Any of the adverse reactions listed below may occur. Therefore, patients receiving Elobixibat (GOOFICE®) treatment should be carefully monitored, and if any abnormalities are noted, appropriate measures should be taken including discontinuation of Elobixibat (GOOFICE®) treatment.
Other Adverse Reactions
| ≥5% | 1% to <5% | <1% | Frequency unknown |
|
| Hepatic | Abnormal hepatic function (increased ALT, increased AST, Increased γ-GTP, increased Al-P, increased LAP) |
Increased LDH | ||
| Central and peripheral nervous system |
Dizziness | Headache | ||
| Cardiovascular | Hot flush | |||
| Gastrointestinal | Abdominal pain (23.2%), diarrhea (14.4%) |
Lower abdominal pain, abdominal distension, nausea, upper abdominal pain, abdominal discomfort, soft feces |
Stomatitis, thirst | Flatulence, defecation urgency, vomiting, abnormal gastrointestinal sounds, constipation, ischaemic colitis, haematochezia, frequent bowel movements, discoloured faeces, anal incontinence, decreased appetite |
| Hypersensitivity | Urticaria | Rash | ||
| Hematologic | Anemia | Increased vitamin E | Increased eosinophil count |
|
| Others | Increased CK | Dysmenorrhea |
| 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 |