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Study · Observational study · 2026

8 results

Comparative pharmacovigilance analysis of suicidality-related adverse events among GLP-1 and non-GLP-1 anti-obesity drugs in the FDA Adverse Event Reporting System.

Seijas-Amigo J, Salgado-Barreira Á, Rodriguez-Penas D, Cardeso-Paredes B, Ribeiro-Ferreiro M, Rodriguez-Mañero M, Gonzalez-Juanatey JR

International journal of clinical pharmacy25 Feb 2026Cited by 2 (Europe PMC)

PMID41739406 (opens in a new tab)PMCIDPMC13176177 (opens in a new tab)DOI10.1007/s11096-026-02099-y (opens in a new tab)PepBankPUB-41739406
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Summary

IntroductionRegulatory reviews in 2023-2024 reignited concern about possible suicidality with Glucagon-like peptide-1 (GLP-1) receptor agonists used for weight management. While clinical trials and real-world studies have not confirmed an increased risk, comparative post-marketing analyses across all anti-obesity agents are scarce.AimTo compare disproportional reporting of suicidality-related adverse events among GLP-1/dual incretin versus non-GLP-1 anti-obesity drugs in the FDA Adverse Event Reporting System (FAERS).MethodWe conducted a retrospective disproportionality study using FAERS (January 2012-February 2025). Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA. Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide). Reporting Odds Ratios (RORs) with 95% confidence intervals (CIs) were calculated for each drug and at class level (GLP-1/dual incretin vs non-GLP-1). Haldane-Anscombe corrections were applied where needed.ResultsAmong approximately 78,000 anti-obesity reports, 207 (approximately 0.3%) involved suicidality-related events. For semaglutide, RORs were 1.39 (95% CI 0.99-1.94) for suicidal ideation, 1.38 (0.46-4.15) for suicide attempt, and 1.72 (0.62-4.74) for completed suicide, none statistically significant. Liraglutide showed ROR 1.01 (0.66-1.55) for suicidal ideation and 18.11 (6.96-47.15) for completed suicide based on 14 cases. Tirzepatide yielded RORs below unity for all outcomes. Naltrexone/bupropion showed elevated disproportional reporting for suicidal ideation (ROR 3.84; 95% CI 2.89-5.12) and suicide attempt (ROR 4.11; 95% CI 1.62-10.45.ConclusionGLP-1 and dual-incretin agents did not show disproportionality signals for suicidal ideation or suicide attempt. A statistically significant disproportionality signal for completed suicide was observed for liraglutide; however, this estimate was based on few cases and displayed wide confidence intervals, warranting cautious interpretation. These findings support an overall neutral psychiatric safety profile for incretin-based therapies while underscoring the need for continued monitoring of rare events such as completed suicide.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanObservational studySafety outcome

    In US FAERS reports, semaglutide had a reporting odds ratio of 1.39 for suicidal ideation (95% CI 0.99-1.94); no significant reporting signal was found.

    In plain wordsIn FAERS reports, semaglutide did not show a significant signal for suicidal thoughts.

    Peptide
    Semaglutide
    Outcome
    No significant changeSuicidal ideation reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated

    Measurements

    Reporting odds ratio
    1.39
    US FAERS disproportionality; suicidal ideation

    Source sentences

    Summary
    For semaglutide, RORs were 1.39 (95% CI 0.99-1.94) for suicidal ideation, 1.38 (0.46-4.15) for suicide attempt, and 1.72 (0.62-4.74) for completed suicide, none statistically significant.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).
  2. 02HumanObservational studySafety outcome

    In US FAERS reports, semaglutide had a reporting odds ratio of 1.38 for suicide attempt (95% CI 0.46-4.15); no significant reporting signal was found.

    In plain wordsIn FAERS reports, semaglutide did not show a significant signal for suicide attempts.

    Peptide
    Semaglutide
    Outcome
    No significant changeSuicide attempt reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated

    Measurements

    Reporting odds ratio
    1.38
    US FAERS disproportionality; suicide attempt

    Source sentences

    Summary
    For semaglutide, RORs were 1.39 (95% CI 0.99-1.94) for suicidal ideation, 1.38 (0.46-4.15) for suicide attempt, and 1.72 (0.62-4.74) for completed suicide, none statistically significant.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).
  3. 03HumanObservational studySafety outcome

    In US FAERS reports, semaglutide had a reporting odds ratio of 1.72 for completed suicide (95% CI 0.62-4.74); no significant reporting signal was found.

