Study: NCT01553084

Adverse event: Itching/hives
Serious: no
Organ System: Immune system disorders
Frequency: 53 affected / 241 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 241 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 241 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 241 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 241 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 241 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 241 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 241 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 241 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 10 affected / 241 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 241 at risk

Adverse event: Mouth Problems
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 241 at risk

Adverse event: Heart Symptoms
Serious: no
Organ System: Cardiac disorders
Notes: Chest tightness, angina (heart pain), shortness of breath.
Frequency: 14 affected / 241 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling depressed or hopeless.
Frequency: 10 affected / 241 at risk

Adverse event: Anxious
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling worried, nervous, scared or anxious.
Frequency: 18 affected / 241 at risk

Adverse event: Agitated/restless
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling agitated or restless.
Frequency: 15 affected / 241 at risk

Adverse event: Hostile/angry
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling hostile or angry towards others.
Frequency: 7 affected / 241 at risk

Adverse event: Itching/hives
Serious: no
Organ System: Immune system disorders
Frequency: 74 affected / 421 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 55 affected / 421 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 45 affected / 421 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 421 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 421 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 421 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 421 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 421 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 421 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 26 affected / 421 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 421 at risk

Adverse event: Mouth Problems
Serious: no
Organ System: Product Issues
Frequency: 33 affected / 421 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 421 at risk

Adverse event: Heart Symptoms
Serious: no
Organ System: Cardiac disorders
Notes: Chest tightness, angina (heart pain), shortness of breath.
Frequency: 13 affected / 421 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling depressed or hopeless.
Frequency: 13 affected / 421 at risk

Adverse event: Anxious
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling worried, nervous, scared or anxious.
Frequency: 26 affected / 421 at risk

Adverse event: Agitated/restless
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling agitated or restless.
Frequency: 14 affected / 421 at risk

Adverse event: Hostile/angry
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling hostile or angry towards others.
Frequency: 11 affected / 421 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 424 at risk

Adverse event: Itching/hives
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 424 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 98 affected / 424 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 94 affected / 424 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 424 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 121 affected / 424 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 424 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 424 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 424 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 424 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 68 affected / 424 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 424 at risk

Adverse event: Mouth Problems
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 424 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 424 at risk

Adverse event: Heart Symptoms
Serious: no
Organ System: Cardiac disorders
Notes: Chest tightness, angina (heart pain), shortness of breath.
Frequency: 26 affected / 424 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling depressed or hopeless.
Frequency: 25 affected / 424 at risk

Adverse event: Anxious
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling worried, nervous, scared or anxious.
Frequency: 20 affected / 424 at risk

Adverse event: Agitated/restless
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling agitated or restless.
Frequency: 35 affected / 424 at risk

Adverse event: Hostile/angry
Serious: no
Organ System: Psychiatric disorders
Notes: Feeling hostile or angry towards others.
Frequency: 23 affected / 424 at risk