Does IVACAFTOR Cause Off label use? 74 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 74 reports of Off label use have been filed in association with IVACAFTOR (Kalydeco). This represents 1.1% of all adverse event reports for IVACAFTOR.
74
Reports of Off label use with IVACAFTOR
1.1%
of all IVACAFTOR reports
1
Deaths
12
Hospitalizations
How Dangerous Is Off label use From IVACAFTOR?
Of the 74 reports, 1 (1.4%) resulted in death, 12 (16.2%) required hospitalization.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for IVACAFTOR. However, 74 reports have been filed with the FAERS database.
What Other Side Effects Does IVACAFTOR Cause?
Hospitalisation (1,209)
Infective pulmonary exacerbation of cystic fibrosis (550)
Infection (227)
Malaise (226)
Lower respiratory tract infection (224)
Pneumonia (215)
Death (203)
Cough (180)
Cystic fibrosis (167)
Headache (163)
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 IVACAFTOR Alternatives Have Lower Off label use Risk?
IVACAFTOR vs IVACAFTOR\LUMACAFTOR
IVACAFTOR vs IVACAFTOR\TEZACAFTOR
IVACAFTOR vs IVERMECTIN
IVACAFTOR vs IVOSIDENIB
IVACAFTOR vs IXABEPILONE