Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis.

Guirguis A, Chiappini S, Papanti P GD, Vickers-Smith R, Harris D, Corkery JM, Arillotta D, Floresta G, Martinotti G, Schifano F

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology19 Mar 2024Cited by 52 (Europe PMC)

PMID38508100DOI10.1016/j.euroneuro.2024.02.003PepBankPUB-38508100

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Summary

IntroductionThe study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA).AimThe aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.MethodsDescriptive and pharmacovigilance disproportionality analyses was performed.ResultsA total of 209,354 ADRs were reported, including 59,300 serious cases. Of those, a total of 5378 psychiatric disorder cases, including 383 'serious' cases related to selected ADRs were registered during 2005-2023. After unmasking, 271 cases where individual GLP-1 RA were implicated showing liraglutide (n = 90; Reported Odds Ratio (ROR) = 1.64), exenatide (n = 67; ROR = 0.80), semaglutide (n = 61; ROR = 2.03), dulaglutide (n = 45; ROR = 0.84), tirzepatide (n = 5; ROR = 1.76) and albiglutide (n = 2; ROR = 0.04). A greater association between these ADRs with metformin was observed, but not orlistat. With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded. Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).DiscussionSuicide/self-injury reports pertaining to semaglutide; tirzepatide; and liraglutide were characterised, although lower than metformin. It is postulated that rapid weight loss achieved with GLP-1 RA can trigger significant emotional, biological, and psychological responses, hence possibly impacting on suicidal and self-injurious ideations.ConclusionsWith the current pharmacovigilance approach, no causality link between suicidal ideation and use of any GLP-1 RA can be inferred. There is a need for further research and vigilance in GLP-1 RA prescribing, particularly in patients with co-existing psychiatric disorders.

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

Results from this study16

4 results from studies that gave the peptide. 4 results from people.

01HumanObservational studySafety outcome
In FAERS reports, liraglutide had a suicide/self-injury reporting odds ratio of 1.64 after unmasking.
In plain wordsIn FAERS reports, liraglutide was linked to a suicide/self-injury reporting odds ratio of 1.64 after unmasking.
Peptide
Liraglutide
Outcome
Direction not reportedSuicide/self-injury reporting odds
Study
n = 90
Outcome group
Adverse events · Mental health and mood
Studied dose
Dose not stated
Measurements
Reporting odds ratio
1.64 ratio
liraglutide after unmasking
Source sentences
Summary
After unmasking, 271 cases where individual GLP-1 RA were implicated showing liraglutide (n = 90; Reported Odds Ratio (ROR) = 1.64)
3 context sentences(design, population, supporting numbers)
Title · context
Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis.
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
Show in the study text Report a problemFND-3850810002
02HumanObservational studySafety outcome
In FAERS reports, semaglutide had a suicide/self-injury reporting odds ratio of 2.03 after unmasking.
In plain wordsIn FAERS reports, semaglutide was linked to a suicide/self-injury reporting odds ratio of 2.03 after unmasking.
Peptide
Semaglutide
Outcome
Direction not reportedSuicide/self-injury reporting odds
Study
n = 61
Outcome group
Adverse events · Mental health and mood
Studied dose
Dose not stated
Measurements
Reporting odds ratio
2.03 ratio
semaglutide after unmasking
Source sentences
Summary
semaglutide (n = 61; ROR = 2.03)
3 context sentences(design, population, supporting numbers)
Title · context
Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis.
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
Show in the study text Report a problemFND-3850810003
03HumanObservational studySafety outcome
In FAERS reports, dulaglutide had a suicide/self-injury reporting odds ratio of 0.84 after unmasking.
In plain wordsIn FAERS reports, dulaglutide was linked to a suicide/self-injury reporting odds ratio of 0.84 after unmasking.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedSuicide/self-injury reporting odds
Study
n = 45
Outcome group
Adverse events · Mental health and mood
Studied dose
Dose not stated
Measurements
Reporting odds ratio
0.84 ratio
dulaglutide after unmasking
Source sentences
Summary
dulaglutide (n = 45; ROR = 0.84)
3 context sentences(design, population, supporting numbers)
Title · context
Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis.
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
Show in the study text Report a problemFND-3850810001
04HumanObservational studySafety outcome
In FAERS reports, tirzepatide had a suicide/self-injury reporting odds ratio of 1.76 after unmasking.
In plain wordsIn FAERS reports, tirzepatide was linked to a suicide/self-injury reporting odds ratio of 1.76 after unmasking.
Peptide
Tirzepatide
Outcome
Direction not reportedSuicide/self-injury reporting odds
Study
n = 5
Outcome group
Adverse events · Mental health and mood
Studied dose
Dose not stated
Measurements
Reporting odds ratio
1.76 ratio
tirzepatide after unmasking
Source sentences
Summary
tirzepatide (n = 5; ROR = 1.76)
3 context sentences(design, population, supporting numbers)
Title · context
Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis.
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
Show in the study text Report a problemFND-3850810004

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.

05HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including dulaglutide, 42 deaths were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including dulaglutide, 42 deaths were recorded.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedDeaths in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Whole body
Measurements
Deaths in selected preferred terms
42 deaths
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810005
06HumanNot a test of Liraglutide aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including liraglutide, 42 deaths were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including liraglutide, 42 deaths were recorded.
Peptide
Liraglutide
Outcome
Direction not reportedDeaths in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Whole body
Measurements
Deaths in selected preferred terms
42 deaths
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810006
07HumanNot a test of Semaglutide aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including semaglutide, 42 deaths were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including semaglutide, 42 deaths were recorded.
Peptide
Semaglutide
Outcome
Direction not reportedDeaths in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Whole body
Measurements
Deaths in selected preferred terms
42 deaths
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810007
08HumanNot a test of Tirzepatide aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including tirzepatide, 42 deaths were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including tirzepatide, 42 deaths were recorded.
Peptide
Tirzepatide
Outcome
Direction not reportedDeaths in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Whole body
Measurements
Deaths in selected preferred terms
42 deaths
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
In this study, Tirzepatide 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 Tirzepatide.
Show in the study text Report a problemFND-3850810008
09HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including dulaglutide, 13 completed suicides were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including dulaglutide, 13 completed suicides were recorded.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedCompleted suicides in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Mental health and mood
Measurements
Completed suicides in selected preferred terms
13 completed suicides
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810009
10HumanNot a test of Liraglutide aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including liraglutide, 13 completed suicides were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including liraglutide, 13 completed suicides were recorded.
Peptide
Liraglutide
Outcome
Direction not reportedCompleted suicides in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Mental health and mood
Measurements
Completed suicides in selected preferred terms
13 completed suicides
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810010
11HumanNot a test of Semaglutide aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including semaglutide, 13 completed suicides were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including semaglutide, 13 completed suicides were recorded.
Peptide
Semaglutide
Outcome
Direction not reportedCompleted suicides in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Mental health and mood
Measurements
Completed suicides in selected preferred terms
13 completed suicides
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810011
12HumanNot a test of Tirzepatide aloneObservational studySafety outcome
In selected pooled GLP-1 receptor agonist reports, including tirzepatide, 13 completed suicides were recorded.
In plain wordsIn selected pooled reports for GLP-1 receptor agonists, including tirzepatide, 13 completed suicides were recorded.
Peptide
Tirzepatide
Outcome
Direction not reportedCompleted suicides in pooled reports
Study
n: not reported in source
Outcome group
Mortality · Mental health and mood
Measurements
Completed suicides in selected preferred terms
13 completed suicides
pooled GLP-1 receptor agonist reports
Source sentences
Summary
With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded.
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
In this study, Tirzepatide 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 Tirzepatide.
Show in the study text Report a problemFND-3850810012
13HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
Across pooled GLP-1 receptor agonist reports, including dulaglutide, suicidal ideation occurred in 236 cases.
In plain wordsAcross pooled reports for GLP-1 receptor agonists, including dulaglutide, suicidal ideation occurred in 236 cases.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedSuicidal ideation in pooled reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
Cases with suicidal ideation
236 cases
pooled reports, 6 of 7 GLP-1 receptor agonists
Source sentences
Summary
Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810013
14HumanNot a test of Liraglutide aloneObservational studySafety outcome
Across pooled GLP-1 receptor agonist reports, including liraglutide, suicidal ideation occurred in 236 cases.
In plain wordsAcross pooled reports for GLP-1 receptor agonists, including liraglutide, suicidal ideation occurred in 236 cases.
Peptide
Liraglutide
Outcome
Direction not reportedSuicidal ideation in pooled reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
Cases with suicidal ideation
236 cases
6 of 7 GLP-1 receptor agonists, excluding lixisenatide
Source sentences
Summary
Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810014
15HumanNot a test of Semaglutide aloneObservational studySafety outcome
Across pooled GLP-1 receptor agonist reports, including semaglutide, suicidal ideation occurred in 236 cases.
In plain wordsAcross pooled reports for GLP-1 receptor agonists, including semaglutide, suicidal ideation occurred in 236 cases.
Peptide
Semaglutide
Outcome
Direction not reportedSuicidal ideation in pooled reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
Cases with suicidal ideation
236 cases
6 of 7 GLP-1 receptor agonists, excluding lixisenatide
Source sentences
Summary
Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
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-3850810015
16HumanNot a test of Tirzepatide aloneObservational studySafety outcome
Across pooled GLP-1 receptor agonist reports, including tirzepatide, suicidal ideation occurred in 236 cases.
In plain wordsAcross pooled reports for GLP-1 receptor agonists, including tirzepatide, suicidal ideation occurred in 236 cases.
Peptide
Tirzepatide
Outcome
Direction not reportedSuicidal ideation in pooled reports
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Measurements
Cases with suicidal ideation
236 cases
6 of 7 GLP-1 receptor agonists, excluding lixisenatide
Source sentences
Summary
Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).
2 context sentences(design, population, supporting numbers)
Summary · context
The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.
Summary · context
Descriptive and pharmacovigilance disproportionality analyses was performed.
In this study, Tirzepatide 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 Tirzepatide.
Show in the study text Report a problemFND-3850810016

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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