Ranitidine is a medication belonging to the H2-receptor antagonist class, used to decrease the amount of acid the stomach produces [1]. Its chemical composition is N-(2-[({5-[(dimethylamino)methyl]-2-furanyl}methyl)thio]ethyl)-N'-methyl-2-nitro-1,1-ethenediamine [1].
What is ranitidine used for?
Ranitidine is prescribed to treat and prevent ulcers in the stomach and intestines, as well as gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid [1].
What are the active ingredients in ranitidine?
The active ingredient in ranitidine is ranitidine hydrochloride [1].
Why was ranitidine recalled?
Ranitidine was recalled from the market due to the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen [2]. This impurity was found to degrade over time, increasing with storage [2].
When did the ranitidine recall happen?
The U.S. Food and Drug Administration (FDA) requested the withdrawal of all prescription and over-the-counter (OTC) ranitidine products from the market in April 2020 [2].
What are the alternatives to ranitidine?
Alternative medications for reducing stomach acid include other H2-receptor antagonists like famotidine, cimetidine, and nizatidine, as well as proton pump inhibitors (PPIs) such as omeprazole, lansoprazole, and esomeprazole [3, 4]. These alternatives do not currently have the same issues with NDMA contamination associated with ranitidine [3, 4].
Can you still get ranitidine?
Ranitidine products are no longer available in the U.S. market due to the voluntary recalls [2].
What is NDMA contamination?
NDMA is a nitrosamine that can form in ranitidine products during manufacturing or storage [2]. It is classified as a probable human carcinogen [2].
What are the risks of taking ranitidine?
The primary risk associated with ranitidine identified by regulatory bodies was the potential exposure to NDMA, a probable carcinogen [2].
What are generic versions of ranitidine?
Generic versions of ranitidine were available before the market withdrawal. These generics contained the same active ingredient, ranitidine, and faced the same contamination issues [2].
What are the side effects of ranitidine?
Common side effects of ranitidine have included headache, dizziness, diarrhea, constipation, and nausea [1]. However, the major concern leading to its withdrawal was the presence of NDMA [2].