Does FIDAXOMICIN Cause Hepatitis? 14 Reports in FDA Database

Q: Does FIDAXOMICIN cause Hepatitis?

14 reports of Hepatitis have been filed with the FDA for FIDAXOMICIN, representing 0.9% of all FIDAXOMICIN adverse event reports.

Q: How dangerous is Hepatitis from FIDAXOMICIN?

Of 14 reports, 6 (42.9%) resulted in death and 13 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 14 reports of Hepatitis have been filed in association with FIDAXOMICIN (Dificid). This represents 0.9% of all adverse event reports for FIDAXOMICIN.

Reports of Hepatitis with FIDAXOMICIN

0.9%

of all FIDAXOMICIN reports

Deaths

Hospitalizations

How Dangerous Is Hepatitis From FIDAXOMICIN?

Of the 14 reports, 6 (42.9%) resulted in death, 13 (92.9%) required hospitalization.

Is Hepatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for FIDAXOMICIN. However, 14 reports have been filed with the FAERS database.

What Other Side Effects Does FIDAXOMICIN Cause?

Clostridium difficile infection (309) Drug ineffective (302) Diarrhoea (144) Treatment failure (95) No adverse event (75) Clostridium difficile colitis (54) Off label use (51) Death (50) Nausea (49) Pyrexia (43)

What Other Drugs Cause Hepatitis?

METHOTREXATE (1,835) ACETAMINOPHEN (1,450) TOCILIZUMAB (1,184) HYDROXYCHLOROQUINE (1,133) ADALIMUMAB (1,096) RITUXIMAB (1,017) ETANERCEPT (1,013) LEFLUNOMIDE (997) PEMBROLIZUMAB (935) NIVOLUMAB (930)

Which FIDAXOMICIN Alternatives Have Lower Hepatitis Risk?

FIDAXOMICIN vs FILGOTINIB FIDAXOMICIN vs FILGRASTIM FIDAXOMICIN vs FILGRASTIM-AAFI FIDAXOMICIN vs FILGRASTIM-SNDZ FIDAXOMICIN vs FINASTERIDE

FIDAXOMICIN Full Profile All Hepatitis Reports All Drugs Causing Hepatitis FIDAXOMICIN Demographics