Authors
Liang Tian, Shanshan Xu, Hui Guo
Published in
Medical science monitor : international medical journal of experimental and clinical research. Volume 32. Pages e951518. Jul 07, 2026. Epub Jul 07, 2026.
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 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.
PMID:
42412716
Bibliographic data and abstract were imported from PubMed on 08 Jul 2026.
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