Oseltamivir: A New Option for the Management of Influenza in Children

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2001;7(2) 

In This Article

Adverse Reactions

In clinical trials, oseltamivir has been generally well tolerated by both adults and children. Information on adverse effects in children has been gathered from the results of Phase III trials of oseltamivir involving 1,032 patients between 1 and 12 years of age. In the 515 children receiving oseltamivir in these trials, the most frequently reported adverse effects were vomiting (15.0%), diarrhea (9.5%), and abdominal pain (4.7%). These percentages were not significantly different in the children receiving placebo. They were also similar to values reported in adults receiving oseltamivir during earlier clinical trials.[7]

Otitis media was diagnosed in 8.7% of patients during oseltamivir treatment, and symptoms of asthma were reported in 3.5%; in both cases, similar responses occurred with placebo. Other adverse effects reported in 1-3% of pediatric trial participants included (in order of frequency): nausea, epistaxis, pneumonia, sinusitis, bronchitis, conjunctivitis, dermatitis, lymphadenopathy, and unspecified ear disorders. All of these occurred in higher or equivalent percentages of children given placebo.[7,8]

There is currently no information on oseltamivir overdosage in children. In adults, single doses of up to 1,000 mg produced only nausea and vomiting, without clinically significant changes in vital signs, electrocardiogram readings, or other routine laboratory tests.[5]

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