Does SAPROPTERIN Cause Off label use? 80 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 80 reports of Off label use have been filed in association with SAPROPTERIN (JAVYGTOR). This represents 1.4% of all adverse event reports for SAPROPTERIN.
80
Reports of Off label use with SAPROPTERIN
1.4%
of all SAPROPTERIN reports
3
Deaths
14
Hospitalizations
How Dangerous Is Off label use From SAPROPTERIN?
Of the 80 reports, 3 (3.8%) resulted in death, 14 (17.5%) required hospitalization, and 2 (2.5%) 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 SAPROPTERIN. However, 80 reports have been filed with the FAERS database.
What Other Side Effects Does SAPROPTERIN Cause?
Drug ineffective (356)
Therapy non-responder (348)
Headache (309)
Maternal exposure during pregnancy (277)
Vomiting (260)
Diarrhoea (238)
Amino acid level increased (194)
Nausea (189)
Abdominal pain upper (179)
Anxiety (174)
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 SAPROPTERIN Alternatives Have Lower Off label use Risk?
SAPROPTERIN vs SAQUINAVIR
SAPROPTERIN vs SARECYCLINE
SAPROPTERIN vs SARGRAMOSTIM
SAPROPTERIN vs SARILUMAB
SAPROPTERIN vs SATRALIZUMAB