Pharmacy Services Alerts
Some Nizatidine Products May Contain a Probable Carcinogen
Jan 9, 2020 1:00 PM
Some nizatidine products may contain low concentrations of a probable human carcinogen called N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine is an environmental contaminant found in various foods and water. In September 2019, FDA became aware of low levels of NDMA in ranitidine, which is chemically similar to nizatidine. FDA recommends manufacturers recall nizatidine or ranitidine products containing NMDA levels above the acceptable daily intake limit of 96 nanograms per day. FDA is working with international regulatory agencies and manufacturers to identify the source of NDMA contamination, and will provide updated information when available. FDA is asking that manufacturers test for NDMA contamination prior to the release of the product to consumers. FDA is also requiring manufacturers to report any excessive impurities to the agency.
Nizatidine is a prescription histamine-2 antagonist. It decreases stomach acid production, and prevents and treats heartburn and gastrointestinal ulcers. Patients taking nizatidine should discuss other treatment options with their health care provider before stopping therapy.
Patients and health care providers can report any adverse reaction related to nizatidine 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:
- Ongoing list of press alerts for NDMA in ranitidine and nizatidine products:
- NDMA in ranitidine FAQ:
- Manufacturer Recalls
- Mylan – 3 lots of nizatidine 150 mg and 300 mg capsule presentations (1/08/2020)