Mild side effects of sulfasalazine (mainly headache, nausea, epigastric pain, and diarrhoea) occur in 10-45% of patients, whereas serious idiosyncratic reactions (including Stevens Johnson syndrome, pancreatitis, agranulocytosis, or alveolitis) are rare. These reactions are mainly associated with the sulphonamidic part of the molecule, which explains why mesalazine or olsalazine are associated with a frequency of adverse events (diarrhoea, headache, nausea, and rash, bloody diarrhoea) similar to placebo [30, 31]. No comparison between balsalazide and placebo has been published, but adverse events are lower than with sulfasalazine . A population based study found that renal derangement (interstitial nephritis and nephrotic syndrome) is associated with disease severity rather than with dosage or type of mesalazine and that, in any case, the risk is only marginally increased (OR 1.60 vs. normal) . Patients with pre-existing renal impairment or using other potentially nephrotoxic drugs, should have renal function monitored during 5-ASA therapy.
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