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Index of reports
> Cases resulting in other serious reactions (24)
> Cases with Somnolence (9)
Below is the selection of adverse event reports related to Actiq (Fentanyl Oral Transmucosal) that includes cases resulting in other serious reactions where reactions include somnolence.
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 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 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 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 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 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):
Actiq
Indication: Back Pain
Actiq
Indication: Pain in Extremity
Hydrocodone Bitartrate
Xanax
Administration route: Oral
Indication: Anxiety
Start date: 2007-03-07
End date: 2007-03-01
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):
Actiq
Dosage: 400 mg five times/day
Administration route: Oral
Indication: Fibromyalgia
Start date: 2005-01-01
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
Other drugs received by patient: Aspirin; Nexium; Lotrel; Mirapex; Levsin; Neurontin; Darvocet; Crestor
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