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Actiq (Fentanyl Oral Transmucosal) - Adverse Event Reports - Other Serious Reactions

 



Index of reports > Cases resulting in other serious reactions (24)

     Somnolence (9)Lethargy (7)Suicide Attempt (4)Drug Abuser (3)Drug Withdrawal Syndrome (3)Accidental Drug Intake by Child (3)Nausea (2)Respiratory Depression (2)Delusion (2)Hallucination (2)

Below is the selection of adverse event reports related to Actiq (Fentanyl Oral Transmucosal) that includes cases resulting in other serious reactions.

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 18 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10

Patient: 18 year old male

Adverse reactions / side effects: Tachycardia, Suicide Attempt, Hypertension

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 female receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10

Patient: female

Adverse reactions / side effects: Incorrect Dose Administered, Coma

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 43 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10

Patient: 43 year old male

Adverse reactions / side effects: Suicide Attempt

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 34 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10

Patient: 34 year old male, weighing 84.1 kg (185.0 pounds)

Adverse reactions / side effects: Tachycardia, Drug Abuser, Hallucination, Delusion

Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)



Adverse event in 43 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-29

Patient: 43 year old male, weighing 99.8 kg (219.5 pounds)

Adverse reactions / side effects: Dyspnoea, Delirium Tremens, Pain in Extremity, Drug Withdrawal Syndrome, Drug Prescribing Error, Abdominal Pain Upper, Convulsion, Abnormal Dreams, Fatigue, Diarrhoea, Anorexia, Drug Dependence, Muscle Spasms

Suspect drug(s):
Actiq
    Dosage: 7200 ug qd buccal
    Indication: Musculoskeletal Pain
    End date: 2006-11-01

Actiq
    Dosage: 7200 ug qd buccal
    Indication: Musculoskeletal Pain
    Start date: 2006-12-01

Other drugs received by patient: Clonazepam; Ambien; Morphine Time Release; Fentora



Adverse event in female receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-06-27

Patient: female

Adverse reactions / side effects: Intestinal Obstruction

Suspect drug(s):
Actiq
    Administration route: Oral
    Indication: Lymphoedema

Fentanyl Transdermal System
    Indication: Lymphoedema



Adverse event in 46 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-06-08

Patient: 46 year old male, weighing 77.1 kg (169.6 pounds)

Adverse reactions / side effects: Grand MAL Convulsion, Drug Effect Decreased, Pain, Drug Withdrawal Syndrome

Suspect drug(s):
Actiq
    Dosage: 600ug qid prn buccal
    Indication: Back Pain
    Start date: 2004-01-01
    End date: 2006-11-01

Actiq
    Dosage: 600ug qid prn buccal
    Indication: Back Pain
    Start date: 2007-01-01
    End date: 2007-05-01

Other drugs received by patient: Fentora; Duragesic-100; Soma; Zonegran; Carbatrol; Lyrica; Cymbalta; Asmanex Twisthaler; Dilaudid; Lidoderm



Adverse event in 33 year old female receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-05-23

Patient: 33 year old female, weighing 117.9 kg (259.4 pounds)

Adverse reactions / side effects: Weight Increased, Tooth Loss, Lymphoedema

Suspect drug(s):
Actiq
    Dosage: 200 ug, qid, other
    Indication: Breakthrough Pain
    Start date: 2000-12-01

Methadose
    Dosage: 40 mg, tid (q 8 hrs), oral
    Administration route: Oral
    Indication: Pain
    Start date: 2000-10-19
    End date: 2001-02-01

Methadose
    Dosage: 10 mg, bid (q 12 hrs), oral
    Administration route: Oral
    Indication: Pain
    Start date: 2001-02-01
    End date: 2002-05-01

Other drugs received by patient: Promethazine; Reglan / 00041901 / (Metoclopramide); Ranitidine; Depo-Provera; Lidocaine



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 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 19 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-14

Patient: 19 year old male

Adverse reactions / side effects: Coma, Respiratory Depression, Intentional Drug Misuse

Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)



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 48 year old female receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-14

Patient: 48 year old female, weighing 66.9 kg (147.2 pounds)

Adverse reactions / side effects: Agitation, Confusional State, Anion GAP Increased, Alanine Aminotransferase Increased, Acidosis, Intentional Drug Misuse, Respiratory Depression, Delusion, Irritability, Aspartate Aminotransferase Increased, Suicide Attempt, Electrolyte Imbalance, Hallucination

Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)



Adverse event in 45 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a pharmacist from United States on 2007-05-02

Patient: 45 year old male, weighing 226.8 kg (499.0 pounds)

Adverse reactions / side effects: Weight Decreased, Tooth Loss, Tooth Fracture, Glossitis, Dental Caries, Condition Aggravated, Oral Pain, Ageusia

Suspect drug(s):
Actiq
    Dosage: 800 ug qd buccal
    Indication: Arthralgia
    Start date: 2006-10-01

Actiq
    Dosage: 800 ug qd buccal
    Indication: Back Pain
    Start date: 2006-10-01

Actiq
    Dosage: 800 ug qd buccal
    Indication: Nerve Injury
    Start date: 2006-10-01

Other drugs received by patient: Percocet; Oxycontin



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



Adverse event in male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-04-05

Patient: male, weighing 106.6 kg (234.5 pounds)

Adverse reactions / side effects: Nausea, Alanine Aminotransferase Increased

Suspect drug(s):
Actiq
    Indication: Breakthrough Pain

Tylox
    Indication: Bone Pain

Other drugs received by patient: Micardis Hctz



Adverse event in 39 year old female receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-03-27

Patient: 39 year old female, weighing 56.8 kg (125.0 pounds)

Adverse reactions / side effects: Drug Abuser, Drug Withdrawal Syndrome

Suspect drug(s):
Actiq (Fentanyl Oral Transmucosal)

Other drugs received by patient: Botox



Adverse event in male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a pharmacist from France on 2007-02-13

Patient: male, weighing 55.0 kg (121.0 pounds)

Adverse reactions / side effects: Death, Hallucination, Visual, Delirium

Adverse event resulted in: death

Suspect drug(s):
Actiq
    Indication: Cancer Pain

Duragesic-100

Duragesic-100
    Indication: Cancer Pain

Other drugs received by patient: Amitriptyline HCL; Augmentin '125'



Adverse event in 59 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a pharmacist from France on 2007-01-05

Patient: 59 year old male, weighing 57.0 kg (125.4 pounds)

Adverse reactions / side effects: Hallucination, Visual, Delirium

Suspect drug(s):
Actiq
    Indication: Cancer Pain

Duragesic-100

Duragesic-100
    Indication: Cancer Pain

Other drugs received by patient: Amitriptyline HCL

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