Premarketing surveillance of ibuprofen suppositories in febrile children

Dan Hadas, Ilan Youngster*, Avner Cohen, Eugene Leibovitch, Itai Shavit, Ilan Erez, Yosef Uziel, Matitiahu Berkovitch

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

11 Scopus citations


In many countries, ibuprofen is available only in oral formulations. The authors aimed to investigate parental satisfaction and possible adverse reactions among children receiving newly marketed ibuprofen suppositories, prior to their arrival at the pharmaceutical points of distribution. Children needing antipyretic medication were recruited from 11 pediatric wards and clinics in Israel. Each patient received ibuprofen suppositories (5-10 mg/kg/dose) after completing a data collection form. After 3 to 7 days of treatment, information regarding parent satisfaction, possible adverse reactions, and concomitant use of drugs was obtained. Overall, 490 children completed the study. Parents' satisfaction was high (4.5 ± 0.47 on a scale of 1-5), and 92.2% reported that they would use the medication in the future. Adverse reactions were reported in 8 patients (1.63%, 95% confidence interval = 1.77-3.25), the most common being diarrhea. Rectal administration of ibuprofen suppositories is well tolerated and overall satisfaction and the repeated expected use were high.

Original languageEnglish
Pages (from-to)196-199
Number of pages4
JournalClinical Pediatrics
Issue number3
StatePublished - Mar 2011
Externally publishedYes


  • adverse effects
  • children
  • ibuprofen
  • parental satisfaction
  • suppositories


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