Epadel S900

Epadel S900 Adverse Reactions


Catalent Japan




Full Prescribing Info
Adverse Reactions
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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