Based on the adverse event reporting system (FAERS) database of the US Food and Drug Administration (FDA), drugs related to pseudomembranous colitis (PMC) were identified to provide a reference for clinical safe medication.

Extract the reports of drug-related adverse events (AEs) of PMC from the FAERS database for the period from the first quarter of 2004 to the fourth quarter of 2024. Risk signal detection was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods. Analysis was conducted on the top 20 drugs in terms of the number of reports and the top 20 drugs in terms of signal values.

A total of 18 356 cases of drug induced PMC were retrieved, and 485 drugs with positive risk signals were identified. The proportion of females was the highest, accounting for 52.09% (9 562 cases/18 356 cases). The number of patients over 60 years old was the largest, accounting for 36.88% (6 769 cases/18 356 cases). Among drug-related diagnoses, Crohn’s disease accounted for 5.67% (1 040 cases/18 356 cases) and ulcerative colitis for 5.53% (1 016 cases/18 356 cases), with a larger number of cases. Among the patient outcomes, the hospitalization-initial or prolonged rate was the highest, accounting for 50.43% (9 257 cases/18 356 cases). Among the top 20 drugs by number of reports, infliximab ranked first. According to the ATC classification, antineoplastic and immunomodulating agents and anti-infectives for systemic use were the most numerous, each accounting for 30% (6 varieties/20 varieties), among which vedolizumab was not mentioned PMC in the label. In the top 20 drugs ranked by ROR signal intensity, anti-infective drugs accounted for the highest proportion of 60% (12 varieties/20 varieties), and belladonna was not mentioned in relation to PMC in the label.

A variety of drugs can cause PMC. Clinicians should remain vigilant, promptly perform diagnostic evaluations, discontinue the offending drugs, and initiate appropriate treatment to ensure medication safety.