Does ECULIZUMAB Cause Off label use? 4,228 Reports in FDA Database

Q: Does ECULIZUMAB cause Off label use?

4,228 reports of Off label use have been filed with the FDA for ECULIZUMAB, representing 9.6% of all ECULIZUMAB adverse event reports.

Q: How dangerous is Off label use from ECULIZUMAB?

Of 4,228 reports, 577 (13.6%) resulted in death and 658 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 4,228 reports of Off label use have been filed in association with ECULIZUMAB (SOLIRIS). This represents 9.6% of all adverse event reports for ECULIZUMAB.

4,228

Reports of Off label use with ECULIZUMAB

9.6%

of all ECULIZUMAB reports

577

Deaths

658

Hospitalizations

How Dangerous Is Off label use From ECULIZUMAB?

Of the 4,228 reports, 577 (13.6%) resulted in death, 658 (15.6%) required hospitalization, and 91 (2.2%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ECULIZUMAB. However, 4,228 reports have been filed with the FAERS database.

What Other Side Effects Does ECULIZUMAB Cause?

Fatigue (4,858) 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) Malaise (1,562)

What Other Drugs Cause Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which ECULIZUMAB Alternatives Have Lower Off label use Risk?

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

ECULIZUMAB Full Profile All Off label use Reports All Drugs Causing Off label use ECULIZUMAB Demographics