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Index of reports
> Cases resulting in a serious event (62)
> Cases with Accidental Drug Intake by Child (9)
Below is the selection of adverse event reports related to Actiq (Fentanyl Oral Transmucosal) that includes cases resulting in a serious event where reactions include accidental drug intake by child.
Adverse event in 20 month old male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 20 month old male
Adverse reactions / side effects: Accidental Drug Intake by Child
Adverse event resulted in: hospitalization
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 5 year old male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 5 year old male
Adverse reactions / side effects: Vertigo, Dizziness, Accidental Drug Intake by Child, Somnolence, Lethargy
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 4 year old male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 4 year old male, weighing 12.6 kg (27.7 pounds)
Adverse reactions / side effects: Vomiting, Nausea, Accidental Drug Intake by Child, Somnolence, Lethargy
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 16 month old female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 16 month old female
Adverse reactions / side effects: Mydriasis, Tachycardia, Coma, Acidosis, Muscle Rigidity, Convulsion, Coordination Abnormal, Hypertension, Accidental Drug Intake by Child, Pneumonitis
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 2 year old male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 2 year old male, weighing 14.6 kg (32.0 pounds)
Adverse reactions / side effects: Hypotension, Somnolence, Accidental Drug Intake by Child, Lethargy
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 1 year old female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 1 year old female
Adverse reactions / side effects: Cyanosis, Respiratory Arrest, Coma, Accidental Drug Intake by Child
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 20 month old female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 20 month old female
Adverse reactions / side effects: Vertigo, Dizziness, Accidental Drug Intake by Child, Somnolence, Lethargy
Adverse event resulted in: hospitalization
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 12 month old female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-22
Patient: 12 month old female, weighing 10.0 kg (22.0 pounds)
Adverse reactions / side effects: Peripheral Coldness, Vomiting, Tongue Discolouration, Accidental Death, Loss of Consciousness, Drug Toxicity, Gingival Discolouration, Abdominal Distension, Accidental Drug Intake by Child, Vascular Access Complication, Cardiac Arrest, Blood Glucose Increased
Adverse event resulted in: death
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 12 month old female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a physician from United States on 2007-02-07
Patient: 12 month old female
Adverse reactions / side effects: Drug Toxicity, Accidental Drug Intake by Child, Cardiac Arrest
Adverse event resulted in: death
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
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