Study: NCT00710866

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 124 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 124 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 124 at risk

Adverse event: Tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 124 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 124 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 74 affected / 124 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 48 affected / 124 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 49 affected / 124 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 68 affected / 124 at risk

Adverse event: Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 124 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 124 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 124 at risk

Adverse event: Teething
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 128 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 126 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 126 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 126 at risk

Adverse event: Tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 126 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 126 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 77 affected / 126 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 55 affected / 126 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 53 affected / 126 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 64 affected / 126 at risk

Adverse event: Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 126 at risk

Adverse event: Ocular
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 126 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 126 at risk

Adverse event: Teething
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 126 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 7 affected / 126 at risk