• adverse drug reactions;
  • children;
  • cough and cold products;
  • over-the-counter


Background and objective:  Prompted by continuing concerns about the safety of over-the-counter (OTC) cough and cold medications, we examined the frequency and severity of pediatric adverse drug reactions (ADRs) to OTC cough and cold products reported to a major poison control center. The goal was to focus on cases that are usually managed out of hospitals and may not be recognized by the traditional adverse events surveillance and reporting programs.

Methods:  We conducted a retrospective review of electronic records on ADRs reported to the New Jersey Poison Information and Education System (NJPIES) through the National Poison Data System. Analyses included ADRs involving a single OTC cough and cold product. The number and proportion of reported ADRs to OTC cough and cold medicines were examined and compared by severity level between children <2 years of age, and children from 2 through 11 years of age.

Results:  A total of 91 pediatric ADRs to OTC cough and cold products were reported to the NJPIES from 2000 through 2007. Of these, 61 cases (67%) were of minor severity. A larger proportion of the children 2–11 years of age (21·2%), compared with children <2 years of age (8·0%), experienced a reaction of moderate to major severity.

Conclusions:  While we found fewer ADR cases of moderate to major severity in younger children, our results call for a further review of the safety of OTC cough and cold medicines in children 2 years of age and older.