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Label Changes for:

Invega (paliperidone) Extended-Release Tablets

March 2016

Changes have been made to the CONTRAINDICATIONS sections of the safety label.

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

March 2016


  • RISPERDAL/RISPERDAL CONSTA/INVEGA(s) is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL/RISPERDAL CONSTA/ INVEGA(s) formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.