Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset.

Chiappini S, Vickers-Smith R, Harris D, Papanti Pelletier GD, Corkery JM, Guirguis A, Martinotti G, Sensi SL, Schifano F

Pharmaceuticals (Basel, Switzerland)11 Jul 2023Cited by 60 (Europe PMC)

PMID37513906PMCIDPMC10384093DOI10.3390/ph16070994PepBankPUB-37513906

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Summary

Recent media reports commented about a possible issue of the misuse of antidiabetics related to molecules promoted as a weight-loss treatment in non-obese people. We evaluated here available pharmacovigilance misuse/abuse signals related to semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, in comparison to other GLP-1 receptor agonists (albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, and tirzepatide) and the phentermine-topiramate combination. To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR). During January 2018-December 2022, a total of 31,542 AERs involving the selected molecules were submitted to FAERS; most involved dulaglutide (n = 11,858; 37.6%) and semaglutide (n = 8249; 26.1%). In comparing semaglutide vs. the remaining molecules, the respective PRR values of the AERs 'drug abuse', 'drug withdrawal syndrome', 'prescription drug used without a prescription', and 'intentional product use issue' were 4.05, 4.05, 3.60, and 1.80 (all < 0.01). The same comparisons of semaglutide vs. the phentermine-topiramate combination were not associated with any significant differences. To the best of our knowledge, this is the first study documenting the misuse/abuse potential of semaglutide in comparison with other GLP1 analogues and the phentermine-topiramate combination. The current findings will need to be confirmed by further empirical investigations to fully understand the safety profile of those molecules.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanObservational studySafety outcome
In FAERS, dulaglutide accounted for 11,858 adverse event reports, or 37.6% of reports involving selected drugs.
In plain wordsIn safety records, dulaglutide appeared in 11,858 adverse event reports. These counts do not measure event incidence.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableAdverse event report count
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
Adverse event reports
11,858 reports
dulaglutide, FAERS January 2018-December 2022
Report proportion
37.6%
selected drugs
Source sentences
Summary
During January 2018-December 2022, a total of 31,542 AERs involving the selected molecules were submitted to FAERS; most involved dulaglutide (n = 11,858; 37.6%) and semaglutide (n = 8249; 26.1%).
1 context sentence(design, population, supporting numbers)
Summary · context
To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR).
Show in the study text Report a problemFND-3751390601
02HumanObservational studySafety outcome
In FAERS, semaglutide accounted for 8249 adverse event reports, or 26.1% of reports involving selected drugs.
In plain wordsIn safety records, semaglutide appeared in 8249 adverse event reports. These counts do not measure event incidence.
Peptide
Semaglutide
Outcome
Not applicableAdverse event report count
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
Adverse event reports
8249 reports
semaglutide, FAERS January 2018-December 2022
Report proportion
26.1%
selected drugs
Source sentences
Summary
During January 2018-December 2022, a total of 31,542 AERs involving the selected molecules were submitted to FAERS; most involved dulaglutide (n = 11,858; 37.6%) and semaglutide (n = 8249; 26.1%).
1 context sentence(design, population, supporting numbers)
Summary · context
To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR).
Show in the study text Report a problemFND-3751390602
03HumanObservational studySafety outcome
In FAERS, semaglutide had greater proportional reporting of drug abuse than the remaining selected drugs, with PRR 4.05.
In plain wordsIn safety reports, semaglutide was linked to proportionally more drug abuse reports than the remaining selected drugs.
Peptide
Semaglutide
Outcome
IncreaseDrug abuse reporting
Study
n: not reported in source
Comparator
Remaining selected drugs
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
PRR
4.05 ratio
semaglutide vs remaining molecules, drug abuse reports
Source sentences
Summary
In comparing semaglutide vs. the remaining molecules, the respective PRR values of the AERs 'drug abuse', 'drug withdrawal syndrome', 'prescription drug used without a prescription', and 'intentional product use issue' were 4.05, 4.05, 3.60, and 1.80 (all < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR).
Show in the study text Report a problemFND-3751390603
04HumanObservational studySafety outcome
