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Objective <p>This study aimed to evaluate the potential association between proton pump inhibitors (PPIs) and parathyroid dysfunction (including hyperparathyroidism and hypoparathyroidism) by analyzing data from the U.S. FDA Adverse Event Reporting System (FAERS). A secondary objective was to describe the clinical and demographic characteristics of the identified cases.</p> Methods <p>We conducted a retrospective pharmacovigilance analysis using FAERS data from the first quarter of 2004 to the third quarter of 2025. Adverse events related to parathyroid function were identified using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. To assess signal strength, we performed disproportionality analyses employing the reporting odds ratio and the Bayesian confidence propagation neural network.</p> Results <p>A total of 1,604 cases of PPI-associated parathyroid dysfunction were analyzed. Hyperparathyroidism accounted for 1,327 cases, while hypoparathyroidism accounted for 277. The cohort was predominantly aged 18–64.9 years (55.9%). Overall, 29.8% of cases resulted in hospitalization or prolonged hospitalization, and 13.1% were fatal. A significant disparity in severity was observed: hypoparathyroidism was associated with a much higher proportion of serious outcomes, including hospitalization (50.2% vs. 25.5%) and life-threatening events (28.2% vs. 0.8%), compared to hyperparathyroidism. Severe outcomes collectively accounted for 96.3% of all reports.</p> Conclusion <p>The analysis identifies a significant pharmacovigilance signal associating PPI use with parathyroid dysfunction. Although hyperparathyroidism is reported more frequently, hypoparathyroidism is linked to markedly more severe clinical outcomes. These findings underscore the need for heightened vigilance and suggest that long-term PPI users may benefit from regular monitoring of electrolytes and parathyroid function.</p>

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Adverse events of proton pump inhibitor–associated parathyroid dysfunction: a real-world study based on the FDA adverse event reporting system

  • 期刊论文

  • 发表日期：

    2026年4月9日

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  • Li Wang,
  • Ning Yuan,
  • Xue Fan

摘要

Objective

This study aimed to evaluate the potential association between proton pump inhibitors (PPIs) and parathyroid dysfunction (including hyperparathyroidism and hypoparathyroidism) by analyzing data from the U.S. FDA Adverse Event Reporting System (FAERS). A secondary objective was to describe the clinical and demographic characteristics of the identified cases.

Methods

We conducted a retrospective pharmacovigilance analysis using FAERS data from the first quarter of 2004 to the third quarter of 2025. Adverse events related to parathyroid function were identified using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. To assess signal strength, we performed disproportionality analyses employing the reporting odds ratio and the Bayesian confidence propagation neural network.

Results

A total of 1,604 cases of PPI-associated parathyroid dysfunction were analyzed. Hyperparathyroidism accounted for 1,327 cases, while hypoparathyroidism accounted for 277. The cohort was predominantly aged 18–64.9 years (55.9%). Overall, 29.8% of cases resulted in hospitalization or prolonged hospitalization, and 13.1% were fatal. A significant disparity in severity was observed: hypoparathyroidism was associated with a much higher proportion of serious outcomes, including hospitalization (50.2% vs. 25.5%) and life-threatening events (28.2% vs. 0.8%), compared to hyperparathyroidism. Severe outcomes collectively accounted for 96.3% of all reports.

Conclusion

The analysis identifies a significant pharmacovigilance signal associating PPI use with parathyroid dysfunction. Although hyperparathyroidism is reported more frequently, hypoparathyroidism is linked to markedly more severe clinical outcomes. These findings underscore the need for heightened vigilance and suggest that long-term PPI users may benefit from regular monitoring of electrolytes and parathyroid function.