[Levofloxacin adverse effects, data from clinical trials and pharmacovigilance]

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.