Ranitidine Removal from US Market

Apr 2, 2020 2:56 PM

On April 1, 2020, FDA requested all manufacturers of ranitidine products to immediately withdraw their products from the US market. This market withdrawal applies to prescription and over-the-counter products and includes both oral liquids and oral tablets. Some ranitidine products contain low concentrations of a probable human carcinogen called N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine is an environmental contaminant found in various foods and water. Concentrations of this impurity in ranitidine increase both over time and when stored at temperatures higher than room temperatures. In these situations, use of the affected ranitidine may expose the user to unacceptably high levels of NDMA.

Ranitidine is a histamine-2 antagonist that decreases stomach acid production, and prevents and treats heartburn and gastrointestinal ulcers. All patients taking over-the-counter ranitidine should immediately stop taking the product and dispose of it appropriately (current disposal recommendations during the COVID-19 pandemic are available on the FDA website). Patients taking prescription ranitidine should discuss other treatment options with their health care provider before stopping therapy. Other similar medications are available that FDA has tested and not found NDMA, including cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), and omeprazole (Prilosec).

Patients and health care providers can report any adverse reaction related to ranitidine therapy to FDA's MedWatch Program in 1 of 2 ways.

• Submit a report online at www.fda.gov/medwatch/report.htm
• Complete a paper form and fax to 1-800-FDA-0178

Additional information is available at the following links:

• MedWatch Alert:
  www.fda.gov/safety/medwatch-safety-alerts
• Press Announcement:
  www.fda.gov/news-events/press-announcements
• Ongoing list of press alerts for NDMA in ranitidine products:
  www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
• NDMA in ranitidine FAQ:
  www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac