell your health care professionals about all the
medicines you are taking, including OTC medicines (see Examples of Drugs that Can
Potentially Interact with Loperamide).
Loperamide is approved to help control symptoms of diarrhea, including Travelers’
Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and
16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D,
as store brands, and as generics.

In the 39 years from when loperamide was first approved in 1976 through 2015, FDA
received reports* of 48 cases of serious heart problems associated with use of
loperamide. This number includes only reports submitted to FDA, so there are likely
additional cases about which we are unaware. Thirty-one of these cases resulted in
hospitalizations, and 10 patients died. More than half of the 48 cases were reported after
2010. The serious heart problems occurred mostly in patients who were taking doses
that were much higher than recommended. In other cases, patients were taking the
recommended dose of loperamide, but they were also taking interacting medicines,
causing an increase in loperamide levels. Additional cases of serious heart problems
associated with the use of loperamide were reported in the medical literature.1-9 Cases
reported to FDA and in the medical literature indicate that individuals are taking
significantly high doses of loperamide in situations of both misuse and abuse, often
attempting to achieve euphoria or self-treat opioid withdrawal. They are also combining
loperamide with interacting drugs in attempts to increase these effects.
We urge patients, consumers, and health care professionals to report side effects
involving loperamide or other medicines to the FDA MedWatch program, using the
information in the “Contact FDA” box at the bottom of the page.
*The cases were reported to the FDA Adverse Event Reporting System (FAERS).

Contact FDA
For More Info
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[email protected]
Report a Serious Problem to MedWatch
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Download form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.