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June 7, 2016: Reports of High-Dose Imodium Heart Problems, Warns FDA

High-Dose Imodium Heart Problems

The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication cautioning the public against taking higher than recommended doses of the common over-the-counter and prescription diarrhea medicine Imodium (loperamide), including through abuse or misuse of the product, as this can cause serious heart problems that can lead to death.


Use of higher than recommended doses of Imodium can result in serious cardiac adverse events. High doses of Imodium may cause cardiac events including:

  • QT interval prolongation,
  • Torsades de Pointes
  • other ventricular arrhythmias, syncope, and cardiac arrest.

Details of High-Dose Imodium Heart Problems

Imodium is used to help control symptoms of diarrhea, including Travelers’ Diarrhea. 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 sold under the over-the-counter brand name Imodium A-D, as store brands, and as generics.

Abuse May Lead to High-Dose Imodium Heart Problems

High doses of Imodium are sometimes taken intentionally to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. Misusing and abusing Imopdium accounts for the majority of reported serious heart problems associated with the drug.

In cases of abuse, individuals often use other drugs together with Imodium in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. The combination of Imodium with other drugs may also increase the likelihood of serious cardiac events.

Forty-Eight Reports of High-Dose Imodium Heart Problems

Between 1976 and 2015, the FDA received 48 reports of serious heart problems associated with use of Imodium. Thirty-one of these cases resulted in hospitalizations. Of these thirty-one cases, ten patients died. Over half of cases of cardiac event were reported after 2010. The serious heart problems occurred mostly in patients who were taking doses that were much higher than recommended. Since this count includes only reports submitted to FDA, there are likely more cases that have gone unreported.


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