    In plain wordsIn FAERS reports, semaglutide did not show a significant signal for completed suicide.

    Peptide
    Semaglutide
    Outcome
    No significant changeCompleted suicide reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Mortality · Mental health and mood
    Studied dose
    Dose not stated

    Measurements

    Reporting odds ratio
    1.72
    US FAERS disproportionality; completed suicide

    Source sentences

    Summary
    For semaglutide, RORs were 1.39 (95% CI 0.99-1.94) for suicidal ideation, 1.38 (0.46-4.15) for suicide attempt, and 1.72 (0.62-4.74) for completed suicide, none statistically significant.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).
  4. 04HumanObservational studySafety outcome

    In US FAERS reports, liraglutide had a reporting odds ratio of 1.01 for suicidal ideation (95% CI 0.66-1.55); no significant reporting signal was found.

    In plain wordsIn FAERS reports, liraglutide did not show a significant signal for suicidal thoughts.

    Peptide
    Liraglutide
    Outcome
    No significant changeSuicidal ideation reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated

    Measurements

    Reporting odds ratio
    1.01
    US FAERS disproportionality; suicidal ideation

    Source sentences

    Summary
    Liraglutide showed ROR 1.01 (0.66-1.55) for suicidal ideation and 18.11 (6.96-47.15) for completed suicide based on 14 cases.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).
  5. 05HumanObservational studySafety outcome

    In US FAERS reports, liraglutide had a reporting odds ratio of 18.11 for completed suicide (95% CI 6.96-47.15); the signal was based on 14 cases and has wide uncertainty.

    In plain wordsIn FAERS reports, liraglutide showed a completed-suicide reporting signal based on 14 cases.

    Peptide
    Liraglutide
    Outcome
    IncreaseCompleted suicide reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Mortality · Mental health and mood
    Studied dose
    Dose not stated

    Measurements

    Reporting odds ratio
    18.11
    US FAERS disproportionality; completed suicide

    Source sentences

    Summary
    Liraglutide showed ROR 1.01 (0.66-1.55) for suicidal ideation and 18.11 (6.96-47.15) for completed suicide based on 14 cases.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).
  6. 06HumanObservational studySafety outcome

    In FAERS reports, tirzepatide had a reporting odds ratio below unity for suicidal ideation.

    In plain wordsIn FAERS reports, tirzepatide had a reported odds ratio below one for suicidal thoughts.

    Peptide
    Tirzepatide
    Outcome
    DecreaseSuicidal ideation reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tirzepatide yielded RORs below unity for all outcomes.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).
  7. 07HumanObservational studySafety outcome

    In FAERS reports, tirzepatide had a reporting odds ratio below unity for suicide attempt.

    In plain wordsIn FAERS reports, tirzepatide had a reported odds ratio below one for suicide attempts.

    Peptide
    Tirzepatide
    Outcome
    DecreaseSuicide attempt reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tirzepatide yielded RORs below unity for all outcomes.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).
  8. 08HumanObservational studySafety outcome

    In FAERS reports, tirzepatide had a reporting odds ratio below unity for completed suicide.

    In plain wordsIn FAERS reports, tirzepatide had a reported odds ratio below one for completed suicide.

    Peptide
    Tirzepatide
    Outcome
    DecreaseCompleted suicide reporting odds ratio
    Study

    n: not reported in source

    Outcome group
    Mortality · Mental health and mood
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tirzepatide yielded RORs below unity for all outcomes.
    3 context sentences
    Summary · context
    We conducted a retrospective disproportionality study using FAERS (January 2012-February 2025).
    Summary · context
    Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA.
    Summary · context
    Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide).

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.

  1. Version 4Current

    12 Oct 2026, 11:11 UTC

    Study results updated

  2. Versions 2 to 3

    9 Oct 2026, 03:07 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

  3. Version 1

    9 Oct 2026, 03:04 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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