FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse

FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse 

Today, the U.S. Food and Drug Administration announced approved package size and package type limits for over-the-counter (OTC) brand-name tablet and capsule forms of loperamide, an FDA-approved drug product that helps control symptoms of diarrhea, including Travelers’ diarrhea. The changes to Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules are intended to address the problem of loperamide abuse and misuse by limiting each carton to no more than 48 mg of loperamide and requiring unit-dose blister packaging.

The maximum approved daily dose of OTC loperamide for adults is 8 milligrams per day and 16 milligrams per day for prescription use. While loperamide is safe at approved doses, the FDA has received reports of serious heart problems and deaths associated with loperamide, and the majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide. A Heart Alert warning was added to loperamide Drug Facts labels in the spring of 2017 to warn consumers that taking more than directed can cause serious heart problems or death. Evidence suggests that package size limitations and use of unit-dose packaging may reduce medication overdose and death.

In 2018, the FDA requested that manufacturers and packagers of OTC loperamide products change the way they label and package loperamide to support safe use. The FDA continues to review this important safety issue and to work with manufacturers, including manufacturers of generic and liquid loperamide products, to make appropriate packaging changes to support the safe use of those products.

For more information, please visit:

• Loperamide FDA In Brief
• Loperamide Drug Safety Communication