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Purpose <p>The potential carcinogenic risk of ranitidine has sparked widespread controversy, and its relationship with thyroid cancer remains unclear. This study aimed to evaluate the disproportionality signal for thyroid cancer reporting associated with ranitidine by comprehensively utilizing the FDA Adverse Event Reporting System (FAERS) and VigiAccess databases.</p> Methods <p>The data were sourced from the FAERS database and the VigiAccess database. Initially, data mining and statistical analyses were performed on ranitidine-related thyroid cancer events within the FAERS database to detect and characterize disproportionality signals. Subsequently, the findings were further supplemented using the VigiAccess database to provide additional supportive evidence.</p> Results <p>A disproportionality signal was identified between ranitidine and thyroid cancer (ROR = 40.60, 95% CI: 38.80–42.49, <i>P</i> &lt; 0.05), with VigiAccess providing supplementary corroboration. Time-to-onset analysis showed higher reporting frequency of thyroid cancer with longer ranitidine exposure duration.</p> Conclusion <p>Despite certain limitations, our findings indicate a disproportionality signal suggesting a potential association between ranitidine use and thyroid cancer reporting in pharmacovigilance databases. In light of these findings, the disproportionality signal suggests a potential risk requiring confirmation through prospective studies; pending such validation, clinicians should exercise caution when prescribing ranitidine for extended periods, with attention to thyroid monitoring.</p>

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Association between ranitidine use and thyroid cancer based on FAERS and VigiAccess databases

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月15日

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  • Qingli Shen,
  • Zhonghua Fu,
  • Zhengchao Xia,
  • Yinhui Qin,
  • Chenglong Zhao

摘要

Purpose

The potential carcinogenic risk of ranitidine has sparked widespread controversy, and its relationship with thyroid cancer remains unclear. This study aimed to evaluate the disproportionality signal for thyroid cancer reporting associated with ranitidine by comprehensively utilizing the FDA Adverse Event Reporting System (FAERS) and VigiAccess databases.

Methods

The data were sourced from the FAERS database and the VigiAccess database. Initially, data mining and statistical analyses were performed on ranitidine-related thyroid cancer events within the FAERS database to detect and characterize disproportionality signals. Subsequently, the findings were further supplemented using the VigiAccess database to provide additional supportive evidence.

Results

A disproportionality signal was identified between ranitidine and thyroid cancer (ROR = 40.60, 95% CI: 38.80–42.49, P < 0.05), with VigiAccess providing supplementary corroboration. Time-to-onset analysis showed higher reporting frequency of thyroid cancer with longer ranitidine exposure duration.

Conclusion

Despite certain limitations, our findings indicate a disproportionality signal suggesting a potential association between ranitidine use and thyroid cancer reporting in pharmacovigilance databases. In light of these findings, the disproportionality signal suggests a potential risk requiring confirmation through prospective studies; pending such validation, clinicians should exercise caution when prescribing ranitidine for extended periods, with attention to thyroid monitoring.