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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.
Atrial fibrillation (incidence unknown), atrial flutter (incidence unknown): An increased risk of atrial fibrillation or atrial flutter requiring hospitalization was reported in a global clinical study of ethyl icosapentate (at 4 g/day Note)). In addition, an increased risk of atrial fibrillation has been reported in Japanese and overseas clinical studies of omega-3 fatty acids, including ethyl icosapentate.
Note) The maximum approved daily dose of EPADEL is 2,700 mg for hyperlipidemia.
Other adverse reactions: If the following adverse reactions occur, appropriate measures should be taken according to symptoms. (See Table 2.)
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