Acetaminophen use in kids is not associated with increases in asthma exacerbations

Liz Meszaros, MDLinx | August 19, 2016

As-needed use of acetaminophen in young children with mild, persistent asthma were not associated with a higher incidence of asthma exacerbations or in worsening asthma control compared with the use of ibuprofen, according to study results published August 18, 2016, in the New England Journal of Medicine.


Acetaminophen use in kids

Acetaminophen in kids

Researchers found that as-needed use does not increase asthmatic symptoms, contrary to previous studies.

Findings from previous studies have suggested that there is an association between the use of acetaminophen in children and asthma-related complications. Consequently, some physicians have recommended that acetaminophen use be avoided in children with asthma.

In this multicenter, prospective, randomized, double-blind, parallel-group study, researchers included 300 children aged 12 months to 59 months, who had mild, persistent asthma. Children were randomized to either acetaminophen (160 mg/5 ml) or ibuprofen (100 mg/5 ml) when needed over 48 weeks.

The Individualized Therapy for Asthma in Toddlers (INFANT) trial was a simultaneous, factorially-linked, randomized, double-blind, double-dummy, triple crossover trial in which subjects received standardized asthma-controller therapies including daily inhaled glucocorticoids (fluticasone propionate twice daily at two inhalations [44 mug each]), daily oral leukotriene-receptor antagonist use (montelukast at 4 mg once daily at bedtime), and inhaled glucocorticoid use as needed (fluticasone propionate at two inhalations at 44 mug each, with each use of open label albuterol sulfate).

All subjects received a median of 5.5 doses of study medications, and researchers found no differences in the number of asthma exacerbations between the two groups (acetaminophen men: 0.81 per subject; ibuprofen mean: 0.87 per subject).

In the acetaminophen group, 49% of subjects had at least one asthma exacerbation compared with 47% in the ibuprofen group, and 21% had at least two exacerbations compared with 24% of the ibuprofen group. Researchers found no differences between the groups in the percentage of asthma-control days (85.8% vs 86.8%, respectively; P=0.50), or in the use of an albuterol rescue inhaler (2.8 vs 3.0 inhalations per week; P=0.69), in unscheduled health care use for asthma (0.75 vs 0.76 episodes per subjects; P=0.94), or in adverse events.

“Our findings are in contrast to those of a post hoc analysis of a randomized trial by Lesko et al. that showed that the relative risk of unscheduled visits for asthma was substantially higher in the weeks after taking acetaminophen for febrile illness than in the weeks after taking ibuprofen (relative risk, 1.79). As opposed to a post hoc analysis, our study was specifically designed and intended to prospectively evaluate the effect of the use of acetaminophen versus ibuprofen in carefully screened children with persistent asthma,” the authors noted.

”In conclusion, over the 1-year study period, we did not find that asthma exacerbations or other markers of asthma-related complications occurred more frequently among children who were randomly assigned to receive acetaminophen than among those who were randomly assigned to receive ibuprofen,” they concluded.


Lesko SM, Louik C, Vezina RM, Mitchell AA. Asthma morbidity after the short-term use of ibuprofen in children. Pediatrics. 2002;109:E20-E20.

This study was supported by grants from the National Institutes of Health (NIH). AsthmaNet is a clinical trials network supported by a cooperative agreement with the National Heart, Lung, and Blood Institute (NHLBI).