Study: NCT00474708

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 787 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 787 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 787 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 787 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 787 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 787 at risk

Adverse event: Bitter taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 787 at risk

Adverse event: No appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 787 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 787 at risk

Adverse event: Stomach disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 787 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 787 at risk

Adverse event: Gastrointestinal reaction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 787 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 787 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 787 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 787 at risk

Adverse event: Local anaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 787 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 787 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 787 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 787 at risk

Adverse event: Night sweats
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 787 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 787 at risk

Adverse event: Sluggish
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Dreaminess
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Fidget
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 787 at risk

Adverse event: Insomina
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 787 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 787 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Sexual hypoesthesia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 787 at risk

Adverse event: Drug abuse
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Mania
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Switching
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Completed suicide
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 787 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 787 at risk

Adverse event: Feeble
Serious: no
Organ System: General disorders
Frequency: 7 affected / 787 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 787 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 787 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 787 at risk

Adverse event: Head malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 787 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 21 affected / 787 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 787 at risk

Adverse event: Waist disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 787 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 787 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 787 at risk

Adverse event: Unstable blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 787 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 787 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 787 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 787 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 787 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 787 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 787 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 787 at risk

Adverse event: Oligiomenorrhea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 787 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 787 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 787 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 787 at risk

Adverse event: Micturition disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 787 at risk

Adverse event: Visual abnormal
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 787 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 787 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 787 at risk

Adverse event: Muscel spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 787 at risk

Adverse event: Waist pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 787 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 787 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 787 at risk

Adverse event: Ejaculation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 787 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 787 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 365 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 365 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 365 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 365 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 365 at risk

Adverse event: No appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 365 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 365 at risk

Adverse event: Stomach disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 365 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 365 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 365 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 365 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 365 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 365 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 365 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 365 at risk

Adverse event: Fidget
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 365 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 365 at risk

Adverse event: Insomina
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 365 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 365 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 365 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 365 at risk

Adverse event: Sexual hypoesthesia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 365 at risk

Adverse event: Switching
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 365 at risk

Adverse event: Feeble
Serious: no
Organ System: General disorders
Frequency: 1 affected / 365 at risk

Adverse event: Muscular soreness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 365 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 365 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 365 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 365 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 365 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 365 at risk

Adverse event: Thirst
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 365 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 365 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 365 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 365 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 365 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 365 at risk

Adverse event: Ejaculation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 365 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 365 at risk