Abstract
Lanreotide and Octreotide are used to treat various endocrine and neoplastic diseases. This study aims to compare the adverse event profiles of Lanreotide and Octreotide in somatostatin-responsive diseases using FAERS data. FAERS data from Q1 2004 to Q2 2024 were reviewed for AE reports related to Lanreotide and Octreotide. Reports were categorized using MedDRA system organ classes (SOCs). Disproportionality analysis was conducted using Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), and Information Components (IC) to identify significant AEs. The top 20 AEs for each drug were analyzed, and chi-square tests assessed differences in AE frequencies between the drugs. Detailed comparisons were made across gastrointestinal, cardiovascular, and neoplastic AEs. Lanreotide was more associated with gastrointestinal AEs, such as diarrhea (1457 reports) and cholelithiasis (198 reports), with a notable signal for cholelithiasis (ROR 12.03, 95% CI 10.46-13.85). Octreotide had higher reports of cardiovascular AEs, including systolic (1483 reports) and diastolic (541 reports) blood pressure increases. Additionally, Octreotide was linked to neoplasm progression (1735 reports) and more frequent malignant neoplasms. Injection site reactions, including pain and nodules, were more common with Lanreotide (ROR 19.09, 95% CI 17.2-21.19). Lanreotide and Octreotide exhibit distinct adverse event profiles, with gastrointestinal signals more frequently observed for Lanreotide, and cardiovascular/neoplastic signals more apparent for Octreotide. These patterns should be interpreted with caution due to limitations of the FAERS data.