Does varenicline worsen psychiatric symptoms in patients with schizophrenia or schizoaffective disorder? A review of published studies

J Clin Psychiatry. 2012 Aug;73(8):e1039-47. doi: 10.4088/JCP.11r07410.


Objective: To review published cases and prospective studies describing the use of varenicline in patients with schizophrenia and schizoaffective disorder.

Data sources: PubMed, PsychINFO, and the Cochrane Database were searched in July 2011 using the key words schizophrenia, schizoaffective disorder, psychosis, positive symptoms, negative symptoms, aggression, hostility, suicidal ideation AND varenicline to identify reports published between January 2006 and July 2011 in English.

Study selection: Five case reports, 1 case series, 1 retrospective study, 10 prospective studies (17 publications), and 1 meeting abstract describing the use of varenicline in patients with schizophrenia or schizoaffective disorder were identified. Review articles and articles describing findings other than the use of varenicline in patients with schizophrenia or schizoaffective disorder were excluded. Thirteen reports were included in the final analysis.

Data extraction: Information on each study's patient population, age, diagnosis, medication treatment, tobacco use history, adverse effects, and outcome was collected from the published reports.

Results: Of the 260 patients with schizophrenia or schizoaffective disorder who received varenicline in these published reports, 13 patients (5%) experienced the onset or worsening of any psychiatric symptom, although 3 of the 13 patients experienced a very brief negative effect after 1 dose. No patients experienced suicidal ideation or suicidal behaviors.

Conclusions: Published reports suggest that, in most stable, closely monitored patients with schizophrenia or schizoaffective disorder, varenicline treatment is not associated with worsening of psychiatric symptoms. Current, prospective studies are assessing effectiveness and further assessing safety in this population.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Attention / drug effects
  • Benzazepines / adverse effects*
  • Benzazepines / therapeutic use
  • Cognition Disorders / diagnosis
  • Cognition Disorders / drug therapy
  • Cognition Disorders / psychology
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Humans
  • Nicotinic Agonists / adverse effects*
  • Nicotinic Agonists / therapeutic use
  • Psychiatric Status Rating Scales
  • Psychoses, Substance-Induced / diagnosis*
  • Psychoses, Substance-Induced / drug therapy
  • Psychoses, Substance-Induced / psychology
  • Quinoxalines / adverse effects*
  • Quinoxalines / therapeutic use
  • Risk Factors
  • Schizophrenia / chemically induced*
  • Schizophrenia / diagnosis
  • Schizophrenia / drug therapy
  • Schizophrenic Psychology*
  • Smoking Cessation / psychology*
  • Treatment Outcome
  • Varenicline


  • Benzazepines
  • Nicotinic Agonists
  • Quinoxalines
  • Varenicline