In FAERS, semaglutide had greater proportional reporting of drug withdrawal syndrome than remaining selected drugs, with PRR 4.05.
In plain wordsIn safety reports, semaglutide was linked to proportionally more withdrawal syndrome reports than the remaining selected drugs.
Peptide
Semaglutide
Outcome
IncreaseDrug withdrawal syndrome reporting
Study
n: not reported in source
Comparator
Remaining selected drugs
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
PRR
4.05 ratio
semaglutide vs remaining molecules, drug withdrawal syndrome reports
Source sentences
Summary
In comparing semaglutide vs. the remaining molecules, the respective PRR values of the AERs 'drug abuse', 'drug withdrawal syndrome', 'prescription drug used without a prescription', and 'intentional product use issue' were 4.05, 4.05, 3.60, and 1.80 (all < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR).
Show in the study text Report a problemFND-3751390604
05HumanObservational studySafety outcome
In FAERS, semaglutide had greater proportional reporting of prescription drug use without prescription than remaining selected drugs, with PRR 3.60.
In plain wordsIn safety reports, semaglutide was linked to proportionally more use without a prescription than the remaining selected drugs.
Peptide
Semaglutide
Outcome
IncreaseNonprescription use reporting
Study
n: not reported in source
Comparator
Remaining selected drugs
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
PRR
3.6 ratio
semaglutide vs remaining molecules, prescription drug used without a prescription reports
Source sentences
Summary
In comparing semaglutide vs. the remaining molecules, the respective PRR values of the AERs 'drug abuse', 'drug withdrawal syndrome', 'prescription drug used without a prescription', and 'intentional product use issue' were 4.05, 4.05, 3.60, and 1.80 (all < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR).
Show in the study text Report a problemFND-3751390605
06HumanObservational studySafety outcome
In FAERS, semaglutide had greater proportional reporting of intentional product use issues than remaining selected drugs, with PRR 1.80.
In plain wordsIn safety reports, semaglutide was linked to proportionally more intentional product use issues than the remaining selected drugs.
Peptide
Semaglutide
Outcome
IncreaseIntentional product use issue reporting
Study
n: not reported in source
Comparator
Remaining selected drugs
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
PRR
1.8 ratio
semaglutide vs remaining molecules, intentional product use issue reports
Source sentences
Summary
In comparing semaglutide vs. the remaining molecules, the respective PRR values of the AERs 'drug abuse', 'drug withdrawal syndrome', 'prescription drug used without a prescription', and 'intentional product use issue' were 4.05, 4.05, 3.60, and 1.80 (all < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR).
Show in the study text Report a problemFND-3751390606
07HumanObservational studySafety outcome
In FAERS, semaglutide did not differ significantly from the phentermine-topiramate combination in the same misuse and abuse-related adverse event report comparisons.
In plain wordsIn safety reports, semaglutide and phentermine-topiramate did not differ significantly in the same misuse and abuse-related report comparisons.
Peptide
Semaglutide
Outcome
No significant changeMisuse and abuse-related adverse event reporting versus phentermine-topiramate
Study
n: not reported in source
Comparator
Phentermine-topiramate
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
The same comparisons of semaglutide vs. the phentermine-topiramate combination were not associated with any significant differences.
2 context sentences(design, population, supporting numbers)
Summary · context
In comparing semaglutide vs. the remaining molecules, the respective PRR values of the AERs 'drug abuse', 'drug withdrawal syndrome', 'prescription drug used without a prescription', and 'intentional product use issue' were 4.05, 4.05, 3.60, and 1.80 (all < 0.01).
Summary · context
To acheieve that aim, we analyzed the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AERs) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR).
Show in the study text Report a problemFND-3751390607

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 6Current
27 Oct 2026, 16:36 UTC
Study data updated · source update from Europe PMC
Version 5
22 Oct 2026, 02:25 UTC
Study results updated
Versions 2 to 4
21 Oct 2026, 18:59 UTC
The same notice was added 3 times, first on 9 Oct 2026, 03:06 UTC. The status did not change between them.
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset.

Summary

Results from this study7

Version history

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