Since estrogens may lead to a rise in lipid levels, the prescribing of fibrates in patients taking estrogens or estrogen-containing contraceptives must be critically considered on an individual basis. Fenofibrate is not removed by hemodialysis and should not be used in dialysis patients. While the nature of the adverse reactions reported was similar in both studies, these reactions were observed in most cases at a higher frequency in the longer term, 6-month trial in Type II patients. Adverse reactions for fenofibrate micronized at recommended therapeutic doses in clinical trials have shown a comparable profile with those described for the original fenofibrate formulation. In most trials, sporadic and transient increases in aminotransferase levels have been associated with the use of fenofibrate.
Values usually return to normal without interruption of treatment.
Reductions in alkaline phosphatase levels have also been observed. Mild decreases in hemoglobin, hematocrit and white blood cell counts have been observed occasionally in patients following initiation of fenofibrate therapy. However, these levels stabilize during long-term administration. In addition, a decrease in haptoglobin concentration has been observed in some patients with Type IV hyperlipidemia during long-term use of fenofibrate. The mean plasma levels of urea and creatinine showed increases, particularly during long-term fenofibrate treatment, most of them remaining within the limits of normal values.