Levofloxacin-Induced Cutaneous Adverse Reactions: Characteristics and Rational Use Strategies
Abstract
BACKGROUND Levofloxacin is a fluoroquinolone antibiotic that can cause a range of dermatological adverse drug reactions (ADRs), including rashes, phototoxicity, and hyperpigmentation, as well as severe conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. The China National Adverse Drug Reaction Monitoring System (CADRMS) is an online pharmacovigilance network that includes data from patient medical records. This study evaluated 35 patients with levofloxacin-induced cutaneous ADRs reported to CADRMS in 2021. MATERIAL AND METHODS Individual case safety reports involving levofloxacin-associated cutaneous ADRs in 2021 were retrieved from CADRMS. After excluding duplicates and cases with insufficient details or alternative causative drugs, 35 cases with probable/possible causality were included. Key variables (demographics, administration route/dose, comorbidities, polypharmacy, ADR manifestations, onset, severity, and outcomes) were descriptively analyzed. RESULTS Among 35 patients (mean age 43.7±17.6 years; 60% male), 80% received intravenous levofloxacin (71% at 500 mg/day), primarily as inpatients (77%) for respiratory (43%) or urinary (37%) infections. Polypharmacy was common (89%), and all had comorbidities. Cutaneous manifestations were predominantly mild (89%), including maculopapular rash (37%), pruritus (20%), urticaria (14%), erythema (11%), and photosensitive dermatitis (9%). Onset was…
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