Safety Alerts & Recalls
What does this mean?
Loperamide is a safe drug when used as directed. It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death.
Patients and consumers should only take the dose of loperamide directed by your health care provider or according to the OTC Drug Facts label.
If you are using OTC loperamide and your diarrhea lasts more than 2 days, stop taking the medicine and contact your healthcare provider.
Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following, and tell healthcare providers the person has been taking loperamide:
• 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.
If you have any questions about this safety alert or the use of loperamide, please follow up with your pharmacist or other healthcare provider.
Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
--- Telephone: 1-800-332-1088
--- Fax: 1-800-332-0178
--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
--- Website: http://www.fda.gov/Safety/MedWatch/default.htm
FDA Working with Manufacturers to Limit the Number of Doses in a Package of Over-the counter (OTC) Anti-Diarrhea Drug Loperamide
The Food and Drug Administration (FDA) continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of the over-the counter (OTC) anti-diarrhea drug loperamide These reports are primarily among people who are intentionally misusing or abusing loperamide, despite the addition of a warning to the medicine label and a previous communication
To increase the safe use of loperamide, the FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package..
Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. Loperamide is available under the name Imodium and other brand names.
FDA is continuing to evaluate this safety issue and will update the public when more information is available.
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