Does DAPTOMYCIN Cause Off label use? 791 Reports in FDA Database

Q: Does DAPTOMYCIN cause Off label use?

791 reports of Off label use have been filed with the FDA for DAPTOMYCIN, representing 8.8% of all DAPTOMYCIN adverse event reports.

Q: How dangerous is Off label use from DAPTOMYCIN?

Of 791 reports, 123 (15.5%) resulted in death and 360 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 791 reports of Off label use have been filed in association with DAPTOMYCIN (daptomycin). This represents 8.8% of all adverse event reports for DAPTOMYCIN.

791

Reports of Off label use with DAPTOMYCIN

8.8%

of all DAPTOMYCIN reports

123

Deaths

360

Hospitalizations

How Dangerous Is Off label use From DAPTOMYCIN?

Of the 791 reports, 123 (15.5%) resulted in death, 360 (45.5%) required hospitalization, and 52 (6.6%) 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 DAPTOMYCIN. However, 791 reports have been filed with the FAERS database.

What Other Side Effects Does DAPTOMYCIN Cause?

Drug ineffective (658) Product use in unapproved indication (654) Eosinophilic pneumonia (575) Acute kidney injury (501) Blood creatine phosphokinase increased (461) Pyrexia (447) Eosinophilia (405)</