Identifying Adverse Event Signals and Risk Analysis of Semaglutide Based on the FAERS Database

Zhuo ZHU; Hong XU; Hongying XIA; Feilong TAN

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Zhuo ZHU, Hong XU, Hongying XIA, Feilong TAN. Identifying Adverse Event Signals and Risk Analysis of Semaglutide Based on the FAERS Database[J]. Journal of Kunming Medical University.

Citation:

Zhuo ZHU, Hong XU, Hongying XIA, Feilong TAN. Identifying Adverse Event Signals and Risk Analysis of Semaglutide Based on the FAERS Database[J]. Journal of Kunming Medical University.

Zhuo ZHU, Hong XU, Hongying XIA, Feilong TAN. Identifying Adverse Event Signals and Risk Analysis of Semaglutide Based on the FAERS Database[J]. Journal of Kunming Medical University.

Citation:

Zhuo ZHU, Hong XU, Hongying XIA, Feilong TAN. Identifying Adverse Event Signals and Risk Analysis of Semaglutide Based on the FAERS Database[J]. Journal of Kunming Medical University.

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Identifying Adverse Event Signals and Risk Analysis of Semaglutide Based on the FAERS Database

Department of Pharmacy，The Affiliated Yan'an Hospital of Kunming Medical University，Kunming Yunnan 650001，China

Received Date: 2026-06-04
Available Online: 2026-09-17

Abstract

Abstract

Objective To identify adverse event （AE） signals associated with semaglutide use in the treatment of type 2 diabetes mellitus based on the U.S. Food and Drug Administration Adverse Event Reporting System （FAERS） database. Methods Four algorithms—reporting odds ratio （ROR）, proportional reporting ratio （PRR）, multi-item gamma Poisson shrinker （MGPS）, and Bayesian confidence propagation neural network （BCPNN）—were used to mine the data. Semaglutide-related AE reports recorded in the FAERS database from the first quarter of 2017 through the third quarter of 2025 were analyzed to assess the strength of various risk signals. Results A total of 14, 151 semaglutide-related AE reports were identified, yielding 178 positive signals. Among cases with a documented time to onset, 62.56% of AEs occurred within 30 days after medication use. Serious AEs accounted for 49.09% of all reports. The positive signals involved 19 System Organ Classes （SOCs）, with gastrointestinal disorders and injury, poisoning, and procedural complications accounting for the largest numbers of reports. Nausea, decreased appetite, and vomiting were the most frequently reported AEs. The three strongest risk signals were cyclic vomiting syndrome （ROR = 540.67, 95%CI: 438.66～666.40）, gastric emptying disorder （ROR = 141.76, 95%CI: 133.00～151.10）, ocular infarction （ROR = 63.31, 95%CI: 23.17～172.98）. A total of 37 AEs not previously documented in the product labeling were identified, including ocular infarction （ROR=63.31, 95%CI: 23.17～172.98）, ischemic optic neuropathy （ROR=54.52, 95%CI: 45.50～65.33） and medullary thyroid carcinoma （ROR =53.19, 95%CI: 29.84～94.81）. Conclusion In the clinical application of semaglutide for treating type 2 diabetes mellitus, special vigilance should be exercised regarding gastrointestinal adverse reactions. Given the potential risks identified in this study, a rigorous pre-medication risk assessment should be conducted, and medication monitoring along with patient education should be enhanced to maximize medication safety for patients.
- Semaglutide,
- Adverse events,
- Signal detection

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References(21)

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