FDA places limits on OTC loperamide

The agency is working with manufacturers to use blister packs or other single-dose packaging and curb the number of doses contained in each package.


To foster safer use of over-the-counter loperamide (Imodium), the FDA is implementing restrictions on its packaging. The agency announced on Jan. 30 that it is working with manufacturers to use blister packs or other single-dose packaging and curb the number of doses contained in each package.

For adults, the maximum approved loperamide dose is 8 mg/d for over-the-counter use and 16 mg/d for prescription use. While the drug is safe to use at approved doses, very high doses can lead to serious heart rhythm problems and death. Reports of these adverse events continue, primarily among those who intentionally misuse the product, despite the recent addition of a warning to the product label. The FDA will continue to evaluate the drug's safety.