Zafibral Adverse Reactions

Adverse effects during treatment with ZAFIBRAL most frequently are gastro-intestinal in nature such as loss of appetite, nausea or gastric discomfort. These symptoms generally are transient and do not require withdrawal of therapy. In patients with a sensitive stomach, a slowly increasing dosage over 5 to 7 days may help to avoid such symptoms. More rarely there may be dermal manifestations such as pruritus or urticaria, increased hair loss, disturbances of potency and thyrotoxicity with myasthenia or myalgia in the extremities, with or without raised CPK have been reported. All of these adverse effects generally resolve rapidly following withdrawal of therapy. Rarely headache, decreases of haemoglobin and leucocytes and single cases of increases in transaminases have been reported. Special care is needed in patients with renal disease as progressive increases in the serum creatinine level and/or failure to follow the dosage guidelines may result in myotoxicity (rhabdomyolysis). Bezafibrate may increase the lithogenic index in some patients although studies have shown inconsistent results. However there is no evidence that the administration of ZAFIBRAL is associated with an increased frequency of gallstones.