This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fentora (Fentanyl) 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 (111)
Death (5)
Reports by Reaction Type
Pain (23),
Off Label Use (20),
Drug Prescribing Error (17),
Nausea (9),
Drug Ineffective (8),
Withdrawal Syndrome (7),
Somnolence (6),
Intentional Drug Misuse (4),
Hyperhidrosis (4),
Stomatitis (4),
Vomiting (4),
Rash (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Fentora (Fentanyl). For a complete list or a specific selection of reports, please use the links above.
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Intracranial Aneurysm
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in 80 year old male
Reported by a pharmacist from Japan on 2012-08-22
Patient: 80 year old male, weighing 49.9 kg (109.8 pounds)
Reactions: Dyskinesia, Rash
Drug(s) suspected as cause:
Fentora
Dosage: 1 mg, qd
Administration route: Topical
Indication: Cancer Pain
Start date: 2012-04-30
Famotidine
Dosage: 20 mg, bid
Administration route: Oral
Indication: Prophylaxis
Start date: 2012-05-02
End date: 2012-05-18
Oxycodone Hydrochloride
Dosage: 5 mg, prn
Administration route: Oral
Indication: Cancer Pain
Start date: 2012-04-26
Other drugs received by patient: Sulfamethoxazole and Trimethoprim; Itraconazole; Rituxan; Therarubicin; Cyclophosphamide; Acetaminophen; Oncovin; Predonine
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: male
Reactions: Metastases To Liver, Neuroendocrine Tumour
Adverse event resulted in: death
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: male
Reactions: Road Traffic Accident, Muscular Weakness, Gait Disturbance, Bradyphrenia, Convulsion
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Oxycodone HCL
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: male
Reactions: HIP Fracture, Fall
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-10
Patient: female
Reactions: Off Label Use, Surgery, Drug Prescribing Error
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female
Reactions: Neoplasm Malignant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-28
Patient: 80 year old male, weighing 50.0 kg (110.0 pounds)
Reactions: Dyskinesia, Rash, Muscle Spasms
Drug(s) suspected as cause:
Pepcid RPD
Administration route: Oral
Start date: 2012-05-02
End date: 2012-05-18
Oxycodone Hydrochloride
Administration route: Oral
Indication: Cancer Pain
Start date: 2012-04-26
Fentora
Administration route: Topical
Indication: Cancer Pain
Start date: 2012-04-30
Other drugs received by patient: Baktar; Itraconazole; Acetaminophen; Therarubicin; Oncovin; Prednisolone Sodium Succinate INJ; Cyclophosphamide; Hormones (Unspecified); Analgesic (Unspecified); Corticosteroids (Unspecified); Rituxan
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: male, weighing 82.6 kg (181.8 pounds)
Reactions: Insomnia, Headache
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Oxycodone HCL
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: female
Reactions: Neoplasm Malignant
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-21
Patient: male
Reactions: Off Label Use, Drug Ineffective, Expired Drug Administered, Somnolence
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in male
Reported by a individual with unspecified qualification from United States on 2012-06-21
Patient: male
Reactions: Off Label Use, Drug Ineffective, Expired Drug Administered, Somnolence
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Pregabalin; Baclofen; Lidocaine; Duloxetine Hydrochloride
Possible Fentora side effects in male
Reported by a physician from United States on 2012-06-21
Patient: male, weighing 65.9 kg (145.0 pounds)
Reactions: Osteosarcoma Metastatic
Adverse event resulted in: death
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Hydromorphone Hydrochloride; Percocet
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: female
Reactions: Gingival Recession, Tooth Disorder
Drug(s) suspected as cause:
Fentora
Possible Fentora 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:
Fentora
Other drugs received by patient: Oxycontin; Vicodin
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: female
Reactions: DRY Mouth
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: female, weighing 134.8 kg (296.6 pounds)
Reactions: Vomiting, Nausea
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Lyrica; Singulair; Oxycontin; Humira; Albuterol; Oxycontin; Advair Diskus 100 / 50; Glipizide; Prednisone TAB; Lisinopril; Insulin; Celebrex
Possible Fentora 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 Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: female, weighing 56.8 kg (124.9 pounds)
Reactions: Drug Ineffective FOR Unapproved Indication, Pain
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Dilaudid; Duragesic-100; Exalgo
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in female
Reported by a pharmacist from United States on 2012-06-18
Patient: female
Reactions: Gingival Disorder
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Roxicodone; Klonopin; Soma
Possible Fentora side effects in male
Reported by a physician from United States on 2012-06-18
Patient: male
Reactions: Lung Carcinoma Cell Type Unspecified Stage IV
Adverse event resulted in: death
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Famotidine; Morphine Sulfate
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: female, weighing 84.0 kg (184.8 pounds)
Reactions: Nasopharyngitis, Nausea, Chills, Pain, Rash, Hyperhidrosis, Off Label Use, Diarrhoea, Sneezing, Skin Depigmentation
Drug(s) suspected as cause:
Fentora
Indication: Pain in Extremity
Fentora
Indication: Back Pain
Start date: 2008-01-01
End date: 2012-03-01
Fentora
Indication: Neck Pain
Other drugs received by patient: Alprazolam; Morphine Sulfate; Morphine Sulfate; Oxycodone HCL; Oxycodone HCL; Morphine Sulfate; Oxycodone HCL; Pantoprazole; Famotidine; Carisoprodol; Lansoprazole
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Hydromorphone Hydrochloride
Possible Fentora side effects in
Reported by a physician from United States on 2012-06-18
Patient:
Reactions: Breakthrough Pain, Withdrawal Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 46 year old female
Reactions: Drug Administration Error, Drug Prescribing Error, Somnolence
Drug(s) suspected as cause:
Fentora
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male, weighing 88.5 kg (194.8 pounds)
Reactions: Stomatitis, Drug Prescribing Error
Drug(s) suspected as cause:
Fentora
Other drugs received by patient: Roxicodone; Klonopin; Dilaudid; Zanaflex
Possible Fentora side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male, weighing 63.6 kg (139.8 pounds)
Reactions: Off Label Use, Nausea
Drug(s) suspected as cause:
Fentora
Indication: Back Pain
Start date: 2011-01-01
Fentora
Indication: Neck Pain
Other drugs received by patient: Zolpidem Tartrate; Modafinil; Lisinopril; Oxycodone Hydrochloride; Fingolimod; Baclofen; Ampyra
Possible Fentora side effects in 30 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18
Patient: 30 year old female
Reactions: Intentional Drug Misuse, Somnolence
Drug(s) suspected as cause:
Soma
Fentora
Possible Fentora side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: female
Reactions: Pain
Drug(s) suspected as cause:
Fentora
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