ODEVIXIBAT for Biliary obstruction: Side Effects & Safety Data
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There are 7 adverse event reports in the FDA FAERS database where ODEVIXIBAT was used for Biliary obstruction.
Most Reported Side Effects for ODEVIXIBAT
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 65 | 29.2% | 0 | 10 |
| Pruritus | 55 | 24.7% | 0 | 5 |
| Off label use | 33 | 14.8% | 3 | 6 |
| Drug ineffective | 26 | 11.7% | 1 | 5 |
| Abdominal pain | 17 | 7.6% | 0 | 4 |
| Abdominal pain upper | 17 | 7.6% | 0 | 2 |
| Product dose omission issue | 16 | 7.2% | 0 | 2 |
| Vomiting | 14 | 6.3% | 0 | 4 |
| Blood bilirubin increased | 10 | 4.5% | 0 | 3 |
| Hepatic enzyme increased | 10 | 4.5% | 0 | 1 |
| Nausea | 10 | 4.5% | 0 | 3 |
| Abdominal discomfort | 7 | 3.1% | 0 | 1 |
| Bile acids increased | 7 | 3.1% | 0 | 0 |
| Product use issue | 7 | 3.1% | 0 | 2 |
| Alanine aminotransferase increased | 6 | 2.7% | 0 | 1 |
Other Indications for ODEVIXIBAT
Progressive familial intrahepatic cholestasis (136)
Product used for unknown indication (29)
Alagille syndrome (20)
Off label use (16)
Liver disorder (7)
Pruritus (5)