ENTECAVIR for Autoimmune hepatitis: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where ENTECAVIR was used for Autoimmune hepatitis.
Most Reported Side Effects for ENTECAVIR
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug resistance | 312 | 7.0% | 9 | 61 |
| Death | 298 | 6.6% | 290 | 27 |
| Drug ineffective | 207 | 4.6% | 22 | 32 |
| Hepatitis b | 166 | 3.7% | 64 | 17 |
| Off label use | 129 | 2.9% | 10 | 36 |
| Maternal exposure during pregnancy | 126 | 2.8% | 5 | 8 |
| Viral mutation identified | 121 | 2.7% | 3 | 8 |
| Renal impairment | 118 | 2.6% | 1 | 38 |
| Pathogen resistance | 115 | 2.6% | 2 | 12 |
| Fatigue | 108 | 2.4% | 6 | 16 |
| Hepatic cancer | 94 | 2.1% | 28 | 19 |
| Hepatocellular carcinoma | 94 | 2.1% | 41 | 40 |
| Hospitalisation | 88 | 2.0% | 3 | 75 |
| Hepatic failure | 86 | 1.9% | 72 | 22 |
| Drug dose omission | 82 | 1.8% | 0 | 4 |
Other Indications for ENTECAVIR
Hepatitis b (1,583)
Product used for unknown indication (1,035)
Chronic hepatitis b (705)
Antiviral prophylaxis (64)
Hepatitis b reactivation (63)
Hepatic cirrhosis (57)
Hepatitis (49)
Hepatitis viral (42)
Hiv infection (42)
Prophylaxis (42)
Other Drugs Used for Autoimmune hepatitis
AZATHIOPRINE (378)
MYCOPHENOLATE MOFETIL (297)
PREDNISOLONE (278)
PREDNISONE (211)
TACROLIMUS (131)
METHYLPREDNISOLONE (112)
RITUXIMAB (107)
BUDESONIDE (106)
CYCLOSPORINE (51)
MYCOPHENOLIC ACID (43)