Levofloxacin adverse effects, data from clinical trials and pharmacovigilance
Abstract
With 5388 patients in the marketing application dossiers and post-marketing experience of more than 130 million prescriptions of levofloxacin worldwide, the tolerability profile of this anti-infective is now well defined. During clinical trials, 12 per cent of patients treated with levofloxacin experienced an adverse event considered to be related to the study drug compared with 13 per cent of the patients with a comparator. Nausea and diarrhoea were the most frequent adverse effects. During clinical trials, the frequency of tendinitis, psychotic episodes and seizures was less than 0.1 per cent. Following recent concerns with some fluoroquinolones, specific attention was paid in post-marketing surveillance worldwide. The notification rate of significant severe liver injuries (hepatitis, necrosis, hepatic failure) has been less than 1 for 5 million prescriptions. Cardiac tolerability is satisfactory and the phototoxic potential of levofloxacin is one of the lowest amongst fluoroquinolones.
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 5,388 participants or records.
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