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, Headache |
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| 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: www.fda.gov.ph |
