Skip to Content

Label Changes for:

Isentress (raltegravir potassium) tablets

July 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009


Postmarketing Experience

  • addition of paranoia and anxiety


  • warning about use with UGT (UDP-glucuronosyltransferases) inducers other than rifampin, specifically, Coadministration of Isentress with drugs that are strong inducers of UGT1A1 may result in reduced plasma concentrations of raltegravir