Study: NCT01156051

Adverse event: somnolence / sedation
Serious: no
Organ System: Nervous system disorders
Notes: sedation, somnolence, tired, sense of wanting to sleep
Frequency: 8 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache, head pain
Frequency: 4 affected / 12 at risk

Adverse event: stomachache / abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomachache, abdominal pain, abdominal discomfort
Frequency: 1 affected / 12 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: infectious gastroenteritis
Frequency: 1 affected / 12 at risk

Adverse event: febrile illness
Serious: no
Organ System: Infections and infestations
Notes: febrile illness, fever, acute nonspecific illness with fever
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: upper respiratory infection, cold, URI, coryza, stuffiness
Frequency: 3 affected / 12 at risk

Adverse event: exacerbation of allergic rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: allergic rhinitis, allergies, hay fever
Frequency: 1 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: cough without asthma, cough
Frequency: 1 affected / 12 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Notes: enuresis, bedwetting, nighttime incontinence, bedwetting accidents
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: dizziness, lightheadedness
Frequency: 1 affected / 12 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: chest pain not of cardiac origin, chest wall tenderness, costochondritis
Frequency: 1 affected / 12 at risk

Adverse event: oral pain due to loose teeth
Serious: no
Organ System: General disorders
Notes: oral pain due to loose teeth (developmental in nature)
Frequency: 1 affected / 12 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: dermatitis, rash, contact dermatitis
Frequency: 1 affected / 12 at risk

Adverse event: somnolence / sedation
Serious: no
Organ System: Nervous system disorders
Notes: sedation, somnolence, tired, sense of wanting to sleep
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache, head pain
Frequency: 2 affected / 17 at risk

Adverse event: stomachache / abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomachache, abdominal pain, abdominal discomfort
Frequency: 2 affected / 17 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: infectious gastroenteritis
Frequency: 2 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: decreased appetite, anorexia, appetite decrease
Frequency: 1 affected / 17 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: inguinal hernia detected
Frequency: 1 affected / 17 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: upper respiratory infection, cold, URI, coryza, stuffiness
Frequency: 3 affected / 17 at risk

Adverse event: exacerbation of allergic rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: allergic rhinitis, allergies, hay fever
Frequency: 5 affected / 17 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: exacerbation of asthma, asthma, wheezing, cough
Frequency: 1 affected / 17 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: dermatitis, rash, contact dermatitis
Frequency: 2 affected / 17 at risk

Adverse event: Dysphemia
Serious: no
Organ System: Psychiatric disorders
Notes: stuttering
Frequency: 1 affected / 17 at risk