Table 4.

Frequency of Most Common Clinical Adverse Effects*

Adverse EffectPlacebo (n= 228)Montelukast (n = 461)
Asthma 86 (38%)137 (30%)
Upper respiratory infection63 (28%)123 (27%)
Fever61 (27%)125 (27%)
Vomiting45 (20%)75 (16%)
Pharyngitis35 (15%)54 (12%)
Cough26 (11%)58 (13%)
Abdominal pain21  (9%)51 (11%)
Diarrhea17  (8%)45 (10%)
  • * Most common adverse effects were those occurring in 8% or more of patients in either treatment group.

  • Notable difference between treatment groups (30% vs 38% for montelukast and placebo, respectively, representing an 8% difference with a 95% confidence interval [0.18% to 16.36%]).