Study: NCT00152464

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Anorectal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 255 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 255 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 255 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Eczema infected
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 255 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Haemophilus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 255 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 255 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 255 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 255 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 255 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 255 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 41 affected / 255 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 255 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 255 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 255 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 255 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 71 affected / 255 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 13 affected / 255 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 255 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 255 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 255 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 255 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 255 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 255 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 255 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 255 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 255 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 255 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 255 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 255 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 126 affected / 255 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 255 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 255 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 255 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 255 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 255 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 255 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 255 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 255 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 255 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 255 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 255 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 255 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 255 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 255 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 255 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 255 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 255 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 255 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 255 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 255 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 49 affected / 255 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 255 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 255 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 255 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 255 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 255 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 255 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 255 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 255 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 255 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 255 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 255 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 255 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 255 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 255 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 255 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 255 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 255 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 255 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 131 affected / 255 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 255 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 255 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 255 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 255 at risk