Does MONTELUKAST Cause Off label use? 1,238 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 1,238 reports of Off label use have been filed in association with MONTELUKAST (Montelukast). This represents 4.6% of all adverse event reports for MONTELUKAST.
1,238
Reports of Off label use with MONTELUKAST
4.6%
of all MONTELUKAST reports
149
Deaths
344
Hospitalizations
How Dangerous Is Off label use From MONTELUKAST?
Of the 1,238 reports, 149 (12.0%) resulted in death, 344 (27.8%) required hospitalization, and 83 (6.7%) 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 MONTELUKAST. However, 1,238 reports have been filed with the FAERS database.
What Other Side Effects Does MONTELUKAST Cause?
Asthma (8,372)
Dyspnoea (6,354)
Wheezing (5,159)
Drug ineffective (3,539)
Cough (3,475)
Therapeutic product effect incomplete (3,352)
Anxiety (2,994)
Loss of personal independence in daily activities (2,736)
Sleep disorder due to a general medical condition (2,101)
Obstructive airways disorder (2,073)
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 MONTELUKAST Alternatives Have Lower Off label use Risk?
MONTELUKAST vs MONTELUKAST\MONTELUKAST
MONTELUKAST vs MONTMORILLONITE
MONTELUKAST vs MORNIFLUMATE
MONTELUKAST vs MOROCTOCOG ALFA
MONTELUKAST vs MORPHINE