Label Changes for:
Chantix (varenicline) 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)
WARNINGS AND PRECAUTIONS
Neuropsychiatric Symptoms and Suicidality
- Limited data re available from a single smoking cessation study in patients with stable chizophrenia or schizoaffective disorder.