Aim

The objective of this case-non/case study was to detect the rebamipide-related pulmonary adverse effects compared with other drugs for acid-related disorders based on population-level data.

Methods

From 2009 to 2018, AE reports about drugs for acid-related disorders, which are anatomical therapeutic chemical code A02B drugs, in Korea Adverse Events Reporting System (KAERS) database were examined. The reporting odds ratio (ROR) was calculated so that the odds of reporting pulmonary AEs for rebamipide and pulmonary AEs for all other A02B drugs could be compared. Furthermore, a stratified analysis according to patient age and sex was conducted.

Results

Thirteen (0.05%) and 157 (0.11%) cases of pulmonary AEs were reported for rebamipide and all other A02B drugs, respectively. The risk of reporting pulmonary AEs was significantly lower for rebamipide than for all other A02B drugs (ROR, 0.49; 95% confidence interval [CI], 0.28–0.87). The number of reports of pulmonary AEs for rebamipide was significantly higher among patients aged ≥65 years than those aged <65 years (ROR, 19.36; 95% CI, 2.50–149.97).

Conclusions

Rebamipide was less reported for pulmonary AEs. However, healthcare professionals need to be aware of the risk of pulmonary AEs in elderly patients.

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