Does UREA Cause Off label use? 42 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 42 reports of Off label use have been filed in association with UREA (UREA). This represents 28.0% of all adverse event reports for UREA.
42
Reports of Off label use with UREA
28.0%
of all UREA reports
15
Deaths
14
Hospitalizations
How Dangerous Is Off label use From UREA?
Of the 42 reports, 15 (35.7%) resulted in death, 14 (33.3%) required hospitalization, and 1 (2.4%) 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 UREA. However, 42 reports have been filed with the FAERS database.
What Other Side Effects Does UREA Cause?
Drug ineffective (48)
Condition aggravated (20)
Product use in unapproved indication (19)
Decreased appetite (16)
Drug intolerance (16)
Fatigue (16)
Vomiting (16)
Abdominal discomfort (15)
Arthralgia (15)
C-reactive protein increased (15)
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 UREA Alternatives Have Lower Off label use Risk?
UREA vs URIDINE TRIACETATE
UREA vs UROFOLLITROPIN
UREA vs URSODIOL
UREA vs USTEKINUMAB
UREA vs USTEKINUMAB-STBA