ArticleJournal of endocrinological investigation2024
The real-world safety profile of tirzepatide: pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.
Article in Journal of endocrinological investigation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Long-term efficacy and safety of tirzepatide in participants with type 2 diabetes with inadequate glycaemic control on metformin and/or sulfonylurea: Post-hoc analysis of SURPASS-4.Diabetes, obesity & metabolism · 2025Trial
- Real-World Effectiveness and Treatment Patterns of Tirzepatide in a Large UK Digital Health Cohort.Diabetes, obesity & metabolism · 2026Article
- Multi-target-directed drugs: new additions in 2025 and post-marketing safety surveillance of drugs marketed in 2022-2024.Pharmacological reports : PR · 2026Review
- Adverse events associated with tirzepatide: a focus on subgroup-specific differences.BMC pharmacology & toxicology · 2026Article
- Pancreatic and biliary safety signals of GLP-1 receptor agonists and tirzepatide: a disproportionality analysis of FAERS reports.Frontiers in endocrinology · 2026Article
- Gastrointestinal adverse events associated with tirzepatide: A bibliometric and pharmacovigilance analysis.PloS one · 2026Article
- Co-prescription of metformin and glucagon-like peptide-1 receptor agonists and metformin-associated lactic acidosis: A case series.Clinical nephrology. Case studies · 2026Article
- Tirzepatide for obesity without diabetes: mechanistic insights, clinical evidence, and future directions.Frontiers in pharmacology · 2026Review
- Unilateral Graves' Disease Developing During Treatment With Tirzepatide in a Patient With Diabetes: A Case Report.Case reports in endocrinology · 2026Article
- A narrative review on tirzepatide's therapeutic potential in glycemic control and cardioprotection.Annals of medicine and surgery (2012) · 2026Review
- Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.Frontiers in endocrinology · 2026Article
- Mapping the global research landscape of tirzepatide: a bibliometric analysis of trends, collaborations, and emerging themes in obesity and diabetes managements.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Nutrition and Physical Activity in Optimizing Weight Loss and Lean Mass Preservation in the Incretin-Based Medications Era: A Narrative Review.Nutrients · 2025Review
- Improving our understanding of the biology of aging: findings from the Age-It Research Program.The journals of gerontology. Series B, Psychological sciences and social sciences · 2025Article
- Glucokinase activators contribute to gastrointestinal disease risks through metabolic-immune interplay in the gut-liver axis: insights from a multi-omics study.Acta diabetologica · 2025Article
- Advancing Obstructive Sleep Apnea Management: Recent Trends from Conventional to Innovative Therapies.Journal of clinical medicine · 2025Review
- Unanticipated Adverse Events With Tirzepatide: Three Cases Underscoring the Importance of Postmarketing Monitoring.JCEM case reports · 2025Article
- The effects of incretins as a double-edged sword on cancer.Molecular biology reports · 2025Review
- Real-World Safety Concerns of Tirzepatide: A Retrospective Analysis of FAERS Data (2022-2025).Healthcare (Basel, Switzerland) · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeRandomized controlled trials with tirzepatide (TZP) displayed unprecedented glucose and body weight lowering efficacy in individuals with type 2 diabetes and/or obesity and a safety profile similar to that of glucagon-like peptide-1 receptor agonists (GLP-1RA), mainly characterized by gastrointestinal (GI) adverse events (AE). Concerns on diabetic retinopathy, pancreato-biliary disorders, and medullary thyroid cancer were also addressed. We aimed to investigate whether the same safety issues emerged from the FDA Adverse Event Reporting System (FAERS) post-marketing surveillance database.
methodsOpenVigil 2.1-MedDRA-v24 and AERSMine (data 2004Q1-2023Q3) were used to query the FAERS database. Reports of GI AE, diabetic retinopathy, pancreato-biliary disorders, and medullary thyroid cancer were investigated. The analysis was then filtered for age, gender, and designation as primary suspect. AE occurrence with TZP was compared to insulin, sodium-glucose cotransporter-2 inhibitors, metformin, and GLP-1RA.
resultsDisproportionate reporting of GI [i.e., nausea (ROR 4.01, 95% CI 3.85-4.19)] and pancreato-biliary disorders [i.e., pancreatitis (ROR 3.63, 95% CI 3.15-4.19)], diabetic retinopathy (ROR 4.14, 95% CI 2.34-7.30), and medullary thyroid cancer (ROR 13.67, 95% CI 4.35-42.96) was detected. TZP exhibited a similar risk of GI AE and medullary thyroid cancer and a lower risk of most pancreato-biliary AE and diabetic retinopathy vs. GLP-1RA.
conclusionsTZP was associated with an increased risk of specific AE. However, its safety profile was similar to that of GLP-1RA, without increased risk of pancreato-biliary AE, diabetic retinopathy, and medullary thyroid cancer.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.