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:
Actiq
Dosage: 800 ug
Administration route: Oral
Indication: Breakthrough Pain
Fentanyl
Indication: 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:
Actiq
Indication: Pain
Actiq
Indication: Crohn's Disease
Mercaptopurine
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:
Actiq
Dosage: 600 microgram, unk
Administration route: Oral
Calcium Carbonate
Dosage: 500 mg, unk
Administration route: Oral
Methotrexate Sodium
Dosage: 2.857 mg, unk
Voltaren
Dosage: 200 mg, unk
Administration route: Oral
Zocor
Dosage: 20 mg, unk
Administration route: Oral
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
Calcimagon
Dosage: 500 milligram;
Administration route: Oral
Start date: 2012-02-25
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
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:
Actiq
Administration route: Oral
Start date: 2012-05-15
Alprazolam
Administration route: Oral
Start date: 2012-03-15
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 64.0 kg (140.8 pounds)
Reactions: Vomiting, Nausea, Drug Prescribing Error
Drug(s) suspected as cause:
Actiq
Indication: Breast Cancer Metastatic
Start date: 2005-01-01
Fentora
Start date: 2010-01-01
End date: 2010-01-01
Fentora
Start date: 2008-01-01
End date: 2008-01-01
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 2012-06-20
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 2012-06-19
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 female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: female, weighing 63.6 kg (139.8 pounds)
Reactions: Off Label Use, Drug Ineffective, Pain, Drug Prescribing Error
Drug(s) suspected as cause:
Actiq
Dosage: qd, bid
Indication: Pain
Start date: 2003-01-01
Actiq
Dosage: qd, bid, tid
Start date: 2005-01-01
End date: 2012-02-07
Other drugs received by patient: Alprazolam; Vicodin; Bupropion HCL
Possible Actiq side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18
Patient: female
Reactions: Stress
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
Reactions: Off Label Use, Pain
Drug(s) suspected as cause:
Actiq
Indication: Intervertebral Disc Protrusion
Actiq
Indication: Benign Neoplasm
Possible Actiq side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18
Patient: male
Reactions: Off Label Use, Vomiting, Nausea, Drug Administration Error
Drug(s) suspected as cause:
Actiq
Possible Actiq side effects in 77 year old male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 77 year old male
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Actiq
Possible Actiq side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18
Patient: female, weighing 85.0 kg (187.0 pounds)
Reactions: Off Label Use, Hypotension, Pain, Drug Prescribing Error
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actiq
Other drugs received by patient: Levetiracetam; Mididrine; Mometasone Furoate; Calcium Carbonate; Levothyroxine Sodium; Nephrocaps / 01041101 /; Nystatin; Pravastatin; Cephalexin; Vitamin D; Gabapentin; Albuterol; Ferrous Sulfate TAB; Lorazepam; Esomeprazole Magnesium
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