Study: NCT01378858

Adverse event: Incident psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Assessed using the Mini-International Neuropsychiatric Interview 6.0.0
Frequency: 1 affected / 50 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Wishes to be dead, or thoughts of killing self, assessed using the Columbia Suicide Severity Scale
Frequency: 1 affected / 50 at risk

Adverse event: Change in taste
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 11 affected / 50 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 20 affected / 50 at risk

Adverse event: Change in appetite
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 18 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 19 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 5 affected / 50 at risk

Adverse event: Flatulence
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 10 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 16 affected / 50 at risk

Adverse event: Change in concentration
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 4 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 12 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 4 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 18 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 5 affected / 50 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 3 affected / 50 at risk

Adverse event: Vivid/more frequent dreams
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 11 affected / 50 at risk

Adverse event: Incident major depressive episode
Serious: yes
Organ System: Psychiatric disorders
Notes: Assessed using the Mini-International Neuropsychiatric Interview 6.0.0
Frequency: 2 affected / 50 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Wishes to be dead, or thoughts of killing self, assessed using the Columbia Suicide Severity Scale
Frequency: 1 affected / 50 at risk

Adverse event: Change in taste
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 15 affected / 50 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 24 affected / 50 at risk

Adverse event: Change in appetite
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 19 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 27 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 13 affected / 50 at risk

Adverse event: Flatulence
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 17 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 24 affected / 50 at risk

Adverse event: Change in concentration
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 7 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 13 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 12 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 14 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 4 affected / 50 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 8 affected / 50 at risk

Adverse event: Vivid/more frequent dreams
Serious: no
Organ System: General disorders
Notes: Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment
Frequency: 16 affected / 50 at risk