Signal detection and analysis of adverse events associated with sevelamer post-marketing based on the FAERS database

This study aimed to evaluate adverse events (AEs) associated with sevelamer through data mining of the US FDA Adverse Event Reporting System, identify potential drug-related AEs, and provide guidance for clinical medication safety. AE reports related to sevelamer from the first quarter of 2004 to the second quarter of 2025 were extracted from the US FDA Adverse Event Reporting System database, classified by preferred term (PT) and system organ class, and risk signals were analyzed. Among 6780 AE reports in which sevelamer was the primary suspect drug, 123 PTs spanning 24 system organ classes were identified. Male reports exceeded females (20.66% vs 18.07%), with highest proportion in 60 to 74 years (11.81%). Median AE occurrence time - medication date was 119.00 (interquartile range, 14.00, 476.50) days, with most events occurring more than 60 days after administration (n = 353, 30.46%) and within 7 days (n = 121, 10.44%). Among the positive risk signal PTs, "constipation, gastric or intestinal ulcer/hemorrhage/perforation/necrosis/ischemia, colitis ischemic, erosive esophagitis/gastritis, abdominal pain, dysphagia, nausea, vomiting, peritonitis and pruritus" exhibited high signal strength, consistent with the label. Additionally, new signals included aorto-esophageal fistula, diabetic gastroparesis, large intestinal stenosis, short-bowel syndrome, bezoar, diverticulum intestinal, gastric polyps, large intestine polyp, feces pale, diverticulum, hemorrhagic intestinal diverticulum, crystal deposit intestine, appendicitis (complicated or perforated), renal cyst infection, colonic or abdominal abscess, pseudomembranous colitis, diverticulitis, gangrene, pseudopolyp, mucosal ulceration or necrosis, skin fibrosis, and excessive granulation tissue. Therapeutic use of sevelamer remains associated with risks of diverse AEs. Therefore, clinical practice requires close monitoring of gastrointestinal disorders, metabolic, skin disorders and infections, particularly GI disorders. Prompt intervention is essential to prevent severe complications.