Does ECULIZUMAB Cause Hepatitis? 44 Reports in FDA Database

Q: Does ECULIZUMAB cause Hepatitis?

44 reports of Hepatitis have been filed with the FDA for ECULIZUMAB, representing 0.1% of all ECULIZUMAB adverse event reports.

Q: How dangerous is Hepatitis from ECULIZUMAB?

Of 44 reports, 2 (4.5%) resulted in death and 13 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 44 reports of Hepatitis have been filed in association with ECULIZUMAB (SOLIRIS). This represents 0.1% of all adverse event reports for ECULIZUMAB.

Reports of Hepatitis with ECULIZUMAB

0.1%

of all ECULIZUMAB reports

Deaths

Hospitalizations

How Dangerous Is Hepatitis From ECULIZUMAB?

Of the 44 reports, 2 (4.5%) resulted in death, 13 (29.5%) required hospitalization, and 2 (4.5%) were considered life-threatening.

Is Hepatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ECULIZUMAB. However, 44 reports have been filed with the FAERS database.

What Other Side Effects Does ECULIZUMAB Cause?

Fatigue (4,858) Off label use (4,228) Haemoglobin decreased (3,028) Headache (2,699) Death (2,221) Pyrexia (1,948) Dyspnoea (1,819) Asthenia (1,732) Drug ineffective (1,644) Nausea (1,579)

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 ECULIZUMAB Alternatives Have Lower Hepatitis Risk?

ECULIZUMAB vs EDARAVONE ECULIZUMAB vs EDETATE ECULIZUMAB vs EDOXABAN ECULIZUMAB vs EDOXABAN TOSILATE ECULIZUMAB vs EFALIZUMAB

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