New Drug Safety Communication on Immodium (loperamide) and loperamide products – Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide (see Examples of Drugs that Can Potentially Interact with Loperamide).

The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. We continue to evaluate this safety issue and will determine if additional FDA actions are needed.

Health care professionals should be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events. Consider loperamide as a possible cause of unexplained cardiac events including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. If loperamide ingestion is suspected, measure blood levels, which may require specific testing. For some cases of Torsades de Pointes in which drug treatment is ineffective, electrical pacing or cardioversion may be required.

Advise patients taking loperamide to follow the dosing recommendations on the label because taking higher than recommended doses, either intentionally or unintentionally, may lead to abnormal heart rhythms and serious cardiac events leading to death. Also advise patients that drug interactions with commonly used medicines also increase the risk of serious cardiac adverse events. Refer patients with opioid use disorders for treatment (see Additional Information for Health Care Professionals).

Patients and consumers should only take loperamide in the dose directed by their health care professionals or according to the OTC Drug Facts label. Do not use more than the dose prescribed or listed on the label, as doing so can cause severe heart rhythm problems or death. If your diarrhea lasts more than 2 days, stop taking loperamide and contact your health care professional. Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following:

• Fainting
• 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

For more information, please visit: Immodium (loperamide) and loperamide products.