Ranitidine: recent regulatory issues

Vasudha Sharma, Navyug Raj Singh


Ranitidine is histamine 2 receptor blocker which became commercial in 1981 as an antacid by Glaxosmithkline Pharamceuticals by the brand name of Zantac in various formulations. The drug accelerated in the market as amongst most commonly used drug for peptic ulcer disease, acid reflux and sooner than later it became available as an over-the-counter drug in 1996 for adults and children. Ranitidine’s mechanism of action involves competitive block of histamine 2 receptor leading to decrease cAMP formation which reduces acid secretion from parietal cells of stomach thereby healing the peptic ulcer.



Histamine 2 receptor blocker, Peptic ulcer disease, NDMA, Ranitidine, Carcinogen

Full Text:



Valisure Detects NDMA in Ranitidine. Valisure. 2019. Available at: blog/uncategorized/detection-of-ndma-in-raniditine/. Accessed on 24 November 2019.

Commissioner O of the. Statement on new testing results, including low levels of impurities in ranitidine drugs. FDA. 2019 Available at: Accessed on 25 November 2019.

Pottegård A, Kristensen KB, Ernst MT, Johansen NB, Quartarolo P, Hallas J. Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. BMJ. 2018;362:k3851.

WHO. Chemical hazards in drinking water: N-nitrosodimethylamine (NDMA). WHO. Available at: health/water-quality/guidelines/chemicals/ndma/en/. Accessed on 24 November 2019.

PubChem. N-Nitrosodimethylamine. Available at: Accessed on 25 November 2019.

Research C for DE and. FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). FDA. Available at: Accessed on 25 November 2019.

Research C for DE and. Laboratory Tests. Ranitidine. FDA. 2019. Available at: http://www. -tests-ranitidine. Accessed on 24 November 2019.

Zeng T, Mitch WA. Oral intake of ranitidine increases urinary excretion of N-nitrosodimethyl-amine. Carcinogenesis. 2016;37(6):625-34.

Nitrite in organ protection - Rassaf - 2014 - British Journal of Pharmacology - Wiley Online Library. Available at: https://bpspubs.onlinelibrary.wiley. com/doi/full/10.1111/bph.12291. Accessed on 25 November 2019.

Ariel H, Cooke JP. Cardiovascular Risk of Proton Pump Inhibitors. Methodist DeBakey Cardiovascular J. 2019;15(3):214.

DDAH1 dimethylarginine dimethylaminohydrolase 1 [Homo sapiens (human)] - Gene - NCBI. Available at: Accessed on 25 November 2019.

PubChem. Ranitidine. Available at: https://pubchem. Accessed on 25 November 2019.

Commissioner O of the. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. FDA. FDA; 2020. Available at: http://www.fda. gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market. Accessed on 2 April 2019.