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U.S. Department of Health and Human Services


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Chantix (varenicline) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View


Sections Modified Summary of Changes to Contraindications and Warnings


  • Neuropsychiatric Symptoms


  • Information for Patients (see highlighted text for new or revised labeling)

WARNINGS: Neuropsychiatric Symptoms

Serious neuropsychiatric symptoms have occurred in patients being treated with Chantix. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke. All patients being treated with Chantix should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking Chantix in the postmarketing experience. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of Chantix and the safety and efficacy of Chantix in such patients has not been established. Patients attempting to quit smoking with Chantix and their families and caregivers should be alerted about the need to monitor for these symptoms and to report such symptoms immediately to the patient’s healthcare provider.