Exploration of the potential association between GLP-1 receptor agonists and suicidal or self-injurious behaviors: a pharmacovigilance study based on the FDA Adverse Event Reporting System database.

Zhou J, Zheng Y, Xu B, Long S, Zhu LE, Liu Y, Li C, Zhang Y, Liu M, Wu X

BMC medicine14 Feb 2024Cited by 76 (Europe PMC)

PMID38355513PMCIDPMC10865629DOI10.1186/s12916-024-03274-6PepBankPUB-38355513

Summary

BackgroundEstablishing whether there is a potential relationship between glucagon-like peptide 1 receptor agonists (GLP-1RAs) and suicidal or self-injurious behaviors (SSIBs) is crucial for public safety. This study investigated the potential association between GLP-1RAs and SSIBs by exploring the FDA Adverse Event Reporting System (FAERS) database.MethodsA disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4). SSIB cases associated with GLP-1RAs were identified and analyzed through disproportionality analysis using the information component. The parametric distribution with a goodness-of-fit test was employed to analyze the time-to-onset, and the Ω shrinkage was used to evaluate the potential effect of co-medication on the occurrence of SSIBs.ResultsIn total, 204 cases of SSIBs associated with GLP-1RAs, including semaglutide, liraglutide, dulaglutide, exenatide, and albiglutide, were identified in the FAERS database. Time-of-onset analysis revealed no consistent mechanism for the latency of SSIBs in patients receiving GLP-1RAs. The disproportionality analysis did not indicate an association between GLP-1RAs and SSIBs. Co-medication analysis revealed 81 cases with antidepressants, antipsychotics, and benzodiazepines, which may be proxies of mental health comorbidities.ConclusionsWe found no signal of disproportionate reporting of an association between GLP-1RA use and SSIBs. Clinicians need to maintain heightened vigilance on patients premedicated with neuropsychotropic drugs. This contributes to the greater acceptance of GLP-1RAs in patients with type 2 diabetes mellitus or obesity.

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

Results from this study12

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone12

In this study, the peptide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking the peptide.

01HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
FAERS contained 204 suicidal or self-injurious behavior reports associated with pooled GLP-1RAs, including dulaglutide.
In plain wordsFAERS contained 204 reports of suicidal or self-injurious behavior linked to pooled GLP-1RAs, including dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSuicidal or self-injurious behavior reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
SSIB cases
204 cases
Pooled GLP-1RAs in FAERS
Source sentences
Summary
In total, 204 cases of SSIBs associated with GLP-1RAs, including semaglutide, liraglutide, dulaglutide, exenatide, and albiglutide, were identified in the FAERS database.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Show in the study text Report a problemFND-3835551301
02HumanNot a test of Liraglutide aloneObservational studySafety outcome
FAERS contained 204 suicidal or self-injurious behavior reports associated with pooled GLP-1RAs, including liraglutide.
In plain wordsFAERS contained 204 reports of suicidal or self-injurious behavior linked to pooled GLP-1RAs, including liraglutide.
Peptide
Liraglutide
Outcome
Not applicableSuicidal or self-injurious behavior reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
SSIB cases
204 cases
Pooled GLP-1RAs in FAERS
Source sentences
Summary
In total, 204 cases of SSIBs associated with GLP-1RAs, including semaglutide, liraglutide, dulaglutide, exenatide, and albiglutide, were identified in the FAERS database.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-3835551302
03HumanNot a test of Semaglutide aloneObservational studySafety outcome
FAERS contained 204 suicidal or self-injurious behavior reports associated with pooled GLP-1RAs, including semaglutide.
In plain wordsFAERS contained 204 reports of suicidal or self-injurious behavior linked to pooled GLP-1RAs, including semaglutide.
Peptide
Semaglutide
Outcome
Not applicableSuicidal or self-injurious behavior reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
SSIB cases
204 cases
Pooled GLP-1RAs in FAERS
Source sentences
Summary
In total, 204 cases of SSIBs associated with GLP-1RAs, including semaglutide, liraglutide, dulaglutide, exenatide, and albiglutide, were identified in the FAERS database.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Show in the study text Report a problemFND-3835551303
04HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In FAERS reports, pooled GLP-1RAs showed no consistent mechanism for suicidal or self-injurious behavior latency.
In plain wordsFAERS reports showed no consistent latency mechanism for suicidal or self-injurious behavior with pooled GLP-1RAs.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableLatency pattern
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Source sentences
Summary
Time-of-onset analysis revealed no consistent mechanism for the latency of SSIBs in patients receiving GLP-1RAs.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Show in the study text Report a problemFND-3835551304
05HumanNot a test of Liraglutide aloneObservational studySafety outcome
In FAERS reports, pooled GLP-1RAs showed no consistent mechanism for suicidal or self-injurious behavior latency.
In plain wordsFAERS reports showed no consistent latency mechanism for suicidal or self-injurious behavior with pooled GLP-1RAs.
Peptide
Liraglutide
Outcome
Not applicableLatency pattern
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Source sentences
Summary
Time-of-onset analysis revealed no consistent mechanism for the latency of SSIBs in patients receiving GLP-1RAs.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-3835551305
06HumanNot a test of Semaglutide aloneObservational studySafety outcome
In FAERS reports, pooled GLP-1RAs showed no consistent mechanism for suicidal or self-injurious behavior latency.
In plain wordsFAERS reports showed no consistent latency mechanism for suicidal or self-injurious behavior with pooled GLP-1RAs.
Peptide
Semaglutide
Outcome
Not applicableLatency pattern
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Source sentences
Summary
Time-of-onset analysis revealed no consistent mechanism for the latency of SSIBs in patients receiving GLP-1RAs.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Show in the study text Report a problemFND-3835551306
07HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
FAERS disproportionality analysis did not indicate an association between pooled GLP-1RAs and suicidal or self-injurious behaviors.
In plain wordsFAERS analysis did not link pooled GLP-1RAs to disproportionate reports of suicidal or self-injurious behavior.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeDisproportionate reporting association
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Source sentences
Summary
The disproportionality analysis did not indicate an association between GLP-1RAs and SSIBs.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Show in the study text Report a problemFND-3835551307
08HumanNot a test of Liraglutide aloneObservational studySafety outcome
FAERS disproportionality analysis did not indicate an association between pooled GLP-1RAs and suicidal or self-injurious behaviors.
In plain wordsFAERS analysis did not link pooled GLP-1RAs to disproportionate reports of suicidal or self-injurious behavior.
Peptide
Liraglutide
Outcome
No significant changeDisproportionate reporting association
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Source sentences
Summary
The disproportionality analysis did not indicate an association between GLP-1RAs and SSIBs.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-3835551308
09HumanNot a test of Semaglutide aloneObservational studySafety outcome
FAERS disproportionality analysis did not indicate an association between pooled GLP-1RAs and suicidal or self-injurious behaviors.
In plain wordsFAERS analysis did not link pooled GLP-1RAs to disproportionate reports of suicidal or self-injurious behavior.
Peptide
Semaglutide
Outcome
No significant changeDisproportionate reporting association
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Source sentences
Summary
The disproportionality analysis did not indicate an association between GLP-1RAs and SSIBs.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Show in the study text Report a problemFND-3835551309
10HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
Among pooled GLP-1RA behavior reports, co-medication analysis identified 81 cases with antidepressants, antipsychotics, and benzodiazepines.
In plain wordsAmong pooled GLP-1RA behavior reports, 81 cases involved antidepressants, antipsychotics, and benzodiazepines.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNeuropsychotropic co-medication reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
Cases with antidepressants, antipsychotics, and benzodiazepines
81 cases
Pooled GLP-1RA SSIB reports in FAERS
Source sentences
Summary
Co-medication analysis revealed 81 cases with antidepressants, antipsychotics, and benzodiazepines, which may be proxies of mental health comorbidities.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Show in the study text Report a problemFND-3835551310
11HumanNot a test of Liraglutide aloneObservational studySafety outcome
Among pooled GLP-1RA behavior reports, co-medication analysis identified 81 cases with antidepressants, antipsychotics, and benzodiazepines.
In plain wordsAmong pooled GLP-1RA behavior reports, 81 cases involved antidepressants, antipsychotics, and benzodiazepines.
Peptide
Liraglutide
Outcome
Not applicableNeuropsychotropic co-medication reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
Cases with antidepressants, antipsychotics, and benzodiazepines
81 cases
Pooled GLP-1RA SSIB reports in FAERS
Source sentences
Summary
Co-medication analysis revealed 81 cases with antidepressants, antipsychotics, and benzodiazepines, which may be proxies of mental health comorbidities.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-3835551311
12HumanNot a test of Semaglutide aloneObservational studySafety outcome
Among pooled GLP-1RA behavior reports, co-medication analysis identified 81 cases with antidepressants, antipsychotics, and benzodiazepines.
In plain wordsAmong pooled GLP-1RA behavior reports, 81 cases involved antidepressants, antipsychotics, and benzodiazepines.
Peptide
Semaglutide
Outcome
Not applicableNeuropsychotropic co-medication reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
Cases with antidepressants, antipsychotics, and benzodiazepines
81 cases
Pooled GLP-1RA SSIB reports in FAERS
Source sentences
Summary
Co-medication analysis revealed 81 cases with antidepressants, antipsychotics, and benzodiazepines, which may be proxies of mental health comorbidities.
1 context sentence(design, population, supporting numbers)
Summary · context
A disproportionality analysis was conducted using post-marketing data from the FAERS repository (2018 Q1 to 2022 Q4).
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Show in the study text Report a problemFND-3835551312

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 4Current
22 Oct 2026, 02:25 UTC
Study results updated
Versions 2 to 3
21 Oct 2026, 18:59 UTC
The same notice was added 2 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

Exploration of the potential association between GLP-1 receptor agonists and suicidal or self-injurious behaviors: a pharmacovigilance study based on the FDA Adverse Event Reporting System database.

Summary

Results from this study12

Studies that did not test the peptide alone12

Version history

Subjects

Publication types

MeSH terms

Keywords