title: Adverse drug reaction profile of oseltamivir in children.
abstract: OBJECTIVE
  To monitor and evaluate the pattern of ADRs to oseltamivir in pediatric population suffering from H1N1 influenza at a tertiary care hospital.
  
  
  METHODS
  Children offered oseltamivir for treatment and chemoprophylaxis were monitored for adverse events by direct questioning for symptoms and clinical examination on day 5 and day 10. Assessment of neurological events was done by asking the parents or guardians regarding development of specific symptoms. Adverse events obtained were analyzed for severity, causality and age-group wise.
  
  
  RESULTS
  Out of 191 children (median age, 3 years), 69 (36.1%) developed ADRs. Most common symptoms were vomiting (16.2%) followed by diarrhea (12.0%), ear disorders (8.9%), and insomnia (6.8%). The incidence of neuropsychiatric symptoms was 12.6% which were mild-to-moderate on severity scale. There was no significant difference in the incidence of adverse events between children less than 1 year and other age groups.
  
  
  CONCLUSIONS
  Oseltamivir is well tolerated in Indian children with suspected or confirmed H1N1 influenza. Our study also indicates safety of oseltamivir in infants.
authors.affiliation: Department of Pharmacology, MP Shah Medical College, Jamnagar 361 008, Gujarat, India.
authors.forename: Prashant S
authors.initials: PS
authors.lastname: Dalvi
authors.forename: Anil
authors.initials: A
authors.lastname: Singh
authors.forename: Hiren R
authors.initials: HR
authors.lastname: Trivedi
authors.forename: Suresh D
authors.initials: SD
authors.lastname: Mistry
authors.forename: Bhadresh R
authors.initials: BR
authors.lastname: Vyas