# Gastrointestinal adverse events associated with tirzepatide: A bibliometric and pharmacovigilance analysis

## TL;DR

This study analyzes gastrointestinal side effects of tirzepatide using research trends and real-world data, finding higher risks in certain patient groups.

## Contribution

The study combines bibliometric and pharmacovigilance approaches to reveal real-world gastrointestinal adverse event patterns of tirzepatide.

## Key findings

- Nausea and diarrhea are the most frequently reported gastrointestinal adverse events with tirzepatide.
- Tirzepatide has a higher risk of gastrointestinal adverse events in patients with type 2 diabetes compared to those using it for weight loss.
- Most gastrointestinal adverse events occur within 3 months of treatment initiation.

## Abstract

This study examines gastrointestinal adverse events (GIAEs) associated with tirzepatide using bibliometric and pharmacovigilance analyses.

A bibliometric analysis of Web of Science data identified research trends in tirzepatide-related adverse events, while a pharmacovigilance analysis of FAERS data (Q2 2022–Q2 2024) assessed real-world GIAEs patterns. Disproportionality, time-to-onset, univariate, and comparative analyses were conducted to evaluate reporting odds ratios (RORs), onset timing, and subgroup differences.

Among 110 studies, cardiovascular outcomes predominated as the research focus. FAERS data showed that nausea (27.7%) and diarrhea (12.8%) were the most frequently reported events, whereas eructation and impaired gastric emptying had the highest disproportionality. GIAEs were more common in older adults, males, and patients receiving concomitant medications, and most occurred within 3 months (median onset: 16 days). Tirzepatide had a lower ROR for GIAEs than GLP-1 receptor agonists but a higher ROR than non-GLP-1 drugs, with a greater risk in patients with type 2 diabetes (T2DM) than in those using tirzepatide for weight loss.

Tirzepatide is associated with an increased risk of GIAEs, particularly among patients with T2DM, males, older adults, and those using concomitant medications. FAERS-based real-world evidence complements clinical trial data and highlights the need for individualized patient monitoring and management strategies.