Study: NCT01299389

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 164 at risk

Adverse event: Psychiatric symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 164 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 164 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 164 at risk

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Self-destructive behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Ovarian cyst torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 164 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 164 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 164 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 164 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Adenoviral conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 164 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 164 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 164 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 164 at risk

Adverse event: Psychiatric symptom
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 164 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 164 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 164 at risk

Adverse event: Hallucination, auditory
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 164 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Persecutory delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 164 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 164 at risk

Adverse event: Self-destructive behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 164 at risk

Adverse event: Inappropriate affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Obsessive thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Soliloquy
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Impulse-control disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 164 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 164 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 164 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 164 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 164 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Parkinsonism
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 164 at risk

Adverse event: Bradykinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Irregular sleep wake rhythm disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Intracranial haematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Thermohyperaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 164 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 164 at risk

Adverse event: Auricular swelling
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 164 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 164 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 164 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Left ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 164 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Labile blood pressure
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 164 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 164 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 164 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 164 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Eczema nummular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Nail bed inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 164 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 164 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 164 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 164 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 164 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 164 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 164 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Periorbital haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Anal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 164 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 164 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 164 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 164 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 164 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 164 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 164 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 164 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 164 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 164 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 164 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 164 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 164 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 164 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 164 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 164 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 164 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 164 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 164 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Abnormal behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 164 at risk

Adverse event: Poor quality sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 164 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Muscle fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Nuchal rigidity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 164 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 164 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Vessel puncture site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Urobilinogen urine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Blood chloride increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 164 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 164 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Tardive dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dysstasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Psychiatric symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 159 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 159 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 159 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 159 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 159 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 159 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Diet refusal
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hyperphagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 159 at risk

Adverse event: Psychiatric symptom
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 159 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 159 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 159 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hallucination, auditory
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 159 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 159 at risk

Adverse event: Persecutory delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Anger
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Catatonia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Emotional disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Somatic delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 159 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 159 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 159 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 159 at risk

Adverse event: Parkinsonism
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 159 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 159 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 159 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Head titubation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Oculogyric crisis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 159 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 159 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 159 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 159 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 159 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 159 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 159 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Gouty arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 159 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 159 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 159 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 159 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 159 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 159 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 159 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 159 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 159 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 159 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 159 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 159 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 159 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 159 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 159 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 159 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Muscle rigidity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 159 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 159 at risk

Adverse event: Weight fluctuation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Abnormal behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Defaecation urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 159 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Nipple pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 159 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 159 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 159 at risk

Adverse event: Urobilinogen urine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Lymphocyte percentage decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 159 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Psychiatric symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 156 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 156 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 156 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 156 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 156 at risk

Adverse event: Psychiatric symptom
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 156 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 156 at risk

Adverse event: Hallucination, auditory
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Self-destructive behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 156 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 156 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 156 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 156 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 156 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 156 at risk

Adverse event: Parkinsonism
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 156 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 156 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 156 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 156 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 156 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 156 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 156 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 156 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 156 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 156 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Carbuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 156 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 156 at risk

Adverse event: Polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 156 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Self-injurious ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Burnout syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 156 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Essential tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 156 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 156 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 156 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 156 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Bronchitis chronic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 156 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 156 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 156 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 156 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 156 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 156 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Muscle rigidity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 156 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 156 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 156 at risk

Adverse event: Urge incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 156 at risk

Adverse event: Stress urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 156 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 156 at risk

Adverse event: Ejaculation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 156 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 156 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 156 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 156 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 156 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 156 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 1 affected / 156 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 156 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 156 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 156 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 156 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 156 at risk

Adverse event: Blood prolactin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 156 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 156 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 156 at risk

Adverse event: Influenza A virus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 156 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 156 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 156 at risk

Adverse event: Chillblains
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Superficial injury of eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Tardive dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Psychiatric symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 155 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 155 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Akathisia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 155 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 155 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 155 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 155 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 155 at risk

Adverse event: Psychiatric symptom
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 155 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 155 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 155 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 155 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 155 at risk

Adverse event: Parkinsonism
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 155 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 155 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 155 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 155 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 155 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 155 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 155 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 155 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 155 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 155 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 155 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 155 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Helicobacter infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 155 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Thinking abnormal
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 155 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 155 at risk

Adverse event: Diastolic dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 155 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 155 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 155 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 155 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 155 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 155 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 155 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Tongue discolouration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Lip haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Tongue haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Hepatitis toxic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 155 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 155 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 155 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 155 at risk

Adverse event: Micturition disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 155 at risk

Adverse event: Ejaculation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 155 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 155 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 155 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 155 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 155 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 155 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 155 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 155 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 155 at risk

Adverse event: Hepatic enzyme abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 155 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 155 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 155 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 155 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 155 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 155 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 155 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 155 at risk

Adverse event: Tardive dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk