• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Prezista (darunavir) suspension and tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011


Summary View



Was update to reflect clinical trial experience in pediatric patients from Study TMC1140C228 as follows:

  • ADRs to Prezista/ritonavir (all grades, greater than or equal to 3%), excluding laboratory abnormalities, were diarrhea (19%), vomiting (14%) and rash (10%).
  • There were no Grade 3 or 4 laboratory abnormalities considered as ADRs in this study.