Adverse Drug Reactions

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:

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.


Other Adverse Reactions:

1 to <2% <1% Frequency unknown
Hypersensitivity Edema Rash, Urticaria
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
Cardiovascular Palpitations
Psychoneurologic Dizziness/Lightheadedness,
Others Increased triglycerides Malaise Tremor


Reporting of suspected adverse drug reactions
Please contact:
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: