Study: NCT00667745

Adverse event: Alcohol detoxification
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 141 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 141 at risk

Adverse event: Chron's Disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 141 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 141 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 141 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 141 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 141 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 141 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 141 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 141 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 141 at risk

Adverse event: Aches/pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 141 at risk

Adverse event: Diarrhea/gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 141 at risk

Adverse event: Fatigue/sedation/drowsiness
Serious: no
Organ System: General disorders
Frequency: 20 affected / 141 at risk

Adverse event: Dizziness/Headaches
Serious: no
Organ System: General disorders
Frequency: 8 affected / 141 at risk

Adverse event: Memory/Concentration/Cognitive Impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 141 at risk

Adverse event: Tremors
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 141 at risk

Adverse event: Increased appetite/weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 141 at risk

Adverse event: Dry mouth/thirst
Serious: no
Organ System: General disorders
Frequency: 8 affected / 141 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 142 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 142 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 142 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 142 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 142 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 142 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Aches/pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 142 at risk

Adverse event: Diarrhea/gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 142 at risk

Adverse event: Fatigue/sedation/drowsiness
Serious: no
Organ System: General disorders
Frequency: 19 affected / 142 at risk

Adverse event: Dizziness/Headaches
Serious: no
Organ System: General disorders
Frequency: 13 affected / 142 at risk

Adverse event: Memory/Concentration/Cognitive Impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 142 at risk

Adverse event: Tremors
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 142 at risk

Adverse event: Increased appetite/weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 142 at risk

Adverse event: Dry mouth/thirst
Serious: no
Organ System: General disorders
Frequency: 5 affected / 142 at risk