PMID- 38269492 OWN - NLM STAT- MEDLINE DCOM- 20240131 LR - 20240206 IS - 1751-2441 (Electronic) IS - 1751-2433 (Linking) VI - 17 IP - 2 DP - 2024 Jan-Jun TI - Metformin adverse event profile: a pharmacovigilance study based on the FDA Adverse Event Reporting System (FAERS) from 2004 to 2022. PG - 189-201 LID - 10.1080/17512433.2024.2306223 [doi] AB - BACKGROUND: Metformin has the potential for treating numerous diseases, but there are still many unrecognized and unreported adverse events (AEs). METHODS: We selected data from the United States FDA Adverse Event Reporting System (FAERS) database from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2022 for disproportionality analysis to assess the association between metformin and related adverse events. RESULTS: In this study 10,500,295 case reports were collected from the FAERS database, of which 56,674 adverse events related to metformin were reported. A total of 643 preferred terms (PTs) and 27 system organ classes (SOCs) that were significant disproportionality conforming to the four algorithms simultaneously were included. The SOCs included metabolic and nutritional disorders (p = 0.00E + 00), gastrointestinal disorders (p = 0.00E + 00) and others. PT levels were screened for adverse drug reaction (ADR) signals such as acute pancreatitis (p = 0.00E + 00), melas syndrome, pemphigoid (p = 0.00E + 00), skin eruption (p = 0.00E + 00) and drug exposure during pregnancy (p = 0.00E + 00). CONCLUSION: Most of our results were consistent with the specification, but some new signals of adverse reactions such as acute pancreatitis were not included. Therefore, further studies are needed to validate unlabeled adverse reactions and provide important support for clinical monitoring and risk identification of metformin. FAU - Du, Yikuan AU - Du Y AD - Central Laboratory, The Tenth Affiliated Hospital of Southern Medical University, Dongguan, People's Republic of China. FAU - Zhu, Jinfeng AU - Zhu J AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Guo, Zhuoming AU - Guo Z AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Wang, Zhenjie AU - Wang Z AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Wang, Yuni AU - Wang Y AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Hu, Mianda AU - Hu M AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Zhang, Lingzhi AU - Zhang L AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Yang, Yurong AU - Yang Y AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Wang, Jinjin AU - Wang J AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Huang, Yixing AU - Huang Y AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Huang, Peiying AU - Huang P AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Chen, Mianhai AU - Chen M AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Chen, Bo AU - Chen B AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. FAU - Yang, Chun AU - Yang C AD - Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, China. LA - eng PT - Journal Article DEP - 20240129 PL - England TA - Expert Rev Clin Pharmacol JT - Expert review of clinical pharmacology JID - 101278296 RN - 9100L32L2N (Metformin) SB - IM MH - Humans MH - United States MH - *Metformin/adverse effects MH - Pharmacovigilance MH - Acute Disease MH - *Pancreatitis MH - Adverse Drug Reaction Reporting Systems MH - United States Food and Drug Administration MH - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology OTO - NOTNLM OT - FAERS OT - Metformin OT - adverse drug reactions OT - lactic acidosis OT - pharmacovigilance EDAT- 2024/01/25 06:43 MHDA- 2024/01/31 06:42 CRDT- 2024/01/25 04:44 PHST- 2024/01/31 06:42 [medline] PHST- 2024/01/25 06:43 [pubmed] PHST- 2024/01/25 04:44 [entrez] AID - 10.1080/17512433.2024.2306223 [doi] PST - ppublish SO - Expert Rev Clin Pharmacol. 2024 Jan-Jun;17(2):189-201. doi: 10.1080/17512433.2024.2306223. Epub 2024 Jan 29.