Analysis of the frequency of ceftriaxone-induced encephalopathy using the Japanese Adverse Drug Event Report database

Background: The profile of ceftriaxone-induced encephalopathy is not well understood.

Aim: To identify risk factors associated with ceftriaxone-induced encephalopathy.

Method: In this observational study, anonymised patient data were retrieved from the open-access Japanese Adverse Drug Event Report database for ceftriaxone users aged 20 years or higher.

Results: Data of 256,788 individuals and 12,160 cases of encephalopathy were extracted, and 2,939 ceftriaxone users, of whom 193 had encephalopathy, were identified. A disproportionate prevalence of encephalopathy was observed among the ceftriaxone users (reported odds ratio = 1.42; 95% confidence interval [CI] = 1.23-1.65; p < 0.001). Multivariate logistic regression analysis of 2,057 ceftriaxone users showed encephalopathy was associated with female sex (odds ratio [OR] = 1.52; 95% CI, 1.05-2.19; p = 0.027), chronic kidney disease (OR = 2.32; 95% CI, 1.47-3.67; p < 0.001), a ceftriaxone dosage of > 2 g/day (OR = 2.66; 95% CI, 1.66-4.26; p < 0.001), and a treatment duration of > 14 days (OR = 1.94; 95% CI, 1.21-3.11; p = 0.006).

Conclusion: Patients with chronic kidney disease, receiving ceftriaxone at a dosage of > 2 g/day, being treated for over 14 days, and/or females may be at an increased risk of ceftriaxone-induced encephalopathy.