Label Changes for:
Invega (paliperidone) ER tablets
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 has been reported with Invega during postmarketing surveillance
- 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.