Antibiotics-associated pseudomembranous colitis: a disproportionality analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) database

Abstract

Abstract Antibiotics have been established as an important risk factor for pseudomembranous colitis (PMC), a potential life-threatening complication. Evaluating the antibiotics most commonly associated with PMC is of great significance. In this study, we extracted the data from fourth quarter of 2003 to third quarter of 2023 in the US Food and Drug Administration Adverse Event Reporting System (FAERS). Disproportionality analysis was performed to evaluate the potential association between antibiotics and PMC. The results showed that eighty-one antibiotics which met the three algorithms simultaneously were enrolled. A total of 11737133 adverse event (ADE) reports were identified in the FAERS database, of which 1683 reports were associated with the enrolled antibiotics related PMC. It showed that the elderly and females are more susceptible to the antibiotics-associated PMC, especially for patients aged > 60 years. The top twenty-four antibiotics included four penicillins, eleven cephalosporins, three carbapenems, two lincosamides, one cephamycin, one aminoglycoside, one fosfomycin, and one echinocandin. This study also showed that cefoxitin, streptomycin, fosfomycin, and micafungin have a high risk of PMC, but there are few reports in the literature. This is helpful to reduce the potential damage of antibiotics-associated PMC.