Non-Fatal Adverse Reactions to Ceftriaxone Sodium in Syria: Implications for Patient Safety

Background: Ceftriaxone sodium, a commonly used third-generation cephalosporin, is associated with adverse reactions, particularly hypersensitivity. Recent reports from Syria indicate an increase in allergic reactions to ceftriaxone sodium, highlighting the need to monitor contributing factors such as drug quality and patient demographics. This retrospective study analyzes the incidence and characteristics of non-fatal ceftriaxone-related adverse reactions documented in Syria from 2018 to May 2024, focusing on patient demographics, administration routes, and associated risk factors to enhance patient safety.

Materials and Methods: Data were obtained from the Directorate of Drug Control and Research’s adverse reaction database. Variables such as reaction type, patient demographics, clinical indications, dosage, and administration routes were assessed. Comparisons were made between ceftriaxone monotherapy and combination therapy with sulbactam, and cluster cases linked to specific drug batches or manufacturers were investigated. Descriptive statistical methods (frequencies and percentages) were applied to summarize the findings.

Results: Among 101 non-fatal cases, adverse reactions were more frequently observed in females and adults (56.4% and 61.4%  respectively), with intravenous administration being the most common route (64.4%). Respiratory infections and surgical prophylaxis were the main indications (33.66 and 22.77% respectively) and the most frequently used dose was 1,000 mg. Cluster cases were identified in relation to specific drug batches and administration errors.

Conclusions: These findings highlight the need for strengthened pharmacovigilance, improved batch testing, and stricter adherence to administration guidelines to mitigate adverse reactions and enhance ceftriaxone safety.