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Purpose <p>Quetiapine is an atypical second-generation antipsychotic. Diabetic ketoacidosis (DKA) is an acute metabolic complication, most commonly encountered in type 1 diabetes, and it can be life-threatening if not treated promptly. This study aimed to assess quetiapine-associated DKA using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p> Methods <p>We performed a retrospective investigation on the FAERS from the first quarter of 2004 to the second quarter of 2024 using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) from the disproportionality analysis. According to the Medical Dictionary for Regulatory Activities (MedDRA) 26.1, preferred terms (PTs) of reports on adverse drug reactions (ADRs) were classified using System Organ Classification (SOC), and filtered based on hyperglycemia and new-onset diabetes mellitus in the Standardized MedDRA Query (SMQ).</p> Results <p>We collected 65,536 ADR reports with quetiapine as the primary suspected drug, including 27 system organ classifications. There were 3,046 cases related to DKA, predominantly from the United States, with a slightly higher proportion of females (51.31%) than males (45.63%). The most common severe ADR outcome (539 cases, 17.70%) was hospitalization—initial or prolonged, followed by death (333 cases, 10.93%). Additionally, compared to the other three second-generation antipsychotics (clozapine, olanzapine, and risperidone), quetiapine exhibited a stronger association with DKA (ROR = 31.05, ROR025 = 29.87).</p> Conclusion <p>Quetiapine could be associated with DKA; therefore, physicians should be aware of this potentially fatal adverse event. Studies are needed to investigate the matter further.</p>

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Study on disproportionality in the detection of potential signals between quetiapine and diabetic ketoacidosis

  • 期刊论文

  • 发表日期：

    2025年7月28日

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  • Haiya Liang,
  • Dandan Mao,
  • Yan Zhao,
  • Rongjing Zhou

摘要

Purpose

Quetiapine is an atypical second-generation antipsychotic. Diabetic ketoacidosis (DKA) is an acute metabolic complication, most commonly encountered in type 1 diabetes, and it can be life-threatening if not treated promptly. This study aimed to assess quetiapine-associated DKA using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods

We performed a retrospective investigation on the FAERS from the first quarter of 2004 to the second quarter of 2024 using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) from the disproportionality analysis. According to the Medical Dictionary for Regulatory Activities (MedDRA) 26.1, preferred terms (PTs) of reports on adverse drug reactions (ADRs) were classified using System Organ Classification (SOC), and filtered based on hyperglycemia and new-onset diabetes mellitus in the Standardized MedDRA Query (SMQ).

Results

We collected 65,536 ADR reports with quetiapine as the primary suspected drug, including 27 system organ classifications. There were 3,046 cases related to DKA, predominantly from the United States, with a slightly higher proportion of females (51.31%) than males (45.63%). The most common severe ADR outcome (539 cases, 17.70%) was hospitalization—initial or prolonged, followed by death (333 cases, 10.93%). Additionally, compared to the other three second-generation antipsychotics (clozapine, olanzapine, and risperidone), quetiapine exhibited a stronger association with DKA (ROR = 31.05, ROR025 = 29.87).

Conclusion

Quetiapine could be associated with DKA; therefore, physicians should be aware of this potentially fatal adverse event. Studies are needed to investigate the matter further.