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# Continued Heart Safety Issues Seen with Imodium: FDA
- URL: https://www.fdaweb.com/continued-heart-safety-issues-seen-with-imodium-fda/
- Published: 2018-01-30T12:00:00.000Z
- Updated: 2026-09-14T23:18:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140632

FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium). In a revised [drug safety alert](https://www.fda.gov/Drugs/DrugSafety/ucm594232.htm?utm%5Fcampaign=New%20FDA%20Drug%20Safety%20Communication%20on%20Imodium%20%28loperamide%29%20-%20Drug%20Information%20Update&utm%5Fmedium=email&utm%5Fsource=Eloqua), the agency says most events are among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous 2016 communication ([see earlier story](https://www.fdaweb.com/fda-alert-on-otc-diarrhea-medication/)).

The [agency notes](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594443.htm?ref=fdaweb.com) that loperamide abuse has been increasing in the U.S., particularly in those suffering from opioid addiction who use it to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use. The revised alert says FDA is now working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. 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 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,” it says.