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OBJECTIVE: To examine associations between varenicline and the incidence of a range of adverse outcomes. DESIGN: Population based cohort study using within person analyses to control for confounding by indication. SETTING: Whole population of Sweden. PARTICIPANTS: 7,917,436 people aged 15 and over, of whom 69,757 were treated with varenicline between 2006 and 2009. MAIN OUTCOME MEASURES: Incidence of new psychiatric conditions, suicidal behaviour, suspected and convicted criminal offending, transport accidents, and suspected and convicted traffic offences. RESULTS: In the whole population, 337,393 new psychiatric conditions were diagnosed during follow-up. In addition, 507,823 suspected and 338,608 convicted crimes, 40,595 suicidal events, 124,445 transport accidents, and 99,895 suspected and 57,068 convicted traffic crimes were recorded. Within person analyses showed that varenicline was not associated with significant hazards of suicidal behaviour, criminal offending, transport accidents, traffic offences, or psychoses. However, varenicline was associated with a small increase in the risk of anxiety conditions (hazard ratio 1.23, 95% confidence interval 1.01 to 1.51) and mood conditions (1.31, 1.06 to 1.63), which was only seen in people with pre-existing psychiatric disorders. CONCLUSIONS: Concerns that varenicline is associated with an increased risk of many adverse outcomes, including suicidality and accidents, are not supported in this observational study. The small increase in risk of two psychiatric conditions in people with pre-existing psychiatric disorders needs to be confirmed using other research designs.

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Accidents, Traffic, Adolescent, Adult, Aged, Benzazepines, Cohort Studies, Crime, Epidemiologic Methods, Female, Humans, Male, Mental Disorders, Middle Aged, Nicotinic Agonists, Quinoxalines, Smoking, Smoking Cessation, Smoking Prevention, Substance Withdrawal Syndrome, Suicide, Tobacco Use Cessation Devices, Varenicline, Young Adult