Label Changes for:

Invega (paliperidone) ER tablets

October 2009

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

WARNINGS AND PRECAUTIONS

Priapism
  • Priapism has been reported with Invega during postmarketing surveillance

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reaction has been identified during postapproval use of Invega: because this reaction was reported voluntarily from a population of uncertain size, it is not possible to reliably estimate its frequency: priapism.
Hide
(web5)