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Index of reports
> Cases resulting in a serious event (62)
> Cases with Somnolence (12)
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 somnolence.
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 female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a individual with unspecified qualification from United States on 2007-07-10
Patient: female
Adverse reactions / side effects: Completed Suicide, Somnolence, Lethargy
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 59 year old female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10
Patient: 59 year old female
Adverse reactions / side effects: Agitation, Incorrect Dose Administered, Pain, Coma, Respiratory Depression, Somnolence, Irritability, Syncope, Suicide Attempt, Respiratory Arrest, Lethargy
Adverse event resulted in: life threatening event, 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 year old male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a individual with unspecified qualification from United States on 2007-07-10
Patient: 16 year old male
Adverse reactions / side effects: Drug Abuser, Somnolence, Lethargy
Adverse event resulted in: 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 39 year old male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a individual with unspecified qualification from United States on 2007-07-10
Patient: 39 year old male
Adverse reactions / side effects: Completed Suicide, Somnolence, Lethargy
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a consumer/non-health professional from United States on 2007-05-18
Patient: male, weighing 81.6 kg (179.5 pounds)
Adverse reactions / side effects: Respiratory Rate Decreased, Gait Disturbance, Somnolence
Suspect drug(s):
Xanax
Administration route: Oral
Indication: Anxiety
Start date: 2007-03-07
End date: 2007-03-01
Actiq
Indication: Back Pain
Actiq
Indication: Pain in Extremity
Hydrocodone Bitartrate
Other drugs received by patient: Lipitor
Adverse event in 16 year old male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-14
Patient: 16 year old male
Adverse reactions / side effects: Drug Abuser, Somnolence, Lethargy
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in 33 year old female receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-14
Patient: 33 year old female
Adverse reactions / side effects: Agitation, Irritability, Suicide Attempt, Hypertension, Somnolence, Lethargy
Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)
Adverse event in male receiving Actiq (Fentanyl Oral Transmucosal)
Reported by a consumer/non-health professional from United States on 2007-04-27
Patient: male, weighing 88.6 kg (194.9 pounds)
Adverse reactions / side effects: Impaired Driving Ability, Somnolence
Suspect drug(s):
Ambien
Dosage: 5 to 10 mg at night qhs
Administration route: Oral
Indication: Sleep Disorder
Start date: 2003-01-01
Zanaflex
Administration route: Oral
Indication: Myalgia
Start date: 2003-01-01
Actiq
Dosage: 400 mg five times/day
Administration route: Oral
Indication: Fibromyalgia
Start date: 2005-01-01
Other drugs received by patient: Aspirin; Nexium; Lotrel; Mirapex; Levsin; Neurontin; Darvocet; Crestor
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