Zantac Announcement

As of September 11, 2019 the FDA found trace levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen, in the heartburn drug, Zantac and its generic equivalent, ranitidine. NDMA is highly toxic to the liver and other organs, and is a probable human carcinogen. NDMA is an industrial by-product or waste product of several industrial processes, such as manufacturing a component of rocket fuel and water treatment by chlorination or chloramination of organic nitrogen-containing wastewater. First and foremost, the Zantac itself is very safe; however, during the manufacturing process, the drug is being contaminated with NDMA. Of note, this is the same contaminant that was recently found to have “unacceptable levels” in several popular high blood pressure medications. To put it in perspective, the European Medication Agency has estimated the lifetime risk of cancer to be extremely low (~1 in 5000) for an adult patient who had taken valsartan at its highest dose every day from 2012 – 2018. The FDA and other international drug regulators preliminary testing of Zantac have found traces of NDMA that barely exceed the amounts one would find in common foods. Therefore, the FDA has not recommended stopping Zantac at this time. Nevertheless, given that there are other options, we at Gastroenterology Associates recommend discontinuing Zantac for now and switching to Pepcid (famotidine) which is another brand of Histamine 2 blocker.

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