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Reporting a Medication Error

Zantac Reborn

Published January 11, 2023

The brand name Zantac has been recycled and is now used as part of the brand name for the generic drug famotidine (www.ismp.org/ext/688). Famotidine is an over-the-counter (OTC) antihistamine/antacid that is already known by other brand names such as Pepcid. The new Zantac product is formally called Zantac 360° (Figure 1).

Figure 1. Zantac is now a brand of famotidine.

Originally, Zantac was available as a prescription and OTC medicine that contained the active ingredient ranitidine. Ranitidine was also used as an antihistamine/antacid. However, in 2020, the US Food and Drug Administration (FDA) asked companies to remove all prescription and OTC ranitidine products (www.ismp.org/ext/689) from the market due to the presence of a potential cancer-causing chemical in the medicine. The original Zantac (ranitidine) product remains available outside the United States, which means, it will still appear in internet drug searches. Also, Zantac is a medicine that is well known by healthcare professionals and consumers as ranitidine. Therefore, using the brand name Zantac as part of the new product’s name (Zantac 360° [famotidine]) can cause confusion.

It is unclear what the drug name modifier 360° means. One might think it means that the product offers 24-hour protection, but a dose of famotidine generally lasts for only 12 hours. Also, some of the company’s   original advertising highlighted that the new product is the “new original strength Zantac 360° formulation.” Originally, Zantac (ranitidine) was available in 150 mg and 300 mg strength tablets. However, Zantac 360° (famotidine) is available in 10 mg (regular strength) or 20 mg (maximum strength) tablets.

Over the years, many reported errors have resulted from medicine names being confused. To help prevent these types of errors, FDA has outlined recommendations for drug companies to follow when naming their medicines. One of FDA’s recommendations is for companies to avoid using a brand name that is already associated with a marketed product. For example, mix-ups have occurred with OTC products named Dulcolax. One Dulcolax product contains the laxative bisacodyl, and the other contains the stool softener docusate. Years ago, we received a report about a person who mistakenly bought and took the stool softener instead of the laxative in preparation for a colonoscopy.

FDA also discourages drug companies from including numbers within the brand name. Numbers have been mistaken as the strength, the quantity, or how long the medicine will work. We are not sure why the manufacturer of Zantac 360° and FDA chose not to follow these recommendations with the naming of this new product.

Here’s what you can do: When purchasing OTC medicines, read the label carefully to ensure you have the correct product. If you purchase Zantac 360°, know that it contains famotidine which is different than the original Zantac product. Be sure to follow the instructions on the Drug Facts label. If you have any questions about Zantac 360° or any other medicine, ask your pharmacist or healthcare provider for help. If you are not feeling better after taking this medicine, contact your doctor.

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