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U.S. Department of Health and Human Services

Safety

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Invega (paliperidone) ER tablets

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

 

Summary View

 

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.