Study: NCT00474526

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 995 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 995 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 995 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 995 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 995 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 995 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 995 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 995 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 995 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 995 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 995 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 995 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 995 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 995 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 995 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 995 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 995 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 995 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 995 at risk

Adverse event: Synostosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 995 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 995 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 995 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 995 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 995 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 995 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 995 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 995 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 93 affected / 995 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 289 affected / 995 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 995 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 995 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 995 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 217 affected / 995 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 280 affected / 995 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 204 affected / 995 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 651 affected / 995 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 800 affected / 995 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 296 affected / 995 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 108 affected / 995 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 995 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 995 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 995 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 995 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 258 affected / 995 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 995 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 995 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 340 affected / 995 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 995 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 558 affected / 995 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 676 affected / 995 at risk

Adverse event: EATING DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 425 affected / 995 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 995 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 995 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 995 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 995 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 995 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 105 affected / 995 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 154 affected / 995 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 301 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Hypogammaglobulinaemia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 301 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 301 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 301 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Viral pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 301 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 301 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 301 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 30 affected / 301 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 91 affected / 301 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 301 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 301 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 301 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 301 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 108 affected / 301 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 101 affected / 301 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 196 affected / 301 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 240 affected / 301 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 94 affected / 301 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 301 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 301 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 301 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 301 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 301 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 301 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 301 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 108 affected / 301 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 301 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 154 affected / 301 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 184 affected / 301 at risk

Adverse event: EATING DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 122 affected / 301 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 301 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 301 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 301 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 301 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 301 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 301 at risk

Adverse event: Optic nerve hypoplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 203 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 203 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 203 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 203 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 203 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 203 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 203 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 203 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 203 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 203 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 203 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 100 affected / 203 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 78 affected / 203 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 147 affected / 203 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 171 affected / 203 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 74 affected / 203 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 203 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 203 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 203 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 203 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 203 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 203 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 203 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 203 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 203 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 124 affected / 203 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 141 affected / 203 at risk

Adverse event: EATING DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 93 affected / 203 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 203 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 203 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 203 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 203 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 203 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 203 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 203 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Fallot's tetralogy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Haematotympanum
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Blepharitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 2026 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2026 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 2026 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Acarodermatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2026 at risk

Adverse event: Bacterial diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2026 at risk

Adverse event: Botulism
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 2026 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 2026 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2026 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Febrile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 2026 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2026 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2026 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 2026 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 2026 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2026 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2026 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2026 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 2026 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 2026 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2026 at risk

Adverse event: Accidental exposure to product by child
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2026 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2026 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2026 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2026 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2026 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2026 at risk

Adverse event: Dairy intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2026 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 2026 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 2026 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 2026 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2026 at risk

Adverse event: Foreign body aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2026 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2026 at risk

Adverse event: Intestinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2026 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 68 affected / 2026 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 597 affected / 2026 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 2026 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 2026 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 486 affected / 2026 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1245 affected / 2026 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 745 affected / 2026 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1592 affected / 2026 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1120 affected / 2026 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 136 affected / 2026 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 748 affected / 2026 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 180 affected / 2026 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 219 affected / 2026 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2026 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 2026 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 375 affected / 2026 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 2026 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 2026 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 163 affected / 2026 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 2026 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 2026 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 927 affected / 2026 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1198 affected / 2026 at risk

Adverse event: EATING DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 607 affected / 2026 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 2026 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 2026 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 2026 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 2026 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 2026 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 323 affected / 2026 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 824 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 824 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 824 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 824 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 824 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 824 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 824 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 824 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 824 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Abscess oral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Bacterial diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 824 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 824 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 824 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 824 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 824 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 824 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 824 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 824 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 824 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 824 at risk

Adverse event: Viral diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 824 at risk

Adverse event: Limb traumatic amputation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 824 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 824 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 824 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 824 at risk

Adverse event: Psychomotor skills impaired
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 824 at risk

Adverse event: Tonic convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 824 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 824 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 824 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 824 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 824 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 824 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 287 affected / 824 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 824 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 824 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 228 affected / 824 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 548 affected / 824 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 333 affected / 824 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 698 affected / 824 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 474 affected / 824 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 73 affected / 824 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 341 affected / 824 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 824 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 95 affected / 824 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 824 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 824 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 192 affected / 824 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 824 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 824 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 824 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 824 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 824 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 419 affected / 824 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 513 affected / 824 at risk

Adverse event: EATING DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 263 affected / 824 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 824 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 824 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 824 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 824 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 824 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 136 affected / 824 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 183 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 183 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 183 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 183 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 183 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 117 affected / 183 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 90 affected / 183 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 164 affected / 183 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 110 affected / 183 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 74 affected / 183 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 183 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 183 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 183 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 183 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 183 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 183 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 98 affected / 183 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 110 affected / 183 at risk

Adverse event: EATING DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 69 affected / 183 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 183 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 183 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 183 at risk