The FDA recently approved a newly reformulated ranitidine tablet, allowing the H2 receptor blocker to return to the U.S. market after 5 years. The previous version was removed in 2020 because N-nitrosodimethylamine (NDMA), a potential carcinogen, could form in the product over time. The new formulation incorporates stronger manufacturing controls and stability measures to prevent NDMA from forming during storage.
Ranitidine has been used to treat GERD, peptic ulcers, and conditions with excess acid production such as Zollinger–Ellison syndrome. The FDA reported that the reformulated product works the same as earlier approved versions and offers the same expected clinical benefit.
According to Binu V. John, MD, a spokesperson for the American Gastroenterological Association and Chief of Gastroenterology and Hepatology at the Miami VA Health System, since the withdrawal of ranitidine, most patients were switched over to famotidine, a medication with an identical mechanism of action and without similar concerns. “Famotidine at doses of 20 mg is equivalent in potency to the clinically recommended dose of 150 mg of ranitidine,” John said. “Additionally, famotidine has a longer half-life, and unlike ranitidine, does not have drug interactions with medications metabolized by the P450 enzymes. Therefore, the availability of ranitidine back in the market is unlikely to provide a greater clinical benefit over current options.”
The FDA recommends that any switch to ranitidine from another medication should be guided by the patient’s current symptom control, risk factors, and overall treatment plan. The new formulation also comes with updated storage instructions, which are important for keeping the product stable and preventing NDMA formation.
To maintain safety and product quality, the FDA highlighted several key steps that patients and clinicians should follow:
Keep ranitidine tablets in the original bottle and protect the bottle from moisture.
After opening the bottle for the first time, discard any remaining tablets after 90 days, or by the expiration date—whichever comes first.
If multiple bottles are dispensed, open only one at a time; keep the others sealed until needed.
Remove just one tablet per dose and secure the bottle immediately.
Do not remove the desiccant; it must stay in the bottle.
“While it is beneficial to have an alternative drug available for patients, both medications work by the same mechanism and ranitidine does not offer advantages over famotidine,” John said. “The major downside of medications in this class is tachyphylaxis, where these medications lose potency after 6 to 8 weeks of use. Unfortunately, this limitation applies to both drugs.”
John disclosed that he has received research support from Exact Sciences, Takeda, and Genentech, and has served as an advisor to Madrigal and Ipsen.