OBJECTIVES: The study was designed to detect the association between pulmonary embolism and antibiotics by disproportionality analysis in the FDA (Food and Drug Administration) database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAS). Antibiotics are among the most commonly prescribed drugs. Unnecessary use of antibiotics is particularly concerning because antibiotics may be associated with a number of adverse drug events (ADEs). Therefore, this study aimed to analyze the association between the use of antibiotics and pulmonary embolism.

METHODS: A retrospective case/non-case disproportionality analysis was performed in the FAERS database. This study was based on adverse events reported to FAERS from 2004 Q1-2022 Q3. Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC) were applied to measure the disproportionality in reporting. A positive signal of increased AE risk was defined as ROR value >1, Chi square value >4, PRR value ≥ 2 with number of cases >3 and IC >0.

RESULTS: A total adverse events in FAERS database from 2004 Q1 – 2022 Q3 were found to be 2,65,55,430. Among which 80,809 reports of pulmonary embolism were considered. The same were selected for further analysis which showed that 11 antibiotics were reported for pulmonary embolism. The number of repots for Minocycline, Chloramphenicol, and Moxifloxacin was found to be 113, 14, 179. Significant potential signal was noted for Minocycline (ROR – 2.87, Chi-square – 135.95, IC – 1.22), Chloramphenicol (ROR – 3.35, Chi-square – 22.80, IC – 0.77), Moxifloxacin (ROR – 2.08, Chi-square – 99.37, IC – 0.83).

CONCLUSIONS: This study found statistically significant increased risk of reporting pulmonary embolism with Minocycline, Chloramphenicol, Moxifloxacin, although a causal relation cannot be definitively established. Further pharmacoepidemiologic studies are necessary to confirm this conclusion and to improve the precision of the prevalence and/or the risk factors of this ADRs.