FDA Warns Imodium A-D May Dangerously Stop More Than Diarrhea

A new safety alert issued by the FDA warns consumers, pharmacists and health care providers about the dangers of intentionally or accidentally overdosing on diarrhea medicine. Over-the-counter and prescription loperamide, most commonly known through its over-the-counter (OTC) name Imodium A-D, may cause serious heart problems and increased risk of death. Taking higher than recommended daily amounts of loperamide may cause abnormal heart rhythms and other serious heart problems, or may negatively interact with other medicines, thereby increasing the risk of death.

Loperamide was first approved in 1976 to treat diarrhea. It can be taken in tablet, capsule or liquid form with the maximum daily adult dose 8mg for the OTC formula, and 16mg for the prescription. Some people are accidentally overdosing, but most adverse event reports received by the FDA are of people purposefully overdosing using loperamide to treat symptoms of opioid withdrawal or to create feelings of euphoria. Between 1976 and 2015, the FDA received 48 cases of serious heart problems with loperamide use resulting in 31 hospitalizations and 10 deaths.

The FDA is alerting health care providers to consider loperamide overdose if a patient presents with sudden cardiac symptoms of unknown origin absent prior history of cardiac problems.

Consumers are warned to take only the recommended daily dose, and to contact their health care provider if diarrhea persists after taking loperamide for 2 days. Talk to your pharmacist or health care provider if you are unsure about the proper daily dosage. Never give this medication to a child younger than 2 years of age.

Drugs that can potentially adversely interact with loperamide include:

Brand Name (generic)

  • Tagamet HB (cimetidine) – treat heartburn, GERD symptoms
  • Zantac (rantidine) – treat heartburn, GERD symptoms
  • Prevpac – proton-pump inhibitor; used to treat heartburn, acid reflux
  • Biaxin (clarithromycin) – antibiotic
  • E.E.S., Ery-Tab, Eryc, Eryped, PCE (erythromycin) – antibiotic
  • Lopid (gemfibrozil) – treats high cholesterol
  • Onmel, Sporanox (itraconazole) – anti-fungal medications
  • Ketoconazole (generic only) – anti-fungal medication
  • Nuedexta (quinidine) – used to treat mental/mood disorders
  • Qualaquin (quinine) – anti-malaria drug; also used to treat nocturnal leg cramps
  • Kaletra, Norvir, Technivie, Viekira Pak (ritonavir) – anti-HIV treatment
  • Quinine is also found in tonic water.

Consumers should look for the following signs of overdose, and seek immediate medical attention if the following occurs after taking loperamide:

  • Fainting
  • Rapid heartbeat
  • Irregular heart rhythm
  • Unresponsiveness

The FDA is also asking consumers and health care providers to file Adverse Event Reports if side effects or adverse events occur when using loperamide. Adverse Event reports can be found and submitted online at www.fda.gov/MedWatch/report, or by calling 1-800-332-1088 to request a form.