Safety Evaluation of Nitroimidazole Antibiotics Based on the FAERS Database

= 17.46), while tinidazole was associated with weaker but notable signals for skin and blood disorders. Notably, SMQ-level analysis uncovered significant safety signals not currently emphasised in drug labelling, including acute pancreatitis, hepatic failure, fibrosis/cirrhosis, and tachyarrhythmias for tinidazole and ornidazole. These findings highlight the potential need for intensified clinical monitoring of hepatic and cardiac function during treatment with these antibiotics. Although limited by the nature of spontaneous reporting data, this study offers important insights into both established and emerging risks associated with nitroimidazole antibiotics, reinforcing the value of continuous pharmacovigilance to optimise patient safety.