Does GALSULFASE Cause Off label use? 14 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 14 reports of Off label use have been filed in association with GALSULFASE (NAGLAZYME). This represents 0.5% of all adverse event reports for GALSULFASE.
14
Reports of Off label use with GALSULFASE
0.5%
of all GALSULFASE reports
1
Deaths
4
Hospitalizations
How Dangerous Is Off label use From GALSULFASE?
Of the 14 reports, 1 (7.1%) resulted in death, 4 (28.6%) required hospitalization.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for GALSULFASE. However, 14 reports have been filed with the FAERS database.
What Other Side Effects Does GALSULFASE Cause?
Pyrexia (338)
Pneumonia (197)
Cough (181)
Dyspnoea (154)
Spinal cord compression (108)
Vomiting (106)
Oxygen saturation decreased (100)
Fatigue (92)
Pain (81)
Headache (75)
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 GALSULFASE Alternatives Have Lower Off label use Risk?
GALSULFASE vs GAMMAGARD LIQUID
GALSULFASE vs GANAXOLONE
GALSULFASE vs GANCICLOVIR
GALSULFASE vs GANIRELIX
GALSULFASE vs GATIFLOXACIN