Table 2.

  Adverse events during treatment (all causes) and discontinuation of treatment because of adverse events. Figures are numbers (percentages) of participants

Adverse events	Varenicline (n=213)	Placebo (n=218)
Occurrence of any adverse event	168 (79)	126 (58)
Dose reductions or temporary withdrawal	17 (8)	12 (6)
Permanent discontinuations	19 (9)	9 (4)
Occurrence of serious adverse events	2 (1)	3 (1)
Most commonly reported adverse events (≥5% in either treatment group):
Gastrointestinal disorders
Abdominal pain	11 (5)	5 (2)
Diarrhoea	10 (5)	11 (5)
Flatulence	18 (9)	7 (3)
Nausea	74 (35)	14 (6)
General disorders and administration site conditions:
Fatigue	22 (10)	15 (7)
Irritability	11 (5)	9 (4)
Infections and infestations
Nasopharyngitis	12 (6)	8 (4)
Nervous system disorders
Headache	22 (10)	20 (9)
Reported neuropsychiatric adverse events (all frequencies):
Sleep disorder	22 (10)	15 (7)
Abnormal dreams	17 (8)	3 (1)
Insomnia	13 (6)	6 (3)
Nightmare	4 (2)	3 (1)
Depressed mood	4 (2)	3 (1)
Restlessness	2 (1)	4 (2)
Depression	2 (1)	5 (2)