Study: NCT02136498

Adverse event: Anger or irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 33 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 33 at risk

Adverse event: Change in appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 33 at risk

Adverse event: Confusion/difficulty concentrating
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 33 at risk

Adverse event: Craving to smoke
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 33 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 33 at risk

Adverse event: Diarhhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: vivid or unusual dreams
Serious: no
Organ System: General disorders
Frequency: 21 affected / 33 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 4 affected / 33 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 33 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 12 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 33 at risk

Adverse event: stomach pain or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Memory problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Passive suicidal ideation without intent
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant reported passive suicidal ideation (without intent) on his wedding anniversary from his estranged wife. Participant had a history of psychiatric issues and was not taking varenicline at the time.
Frequency: 1 affected / 33 at risk

Adverse event: Anger or irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 33 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 33 at risk

Adverse event: Change in appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Confusion/difficulty concentrating
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 33 at risk

Adverse event: Craving to smoke
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 33 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 33 at risk

Adverse event: Diarhhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: vivid or unusual dreams
Serious: no
Organ System: General disorders
Frequency: 19 affected / 33 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 33 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 18 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 33 at risk

Adverse event: Rapid heart beat or chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: stomach pain or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 33 at risk