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Actiq (Fentanyl Oral Transmucosal) - Adverse Event Reports - Hospitalization

 



Index of reports > Cases resulting in hospitalization (22)

     Drug Withdrawal Syndrome (5)Tooth Fracture (4)Coma (4)Accidental Drug Intake by Child (4)Lethargy (4)Tooth Loss (3)Dental Caries (3)Somnolence (3)Convulsion (3)Overdose (3)

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

Adverse event in male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-10-31

Patient: male, weighing 81.6 kg (179.6 pounds)

Adverse reactions / side effects: Tooth Fracture, Paranoia, Drug Withdrawal Syndrome, Hypoaesthesia, Fall, Mental Disorder, Toothache, Lethargy

Adverse event resulted in: hospitalization

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

Other drugs received by patient: Dilaudid; Clonidine; Atenolol; Pravachol; Flomax; Avodart; Depo-Testosterone; Valium; Zonegran; Cymbalta; Constipation Medication



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

Reported by a consumer/non-health professional from United States on 2007-10-26

Patient: 46 year old male, weighing 68.0 kg (149.7 pounds)

Adverse reactions / side effects: Bedridden, Economic Problem, Dental Caries

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Dosage: 400 ug bid buccal
    Indication: Back Pain
    Start date: 2002-01-01

Actiq
    Dosage: 400 ug bid buccal
    Indication: Pain in Extremity
    Start date: 2002-01-01

Actiq
    Dosage: 1600 ug bid buccal
    Indication: Back Pain
    End date: 2007-07-03

Actiq
    Dosage: 1600 ug bid buccal
    Indication: Pain in Extremity
    End date: 2007-07-03

Other drugs received by patient: Sufentanil Citrate; Paxil; Klonopin; Lortab



Adverse event in 30 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-10-26

Patient: 30 year old male, weighing 74.8 kg (164.7 pounds)

Adverse reactions / side effects: Drug Withdrawal Syndrome, Drug Dependence, Convulsion

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Dosage: 600 ug q3hr buccal
    Indication: Abdominal Pain
    Start date: 2004-01-01

Actiq
    Dosage: 600 ug q3hr buccal
    Indication: Proctalgia
    Start date: 2004-01-01

Adderall 10
    Indication: Drug Withdrawal Syndrome
    Start date: 2007-02-01

Cymbalta
    Dosage: 20 mg qd oral
    Administration route: Oral
    Indication: Depression
    Start date: 2004-01-01

Other drugs received by patient: Fentanyl; Depakote; Geodon; Valium



Adverse event in 70 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-10-08

Patient: 70 year old male

Adverse reactions / side effects: Overdose, Medication Error, Intentional Drug Misuse

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Fentanyl
    Indication: Pain

Actiq
    Indication: Pain



Adverse event in 50 year old male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-07-16

Patient: 50 year old male, weighing 115.7 kg (254.5 pounds)

Adverse reactions / side effects: Thrombosis, Tooth Loss, Pneumonia, Pulmonary Embolism, Amnesia, Gastric Haemorrhage, Weight Increased, Overdose, Gingival Pain, Respiratory Failure, Unevaluable Event, Post Procedural Haemorrhage, Cardiac Arrest, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Dosage: 1200 ug bid buccal
    Indication: Pain
    Start date: 2004-01-01
    End date: 2006-10-01

Actiq
    Dosage: 200 ug bid buccal
    Indication: Pain
    Start date: 2006-10-01

Other drugs received by patient: MS Contin; Skelaxin; Celebrex; Neurontin; Lorazepam; Ambien; Miralax; Msir; Lidoderm; Ativan; Cymbalta



Adverse event in 48 year old male receiving Actiq (Fentanyl Oral Transmucosal)

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

Patient: 48 year old male

Adverse reactions / side effects: Tachycardia, Hallucination, Tremor, Delusion

Adverse event resulted in: hospitalization

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 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 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 19 year old male receiving Actiq (Fentanyl Oral Transmucosal)

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

Patient: 19 year old male

Adverse reactions / side effects: Agitation, Blood Creatine Phosphokinase Increased, Incorrect Dose Administered, Alanine Aminotransferase Increased, Hypotension, Coma, Respiratory Depression, Acidosis, Convulsion, Irritability, Cyanosis, Aspartate Aminotransferase Increased

Adverse event resulted in: life threatening event, hospitalization

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 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 male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a physician from United States on 2007-06-29

Patient: male, weighing 77.1 kg (169.6 pounds)

Adverse reactions / side effects: Grand MAL Convulsion, Drug Effect Decreased, Chills, Pain, Drug Withdrawal Syndrome, Asthenia, Cold Sweat, Tremor

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Dosage: 600ug qid prn buccal
    Indication: Back Pain
    Start date: 2001-01-01
    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 50 year old male receiving Actiq (Fentanyl Oral Transmucosal)

