FDA Clears New, Safer Formulation of Ranitidine After Full Safety Evaluation

The U.S. Food and Drug Administration has approved reformulated ranitidine tablets, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life.

Ranitidine, an H2 receptor antagonist, is widely used to treat conditions including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

Clinical Considerations: Healthcare providers and patients should be aware that the reformulated ranitidine maintains the same therapeutic effectiveness as previously approved products. Patients currently using alternative H2 blockers or proton pump inhibitors should consult their healthcare providers before switching medications. Approved products will include updated labeling with storage and handling instructions. Patients and healthcare providers should consider the new storage conditions for the safe and effective use of the product which include:

• Keep Ranitidine Tablets in the original container (bottle) and protect from moisture.

• After the first opening of the bottle, discard unused tablets after 3 months (90 days), or by the expiration date on the bottle, whichever is sooner.

• If more than one bottle is dispensed, open only one bottle at a time. Store additional bottles without opening until needed for dosing.

• At the time of dosing, remove one tablet from the bottle. Immediately close the bottle, secure the cap, and keep the bottle tightly closed.

• Keep the desiccant in the bottle.