Study: NCT01944046

Adverse event: Sedation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 146 at risk

Adverse event: Aggression Or Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 146 at risk

Adverse event: Anger Or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 146 at risk

Adverse event: Frustration tolerance decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 146 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 146 at risk

Adverse event: Inappropriate affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 146 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 146 at risk

Adverse event: Impulse-control disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 146 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 146 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 146 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 146 at risk

Adverse event: Obsessive rumination
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 146 at risk

Adverse event: Apathy Or Boredom
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 146 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 146 at risk

Adverse event: Perseveration
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 146 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 146 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 146 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 146 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 146 at risk

Adverse event: Mania Or Hypomania
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 146 at risk

Adverse event: Pressure of speech
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 146 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 146 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 146 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 146 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 146 at risk

Adverse event: Stereotypy
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 146 at risk

Adverse event: Terminal insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 146 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 146 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 146 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 146 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 146 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 146 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Photophobia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 146 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 146 at risk

Adverse event: Abdominal Pain Or Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 146 at risk

Adverse event: Vomiting Or Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 146 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 146 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 146 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 146 at risk

Adverse event: Encopresis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 146 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 146 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 146 at risk

Adverse event: Abnormal weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 146 at risk

Adverse event: Abnormal Weight Loss
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 146 at risk

Adverse event: Thirst
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 146 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 146 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 146 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 146 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 146 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 146 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 146 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Energy increased
Serious: no
Organ System: General disorders
Frequency: 14 affected / 146 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 146 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 146 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 146 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 146 at risk

Adverse event: Chest Pain Or Discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 146 at risk

Adverse event: Allergic Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 146 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 146 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 146 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 146 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 146 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 146 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 146 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 146 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 146 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 146 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 146 at risk

Adverse event: Libido increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 146 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 146 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 146 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 146 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 146 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 146 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 146 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 146 at risk

Adverse event: Growing pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 146 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 146 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 146 at risk

Adverse event: Precocious puberty
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 146 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Dysphoria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Irritability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 144 at risk

Adverse event: Aggression Or Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 144 at risk

Adverse event: Anger Or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 144 at risk

Adverse event: Frustration tolerance decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 144 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 144 at risk

Adverse event: Inappropriate affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 144 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 144 at risk

Adverse event: Impulse-control disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 144 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 144 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 144 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 144 at risk

Adverse event: Obsessive rumination
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 144 at risk

Adverse event: Apathy Or Boredom
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 144 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 144 at risk

Adverse event: Perseveration
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 144 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 144 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 144 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 144 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 144 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 144 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 144 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 144 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 144 at risk

Adverse event: Stereotypy
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 144 at risk

Adverse event: Terminal insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 144 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 144 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 144 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 144 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 144 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 67 affected / 144 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 144 at risk

Adverse event: Abdominal Pain Or Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 144 at risk

Adverse event: Vomiting Or Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 144 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 144 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 144 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 144 at risk

Adverse event: Encopresis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 144 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 144 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 144 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 144 at risk

Adverse event: Abnormal weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 144 at risk

Adverse event: Abnormal Weight Loss
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 144 at risk

Adverse event: Thirst
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 144 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 144 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 144 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 144 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 144 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 144 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 144 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 144 at risk

Adverse event: Energy increased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 144 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 144 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 144 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 144 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 144 at risk

Adverse event: Chest Pain Or Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Allergic Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 144 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 144 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 144 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 144 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 144 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 144 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 144 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 144 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 144 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 144 at risk

Adverse event: Libido increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 144 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 144 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 144 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 144 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 144 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 144 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Increased tendency to bruise
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 144 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 144 at risk

Adverse event: Cardiac Rhythm Abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 144 at risk

Adverse event: Enamel Discoloration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Pituitary Analyses Anterior
Serious: no
Organ System: Investigations
Frequency: 1 affected / 144 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 127 at risk

Adverse event: Aggression Or Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 127 at risk

Adverse event: Anger Or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 127 at risk

Adverse event: Frustration tolerance decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 127 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 127 at risk

Adverse event: Inappropriate affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 127 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 127 at risk

Adverse event: Impulse-control disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 127 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 127 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 127 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 127 at risk

Adverse event: Obsessive rumination
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 127 at risk

Adverse event: Apathy Or Boredom
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 127 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 127 at risk

Adverse event: Perseveration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 127 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 127 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 127 at risk

Adverse event: Pressure of speech
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 127 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 127 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 127 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 127 at risk

Adverse event: Stereotypy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 127 at risk

Adverse event: Terminal insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 127 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Seizure Or Convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Somnambulism
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 127 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Abdominal Pain Or Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Vomiting Or Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 127 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 127 at risk

Adverse event: Encopresis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 127 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 127 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 127 at risk

Adverse event: Abnormal weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 127 at risk

Adverse event: Abnormal Weight Loss
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 127 at risk

Adverse event: Thirst
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 127 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 127 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 127 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 127 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 127 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Energy increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 127 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 127 at risk

Adverse event: Chest Pain Or Discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 127 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Allergic Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 127 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 127 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 127 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 127 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 127 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 127 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 127 at risk

Adverse event: Libido increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 127 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 127 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 127 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 127 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 127 at risk

Adverse event: Specific Muscle Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 127 at risk

Adverse event: Abnormal Urinalysis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 127 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 127 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 127 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 122 at risk

Adverse event: Aggression Or Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 122 at risk

Adverse event: Anger Or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 122 at risk

Adverse event: Frustration tolerance decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 122 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 122 at risk

Adverse event: Inappropriate affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 122 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 122 at risk

Adverse event: Impulse-control disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 122 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 122 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 122 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 122 at risk

Adverse event: Obsessive rumination
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 122 at risk

Adverse event: Apathy Or Boredom
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 122 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 122 at risk

Adverse event: Perseveration
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 122 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 122 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 122 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 122 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 122 at risk

Adverse event: Pressure of speech
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 122 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 122 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 122 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 122 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 122 at risk

Adverse event: Stereotypy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 122 at risk

Adverse event: Terminal insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 122 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 122 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 122 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 122 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 122 at risk

Adverse event: Photophobia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 122 at risk

Adverse event: Coordination abnormal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 122 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 122 at risk

Adverse event: Abdominal Pain Or Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 122 at risk

Adverse event: Vomiting Or Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 122 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 122 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 122 at risk

Adverse event: Encopresis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Anorectal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 122 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 122 at risk

Adverse event: Abnormal weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 122 at risk

Adverse event: Abnormal Weight Loss
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 122 at risk

Adverse event: Thirst
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 122 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 122 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 122 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 122 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 122 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 122 at risk

Adverse event: Energy increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 122 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 122 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 122 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 122 at risk

Adverse event: Allergic Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 122 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 122 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 122 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 122 at risk

Adverse event: Micturition frequency decreased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 122 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 122 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 122 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 122 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 122 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 122 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 122 at risk

Adverse event: Libido increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 122 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 122 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 122 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 122 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 122 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 122 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 122 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 122 at risk