Does DOLUTEGRAVIR Cause Off label use? 413 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 413 reports of Off label use have been filed in association with DOLUTEGRAVIR (Juluca). This represents 3.8% of all adverse event reports for DOLUTEGRAVIR.
413
Reports of Off label use with DOLUTEGRAVIR
3.8%
of all DOLUTEGRAVIR reports
116
Deaths
48
Hospitalizations
How Dangerous Is Off label use From DOLUTEGRAVIR?
Of the 413 reports, 116 (28.1%) resulted in death, 48 (11.6%) required hospitalization, and 5 (1.2%) 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 DOLUTEGRAVIR. However, 413 reports have been filed with the FAERS database.
What Other Side Effects Does DOLUTEGRAVIR Cause?
Foetal exposure during pregnancy (1,036)
Exposure during pregnancy (776)
Virologic failure (770)
Pathogen resistance (586)
Maternal exposure during pregnancy (517)
Viral mutation identified (510)
Treatment failure (453)
Drug ineffective (447)
Blood hiv rna increased (410)
Treatment noncompliance (409)
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 DOLUTEGRAVIR Alternatives Have Lower Off label use Risk?
DOLUTEGRAVIR vs DOLUTEGRAVIR\LAMIVUDINE
DOLUTEGRAVIR vs DOLUTEGRAVIR\LAMIVUDINE\TENOFOVIR DISOPROXIL
DOLUTEGRAVIR vs DOLUTEGRAVIR\RILPIVIRINE
DOLUTEGRAVIR vs DOMPERIDONE
DOLUTEGRAVIR vs DOMPERIDONE\PANTOPRAZOLE