MONTELUKAST for Off label use: Side Effects & Safety Data

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There are 5 adverse event reports in the FDA FAERS database where MONTELUKAST was used for Off label use.

Most Reported Side Effects for MONTELUKAST

Side Effect	Reports	%	Deaths	Hosp.
Asthma	8,372	31.0%	208	3,766
Dyspnoea	6,354	23.6%	88	3,164
Wheezing	5,159	19.1%	52	2,588
Drug ineffective	3,539	13.1%	142	1,358
Cough	3,475	12.9%	25	1,633
Therapeutic product effect incomplete	3,352	12.4%	55	1,765
Anxiety	2,994	11.1%	72	666
Loss of personal independence in daily activities	2,736	10.1%	42	1,539
Sleep disorder due to a general medical condition	2,101	7.8%	46	1,156
Obstructive airways disorder	2,073	7.7%	45	1,209
Pneumonia	2,071	7.7%	78	890
Headache	2,047	7.6%	132	642
Depression	2,041	7.6%	37	419
Fatigue	1,959	7.3%	131	604
Drug hypersensitivity	1,792	6.6%	122	313