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Actiq (Fentanyl Oral Transmucosal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Actiq (Fentanyl Oral Transmucosal) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (228)
Death (11)
Life Threatening Events (8)
Disability (1)

Reports by Reaction Type

Off Label Use (78)Drug Prescribing Error (43)Pain (40)Dental Caries (24)Malaise (17)Vomiting (16)Drug Dependence (16)Nausea (15)Withdrawal Syndrome (14)Tooth Disorder (14)Drug Ineffective (12)Overdose (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Actiq (Fentanyl Oral Transmucosal). For a complete list or a specific selection of reports, please use the links above.

Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Off Label Use, Pneumonia, Drug Ineffective, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fentanyl
    Indication: Pain

Actiq
    Dosage: 800 ug
    Administration route: Oral
    Indication: Breakthrough Pain



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female, weighing 37.2 kg (81.9 pounds)

Reactions: Tooth Loss, Respiratory Rate Increased, Pain, Off Label Use, Thinking Abnormal, Malaise, Euphoric Mood, Palpitations, Heart Rate Increased, Pancreatitis, Dizziness

Drug(s) suspected as cause:
Actiq
    Indication: Pain

Actiq
    Indication: Crohn's Disease

Mercaptopurine

Other drugs received by patient: Ciprofloxacin HCL; Morphine; Flagyl; Pentasa



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female, weighing 37.2 kg (81.9 pounds)

Reactions: Respiratory Rate Increased, Tooth Loss, Pain, Off Label Use, Thinking Abnormal, Malaise, Euphoric Mood, Palpitations, Heart Rate Increased, Dizziness, Pancreatitis

Drug(s) suspected as cause:
Mercaptopurine

Actiq
    Indication: Pain

Actiq
    Indication: Crohn's Disease

Other drugs received by patient: Pentasa; Ciprofloxacin HCL; Flagyl



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Off Label Use, Hepatic Pain, Hepatic Enzyme Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: Reyetaz; Truvada; Norvir; Oxycontin



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Rectocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: female

Reactions: Diffuse Large B-Cell Lymphoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: Oxycodone HCL; Acyclovir; Dexilant; Klor-CON; Zofran; Lomotil; Reglan; Ativan



Possible Actiq side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Off Label Use, Weight Decreased, Diarrhoea

Drug(s) suspected as cause:
Voltaren
    Dosage: 200 mg, unk
    Administration route: Oral

Calcium Carbonate
    Dosage: 500 mg, unk
    Administration route: Oral

Zocor
    Dosage: 20 mg, unk
    Administration route: Oral

Actiq
    Dosage: 600 microgram, unk
    Administration route: Oral

Methotrexate Sodium
    Dosage: 2.857 mg, unk



Possible Actiq side effects in male

Reported by a physician from Italy on 2012-08-01

Patient: male

Reactions: Sopor, Loss of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: Albumina Umana; MS Contin; Cyclophosphamide; Rocephin; Dexamethasone Sodium Phosphate



Possible Actiq side effects in female

Reported by a pharmacist from France on 2012-07-26

Patient: female

Reactions: Off Label Use, Overdose, Drug Dependence

Drug(s) suspected as cause:
Actiq
    Dosage: 4800 microgram;
    Administration route: Oral
    Indication: Pain
    End date: 2012-01-01

Actiq
    Dosage: 7200 microgram;
    Administration route: Oral
    Start date: 2012-01-01

Other drugs received by patient: Durogesic (Non Teva Drug)



Possible Actiq side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-25

Patient: female

Reactions: Off Label Use, Intentional Overdose, Choking, Somnolence, Altered State of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actiq
    Administration route: Oral
    Start date: 2011-05-15
    End date: 2011-05-15

Alprazolam
    Administration route: Oral
    Start date: 2011-05-15
    End date: 2011-05-15

Other drugs received by patient: Paroxetine; Atarax; Foradil; Lyrica; Beclomethasone Dipropionate; Irbesartan and Hydrochlorothiazide; Amlodipine Besylate; Spasfon



Possible Actiq side effects in 45 year old male

Reported by a physician from United States on 2012-07-20

Patient: 45 year old male, weighing 170.2 kg (374.6 pounds)

Reactions: Tooth Loss, Weight Decreased, Gastrointestinal Haemorrhage, Diabetes Mellitus, Glossitis, Cardiac Disorder, Gynaecomastia, Off Label Use, Weight Increased, Hepatic Enzyme Abnormal, Tooth Fracture, Dental Caries, Androgen Deficiency, Drug Prescribing Error, Mental Impairment, Oral Pain, Ageusia, Hypertension, Sleep Apnoea Syndrome, Drug Dependence, Infection

Drug(s) suspected as cause:
Actiq
    Dosage: 4000 microgram;
    Indication: Back Pain
    Start date: 2006-10-01

Actiq
    Indication: Nerve Injury
    Start date: 2004-09-16
    End date: 2008-11-01

Actiq
    Indication: Arthralgia

Other drugs received by patient: Vistaril; Lidocaine; Oxycontin; Valium; Percocet; Oxycontin; Percocet; Oxycontin



