Postmarketing Safety Signals and Medication-Use Risks of GLP-1-Based Therapies in Diabetes and Obesity: A Multi-Source Pharmacovigilance and Regulatory Evidence-Mapping Study.

Ren L, Zhang Y, Fang F, Ma Y

Diabetes, obesity & metabolism3 Sept 2026

PMID42687799DOI10.1111/dom.71303PepBankPUB-42687799

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

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

Studies that did not test the peptide alone8

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
Pooled GLP-1 reports frequently included dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use.
In plain wordsClinical adverse event report analysis of pooled GLP-1 reports found frequent dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedFrequent reporting terms
Study
Homo sapiensn: not reported in source
FDA Adverse Event Reporting System clinical adverse event reports
Outcome group
Adverse events · Whole body
Source sentences
Summary
Frequently reported terms included incorrect dose administered, nausea, injection-site pain, diarrhoea, vomiting, off-label use, and extra dose administered.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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).
Report a problemFND-4268779904
02HumanNot a test of Liraglutide aloneObservational studySafety outcome
In FAERS analysis, pooled GLP-1 primary-suspect reports frequently included dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use.
In plain wordsAnalysis of adverse event reports found frequent dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use across pooled GLP-1 drugs.
Peptide
Liraglutide
Outcome
Direction not reportedFrequent reporting terms
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Frequently reported terms included incorrect dose administered, nausea, injection-site pain, diarrhoea, vomiting, off-label use, and extra dose administered.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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.
Report a problemFND-4268779905
03HumanNot a test of Semaglutide aloneObservational studySafety outcome
In FAERS analysis, pooled GLP-1 primary-suspect reports frequently included dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use.
In plain wordsAnalysis of adverse event reports found frequent dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use across pooled GLP-1 drugs.
Peptide
Semaglutide
Outcome
Direction not reportedFrequent reporting terms
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Frequently reported terms included incorrect dose administered, nausea, injection-site pain, diarrhoea, vomiting, off-label use, and extra dose administered.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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.
Report a problemFND-4268779906
04HumanNot a test of Tirzepatide aloneObservational studySafety outcome
In FAERS analysis, pooled GLP-1 primary-suspect reports frequently included dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use.
In plain wordsAnalysis of adverse event reports found frequent dosing errors, nausea, injection-site pain, diarrhoea, vomiting, and off-label use across pooled GLP-1 drugs.
Peptide
Tirzepatide
Outcome
Direction not reportedFrequent reporting terms
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Frequently reported terms included incorrect dose administered, nausea, injection-site pain, diarrhoea, vomiting, off-label use, and extra dose administered.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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.
Report a problemFND-4268779907
05HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In FAERS analysis, prioritised domains for pooled GLP-1 therapies included gastrointestinal intolerance, medication-use/device events, impaired gastric emptying, pancreatobiliary events, renal/dehydration events, and hypoglycaemia.
In plain wordsClinical adverse event report analysis prioritised gastrointestinal, medication-use, stomach-emptying, pancreatobiliary, kidney/dehydration, and low blood sugar domains for pooled GLP-1 therapies.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedPrioritised safety domains
Study
Homo sapiensn: not reported in source
FDA Adverse Event Reporting System clinical adverse event reports
Outcome group
Adverse events · Whole body
Source sentences
Summary
Prioritised domains included gastrointestinal intolerance, medication-use/device events, impaired gastric emptying, pancreatobiliary events, renal/dehydration events, and hypoglycaemia.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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).
Report a problemFND-4268779908
06HumanNot a test of Liraglutide aloneObservational studySafety outcome
In FAERS analysis, gastrointestinal, medication-use, gastric-emptying, pancreatobiliary, renal/dehydration, and hypoglycaemia domains were prioritised for pooled GLP-1 therapies.
In plain wordsAnalysis of adverse event reports prioritised gastrointestinal, medication-use, stomach-emptying, pancreatobiliary, kidney/dehydration, and low blood sugar domains for pooled GLP-1 drugs.
Peptide
Liraglutide
Outcome
Direction not reportedPrioritised safety domains
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Prioritised domains included gastrointestinal intolerance, medication-use/device events, impaired gastric emptying, pancreatobiliary events, renal/dehydration events, and hypoglycaemia.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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.
Report a problemFND-4268779909
07HumanNot a test of Semaglutide aloneObservational studySafety outcome
In FAERS analysis, gastrointestinal, medication-use, gastric-emptying, pancreatobiliary, renal/dehydration, and hypoglycaemia domains were prioritised for pooled GLP-1 therapies.
In plain wordsAnalysis of adverse event reports prioritised gastrointestinal, medication-use, stomach-emptying, pancreatobiliary, kidney/dehydration, and low blood sugar domains for pooled GLP-1 drugs.
Peptide
Semaglutide
Outcome
Direction not reportedPrioritised safety domains
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Prioritised domains included gastrointestinal intolerance, medication-use/device events, impaired gastric emptying, pancreatobiliary events, renal/dehydration events, and hypoglycaemia.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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.
Report a problemFND-4268779910
08HumanNot a test of Tirzepatide aloneObservational studySafety outcome
In FAERS analysis, gastrointestinal, medication-use, gastric-emptying, pancreatobiliary, renal/dehydration, and hypoglycaemia domains were prioritised for pooled GLP-1 therapies.
In plain wordsAnalysis of adverse event reports prioritised gastrointestinal, medication-use, stomach-emptying, pancreatobiliary, kidney/dehydration, and low blood sugar domains for pooled GLP-1 drugs.
Peptide
Tirzepatide
Outcome
Direction not reportedPrioritised safety domains
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Prioritised domains included gastrointestinal intolerance, medication-use/device events, impaired gastric emptying, pancreatobiliary events, renal/dehydration events, and hypoglycaemia.
3 context sentences(design, population, supporting numbers)
Summary · context
FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level.
Summary · context
Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component.
Summary · context
Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.
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.
Report a problemFND-4268779911

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

Subjects

Terms as the source lists them.

Publication types

Journal Article

Keywords

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