U.S. FDA Grants Approval for Ranitidine Comeback

December 6, 2025: The U.S. Food and Drug Administration (US FDA) in November 2025 has approved reformulated ranitidine tablets, marking the return of this important H₂ receptor antagonist to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that ensure product quality throughout its shelf life. The reformulated product maintains the same therapeutic effectiveness as previously approved formulations, with updated labeling that includes enhanced storage and handling guidance.

Aligning with the US FDA approval, the recently released WHO 24th Model List of Essential Medicines (EML) has included ranitidine among its 523 medicines across therapeutic categories, reaffirming the continued importance of H₂ receptor antagonists in clinical practice. The inclusion of ranitidine on the WHO’s essential medicines list indicates its clinical relevance and ongoing utility, particularly in resource-limited environments where safe, affordable, and effective therapies are essential for public health.

Similarly, earlier this year, the Therapeutic Goods Administration in Australia (2025) and the Ministry of Health, New Zealand (2025) approved the reintroduction of ranitidine to their pharmaceutical markets. These reapprovals followed comprehensive reviews of manufacturing processes and implementation of enhanced quality assurance protocols to ensure NDMA compliance. This development signals a broader international trend toward evidence-based reassessment of ranitidine's clinical utility. ,

Previously, a multinational cohort study analysing over 1.18 million adults across 11 databases spanning Europe, North America, and Asia explored the potential cancer-related risks linked to Ranitidine usage and found no increase in overall cancer risk with ranitidine use with hazard ratios showing no meaningful difference, equivalent to a 0% change (HR 1.00; 95% CI: 0.97–1.03) in the AmbEMR database and about a 3% lower risk (HR 0.97; 95% CI: 0.87–1.08) in the CUIMC database, indicating no measurable elevation in cancer incidence compared with other H2RA.

Ranitidine, an H2RA agent, has been widely used in the treatment of gastroesophageal reflux disease (GERD) since its introduction in 1981 and is one of the most prescribed drugs globally for GERD and peptic ulcer disease. Ranitidine is available in oral and parenteral dosage forms, tablets, capsules, or oral syrup, and injectables.

Ranitidine inhibits acid secretion by blocking histamine from binding to the parietal cell H2 receptor, thereby preventing its stimulatory effects. Ranitidine effectively reduces gastric acid secretion by blocking the binding of histamine and diminishing the response to other stimulatory agents. Ranitidine has been reported to have fewer adverse events, thus making it a safer and more tolerable option for patients.

The US FDA’s approval of the reformulated ranitidine marks a significant reaffirmation of its clinical value, confirming the medication’s continued role in evidence-based acid suppression therapy. Alongside this, the WHO Essential Medicines List also retains ranitidine, and its relevance is further supported for use across diverse healthcare systems, particularly where accessible and effective treatment options are needed.

References

1. U.S. Food and Drug Administration. (2025, November 24). FDA approves reformulated ranitidine following comprehensive safety review.https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-reformulated-ranitidine-following-comprehensive-safety-review

2. World Health Organization. (2025). WHO Model List of Essential Medicines 2025 (24th list). WHO. https://www.who.int/publications/

3. New Zealand Government. (2025, January 30). Consent to the distribution of new medicines: Zantac (general sale) and Zantac (pharmacy only) (Notice No. 2025-go458). New Zealand Gazette. https://gazette.govt.nz/

4. Australian Government Department of Health and Aged Care, Therapeutic Goods Administration. (2025). Application under s. 23 to register a new medicine under s. 25 in the Australian Register of Therapeutic Goods: Zantac ranitidine 150 mg (as hydrochloride) tablets (Submission No. OM-2024-00299-1). https://www.tga.gov.au/

5. You SC, Seo SI, Falconer T, et al. Ranitidine Use and Incident Cancer in a Multinational Cohort. JAMA Netw Open. 2023;6(9):e2333495. Published 2023 Sep 5. doi:10.1001/jamanetworkopen.2023.33495

6. Morgan KA, Ahlawat R. Ranitidine. [Updated 2022 Dec 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532989/