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ABSTRACT
Background
Ranitidine induced tumor adverse events remains a contradictory clinical question, due to the limited evidence of tumor risk associated with ranitidine in the real world. The purpose of this study was to evaluate the association of ranitidine with all types of tumors through the FAERS database and to provide a reference for clinical use.
Research design and methods
Cancer cases associated with ranitidine in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were extracted to analyze demographic characteristics, and a disproportion analysis was performed.
Result
A total of 662,998 ranitidine-related cancer cases were screened, and the 50–59 and 60–69 groups accounted for the largest proportion. In PT signal detection, ranitidine was associated with 98 PT, including penal cancer stage II, gastric cancer stage II, et al. In terms of outcome events, adverse events were higher in men (20.65%) than in women (18.47%).
Conclusions
Ranitidine may induce various tumor-related adverse reactions, especially in long-term users and elderly patients. For these patients, tumor screening should be strengthened, and long-term use of ranitidine should be avoided. Since this study cannot prove causality, further evidence is needed for prospective studies with a larger sample size.
Abbreviations
| FAERS | = | Food and Drug Administration Adverse Event Reporting System |
| AEs | = | adverse events |
| OTC | = | Over The Counter |
| NDMA | = | N-Nitrosodimethylamine |
| FDA | = | Food and Drug Administration |
| ICH | = | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use |
| SOC | = | System Organ Class |
| MedDRA | = | Medical Dictionary for Regulatory Activities |
| PT | = | Preferred Terms |
| ROR | = | Reporting Odds Ratio |
| PRR | = | Proportional Reporting Ratio |
| CI | = | Confidence Interval |
| N | = | Number of Co-occurrences |
| χ2 | = | Chi-square |
| ADRs | = | Adverse Drug Reactions |
| IQR | = | interquartile range |
Declarations of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
M Liu, D Luo, and Y Shao made significant contributions to the work of the report, and all authors made significant contributions in conceptualization, study design, execution, data acquisition, analysis and interpretation. M Liu, Y Shao, X Gao and B Zheng drafted and wrote the article, all authors revised and polished the article, while M Liu, D Luo and T Liu substantially revised and critically reviewed the article.
Availability of data and materials
The data used to support the findings of this study are included in the article, and all methods were performed in accordance with the relevant guidelines and regulations.
Acknowledgments
Thanks to the FDA Adverse Event Reporting System (FAERS) for sharing data and code. Thanks to the easyFAERS team for their technical support.
Ethical approval
No ethical approval is required for this study. And the data sources of this study were all public data.