Study: NCT01136772

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 20 affected / 147 at risk

Adverse event: Suicidal Act
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 147 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 147 at risk

Adverse event: Violence-related symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 147 at risk

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 44 affected / 147 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Events rated moderate or severe
Frequency: 49 affected / 147 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Notes: Events rated moderate or severe
Frequency: 41 affected / 147 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Events rated moderate or severe
Frequency: 40 affected / 147 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: Events rated moderate or severe
Frequency: 33 affected / 147 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Events rated moderate or severe
Frequency: 24 affected / 147 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: General disorders
Notes: Events rated moderate or severe
Frequency: 24 affected / 147 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Events rated moderate or severe
Frequency: 21 affected / 147 at risk

Adverse event: Orthostatic faintness
Serious: no
Organ System: Cardiac disorders
Notes: Events rated moderate or severe
Frequency: 14 affected / 147 at risk

Adverse event: Incontinence/nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Events rated moderate or severe
Frequency: 13 affected / 147 at risk

Adverse event: Menstrual irregularities
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Events rated moderate or severe
Frequency: 12 affected / 147 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Notes: Events rated moderate or severe
Frequency: 7 affected / 147 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 16 affected / 147 at risk

Adverse event: Suicidal Act
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 147 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 147 at risk

Adverse event: Homocidal Act
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 147 at risk

Adverse event: Violence-related symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 147 at risk

Adverse event: Violent act
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 147 at risk

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 34 affected / 147 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Events rated moderate or severe
Frequency: 54 affected / 147 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Notes: Events rated moderate or severe
Frequency: 44 affected / 147 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Events rated moderate or severe
Frequency: 34 affected / 147 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: Events rated moderate or severe
Frequency: 26 affected / 147 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Events rated moderate or severe
Frequency: 20 affected / 147 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: General disorders
Notes: Events rated moderate or severe
Frequency: 16 affected / 147 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Events rated moderate or severe
Frequency: 20 affected / 147 at risk

Adverse event: Orthostatic faintness
Serious: no
Organ System: Cardiac disorders
Notes: Events rated moderate or severe
Frequency: 12 affected / 147 at risk

Adverse event: Incontinence/nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Events rated moderate or severe
Frequency: 8 affected / 147 at risk

Adverse event: Menstrual irregularities
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Events rated moderate or severe
Frequency: 5 affected / 147 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Notes: Events rated moderate or severe
Frequency: 9 affected / 147 at risk