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 | |
| 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 |
||
| Others | Increased triglycerides | Malaise | Tremor |
Reporting of Suspected Adverse Reactions
Please contact:
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: www.fda.gov.ph
