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Published on: December 11, 2016
Metformin adverse event profile: a pharmacovigilance study based on the FDA Adverse Event Reporting System (FAERS)
Yikuan Du1, Jinfeng Zhu2, Zhuoming Guo2
1Central Laboratory, The Tenth Affiliated Hospital of Southern Medical University, Dongguan, People's Republic of China.
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.
Insights
Metformin, a common drug, has potential unreported adverse events (AEs). This study identified new AEs like acute pancreatitis, highlighting the need for further clinical monitoring and risk assessment.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Clinical Pharmacology
Background:
- Metformin is widely used for various diseases.
- Numerous unrecognized and unreported adverse events (AEs) associated with metformin exist.
- Understanding these AEs is crucial for patient safety.
Purpose of the Study:
- To identify and assess adverse drug reactions (ADRs) linked to metformin.
- To analyze disproportionality in adverse event reports for metformin.
- To uncover potential new safety signals for metformin.
Main Methods:
- Utilized the US FDA Adverse Event Reporting System (FAERS) database.
- Analyzed data from Q1 2004 to Q4 2022.
- Employed disproportionality analysis with four algorithms to identify significant associations.
Main Results:
- Over 10.5 million case reports were analyzed, with 56,674 related to metformin.
- Identified 643 significant preferred terms (PTs) and 27 system organ classes (SOCs).
- Key findings included metabolic, nutritional, and gastrointestinal disorders, alongside ADR signals like acute pancreatitis, melas syndrome, pemphigoid, skin eruption, and drug exposure during pregnancy.
Conclusions:
- Results largely align with known metformin side effects.
- Identified potential new adverse reaction signals, including acute pancreatitis.
- Further research is essential to validate these unlabeled adverse reactions and enhance clinical monitoring and risk management for metformin.
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