FDA Requests Withdrawal of All Ranitidine Products

The action is the latest step in an ongoing investigation of a contaminant known as N-nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac^®). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA determined that the impurity in some ranitidine products increases over time and, when stored at higher-than-room temperatures, may result in consumer exposure to unacceptable levels of the impurity. As a result, ranitidine products will not be available for new or existing prescriptions or OTC use in the United States.

Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

Recommendation

• Consumers: FDA is advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly, and not buy more; those who wish to continue treating their condition should consider using other approved OTC products.
• Patients: Patients taking prescription ranitidine should speak with their healthcare professional about other treatment options before stopping the medicine. Multiple drugs are approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, FDA’s testing has not found NDMA in famotidine (Pepcid®), cimetidine (Tagamet®), esomeprazole (Nexium®), lansoprazole (Prevacid®), or omeprazole (Prilosec®).
• Consumers and Patients: Because of the COVID-19 pandemic, patients and consumers should not take their medicines to a drug take-back location but rather follow FDA’s recommended steps (https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-dispose-non-flush-list-medicine-trash), which include ways to safely dispose medications at home.

Healthcare professionals and patients should report adverse events or side effects related to the use of the products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm).
• Download the form (https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting) or call 800-332-1088 to request a reporting form, then complete it and return to the address on the form or fax to 800-FDA-0178.