Study: NCT02543203

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper respiratory infection
Frequency: 5 affected / 24 at risk

Adverse event: Increased Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Increased Irritability
Frequency: 4 affected / 24 at risk

Adverse event: Streptococcal pharyngitis,
Serious: no
Organ System: Infections and infestations
Notes: Streptococcal pharyngitis
Frequency: 3 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting
Frequency: 3 affected / 24 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Notes: Enuresis
Frequency: 2 affected / 24 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergy
Frequency: 2 affected / 24 at risk

Adverse event: Tussis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Tussis or cough
Frequency: 1 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever
Frequency: 2 affected / 24 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal upset
Frequency: 2 affected / 24 at risk

Adverse event: Increased Self Injury
Serious: no
Organ System: Psychiatric disorders
Notes: Increased Self Injury (biting self)
Frequency: 1 affected / 24 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Rhinorrhea
Frequency: 2 affected / 24 at risk

Adverse event: Viral rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Exanthem rash or eruption on the skin due to virus
Frequency: 2 affected / 24 at risk

Adverse event: Adverse reaction to noxious oil smell
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Noxious oil smell
Frequency: 2 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper respiratory infection
Frequency: 5 affected / 23 at risk

Adverse event: Increased Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Increased Irritability
Frequency: 1 affected / 23 at risk

Adverse event: Streptococcal pharyngitis,
Serious: no
Organ System: Infections and infestations
Notes: Streptococcal pharyngitis
Frequency: 1 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting
Frequency: 6 affected / 23 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Notes: Enuresis
Frequency: 2 affected / 23 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergy
Frequency: 3 affected / 23 at risk

Adverse event: Tussis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Tussis or cough
Frequency: 4 affected / 23 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever
Frequency: 2 affected / 23 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastroenteritis
Frequency: 3 affected / 23 at risk

Adverse event: Increased Self Injury
Serious: no
Organ System: Psychiatric disorders
Notes: Increased Self Injury (biting self)
Frequency: 2 affected / 23 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Otitis media
Frequency: 2 affected / 23 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Rhinorrhea
Frequency: 2 affected / 23 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Sleep disturbance
Frequency: 2 affected / 23 at risk

Adverse event: Increase of verbal stemming
Serious: no
Organ System: Psychiatric disorders
Notes: Increase in verbal stemming (squealing)
Frequency: 3 affected / 23 at risk