


Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label, as taking more than prescribed or listed on the label can cause severe heart rhythm problems or death. 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. Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. Loperamide is FDA-approved to help control symptoms of diarrhea, including Travelers’ Diarrhea. Loperamide is a safe drug when used as directed.

We continue to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Food and Drug Administration (FDA) is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, the U.S.
#Bubble gut pack update
This is an update to the FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse issued on June 7, 2016
