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Study · Observational study · 2026

6 results

Pancreatic and biliary safety signals of GLP-1 receptor agonists and tirzepatide: a disproportionality analysis of FAERS reports.

Wu Y, Li K, Wang Y, Chen Z, Shi M, Zhao J

Frontiers in endocrinology28 Sept 2026

PMID42865361 (opens in a new tab)DOI10.3389/fendo.2026.1941948 (opens in a new tab)PepBankPUB-42865361
Publisher pagePubMedAsk about this study
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Summary

BackgroundThe use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) and tirzepatide is increasing rapidly worldwide, and the pancreatic and biliary safety of these drugs has been a concern. This study was based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the pancreatic and biliary adverse event reporting signals of liraglutide, semaglutide, tirzepatide and dulaglutide.ObjectivesTo describe the reporting patterns of pancreatic and biliary adverse events for liraglutide, semaglutide, dulaglutide, and tirzepatide, and to identify signals in both organ systems within a single framework.DesignRetrospective disproportionality analysis of individual case safety reports.MethodsFAERS data from Q3-2009 through Q3-2025 were extracted, and deduplicated ICSRs were used as the unit of analysis. Reporting odds ratios (RORs) and information components (ICs) were computed at composite and Preferred Term levels; signals required the lower 95% confidence bound for the ROR to exceed 1 and IC025 to exceed 0. Metformin and sodium-glucose cotransporter-2 inhibitors were included as contextual benchmarks. Analyses were stratified by brand (diabetes/obesity indication), sex, age, and reporter type, and time to onset was examined.ResultsA disproportionality signal for pancreatic adverse events was observed for all four study drugs, but the control drugs metformin and SGLT2i also showed positive signals. For biliary events, all four study drugs showed signals, whereas the two control drugs showed no signals. After stratification by brand, the pancreatic signal remained for brands with diabetes indications, while the signal was weaker for brands with obesity indications. After excluding the cases of biliary tract co-reporting, the pancreatic signal still existed. Median time to onset ranged from 85.5 to 136 days for pancreatic events and from 146.5 to 320 days for biliary events.ConclusionBoth GLP-1RAs and tirzepatide are associated with disproportionate reporting of pancreatic and biliary adverse events in FAERS. Signals are influenced by indication, reporting behavior, and time effects and cannot be used to estimate incidence or prove causality. These signals suggest the need for further validation in real-world cohort studies.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanObservational studySafety outcome

    In FAERS analysis, dulaglutide showed a pancreatic adverse event reporting signal, as did metformin and SGLT2 inhibitors.

    In plain wordsClinical adverse event report analysis found a pancreatic adverse event reporting signal for dulaglutide and also for the control drugs.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreasePancreatic adverse event signal
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    A disproportionality signal for pancreatic adverse events was observed for all four study drugs, but the control drugs metformin and SGLT2i also showed positive signals.
    3 context sentences
    Summary · context
    This study was based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the pancreatic and biliary adverse event reporting signals of liraglutide, semaglutide, tirzepatide and dulaglutide.
    Summary · context
    FAERS data from Q3-2009 through Q3-2025 were extracted, and deduplicated ICSRs were used as the unit of analysis.
    Summary · context
    Reporting odds ratios (RORs) and information components (ICs) were computed at composite and Preferred Term levels; signals required the lower 95% confidence bound for the ROR to exceed 1 and IC025 to exceed 0.
  2. 02HumanObservational studySafety outcome

    In FAERS analysis, dulaglutide showed a biliary reporting signal, whereas metformin and SGLT2 inhibitors showed no signal.

    In plain wordsClinical adverse event report analysis found a biliary reporting signal for dulaglutide, while the control drugs showed no signal.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseBiliary adverse event signal
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    For biliary events, all four study drugs showed signals, whereas the two control drugs showed no signals.
    3 context sentences
    Summary · context
    This study was based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the pancreatic and biliary adverse event reporting signals of liraglutide, semaglutide, tirzepatide and dulaglutide.
    Summary · context
    FAERS data from Q3-2009 through Q3-2025 were extracted, and deduplicated ICSRs were used as the unit of analysis.
    Summary · context
    Reporting odds ratios (RORs) and information components (ICs) were computed at composite and Preferred Term levels; signals required the lower 95% confidence bound for the ROR to exceed 1 and IC025 to exceed 0.

