Real-world pharmacovigilance assessment of ciprofloxacin hydrochloride tablets using the FDA adverse event reporting system (January 1, 2014 to June 30, 2024)

Abstract Objectives Ciprofloxacin hydrochloride tablets are widely prescribed for urinary tract and other bacterial infections. Despite well-documented adverse drug reactions (ADRs), emerging safety concerns require continuous post-marketing surveillance. Methods We retrieved ADR reports related to ciprofloxacin hydrochloride tablets from the FDA Adverse Event Reporting System (FAERS) between January 1, 2014 to June 30, 2024. Disproportionality analyses were conducted using reporting odds ratio (ROR) and Bayesian confidence propagation neural network methods. Adverse events were coded according to MedDRA preferred terms (PTs) and system organ classes (SOCs). Key findings A total of 27 825 valid reports identified ciprofloxacin hydrochloride tablets as the primary suspect drug. Female patients accounted for 53.7% of cases, and the majority (45.6%) were aged 18–65 years. Forty-eight positive safety signals were detected, with musculoskeletal, immune system, and nervous system disorders being most frequently reported. Notably, 43 potential new ADRs not listed in the product label were identified, including crystalline nephropathy (ROR = 48.44), renal vein compression (ROR = 63.39), urethral pain (ROR = 12.67), and interstitial cystitis (ROR = 10.05). Duration of therapy was significantly associated with urinary system ADR incidence (P < .05). Conclusions This large-scale FAERS analysis confirmed known ADRs and revealed previously unreported signals for ciprofloxacin hydrochloride tablets, underscoring the need for targeted pharmacovigilance. Findings provide actionable evidence for regulatory updates and clinical risk mitigation.