Frontiers in pharmacology · 2026
Metformin-associated diarrhea in FAERS: a structured pharmacovigilance study with long-term temporal consistency assessment.
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Chen Shida, Xu Chengan
Аннотация
BACKGROUND: Metformin-associated diarrhea is well recognized, but spontaneous-report analyses remain sensitive to outcome definition, reporting background, and incomplete event-date data. This study evaluated whether the reporting imbalance persisted across prespecified definitions, comparator sets, and calendar periods.
METHODS: U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) reports from the first quarter of 2020 through the first quarter of 2026 were deduplicated and analyzed with metformin coded as a primary or secondary suspect drug. The primary outcome was the Medical Dictionary for Regulatory Activities preferred term DIARRHOEA. Sensitivity analyses used a broad loose-stool phenotype, a clean gastrointestinal event composite, alternative exposure roles, active comparators, co-medication exclusions, and stratification. Exact-date report-level event-date intervals among reports containing the strict-diarrhea preferred term were summarized descriptively. A separately processed dataset covering the first quarter of 2004 through the first quarter of 2026 assessed temporal consistency.
RESULTS: Among 9,112,609 reports, 60,452 involved metformin as a primary or secondary suspect drug and 4,868 included strict diarrhea. The primary reporting odds ratio (ROR) was 2.72 (95% confidence interval, 2.64-2.80). Restriction to non-metformin antidiabetic reports attenuated the ROR to 1.95 (1.89-2.01), showing sensitivity to the reporting background. Only 595 reports (12.2%) yielded a valid report-level event-date interval; the median interval was 14 days (interquartile range, 1-363). The long-term ROR was 2.76 (2.71-2.81), with marked annual variation.
CONCLUSION: Metformin showed a persistent but context-dependent diarrhea reporting imbalance in FAERS. Active-comparator attenuation limits causal and clinical-risk interpretation. The selected interval subset supports descriptive reporting only and cannot define diarrhea-specific onset or a clinical monitoring window.
METHODS: U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) reports from the first quarter of 2020 through the first quarter of 2026 were deduplicated and analyzed with metformin coded as a primary or secondary suspect drug. The primary outcome was the Medical Dictionary for Regulatory Activities preferred term DIARRHOEA. Sensitivity analyses used a broad loose-stool phenotype, a clean gastrointestinal event composite, alternative exposure roles, active comparators, co-medication exclusions, and stratification. Exact-date report-level event-date intervals among reports containing the strict-diarrhea preferred term were summarized descriptively. A separately processed dataset covering the first quarter of 2004 through the first quarter of 2026 assessed temporal consistency.
RESULTS: Among 9,112,609 reports, 60,452 involved metformin as a primary or secondary suspect drug and 4,868 included strict diarrhea. The primary reporting odds ratio (ROR) was 2.72 (95% confidence interval, 2.64-2.80). Restriction to non-metformin antidiabetic reports attenuated the ROR to 1.95 (1.89-2.01), showing sensitivity to the reporting background. Only 595 reports (12.2%) yielded a valid report-level event-date interval; the median interval was 14 days (interquartile range, 1-363). The long-term ROR was 2.76 (2.71-2.81), with marked annual variation.
CONCLUSION: Metformin showed a persistent but context-dependent diarrhea reporting imbalance in FAERS. Active-comparator attenuation limits causal and clinical-risk interpretation. The selected interval subset supports descriptive reporting only and cannot define diarrhea-specific onset or a clinical monitoring window.