Ranitidine – update on latest FDA actions
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20260335Keywords:
Ranitidine, GERD, Heartburn, SafetyAbstract
Ranitidine has maintained a key therapeutic role in managing acid-related disorders due to its favourable efficacy–tolerability profile and consistent pharmacodynamic behaviour. Since its introduction, clinicians have relied on its consistent and sustained suppression of gastric acid secretion, which has translated into effective relief of gastroesophageal reflux symptoms, improved healing of peptic ulcers, and dependable control of episodic acid-related discomfort. Decades of clinical use have generated a robust and reassuring evidence base demonstrating ranitidine’s safety and effectiveness across diverse patient populations.
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References
Shukla A, Kher V. Revisiting the efficacy and safety of ranitidine. J Indian Med Assoc. 2021;119(11):66-73.
Sirgo MA, Mills R, Euler AR, Walker S. The safety of ranitidine in elderly versus non-elderly patients. J Clin Pharmacol. 1993;33(1):79-83. DOI: https://doi.org/10.1002/j.1552-4604.1993.tb03908.x
Humphries TJ, Merritt GJ. Review article: drug interactions with agents used to treat acid-related diseases. Aliment Pharmacol Ther. 1999;13(s3):18–26. DOI: https://doi.org/10.1046/j.1365-2036.1999.00021.x
Scheen AJ. Cytochrome P450-mediated cardiovascular drug interactions. Expert Opin Drug Metab Toxicol. 2011;7(9):1065-82. DOI: https://doi.org/10.1517/17425255.2011.586337
Peghini PL, Katz PO, Castell DO. Ranitidine controls nocturnal gastric acid breakthrough on omeprazole: a controlled study in normal subjects. Gastroenterology. 1998;115(6):1335-9. DOI: https://doi.org/10.1016/S0016-5085(98)70010-1
Xue S, Katz PO, Banerjee P, Tutuian R, Castell DO. Bedtime H2 blockers improve nocturnal gastric acid control in GERD patients on proton pump inhibitors. Aliment Pharmacol Ther. 2001;15(9):1351-6. DOI: https://doi.org/10.1046/j.1365-2036.2001.01050.x
Rossi A, Perrella L, Scotti S, Olmastroni E, Galimberti F, Ardoino I, et al. Approaches to Deprescribing Proton Pump Inhibitors in Clinical Practice: A Systematic Review. J Clin Med. 2024;13(20):6283.. DOI: https://doi.org/10.3390/jcm13206283
US Food and Drug Administration. FDA Approves Reformulated Ranitidine Following Comprehensive Safety Review. Silver Spring (MD): U.S. Food & Drug Administration; 2025. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-reformulated-ranitidine-following-comprehensive-safety-review. Accessed on 11 December 2025.
