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 rapid (89% within 24 hours). One severe case (3%; exfoliative dermatitis) occurred. All reactions resolved fully after drug discontinuation and supportive therapy (antihistamines in 37%; corticosteroids in a few cases).
CONCLUSIONS
Levofloxacin-induced cutaneous ADRs are typically mild, immediate-onset, and reversible with prompt discontinuation and anti-allergic treatment. Rational prescribing should emphasize allergy history screening, close monitoring during initial intravenous administration, and cautious use in comorbid or polypharmacy settings to minimize risks while preserving clinical utility.

Keywords: Levofloxacin; Urticaria; Cutaneous Elimination; Dermatologic Agents; Estrogen Receptor Modulators; Drug-Related Side Effects and Adverse Reactions; Skin; Clinical Nursing Research; Retrospective Studies