Antibiotics and antibiotic-associated diarrhea: a real-world
disproportionality study of the FDA Adverse Event Reporting System from
2004 to 2022
Abstract
Aims: Our study aimed to assess the risk signals of
antibiotic-associated diarrhea (AAD) caused by various antibiotics using
real-world data and provide references for safe clinical applications.
Methods: We analyzed data extracted from the FDA Adverse Event Reporting
System (FAERS) database, covering the period from the first quarter of
2004 to the third quarter of 2022. We computed the odds ratio (ROR) for
each antibiotic or antibiotic class to compare the signal difference.
Furthermore, we also examined the differences in the onset times and
outcomes of AAD caused by various antibiotics. Results: A total of 5,397
reports met the inclusion requirements. Almost all antibiotics, except
tobramycin and minocycline (ROR 0.98 and 0.42, respectively), showed a
significant correlation with AAD. The analysis of the correlation
between different classes of antibiotics and AAD revealed that
lincomycins (ROR 29.19), third-generation cephalosporins (ROR 15.96),
and first/second generation cephalosporins (ROR 15.29) ranked the top
three. The ROR values for antibiotics from the same class of antibiotics
also varied greatly, with the ROR values for third-generation
cephalosporins ranging from 9.97 to 58.59. There were also differences
in ROR values between β-lactamase inhibitors and their corresponding
β-lactamase drugs, such as amoxicillin-clavulanate (ROR = 13.31) and
amoxicillin (ROR = 6.50). 91.35% antibiotics have an onset time of less
than four weeks. Conclusions: There is a significant correlation between
almost all antibiotics and AAD, particularly lincomycins and β-lactam
antibiotics, as well as a different correlation within the same class.
These findings offer valuable evidence for selecting antibiotics
appropriately.