Does BUROSUMAB Cause Off label use? 12 Reports in FDA Database

Q: Does BUROSUMAB cause Off label use?

12 reports of Off label use have been filed with the FDA for BUROSUMAB, representing 1.8% of all BUROSUMAB adverse event reports.

Q: How dangerous is Off label use from BUROSUMAB?

Of 12 reports, 1 (8.3%) resulted in death and 3 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 12 reports of Off label use have been filed in association with BUROSUMAB (CRYSVITA). This represents 1.8% of all adverse event reports for BUROSUMAB.

Reports of Off label use with BUROSUMAB

1.8%

of all BUROSUMAB reports

Deaths

Hospitalizations

How Dangerous Is Off label use From BUROSUMAB?

Of the 12 reports, 1 (8.3%) resulted in death, 3 (25.0%) 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 BUROSUMAB. However, 12 reports have been filed with the FAERS database.

What Other Side Effects Does BUROSUMAB Cause?

Product dose omission issue (124) Pain (69) Inappropriate schedule of product administration (64) Arthralgia (59) Therapy interrupted (57) Blood phosphorus decreased (53) Pain in extremity (50) Restless legs syndrome (49) Back pain (35) Fatigue (34)

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 BUROSUMAB Alternatives Have Lower Off label use Risk?

BUROSUMAB vs BUROSUMAB-TWZA BUROSUMAB vs BUSPIRONE BUROSUMAB vs BUSULFAN BUROSUMAB vs BUSULFEX BUROSUMAB vs BUTALBITAL

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