Studies that did not test the peptide alone4

In this study, Dulaglutide (Trulicity) 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 Dulaglutide (Trulicity).

  1. 03HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome

    Across pooled study drugs, pancreatic reporting signals persisted for diabetes brands and were weaker for obesity brands.

    In plain wordsClinical adverse event report analysis found persistent pancreatic signals for pooled diabetes brands and weaker signals for obesity brands.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    MixedPancreatic signals by indication
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Gastrointestinal

    Source sentences

    Summary
    After stratification by brand, the pancreatic signal remained for brands with diabetes indications, while the signal was weaker for brands with obesity indications.
    3 context sentences
    Summary · context
    This study was based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the pancreatic and biliary adverse event reporting signals of liraglutide, semaglutide, tirzepatide and dulaglutide.
    Summary · context
    FAERS data from Q3-2009 through Q3-2025 were extracted, and deduplicated ICSRs were used as the unit of analysis.
    Summary · context
    Reporting odds ratios (RORs) and information components (ICs) were computed at composite and Preferred Term levels; signals required the lower 95% confidence bound for the ROR to exceed 1 and IC025 to exceed 0.

    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).

  2. 04HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome

    In pooled drug analysis, pancreatic reporting signals persisted after exclusion of biliary tract co-reporting.

    In plain wordsClinical adverse event report analysis found persistent pancreatic signals for pooled drugs after excluding reports that also mentioned biliary problems.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreasePancreatic signal after biliary exclusion
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Gastrointestinal

    Source sentences

    Summary
    After excluding the cases of biliary tract co-reporting, the pancreatic signal still existed.
    3 context sentences
    Summary · context
    This study was based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the pancreatic and biliary adverse event reporting signals of liraglutide, semaglutide, tirzepatide and dulaglutide.
    Summary · context
    FAERS data from Q3-2009 through Q3-2025 were extracted, and deduplicated ICSRs were used as the unit of analysis.
    Summary · context
    Reporting odds ratios (RORs) and information components (ICs) were computed at composite and Preferred Term levels; signals required the lower 95% confidence bound for the ROR to exceed 1 and IC025 to exceed 0.

    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).

  3. 05HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyOther

    In pooled drug reports, median pancreatic event onset ranged from 85.5 to 136 days.

    In plain wordsClinical adverse event report analysis found median pancreatic event onset from 85.5 to 136 days across pooled drugs.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicablePancreatic event onset
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Gastrointestinal

    Measurements

    Median time to onset
    85.5 to 136 days
    pancreatic events across study drugs

    Source sentences

    Summary
    Median time to onset ranged from 85.5 to 136 days for pancreatic events and from 146.5 to 320 days for biliary events.
    3 context sentences
    Summary · context
    This study was based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the pancreatic and biliary adverse event reporting signals of liraglutide, semaglutide, tirzepatide and dulaglutide.
    Summary · context
    FAERS data from Q3-2009 through Q3-2025 were extracted, and deduplicated ICSRs were used as the unit of analysis.
    Summary · context
    Reporting odds ratios (RORs) and information components (ICs) were computed at composite and Preferred Term levels; signals required the lower 95% confidence bound for the ROR to exceed 1 and IC025 to exceed 0.

    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).

  4. 06HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyOther

    In pooled drug reports, median biliary event onset ranged from 146.5 to 320 days.

    In plain wordsClinical adverse event report analysis found median biliary event onset from 146.5 to 320 days across pooled drugs.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableBiliary event onset
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Gastrointestinal

    Measurements

    Median time to onset
    146.5 to 320 days
    biliary events across study drugs

    Source sentences

    Summary
    Median time to onset ranged from 85.5 to 136 days for pancreatic events and from 146.5 to 320 days for biliary events.
    3 context sentences
    Summary · context
    This study was based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the pancreatic and biliary adverse event reporting signals of liraglutide, semaglutide, tirzepatide and dulaglutide.
    Summary · context
    FAERS data from Q3-2009 through Q3-2025 were extracted, and deduplicated ICSRs were used as the unit of analysis.
    Summary · context
    Reporting odds ratios (RORs) and information components (ICs) were computed at composite and Preferred Term levels; signals required the lower 95% confidence bound for the ROR to exceed 1 and IC025 to exceed 0.

    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).

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 2Current

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

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