In the clinical studies in patients with arteriosclerosis obliterans and hyperlipidemia in Japan and the postmarketing drug use-results survey, adverse reactions were observed in 647 of 14,605 patients who used EPADEL (4.4%) (at the time of completion of reexamination).
In double-blind controlled study in patients with high serum triglyceride, adverse reactions were observed in 9 of 241 subjects (3.7%) in twice-daily administration of 900 mg and 9 of 235 subjects (3.8%) in administration of 600 mg 3 times a day (at the time of approval of additional dosage and administration).
Clinically significant adverse reactions: Hepatic function disorder, jaundice (incidence unknown).
Patients should be closely observed because hepatic function disorder and jaundice with increased AST (GOT), ALT (GPT), Al-P, γ-GTP, LDH, bilirubin, etc may occur. If any abnormality is observed, the administration should be immediately discontinued and appropriate measures should be taken.
Other adverse reactions: If the following adverse reactions occur, appropriate measures should be taken according to symptoms. (See Table 1.)
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