Ranitidine, sold under the brand name Zantac among others, is a medication that is used to decrease stomach acid production. It was first approved in the U.S. in 1983. Glaxo Holdings Ltd., later acquired by GlaxoSmithKline PLC, received approval from the U.S Food and Drugs Administration to market Zantac. It was approved for the treatment of heartburn and ulcers. It was prescribed to treat heartburn along with acid reflux, also known as gastroesophageal reflux disease (GERD). It was the first medication to surpass US$ 1 billion in annual sales in 1988. In 2004, Pfizer received Food and Drugs Administration approval to sell OTC counterpart of Ranitidine in the U.S. Many pharmaceutical companies other than Pfizer marketed Ranitidine in the U.S. include Boehringer, Johnson & Johnson, and Ingelheim Pharmaceuticals.
Ranitidine is a competitive inhibitor of histamine H2-receptor. The reason why it was approved was that it was shown to significantly reduce the stomach's production of gastric acids. The reversible inhibition of the H2-receptors in gastric parietal cells results in a reduction in both gastric acid volume and concentration. However, when it was found that many forms of ranitidine medications had a high content of N-Nitrosodimethylamine (NDMA), in April 2020, the Food and Drugs Administration officially requested to stop the sale of all Zantac and ranitidine products in the U.S. NDMA was used to manufacture rocket fuel. In October 2020, European regulators indicated recall for Zantac and all ranitidine-based heartburn medications.
In India, The National Pharmaceutical Pricing Authority gave its nod to a one-time price hike of Carbamazepine, Ranitidine, and Ibuprofen by 50 percent from the present ceiling limit, in July 2021. Indian doctors have advised patients to avoid ranitidine, following concerns over its contamination by cancer-causing substances.