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: female

Reactions: Systemic Lupus Erythematosus, Back Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in 58 year old female

Reported by a physician from Switzerland on 2012-07-15

Patient: 58 year old female

Reactions: Off Label Use, Weight Decreased, Diarrhoea

Drug(s) suspected as cause:
Actiq
    Dosage: 600 microgram;
    Indication: Pain
    Start date: 2012-04-10

Methotrexate Sodium
    Dosage: 2.8571 milligram;
    Indication: Polyarthritis
    Start date: 2010-07-26

Simvastatin
    Dosage: 20 milligram;
    Administration route: Oral
    Start date: 2010-10-28

Voltaren
    Dosage: 100 milligram;
    Administration route: Oral
    Indication: Pain
    Start date: 1978-01-01

Calcimagon
    Dosage: 500 milligram;
    Administration route: Oral
    Start date: 2012-02-25



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: female

Reactions: Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-27

Patient: female

Reactions: Off Label Use, Choking, Altered State of Consciousness, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Administration route: Oral
    Start date: 2012-03-15

Actiq
    Administration route: Oral
    Start date: 2012-05-15

Other drugs received by patient: Atarax; Amlodipine Besylate; Lyrica; Paroxetine Base; Beclomethasone Dipropionate; Irbesartan and Hydrochlorothiazide; Foradil; Spasfon (Phloroglucinol)



Possible Actiq side effects in female

Reported by a pharmacist from Ireland on 2012-06-21

Patient: female

Reactions: Death, Drug Prescribing Error

Adverse event resulted in: death

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: Paralief; Teva Warfarin; Targin (Oxycodone Hydrochloride, Naloxone Hydrochloride Dihydrate); Lyrica; Amitriptyline (Brand Name NOT Specified); Halicon; Teva Diaglyc; Lanoxin; Lipitor; Targin (Oxycodone Hydrochloride, Naloxone Hydrochloride Dihydrate)



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female, weighing 63.6 kg (139.8 pounds)

Reactions: Blood Pressure Increased, Off Label Use, Cataract, Drug Prescribing Error

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: Clonidine; Enalapril Maleate; Furosemide; Vicodin; Morphine; Carbetolol



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Vomiting, Nausea, Drug Prescribing Error

Drug(s) suspected as cause:
Fentora
    Start date: 2010-01-01
    End date: 2010-01-01

Fentora
    Start date: 2008-01-01
    End date: 2008-01-01

Actiq
    Indication: Breast Cancer Metastatic
    Start date: 2005-01-01

Other drugs received by patient: Tamoxifen Citrate



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Dental Caries, Sepsis

Drug(s) suspected as cause:
Actiq
    Start date: 2002-01-01

Actiq
    Start date: 2002-01-01



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Abdominal Discomfort, Vomiting, Nausea, Drug Prescribing Error

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: Dilaudid



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Contusion, Pain, Vasodilatation, Headache, Memory Impairment, Fall, Loss of Consciousness, Convulsion

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: Levsin PB; Topamax; Wellbutrin; Avinza; Lorazepam; Lexapro



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Dental Caries

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in

Reported by a pharmacist from United States on 2012-06-18

Patient:

Reactions: Diarrhoea, Blood Glucose Increased

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: female

Reactions: Withdrawal Syndrome

Drug(s) suspected as cause:
Actiq



Possible Actiq side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: male, weighing 109.0 kg (239.7 pounds)

Reactions: Pain

Drug(s) suspected as cause:
Actiq

Other drugs received by patient: MS Contin; Opana ER; Morphine Sulfate



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: female, weighing 65.8 kg (144.8 pounds)

Reactions: Speech Disorder, Off Label Use, Pyrexia, Withdrawal Syndrome, Drug Prescribing Error

Drug(s) suspected as cause:
Actiq
    Indication: Back Disorder

Methadone HCL
    Indication: Neck Injury

Actiq
    Indication: Neck Injury

Methadone HCL
    Administration route: Oral
    Indication: Back Disorder
    Start date: 1999-01-01

Other drugs received by patient: Pregabalin; Albuterol; Esomeprazole Magnesium; Alprazolam; Zipsor; Levothyroxine Sodium; Budesonide W / Formoterol Fumarate; Montelukast



Possible Actiq side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: male, weighing 122.6 kg (269.7 pounds)

Reactions: Stomatitis, Vomiting, Wrong Technique in Drug Usage Process, Drug Ineffective FOR Unapproved Indication, Administration Site Reaction, Somnolence

Drug(s) suspected as cause:
Actiq
    Indication: Breakthrough Pain
    Start date: 2011-01-01
    End date: 2011-08-01

Actiq
    Indication: Neuralgia
    Start date: 2008-01-01
    End date: 2011-01-01

Actiq
    Start date: 2011-07-01

Other drugs received by patient: MS Contin; Oxycodone HCL; Phenergan



Possible Actiq side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: female

Reactions: Movement Disorder

Drug(s) suspected as cause:
Actiq

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