Does UREA Cause Product use in unapproved indication? 19 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 19 reports of Product use in unapproved indication have been filed in association with UREA (UREA). This represents 12.7% of all adverse event reports for UREA.
19
Reports of Product use in unapproved indication with UREA
12.7%
of all UREA reports
15
Deaths
13
Hospitalizations
How Dangerous Is Product use in unapproved indication From UREA?
Of the 19 reports, 15 (78.9%) resulted in death, 13 (68.4%) required hospitalization.
Is Product use in unapproved indication Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for UREA. However, 19 reports have been filed with the FAERS database.
What Other Side Effects Does UREA Cause?
Drug ineffective (48)
Off label use (42)
Condition aggravated (20)
Decreased appetite (16)
Drug intolerance (16)
Fatigue (16)
Vomiting (16)
Abdominal discomfort (15)
Arthralgia (15)
C-reactive protein increased (15)
What Other Drugs Cause Product use in unapproved indication?
DUPILUMAB (33,452)
DICLOFENAC (12,197)
METHOTREXATE (8,930)
PREDNISONE (7,625)
RITUXIMAB (7,519)
MYCOPHENOLATE MOFETIL (5,910)
ACETAMINOPHEN (5,819)
CYCLOPHOSPHAMIDE (5,750)
RISPERIDONE (5,551)
TACROLIMUS (5,057)
Which UREA Alternatives Have Lower Product use in unapproved indication Risk?
UREA vs URIDINE TRIACETATE
UREA vs UROFOLLITROPIN
UREA vs URSODIOL
UREA vs USTEKINUMAB
UREA vs USTEKINUMAB-STBA