Table 2.

Adverse events reported in patients aged 5 – 17 years after montelukast primary exposures reported to NPDS for calendar years 2000 – 2016.

Clinical effect	All ingested doses (n=17,069)	Ingested doses ≥ 50mg (n=618)
Abdominal pain	40 (0.23)	9 (1.46)
Vomiting	29 (0.17)	7 (1.13)
Headache	20 (0.12)	4 (0.65)
Nausea	18 (0.11)	5 (0.81)
Dizziness or vertigo	13 (0.08)	2 (0.32)
Rash	12 (0.07)	0
Agitation / irritability	11 (0.06)	1 (0.16)
Diarrhea	1 (0.05)	2 (0.32)
Tachycardia	6 (0.04)	1 (0.16)
Hallucinations or delusions	5 (0.03)	0
Confusion	4 (0.02)	0
Tremor	3 (0.02)	0
Syncope	1 (0.01)	0
Throat irritation	1 (0.01)	0

Values are n (%) and specify those clinical effects recorded as related to the exposure to montelukast, listed in decreasing order of frequency for all ingested doses.

Abbreviation: NPDS, National Poison Data System