Study: NCT01267136

Adverse event: Tonsil bleed requiring hospitalization
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient had hypoplastic left heart syndrome and was pacemaker-dependent. This child experienced a life-threatening tonsil hemorrhage one week after surgery, requiring resuscitation and hospitalization, and discontinuation of the study medication.
Frequency: 1 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 38 at risk

Adverse event: Sedation complication
Serious: no
Organ System: General disorders
Frequency: 14 affected / 38 at risk

Adverse event: Tonsil bleed
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Throat pain requiring hospitalization
Serious: yes
Organ System: General disorders
Notes: Patient was hospitalized for difficulty with oral intake, dehydration, and throat pain. This patient was rehydrated and switched to acetaminophen and hydrocodone (Lortab) for pain management following discharge.
Frequency: 1 affected / 42 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Patient was hospitalized for difficulty with oral intake, dehydration, and throat pain. This patients was rehydrated and switched to acetaminophen and hydrocodone (Lortab) for pain management following discharge.
Frequency: 1 affected / 42 at risk

Adverse event: Difficulty with oral intake
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient was hospitalized for difficulty with oral intake, dehydration, and throat pain. This patients was rehydrated and switched to acetaminophen and hydrocodone (Lortab) for pain management following discharge.
Frequency: 1 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 36 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 36 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 36 at risk

Adverse event: Sedation complication
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk