Since the following adverse reactions may occur, patients should be carefully observed. If any abnormality is observed, appropriate measures such as discontinuation of administration should be taken.
- Clinically Significant Adverse Reaction
1.1 Fulminant hepatitis, Hepatic function disorder and Jaundice (frequency unknown)
Fulminant hepatitis, serious hepatic function disorder accompanied with marked increase in AST, ALT and γ-GTP and jaundice may occur and some of them are fatal.
2. Other Adverse Reactions
|1 to <2%||<1%||Frequency unknown|
|Hematologic||Eosinophilia||Decreased white blood cell|
|Gastrointestinal||Diarrhea/Loose stools||Thirst, Dysgeusia, Abdominal pain, Vomiting||Nausea, Bloating, Oral
numbness (including tongue, lips etc.)
|Hepatic||Increased AST, ALT, ALP, y-GTP and Bilirubin|
Reporting of Suspected Adverse Reactions
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: www.fda.gov.ph