Characterizing the adverse event profile of semaglutide: A comprehensive U.S. food and drug administration adverse event reporting system-based pharmacovigilance study
- Design
- Pharmacovigilance · 43754 participants · Mixed outcome
- Match to healthy normal-weight adults aged 55–75
- Population unclearUNKNOWN: spontaneous FAERS reports; the abstract gives no age, BMI or diabetes data for the reported cases.
- Could weight loss explain it?
- PossiblyPossibly: no weight or glycaemic data are reported, so the evidence model's default applies. Some signals (decreased appetite, dehydration, weight loss poor) may relate to reduced intake, but this was not examined.
- Study tier
- Study tier 4VERY_LOW: a pharmacovigilance disproportionality analysis of spontaneous reports, with no incidence denominator and no comparator group.
- Assessment
- Version 2 · Two independent AI reviews agreed · Oct 19, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
This study searched the US FDA's spontaneous adverse event reporting database for reports naming semaglutide as the main suspected drug, finding 43,754 reports. Stomach and bowel problems such as nausea, vomiting, diarrhoea and constipation were reported most, and the analysis flagged reporting signals for slowed stomach emptying, dehydration, diabetic ketoacidosis and a type of optic nerve damage. Reporting signals show that an event is reported more often than expected with the drug; they do not show how often it happens or that the drug causes it.
01Findings
What the study reported
- Drugs
- Semaglutide
- Comparator
- not reported in abstract
- Primary outcome
- Adverse event reporting signals for semaglutide in FAERS (disproportionality)
- Effect
- Gastrointestinal events most often reported (nausea n = 5637; 12.88%, vomiting n = 4097; 9.36%); signals for impaired gastric emptying, decreased appetite, dehydration, diabetic ketoacidosis, weight loss poor and optic ischaemic neuropathy; no ROR or PRR values given in the abstract
- 95% confidence interval
- not reported in abstract
- Follow-up
- Not stated
- Adverse events
- Reporting signals mainly gastrointestinal (nausea, vomiting, diarrhoea, constipation, impaired gastric emptying) and metabolic (decreased appetite, dehydration, diabetic ketoacidosis), with high signals for weight loss poor and optic ischaemic neuropathy and further signals in psychiatric, renal and hepatobiliary systems.
- Limitations
- Spontaneous-report disproportionality analysis: signals show reporting imbalance, not incidence or causation; no denominator of treated people, no population data and no comparator group are reported. The authors do not list limitations in the abstract.
Who was studied
- Obesity status
- not reported in abstract
- Diabetes status
- not reported in abstract
- Cvd status
- not reported in abstract
- Ckd status
- not reported in abstract
- Baseline condition
- not reported in abstract
- Sample size
- 43754
- Inclusion exclusion
- FAERS reports 2004 Q1 to 2025 Q3 with semaglutide as the primary suspected drug
Study quality details
- Study design
- Pharmacovigilance analysis
- Sample size
- 43754
- Randomization
- no
- Blinding
- n/a
- Comparator
- not reported in abstract
- Follow up duration
- not stated
- Outcome type
- mixed
- Replication
- not assessed
- Consistency with other evidence
- not assessed
- Population applicability
- UNKNOWN
- Statistical precision
- disproportionality statistics (ROR, PRR, RRR, EBGM); no CI reported in abstract; 43,754 reports
- Risk of bias
- not assessed
- Funding conflicts
- unclear
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- not reported in abstract
- Industry funded
- Unclear
- Manufacturer
- not stated in source
- Sponsor role
- not reported in abstract
- Author conflicts
- All authors declared no conflicts of interest.
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[BACKGROUND] Semaglutide, a glucagon-like peptide-1 receptor agonist, is increasingly used for the management of type 2 diabetes mellitus and obesity. Given its expanding clinical use, a comprehensive evaluation of its safety profile using real-world data is warranted. This study aimed to characterize adverse event signals associated with semaglutide using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). [METHODS] Adverse event reports associated with semaglutide were extracted from the FAERS database from 2004 Q1 to 2025 Q3. After data extraction and screening, cases in which semaglutide was recorded as the primary suspected drug were included. Adverse events were classified according to the Medical Dictionary for Regulatory Activities (MedDRA) at the preferred term (PT) and system organ class (SOC) levels. Signal detection was performed using disproportionality methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), relative reporting ratio (RRR), and empirical Bayes geometric mean (EBGM). [RESULTS] A total of 43,754 reports were identified. Gastrointestinal disorders were the most frequently reported system organ class, with nausea (n = 5637; 12.88%), vomiting (n = 4097; 9.36%), diarrhoea (n = 3276; 7.49%) and constipation (n = 2257; 5.16%) being the most frequently reported adverse events. Impaired gastric emptying (n = 2200; 5.03%) showed a markedly elevated reporting signal. Significant signals were also observed for metabolic and nutritional events, including decreased appetite (n = 2221; 5.08%), dehydration (n = 1231; 2.81%) and diabetic ketoacidosis. Notably, high disproportionality signals were detected for weight loss poor and optic ischaemic neuropathy. Additional signals involved psychiatric, renal and hepatobiliary systems. The consistency of findings across multiple statistical methods, including empirical Bayes geometric mean, supports the robustness of the detected signals. [CONCLUSION] Semaglutide is primarily associated with gastrointestinal and metabolic adverse events consistent with its pharmacological effects; however, several less common but potentially important safety signals were identified. These findings highlight the need for continued pharmacovigilance and careful clinical monitoring in real-world use.