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

Patient: 50 year old male, weighing 115.7 kg (254.5 pounds)

Adverse reactions / side effects: Tooth Loss, Weight Decreased, Overdose, Gingival Pain, Respiratory Failure, Cardiac Arrest, Amnesia, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Dosage: 1200 ug bid buccal
    Indication: Pain
    Start date: 2004-01-01
    End date: 2006-10-01

Actiq
    Dosage: 200 ug bid buccal
    Indication: Pain
    Start date: 2006-10-01

Other drugs received by patient: MS Contin; Skelaxin; Celebrex; Neurontin; Lorazepam; Ambien; Miralax



Adverse event in receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-02

Patient:

Adverse reactions / side effects: Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

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



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

Reported by a consumer/non-health professional from United States on 2007-05-02

Patient: 33 year old female, weighing 72.6 kg (159.7 pounds)

Adverse reactions / side effects: Tooth Fracture, Paranoia, Tooth Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Dosage: 1600 ug qid buccal
    Indication: Breakthrough Pain
    Start date: 1999-01-01
    End date: 2005-10-01

Actiq
    Dosage: 1600 ug qid buccal
    Indication: Cancer Pain
    Start date: 1999-01-01
    End date: 2005-10-01

Other drugs received by patient: Oxycontin



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

Reported by a consumer/non-health professional from United States on 2007-04-24

Patient: 45 year old female, weighing 63.6 kg (139.9 pounds)

Adverse reactions / side effects: Tooth Fracture, Dental Caries, Osteomyelitis, Sensitivity of Teeth, Sinusitis, Tooth Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Dosage: various strengths
    Indication: Bone Pain
    Start date: 2004-01-01
    End date: 2005-01-01

Actiq
    Dosage: various strengths
    Indication: Neuralgia
    Start date: 2004-01-01
    End date: 2005-01-01

Other drugs received by patient: Oxycontin; Topamax; Wellbutrin XL; Activella; Methotrexate; Prednisone TAB; Neurontin; Lidoderm; Immune Globulin Intravenous (Human)



Adverse event in female receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a physician from United States on 2007-04-23

Patient: female

Adverse reactions / side effects: Weight Decreased, Speech Disorder, Tooth Loss, Tooth Fracture, Impaired Work Ability, Mastication Disorder

Adverse event resulted in: hospitalization, disablity

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



Adverse event in female receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a physician from United States on 2007-03-27

Patient: female

Adverse reactions / side effects: Inappropriate Schedule of Drug Administration, Rhabdomyolysis, Dental Caries, Drug Abuser, Inadequate Analgesia, Drug Withdrawal Syndrome, Incorrect Drug Administration Rate, Nephrolithiasis, Pericarditis, Depression, Drug Dependence

Adverse event resulted in: hospitalization

Suspect drug(s):
Actiq
    Indication: Back Pain
    Start date: 2005-01-01

Actiq
    Dosage: 1200 ug q4hr buccal
    Indication: Back Pain
    Start date: 2006-02-28



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

Reported by a consumer/non-health professional from United States on 2007-03-12

Patient: 43 year old female, weighing 54.4 kg (119.7 pounds)

Adverse reactions / side effects: Gastrointestinal Motility Disorder, Intra-Uterine Death, Drug Exposure Before Pregnancy, Constipation, Twin Pregnancy, Abdominal Discomfort, Drug Exposure During Pregnancy, Swelling, Hypertension, Cardiac Failure Congestive, Infarction

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Suspect drug(s):
Duragesic-50
    Dosage: patch see instructions transdermal
    Indication: Abdominal Pain Upper

Duragesic-50
    Dosage: patch see instructions transdermal
    Indication: Gastrointestinal Disorder

Actiq
    Dosage: 600 - 800mcg all day
    Indication: Abdominal Pain Upper

Actiq
    Dosage: 600 - 800mcg all day
    Indication: Gastrointestinal Disorder

Actiq
    Dosage: 600 - 800mcg all day
    Indication: OFF Label USE



Adverse event in male receiving Actiq (Fentanyl Oral Transmucosal)

Reported by a consumer/non-health professional from United States on 2007-01-25

Patient: male

Adverse reactions / side effects: Underweight, Drug Exposure During Pregnancy, Pulmonary Malformation, Drug Withdrawal Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Acetaminophen and Hydrocodone Bitartrate
    Dosage: unknown dose up to 8 times daily, transplacental
    Indication: Drug USE FOR Unknown Indication
    Start date: 2002-01-01

Actiq
    Dosage: 1200 ug, up to 8 times daily, transplacental
    Indication: Migraine
    Start date: 2002-07-01

Heroin (Diamorphine)
    Dosage: transplacental
    End date: 2002-10-11

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