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Ranitidine
medication Under reviewAn H2 receptor antagonist medication that reduces stomach acid production, used to treat conditions like GERD and ulcers.
Research summary
Scientific evidence from clinical studies in healthy humans primarily addresses ranitidine's pharmacokinetics, particularly regarding potential formation of N-nitrosodimethylamine (NDMA), a probable carcinogen. These studies demonstrate no elevated NDMA levels in urine or blood after ranitidine administration, even with nitrite-containing meals, refuting concerns about in vivo conversion. Large cohort studies in adults without cancer history, including healthy users of H2 blockers, show no increased cancer risk associated with ranitidine compared to other H2 antagonists like famotidine. Research consensus supports ranitidine's safety profile in healthy subjects for short-term use, with no evidence of carcinogenicity or significant adverse effects beyond rare liver enzyme elevations in isolated cases. However, due to past NDMA contamination issues in formulations, regulatory bodies requested its market withdrawal, though intrinsic risks appear negligible based on human data.
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Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to the Probable Carcinogen NDMA in Humans
FDA Center for Drug Evaluation and Research Researchers
Clinical Study to Investigate the Urinary Excretion of N-Nitrosodimethylamine (NDMA) Following Ranitidine Administration
ClinicalTrials.gov Study Team
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Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to the Probable Carcinogen NDMA in Humans
FDA Center for Drug Evaluation and Research Researchers
Clinical Study to Investigate the Urinary Excretion of N-Nitrosodimethylamine (NDMA) Following Ranitidine Administration
ClinicalTrials.gov Study Team
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Research (2 studies)
Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to the Probable Carcinogen NDMA in Humans
FDA Center for Drug Evaluation and Research Researchers
Clinical Study to Investigate the Urinary Excretion of N-Nitrosodimethylamine (NDMA) Following Ranitidine Administration
ClinicalTrials.gov Study Team
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